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Over half a century after antibiotics revolutionised medicine, overuse threatens existing treatments while the pipeline of replacements is thin

Over half a century after antibiotics revolutionised medicine, overuse threatens existing treatments while the pipeline of replacements is thin

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When drugmaker AstraZeneca closed down its research and development centre in Bangalore six years ago, some of the local scientists managed to find new jobs at a nearby biotech start-up. Since then, they have been working to tackle a problem which is causing concern among doctors in India and around the world: increasing resistance to antibiotics undermining treatments. For Anand Anandkumar, the chief executive of Bugworks, the burden is personal. His father, a leading infectious disease doctor, died after a cardiac intervention led to a Klebsiella pneumoniae bacterial infection that drugs could not treat. His co-founder lost a baby in hospital to a fatal form of E. coli. “This is a silent tsunami,” he says. “We have the biggest superbug problem. In three to five years, many Indian hospitals will delay surgery unless it’s absolutely life threatening. If this isn’t a pandemic, what is it?” The task is substantial for the limited number of researchers like him. Larger companies like AstraZeneca favour prioritising more lucrative lines of drug development and have sold off rights to their existing antibiotics, leaving smaller companies like Bugworks trying to fill the gap of producing new antibiotics which humans are less resistant to. Over 2.8m Number of antibiotic-resistant infections occurring in the US each year For them, finding a sustainable financial model has proved difficult. Last year, for example, the biotech company Achaogen — which had previously received US regulatory approval for its novel antibiotic plazomicin — folded after failing to generate sufficient revenues to win continued backing from its investors. Anand Anandkumar: “In three to five years, many Indian hospitals will delay surgery unless it’s absolutely life threatening. If this isn’t a pandemic, what is it?” © Samyukta Lakshmi/Bloomberg Little more than half a century after the first antibiotics revolutionised medicine, overuse threatens existing treatments while the pipeline of replacements is thin. There are signs of progress, but they have proved sluggish — further slowed after the coronavirus pandemic monopolised the world’s attention. While comprehensive data is lacking, the World Health Organisation calls antibiotic resistance one of the top 10 public health threats facing humanity. According to the Centers for Disease Control and Prevention, the US alone has more than 2.8m cases and over 35,000 deaths a year. The UN fears 10m deaths a year from drug-resistant infections worldwide by 2050. One fundamental driver is misuse. In many countries, drugs are far too easily and cheaply available without a prescription. Counterfeit and poor quality medicines provide insufficient active ingredient to kill an infection, fuelling the development of resistant bacterial strains. Many patients take incomplete courses of treatment because they cannot afford to buy the full dosage or stop early once they feel better, particularly if the drug has side effects. But even if they seek and adhere to professional medical advice, doctors frequently prescribe inappropriately — for example to treat viral rather than bacterial infections. People must be willing to pay for something that is terribly boring — preparedness John Rex Much transmission takes place in hospitals, with strains brought in by some patients and transferred to others, reflecting inadequate detection, isolation, hygiene and control measures. Marc Mendelson, head of infectious diseases and HIV medicine at the University of Cape Town’s Groote Schuur Hospital, says: “In South Africa, we have 42 infectious disease specialist consultants for a population of 60m. I’ve visited hospitals in Italy with more than that. You need microbiologists, laboratory access, an ability to diagnose. And we have a massive cadre of private doctors in the communities who will treat everything with an antibiotic.” Aside from inadequate tools and medical resources, he points to underlying problems of sanitation, clean water and wider social factors that spread disease in poor regions of the world. “The real driver that feeds everything is the massive burden of infection in lower and middle income countries,” he says. The rise in drug-resistant bacteria found in water is affecting the entire food chain © Mohammad Ponir Hossain/Reuters But in parallel, the food chain also fosters antibiotic resistance. Life-saving drugs such as colistin — a so-called last resort antibiotic — reduce infection and promote growth in animals. Human and cattle effluent puts medicines into the water system. Antibiotics are even used in crop cultivation, notably arable and rice production in south-east Asia and China. Despite such pressures, John Rex, a pharmaceutical industry veteran who is chief medical officer at biotech company F2G, professes cautious optimism. “We are in an amazingly strong position relative to 10 years ago,” he says. He points to several scientific and inter-governmental initiatives that have raised awareness and developed a series of reforms. New “push” funding and co-ordination for early scientific research on antibiotics has come through the Global Antibiotic Research and Development Partnership and the Combating Antibiotic-Resistant Bacteria Biopharmaceutical Accelerator, which funds Bugworks in Bangalore. The pharmaceutical industry recently launched a $1bn AMR Action Fund to support companies conducting later-stage trials of experimental drugs. That still leaves a gap for significant “pull” rewards for newly-approved antibiotics. The idea is to “decouple” the payment to companies that develop a new drug, from the normal link to its usage. Instead, they would receive substantial money upfront for simply launching an effective innovative medicine, to slow the speed of resistance by discouraging its widespread prescription. Mr Rex likens the system to fire extinguishers or life insurance — something society funds while hoping it will not need to be used. “People must be willing to pay for something that is terribly boring — preparedness,” he says. The UK’s NHS is running a pilot which would pay rewards of up to £10m a year for new antibiotics regardless of the volumes prescribed. A similar project is under way in Sweden, and in the US, the proposed Pasteur Act would offer upfront incentives totalling $10bn for innovative drugs. But money to stimulate new antibiotics will not be sufficient. Yusuf Hamied, the head of Cipla, the Indian company that bought the rights to plazomicin from Achaogen after the drug was approved in the US, says regulatory barriers remain too high. He also suggests developing “boosters” and inhaled formulations of existing antibiotics to reduce the volumes of medicine required. Financial incentives will also be needed to develop new diagnostics that can more rapidly, reliably and cheaply distinguish whether and which drugs are required; and new practices to promote better “stewardship” by health systems to ensure existing treatments are used more appropriately. To bring pressure on the food chain, fund manager Jeremy Coller, founded the Farm Animal Investment Risk and Return initiative for investors demanding that producers and restaurants switch to more sustainable production methods, including eliminating antibiotics. Coupled with legislation and consumer pressure, companies including McDonald’s are responding. © Bloomberg Separately, Timothy Walsh at Oxford university is researching animal-specific antibiotics, to shift farmers away from using drugs needed for patients. “Instead of spending $1bn to develop a new magic bullet for humans, we’re looking for novel compounds to use in aquaculture and agriculture, particularly for poultry,” he says. Just as regulators have started to scrutinise the financial risks of climate change to banks, the IMF should turn its attention to the dangers to countries from drug resistance Jim O’Neill New regulations limiting the use of antibiotics in farming have been introduced in the US, the EU and China, although Prof Walsh argues they leave loopholes, such as allowing the re-export of drug-infused animal feed from manufacturers in these countries to others with less stringent controls. Others suggest that resistance to antibiotics is inevitable, and that more emphasis should be placed instead on developing and increasing the use of existing as well as new vaccines to prevent the spread of bacterial infections such as meningitis in the first place. Jim O’Neill, who led an influential review of antimicrobial resistance, argues that just as regulators have started to scrutinise the financial risks of climate change to banks, the IMF should turn its attention to the dangers to countries from drug resistance. “It needs to start developing expertise to offer its independent voice on the strength and quality of health systems,” he says. As the UK prepares to host the G7 as well as the UN’s COP26 climate change conference in 2021, and Italy to take on the presidency of the G20, Mr O’Neill says they should focus on antibiotic resistance. “Even if you have the G7, what can you do without India and China in the G20?” he says.

Avrobio tracks improvements in first patient treated with Gaucher gene therapy

DNA helix forming inside a test tube

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Avrobio has shared data on the first Gaucher disease patient to receive its gene therapy AVR-RD-02. The patient, who was stable on enzyme replacement therapy at baseline, experienced a 22% drop in a toxic metabolite after receiving AVR-RD-02 and stopping taking the standard of care.

Gaucher, like the Fabry disease targeted by Avrobio’s lead prospect, is currently treated using enzyme replacement therapies sold by Sanofi and Takeda, which entered the market through its takeover of Shire. However, a significant minority of patients experience physical limitations despite treatment. Negative outcomes include bone pain and spleen enlargement. Johnson & Johnson’s Zavesca offers an oral alternative, but there remain unmet medical needs.

Avrobio is developing AVR-RD-02 to address those needs. The data shared as part of Avrobio’s R&D day mark the start of the effort to show AVR-RD-02 performs as hoped in the clinic.

The first patient to receive AVR-RD-02 discontinued enzyme replacement therapy one month before taking the gene therapy. Three months after receiving the gene therapy, levels of Gaucher biomarker lyso-Gb1 had fallen 22%. The patient’s level of plasma chitotriosidase, a biomarker of cells associated with severe organ damage, was down 17%. Hemoglobin and platelets were in the normal range.

AVR-RD-02 triggered those changes without causing serious adverse events. The data drop offers an early indication that Avrobio may be able to improve outcomes by harvesting hematopoietic stem cells, adding a gene that encodes for glucocerebrosidase and reinfusing the cells back into the same patient. With enzyme replacement therapies costing healthcare systems up to $400,000 a year per patient, there is scope for AVR-RD-02 to cut the cost of treating Gaucher disease.

Avrobio shared the early look at clinical data on AVR-RD-02 alongside updates about other assets. There is now more than three years of data on some Fabry patients treated with Avrobio’s lead asset, putting the company in a position to plot a path to accelerated approval. Avrobio plans to submit its briefing book to the FDA by the end of the year to align on an accelerated approval strategy. 

The update also covered cystinosis candidate AVR-RD-04. The first patient to receive the candidate is off oral and eye drop cysteamine 12 months after receiving the gene therapy. The number of crystals in the patient’s skin are down 56%, leading Avrobio to posit they may have gained the ability to make their own functional cystinosin protein.  

Source: Fierce Biotech

 

Biotechnology timeline: Humans have manipulated genes since the ‘dawn of civilization’

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Historically, biotech has been primarily associated with food, addressing such issues as malnutrition and famine.

Today, biotechnology is most often associated with the development of drugs. But drugs are hardly the future of biotech. We’ve entered the Fourth Industrial Revolution, and genetics are on a new level. Biotech is paving a way for a future open to imagination, and that’s kind of scary.

The next ten years will surely prove exciting as artificial intelligence and biotechnology merge man and machine…

The history of biotechnology can be divided into three distinct phases:

  1. Ancient Biotechnology

  2. Classical Biotechnology

  3. Modern Biotechnology

1. Ancient Biotechnology (Pre-1800)

Most of the biotech developments before the year 1800 can be termed as ‘discoveries’ or ‘developments’. If we study all these developments, we can conclude that these inventions were based on common observations about nature.

 
  • Humans have used biotechnology since the dawn of civilization.
  • After domestication of food crops (corn, wheat) and wild animals, man moved on to other new observations like cheese and curd.  Cheese can be considered as one of the first direct products (or by-product) of biotechnology because it was prepared by adding rennet (an enzyme found in the stomach of calves) to sour milk.
  • Yeast is one of the oldest microbes that have been exploited by humans for their benefit. The oldest fermentation was used to make beer in Sumeria and Babylonia as early as 7,000BCE.
  • By 4,000BCE, Egyptians used yeasts to bake leavened bread.

 

  • Another ancient product of fermentation was wine, made in Assyria as early as 3,500BCE.
  • The Chinese developed fermentation techniques for brewing and cheese making.
  • 500 BCE: In China, the first antibiotic, moldy soybean curds, is put to use to treat boils.
  • Hippocrates treated patients with vinegar in 400 BCE.
  • In 100BCE, Rome had over 250 bakeries which were making leavened bread.

 

  • A.D. 100: The first insecticide is produced in China from powdered chrysanthemums.
  • The use of molds to saccharify rice in the koji process dates back to at least A.D. 700.
  • 13th century: The Aztecs used Spirulina algae to make cakes.
  • One of the oldest examples of crossbreeding for the benefit of humans is mule. Mule is an offspring of a male donkey and a female horse. People started using mules for transportation, carrying loads, and farming, when there were no tractors or trucks.
  • By the 14th century AD, the distillation of alcoholic spirits was common in many parts of the world.

 

  • Vinegar manufacture began in France at the end of the 14th century.
  • 1663: Cells are first described by Hooke.
  • 1673-1723: In the seventeenth century, Antonie van Leeuwenhoek discovered microorganisms by examining scrapings from his teeth under a microscope.
  • 1675: Leeuwenhoek discovers protozoa and bacteria.
  • 1761: English surgeon Edward Jenner pioneers vaccination, inoculating a child with a viral smallpox vaccine.

nucleus

 

2. Classical Biotechnology (1800-1945)

  • The Hungarian Károly Ereky coined the word “biotechnology” in Hungary during 1919 to describe a technology based on converting raw materials into a more useful product. In a book entitled Biotechnologie, Ereky further developed a theme that would be reiterated through the 20th century: biotechnology could provide solutions to societal crises, such as food and energy shortages.
  • 1773-1858: Robert Brown discovered the nucleus in cells.
  • 1802: The word “biology” first appears.
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  • 1822-1895: Vaccination against small pox and rabies developed by Edward Jenner and Louis Pasteur.
  • In 1850, Casimir Davaine detected rod-shaped objects in the blood of anthrax-infected sheep and was able to produce the disease in healthy sheep by inoculation of such blood.
  • 1855: The Escherichia coli bacterium is discovered. It later becomes a major research, development, and production tool for biotechnology.
  • In 1868, Fredrich Miescher reported nuclein, a compound that consisted of nucleic acid that he extracted from white blood cells.
  • 1870: Breeders crossbreed cotton, developing hundreds of varieties with superior qualities.cotton
  • 1870: The first experimental corn hybrid is produced in a laboratory.
  • By 1875, Pasteur of France and John Tyndall of Britain finally demolished the concept of spontaneous generation and proved that existing microbial life came from preexisting life.
  • 1876: Koch’s work led to the acceptance of the idea that specific diseases were caused by specific organisms, each of which had a specific form and function.
  • In 1881, Robert Koch, a German physician, described bacterial colonies growing on potato slices (First ever solid medium).

 

  • In 1888, Heinrich Wilhelm Gottfried Von Waldeyer-Hartz, a German scientist, coined the term ‘Chromosome.’
  • In 1909, the term ‘Gene’ had already been coined by Wilhelm Johannsen (1857-1927), who described ‘gene’ as carrier of heredity. Johannsen also coined the terms ‘genotype’ and ‘phenotype.’
  • 1909: Genes are linked with hereditary disorders.
  • 1911: American pathologist Peyton Rous discovers the first cancer-causing virus.
  • 1915: Phages, or bacterial viruses, are discovered.
  • 1919: The word “biotechnology” is first used by a Hungarian agricultural engineer.
  • Pfizer, which had made fortunes using fermenting processes to produce citric acid in the 1920s, turned its attention to penicillin. The massive production of penicillin was a major factor in the Allied victory in WWII.

 

  • 1924: start of Eugenic Movement in the US.
  • The principle of genetics in inheritance was redefined by T.H. Morgan, who showed inheritance and the role of chromosomes in inheritance by using fruit flies. This landmark work was named, ‘The theory of the Gene in 1926.”
  • Alexander Fleming discovered ‘penicillin’ the antibacterial toxin from the mold Penicillium notatum, which could be used against many infectious diseases. Fleming wrote, “When I woke up just after dawn on September 28, 1928, I certainly didn’t plan to revolutionize all medicine by discovering the world’s first antibiotic, or bacteria killer.

 

  • 1933: Hybrid corn is commercialized.
  • In 1940, a team of researchers at Oxford University found a way to purify penicillin and keep it stable.
  • 1941: The term “genetic engineering” is first used by a Danish microbiologist.
  • 1942: The electron microscope is used to identify and characterize a bacteriophage- a virus that infects bacteria.
  • 1942: Penicillin is mass-produced in microbes for the first time.

DNA

 

3. Modern Biotechnology (1945-present)

The Second World War became a major impediment in scientific discoveries. After the end of the second world war some, very crucial discoveries were reported, which paved the path for modern biotechnology.

The origins of biotechnology culminated with the birth of genetic engineering. There were two key events that have come to be seen as scientific breakthroughs beginning the era that would unite genetics with biotechnology: One was the 1953 discovery of the structure of DNA, by Watson and Crick, and the other was the 1973 discovery by Cohen and Boyer of a recombinant DNA technique by which a section of DNA was cut from the plasmid of an E. coli bacterium and transferred into the DNA of another. Popularly referred to as “genetic engineering,” it came to be defined as the basis of new biotechnology.
  • In Britain, Chaim Weizemann (1874–1952) developed bacterial fermentation processes for producing organic chemicals such as acetone and cordite propellants. During WWII, he worked on synthetic rubber and high-octane gas.

 

  • 1950s: The first synthetic antibiotic is created.
  • 1951: Artificial insemination of livestock is accomplished using frozen semen.
  • In 1953, JD Watson and FHC Crick for the first time cleared the mysteries around the DNA as a genetic material, by giving a structural model of DNA, popularly known as, ‘Double Helix Model of DNA.’
  • 1954: Dr. Joseph Murray performs the first kidney transplant between identical twins.
  • 1955: An enzyme, DNA polymerase, involved in the synthesis of a nucleic acid, is isolated for the first time.
  • 1955: Dr. Jonas Salk develops the first polio vaccine. The development marks the first use of mammalian cells (monkey kidney cells) and the first application of cell culture technology to generate a vaccine.
  • 1957: Scientists prove that sickle-cell anemia occurs due to a change in a single amino acid in hemoglobin cells
  • 1958: Dr. Arthur Kornberg of Washington University in St. Louis makes DNA in a test tube for the first time.
  • Edward Tatum (1909–1975) and Joshua Lederberg (1925–2008) shared the 1958 Nobel Prize for showing that genes regulate the metabolism by producing specific enzymes.

 

  • 1960: French scientists discover messenger RNA (mRNA).
  • 1961: Scientists understand genetic code for the first time.
  • 1962: Dr. Osamu Shimomura discovers the green fluorescent protein in the jellyfish Aequorea victoria. He later develops it into a tool for observing previously invisible cellular processes.
  • 1963: Dr. Samuel Katz and Dr. John F. Enders develop the first vaccine for measles.
  • 1964: The existence of reverse transcriptase is predicted.
  • At a conference in 1964, Tatum laid out his vision of “new” biotechnology: “Biological engineering seems to fall naturally into three primary categories of means to modify organisms. These are: 1. The recombination of existing genes, or eugenics. 2. The production of new genes by a process of directed mutation, or genetic engineering. 3. Modification or control of gene expression, or to adopt Lederberg’s suggested terminology, euphenic engineering.”
  • 1967: The first automatic protein sequencer is perfected.
  • 1967: Dr. Maurice Hilleman develops the first American vaccine for mumps.
  • 1969: An enzyme is synthesized in vitro for the first time.
  • 1969: The first vaccine for rubella is developed.

 

  • 1970: Restriction enzymes are discovered.
  • 1971: The measles/mumps/rubella combo-vaccine was formed.
  • 1972: DNA ligase, which links DNA fragments together, is used for the first time.
  • 1973: Cohen and Boyer perform the first successful recombinant DNA experiment, using bacterial genes.
  • In 1974, Stanley Cohen and Herbert Boyer developed a technique for splicing together strands of DNA from more than one organism. The product of this transformation is called recombinant DNA (rDNA).
  • Kohler and Milestein in 1975 came up with the concept of cytoplasmic hybridization and produced the first ever monoclonal antibodies, which has revolutionized diagnostics.
  • Techniques for producing monoclonal antibodies were developed in 1975.
  • 1975: Colony hybridization and Southern blotting are developed for detecting specific DNA sequences.
  • 1976: Molecular hybridization is used for the prenatal diagnosis of alpha thalassemia.
  • 1978: Recombinant human insulin is produced for the first time.
  • 1978: with the development of synthetic human insulin the biotechnology industry grew rapidly.
  • 1979: Human growth hormone is synthesized for the first time.

 

  • In the 1970s-80s, the path of biotechnology became intertwined with that of genetics.
  • By the 1980s, biotechnology grew into a promising real industry.
  • 1980: Smallpox is globally eradicated following 20-year mass vaccination effort.
  • In 1980, The U.S. Supreme Court (SCOTUS), in Diamond v. Chakrabarty, approved the principle of patenting genetically engineered life forms.
  • 1981: Scientists at Ohio University produce the first transgenic animals by transferring genes from other animals into mice.
  • 1981: The first gene-synthesizing machines are developed.
  • 1981: The first genetically engineered plant is reported.
  • 1982: The first recombinant DNA vaccine for livestock is developed.
  • 1982: The first biotech drug, human insulin produced in genetically modified bacteria, is approved by FDA. Genentech and Eli Lilly developed the product. This is followed by many new drugs based on biotechnologies.
  • 1983: The discovery of HIV/AIDS as a deadly disease has helped tremendously to improve various tools employed by life-scientist for discoveries and applications in various aspects of day-to-day life.
  • In 1983, Kary Mullis developed polymerase chain reaction (PCR), which allows a piece of DNA to be replicated over and over again. PCR, which uses heat and enzymes to make unlimited copies of genes and gene fragments, later becomes a major tool in biotech research and product development worldwide.
  • 1983: The first artificial chromosome is synthesized.
  • In 1983, the first genetic markers for specific inherited diseases were found.
  • 1983: The first genetic transformation of plant cells by TI plasmids is performed.
  • In 1984, the DNA fingerprinting technique was developed.
  • 1985: Genetic markers are found for kidney disease and cystic fibrosis.
  • 1986: The first recombinant vaccine for humans, a vaccine for hepatitis B, is approved.
  • 1986: Interferon becomes the first anticancer drug produced through biotech.
  • 1986: University of California, Berkeley, chemist Dr. Peter Schultz describes how to combine antibodies and enzymes (abzymes) to create therapeutics.
  • 1988: The first pest-resistant corn, Bt corn, is produced.corn
  • 1988: Congress funds the Human Genome Project, a massive effort to map and sequence the human genetic code as well as the genomes of other species.
  • In 1988, chymosin (known as Rennin) was the first enzyme produced from a genetically modified source-yeast-to be approved for use in food.
  • In 1988, only five proteins from genetically engineered cells had been approved as drugs by the United States Food and Drug Administration (FDA), but this number would skyrocket to over 125 by the end of the 1990s.
  • In 1989, microorganisms were used to clean up the Exxon Valdez oil spill.

 

  • 1990: The first successful gene therapy is performed on a 4-year-old girl suffering from an immune disorder.
  • In 1993, The U.S. Food and Drug Administration (FDA) declared that genetically modified (GM) foods are “not inherently dangerous” and do not require special regulation.
  • 1993: Chiron’s Betaseron is approved as the first treatment for multiple sclerosis in 20 years.
  • 1994: The first breast cancer gene is discovered.
  • 1995: Gene therapy, immune-system modulation and recombinantly produced antibodies enter the clinic in the war against cancer.
  • 1995: The first baboon-to-human bone marrow transplant is performed on an AIDS patient.
  • 1995: The first vaccine for Hepatitis A is developed.
  • 1996: A gene associated with Parkinson’s disease is discovered.
  • 1996: The first genetically engineered crop is commercialized.
  • 1997: Ian Wilmut, an Irish scientist, was successful in cloning an adult animal, using sheep as a model and naming the cloned sheep ‘Dolly.’
  • 1997: The first human artificial chromosome is created.
  • 1998: A rough draft of the human genome map is produced, showing the locations of more than 30,000 genes.
  • 1998: Human skin is produced for the first time in the lab.
  • 1999: A diagnostic test allows quick identification of Bovine Spongiform Encephalopathy (BSE, also known as “mad cow” disease) and Creutzfeldt-Jakob Disease (CJD).
  • 1999: The complete genetic code of the human chromosome is deciphered.

 

  • 2000: Kenya field-tests its first biotech crop, virus-resistant sweet potato.
  • Craig Venter, in 2000, was able to sequence the human genome.
  • 2001: The sequence of the human genome is published in Science and Nature, making it possible for researchers all over the world to begin developing treatments.
  • 2001: FDA approves Gleevec® (imatinib), a gene-targeted drug for patients with chronic myeloid leukaemia. Gleevec is the first gene-targeted drug to receive FDA approval.
  • 2002: EPA approves the first transgenic rootworm-resistant corn.
  • 2002: The banteng, an endangered species, is cloned for the first time.
  • 2003: China grants the world’s first regulatory approval of a gene therapy product, Gendicine (Shenzhen SiBiono GenTech), which delivers the p53 gene as a therapy for squamous cell head and neck cancer.
  • In 2003, TK-1 (GloFish) went on sale in Taiwan, as the first genetically modified pet.
  • 2003: The Human Genome Project completes the sequencing of the human genome.
  • 2004: UN Food and Agriculture Organization endorses biotech crops, stating biotechnology is a complementary tool to traditional farming methods that can help poor farmers and consumers in developing nations.
  • 2004: FDA approves the first antiangiogenic drug for cancer, Avastin®.
  • 2005: The Energy Policy Act is passed and signed into law, authorizing numerous incentives for bioethanol development.
  • 2006: FDA approves the recombinant vaccine Gardasil®, the first vaccine developed against human papillomavirus (HPV), an infection implicated in cervical and throat cancers, and the first preventative cancer vaccine.
  • 2006: USDA grantsDow AgroSciences the first regulatory approval for a plant-made vaccine.
  • 2006: The National Institutes of Health begins a 10-year, 10,000-patient study using a genetic test that predicts breast-cancer recurrence and guides treatment.
  • In 2006, the artist Stelarc had an ear grown in a vat and grafted onto his arm.
  • 2007: FDA approves the H5N1 vaccine, the first vaccine approved for avian flu.
  • 2007: Scientists discover how to use human skin cells to create embryonic stem cells.
  • 2008: Chemists in Japan create the first DNA molecule made almost entirely of artificial parts.
  • 2009: Global biotech crop acreage reaches 330 million acres.
  • In 2009, Sasaki and Okana produced transgenic marmosets that glow green in ultraviolet light (and pass the trait to their offspring).
  • 2009: FDA approves the first genetically engineered animal for production of a recombinant form of human antithrombin.
  • In 2010, Craig Venter was successful in demonstrating that a synthetic genome could replicate autonomously.

 

  • 2010: Dr.  J. Craig Venter announces completion of “synthetic life” by transplanting synthetic genome capable of self-replication into a recipient bacterial cell.
  • 2010: Harvard researchers report building “lung on a chip” – technology.
  • 2011: Trachea derived from stem cells transplanted into human recipient.
  • 2011: Advances in 3-D printing technology lead to “skin-printing.”
  • 2012: For the last three billion years, life on Earth has relied on two information-storing molecules, DNA and RNA. Now there’s a third: XNA, a polymer synthesized by molecular biologists Vitor Pinheiro and Philipp Holliger of the Medical Research Council in the United Kingdom. Just like DNA, XNA is capable of storing genetic information and then evolving through natural selection. Unlike DNA, it can be carefully manipulated.
  • 2012: Researchers at the University of Washington in Seattle announced the successful sequencing of a complete fetal genome using nothing more than snippets of DNA floating in its mother’s blood.
  • 2013: Two research teams announced a fast and precise new method for editing snippets of the genetic code. The so-called CRISPR system takes advantage of a defense strategy used by bacteria.

crispr

  • 2013: Researchers in Japan developed functional human liver tissue from reprogrammed skin cells.
  • 2013:  Researchers published the results of the first successful human-to-human brain interface.
  • 2013: Doctors announced that a baby born with HIV had been cured of the disease.
  • 2014: Researchers showed that blood from a young mouse can rejuvenate an old mouse’s muscles and brain.
  • 2014: Researchers figured out how to turn human stem cells into functional pancreatic β cells—the same cells that are destroyed by the body’s own immune system in type 1 diabetes patients.
  • 2014: All life on Earth as we know it encodes genetic information using four DNA letters: A, T, G, and C. Not anymore! In 2014, researchers created new DNA bases in the lab, expanding life’s genetic code and opening the door to creating new kinds of microbes.
  • 2014: For the first time ever, a woman gave birth to a baby after receiving a womb transplant.
  • In 2014, team of scientists reconstructed a synthetic and fully functional yeast chromosome. A breakthrough seven years in the making, the remarkable advance could eventually lead to custom-built organisms (human organisms included).
  • 2014 & Ebola: Until this year, ebola was merely an interesting footnote for anyone studying tropical diseases. Now it’s a global health disaster. But the epidemic started at a single point with one human-animal interaction — an interaction which has now been pinpointed using genetic research. A total of 50 authors contributed to the paper announcing the discovery, including five who died of the disease before it could be published.
  • 2014: Doctors discovered a vaccine that totally blocks infection altogether in the monkey equivalent of the disease — a breakthrough that is now being studied to see if it works in humans.
  • 2015: Scientists from Singapore’s Institute of Bioengineering and Nanotechnology designed short strings of peptides that self-assemble into a fibrous gel when water is added for use as a healing nanogel.
  • 2015 & CRISPR: scientists hit a number of breakthroughs using the gene-editing technology CRISPR. Researchers in China reported modifying the DNA of a nonviable human embryo, a controversial move. Researchers at Harvard University inserted genes from a long-extinct woolly mammoth into the living cells — in a petri dish — of a modern elephant. Elsewhere, scientists reported using CRISPR to potentially modify pig organs for human transplant and modify mosquitoes to eradicate malaria.
  • 2015: Researchers in Sweden developed a blood test that can detect cancer at an early stage from a single drop of blood.
  • 2015: Scientists discovered a new antibiotic, the first in nearly 30 years, that may pave the way for a new generation of antibiotics and fight growing drug-resistance. The antibiotic, teixobactin, can treat many common bacterial infections, such as tuberculosis, septicaemia, and C. diff.
  • 2015: A team of geneticists finished building the most comprehensive map of the human epigenome, a culmination of almost a decade of research. The team was able to map more than 100 types of human cells, which will help researchers better understand the complex links between DNA and diseases.
  • 2015: Stanford University scientists revealed a method that may be able to force malicious leukemia cells to change into harmless immune cells, called macrophages.
  • 2015: Using cells from human donors, doctors, for the first time, built a set of vocal cords from scratch. The cells were urged to form a tissue that mimics vocal fold mucosa – vibrating flaps in the larynx that create the sounds of the human voice.
  • 2016: A little-known virus first identified in Uganda in 1947—Zika—exploded onto the international stage when the mosquito-borne illness began spreading rapidly throughout Latin America. Researchers successfully isolated a human antibody that “markedly reduces” infection from the Zika virus.
  • 2016: CRISPR, the revolutionary gene-editing tool that promises to cure illnesses and solve environmental calamities, took a major step forward this year when a team of Chinese scientists used it to treat a human patient for the very first time.
  • 2016: Researchers found that an ancient molecule, GK-PID, is the reason single-celled organisms started to evolve into multicellular organisms approximately 800 million years ago.
  • 2016: Stem Cells Injected Into Stroke Patients Re-Enable Patient To Walk.
  • 2016:  Cloning does not cause long-term health issues, study finds
  • 2016: For the first time, bioengineers created a completely 3D-printed ‘heart on a chip.’
  • 2017: Researchers at the National Institute of Health discovered a new molecular mechanism that might be the cause of severe premenstrual syndrome known as PMDD.
  • 2017: Scientists at the Salk Institute in La Jolla, CA, said they’re one step closer to being able to grow human organs inside pigs. In their latest research they were able to grow human cells inside pig embryos, a small but promising step toward organ growth.pig embryo
  • 2017: First step taken toward epigenetically modified cotton.

 

  • 2017: Research reveals different aspects of DNA demethylation involved in tomato ripening process.
  • 2017: Sequencing of green alga genome provides blueprint to advance clean energy, bioproducts.
  • 2017: Fine-tuning ‘dosage’ of mutant genes unleashes long-trapped yield potential in tomato plants.
  • 2017: Scientists engineer disease-resistant rice without sacrificing yield.
  • 2017: Blood stem cells grown in lab for the first time.
  • 2017: Researchers at Sahlgrenska Academy – part of the University of Gothenburg, Sweden – generated cartilage tissue by printing stem cells using a 3D-bioprinter.
  • 2017: Two-way communication in brain-machine interface achieved for the first time.

Today, biotechnology is being used in countless areas including agriculture, bioremediation and forensics, where DNA fingerprinting is a common practice. Industry and medicine alike use the techniques of PCR, immunoassays and recombinant DNA.

Genetic manipulation has been the primary reason that biology is now seen as the science of the future and biotechnology as one of the leading industries.

Source: Biotechnology timeline: Humans have manipulated genes since the ‘dawn of civilization’ –  Brian Colwell

Modernising pharma patents: can AI be an inventor?

Modernising pharma patents: can AI be an inventor?

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AI has revolutionised healthcare by dramatically speeding up drug discovery and development. Despite this, patent offices have made it clear that because AI is it not human, it cannot be classed as an inventor in its own right. Allie Nawrat talks to Potter Clarkson IP attorney Peter Finnie about how patent law needs to be brought up to date to reflect the important contribution AI makes to inventions in pharma.

Patents are used to grant exclusive property rights to an inventor and prevent their discovery from being copied by others. The main requirements for a patent are that the invention must be novel, non-obvious and be useful or have an industrial application.

Patents are a central part of how pharma does business. Pharma products require longer and more complex research and development (R&D) cycles than products in other industries. Consequently, companies invest significant amounts of money into their new products early on in their development. Patent protection enables companies to recoup R&D investment and continue to produce innovative, new drugs in the future.

Throughout history, the entity listed as an inventor on a patent application has been a ‘natural person’, or a human, who then might decide to assign those rights to the invention to their employer. For instance, in the pharma industry, the so-called ‘inventor’ is usually the pharmacologist who works for a specific company.

However, as technology – particularly artificial intelligence (AI) – becomes increasingly useful in speeding up innovation and discoveries, a team led by University of Surrey professor Ryan Abbott decided to test whether AI could be an inventor.

Can AI be an inventor?

As part of the Artificial Inventor Project, in mid-2019, Abbott filed patents on behalf of Imagination Engines’ Stephen Thaler for a warning light and a food container to the European Patent Office (EPO) and United Kingdom Intellectual Property Office (UKIPO).

On the patent application, the inventor was listed as DABUS AI, not Thaler, because these were deemed to be so-called AI-generated inventions: “inventions generated autonomously by AI under circumstances, in which we believe that no natural person, as traditionally defined, qualifies as an inventor,” explained Abbott in an article for the World Intellectual Property Organization (WIPO). The application then argued that Thaler, as the AI’s owner, would be the owner of any issued patents.

Although the EPO and UKIPO accepted that these inventions were patentable, in December 2019, both rejected the application because the inventor was not human.

A related issue is that “only a natural person can convey the rights that they would otherwise own as an inventor, such as to their employer,” explains Potter Clarkson partner and patent attorney Peter Finnie.

The EPO’s decision states: “The designation of an inventor… bears a series of legal consequences, notably to ensure that the designated inventor is the legitimate one and that he or she can benefit from rights linked to this status. To exercise these rights, the inventor must have a legal personality that AI systems or machines do not enjoy.”

The bottom line then, according to the EPO and UKIPO’s decision on DABUS sends is that AI cannot be an inventor.

What implications could this have on AI’s contribution to patentable inventions, particularly in the pharma industry where AI’s use is becoming commonplace and patents are central to financial viability?

Implications for AI-assisted discoveries

Finnie is very clear that AI-generated innovation, such as the DABUS example, is not currently mainstream in any industry, and particularly in pharma.

AI has undoubtedly revolutionised the pharma industry. It has drastically accelerated drug discovery, development and repurposing, and thereby brought drugs to at-need patients much more quickly. Life and medical sciences are one of the top three sectors where AI is most employed, according to the WIPO.

Finnie classes the way AI is used in pharma as AI-assisted, rather than generated, invention. “I don’t see a compelling case yet that the use of AI and machine learning in the pharma industry is anything more than a very sophisticated number crunching,” he explains. “There is still an awful lot of inventive effort required to train it and use the results to work out sensible solutions.”

Where AI only assists in discoveries it would not be designated as an inventor – the human who programmed it or performed the related lab work would be. AI-assisted invention “doesn’t change who the inventors are, it just speeds up the process”, notes Finnie.

However, AI “is likely to have, increasingly in the future, a significant impact on the creation, production and distribution of economic and cultural goods and services”, according to a WIPO Secretariat discussion document.

There is a possibility and “risk that AI-assisted innovation in pharma will be assessed to a different [and perhaps higher] standard”. Also, it is possible that “exclusion of the AI contribution will mean there are no true inventors under the current patent system”, notes Finnie.

The obviousness test

Finnie explains: “If it starts to get into people’s minds that somehow computer-assisted innovation should be treated differently from human-generated innovation, then you start to get a challenge.”

He is particularly concerned about people starting to “buy into the anthropomorphic properties of computers”, which could lead to them turn around and say “well if the computer told you to do it, it must be obvious”.

This would threaten pharma’s ability to get a patent for that invention because, for something to be patentable, legally, it must be deemed to be novel and non-obvious. The test for obviousness is whether it would be obvious or not to a ‘person skilled in the relevant art’.

The WIPO Secretariat is aware of this challenge; in a discussion paper, it asks if when looking at AI-assisted or generated inventions, “is it necessary to retain the traditional requirements of inventive step or non-obviousness, which are fundamentally associated with human acts of invention?” and “should the art be the field of technology of the product or process that emerges as the invention from the AI application?”

Making the patent system fit for purpose

There is a need to ensure that “drugs discovered or re-purposed using AI areas patentable as if they were derived without the use of AI”, Finnie states. “The patent system must not evolve to penalise the use of AI by removing or weakening the available protection.” Patents are sacred to the pharma industry: “In the pharma space, if you can’t get a patent then you won’t do it.”

If there becomes a credibility gap about who invented something – particularly around the obviousness of that invention – this could lead to a situation where pharma is disincentivised from using AI to support its inventions, which could have dramatic consequences for drug discovery and, ultimately at-need patients.

Instead, to encourage people to innovate by rewarding that through patents, Finnie argues “we need to recognise that… AI is a contributor to the invention”; currently, regulators do not recognise them as having a contribution, a viewpoint that is increasingly outdated given AI’s important contribution to discoveries in the pharma industry.

The next step would be to give AI as an entity “legal rights in the same way as we give companies legal rights”. “You have natural persons and legal persons, so maybe you could have a third person, which is an electronic person. This could plug the [credibility] gap” and mean you haven’t got a missing contributor to the invention or inventor, notes Finnie.

Finnie also says there needs to be a modification of the definition of a ‘person skilled in the art’ to include an AI platform, as this would deal with the non-obviousness argument. He states: “One way of dealing with this is to raise the bar slightly and say where machine learning is involved the invention has to have a little extra quality to it because it has used these special powers that we [as humans] don’t have.”

Global patent offices are aware of and open to this need to re-evaluate and modernise patent laws so they are fit for purpose in a world with AI. This discussion was already in the process over the past few years, but the DABUS decision in late 2019 has pushed it further up the agenda.

Indeed, the largest five patent offices in the world – the EPO, Korean Intellectual Property Office, Japan Patent Office, China National Intellectual Property Administration and the United States Patent and Trademark Office – collectively known as IP5, are creating a joint task force to look into new emerging technologies, such as AI, and discuss the challenges and potential solutions.

Source: Pharmaceutical-Technology.com

 

Revolutionary Life Sciences and Healthcare solutions for early investors unveiled at MedTech

Early bird families, private wealth holders, healthcare corporations and venture capitalists will access cutting-edge life science innovations at Campden Wealth’s milestone 30th MedTech Investing Europe Conference, only a month away on 21-22 October, 2020.

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Belgian company AuXin Surgery said it was the first and only company to launch medical devices for chemically assisted dissection to aid such operations as spine surgery, ear surgery, musculoskeletal surgery and hand surgery while preserving such critical organs as nerves, muscles or vessels. Its fully innovative dissection system, named CADISS, was already being used by several surgeons and the company was signing multiple distribution contracts around the world.

Benoît Verjans, chief executive of AuXin SurgeryInvented by surgeons for surgeons, AuXin Surgery said the benefits of CADISS were numerous for the patient with fewer side-effects and relapses. The surgeon benefitted with faster and easier surgery, no equipment investment, no change of practice. The healthcare system benefitted with the reduction of costs linked to side-effects and relapses, better success rate for the surgery and better quality of life for the patient.

Benoit Verjans (right) is chief executive of AuXim Surgery.

Based in Denmark, Biomodics devised a new catheter to prevent and treat urinary tract infections, a relief to 20,000 patients who suffer a urinary tract infection every year while they are admitted to a Danish hospital, mainly because they have a catheter inserted.

The balloon that sits at the tip of the Biomodics catheter is made with a new type of permeable silicone material. This meant that some types of liquid, such as liquid antibiotics, could penetrate it. The new catheter has been tested on pigs, which have the same sensitivity to bacteria in the bladder as humans. During six months of tests, the bladders of the pigs that received the new catheter were completely free of bacteria, whereas all the control pigs that had had a regular catheter had cystitis, Biomodics said. It expected to be able to begin testing the catheter on humans later this year then put the device into production upon approval.

Peter Thomsen (below) is chief executive of Biomedics.

Peter Thomsen, chief executive of Biomodics

ORamaVR said it was working to revolutionise medical and surgical education through intelligent virtual reality training simulations. The Swiss company wanted to bridge the skills gap, modernise standards and foster remote access using MAGES, its hyper-realistic, virtual-reality simulation-based proprietary software platform for accelerated medical training and assessment.

ORamaVR said the cohort of medics which used its technology demonstrated greater improvement in all score categories compared to the standard group in a clinical trial. Proficiency increased 8% after only two 20-minute VR sessions, the company said.

ORamaVR said it is one year ahead of the $680 billion medical and surgical education market. Its target customers included medical universities, hospital systems, surgical training centres and non-governmental organisations.

Paolo Alejandro Catilo (below) is chief commercial officer of ORamaVR.

US industry experts who worked in endoscopy visual optics for years and successfully introduced impactful devices for physicians and their patients founded their own medtech company 270Surgical in 2016. The first 270Surgical product was the SurroundScope System, which consisted of a hardware, software and electro-optic solution that incorporated a myriad of lenses at the distal end of the scope. The result was a specialty laparoscopic system that addressed three long-standing challenges in laparoscopy, including restricted field-of-view, surgical smoke (plume), and lens fogging.

Paolo Alejandro Catilo, chief commercial officer of ORamaVR

The SurroundScope was the first marketable laparoscope that offered up to a 270-degree field-of-view, which was an increase of 200% compared to other laparoscopes in the market. The company said this expanded field-of-view would considerably benefit general surgery, trauma, OBGYN, and thoracic surgery.

The venture was backed by leading surgeons and by investment funds specialised in medical devices.

Visit MedTechInvesting.com for more information, to download the brochure and to register for the Campden Wealth 30th MedTech Investing Europe Conference on 21-22 October, 2020.

Source: campden FB

Researchers Vie To Employ AI For Cancer Immunotherapy

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In the bid to develop tools for the fight against cancer, artificial intelligence (AI) tools being developed at Case Western Reserve University have to be established in strict human clinical trials. The validation of the tool may be a step close following two recent agreements a bioengineering pioneer at New York University and select large pharmaceutical companies.

“The step is an important one for validating the research, and for further advancing efforts to get the right treatment for patients who will benefit most,” stated the research associate. The potential of AI, computational imaging tools to predict an individual response of cancer patient to immunotherapy is shown, added the research associate.

Meanwhile, recent research at the Center for Computational Imaging and personalized Diagnostics demonstrates that AI and ML can be employed in the fight against cancer. These technologies can predict patients who will benefit from immunotherapy.

To use AI and ML, researchers intrinsically teach computers to seek and detect changes in patterns of CT scans. It involves detecting changes in patterns of CT scans taken at the time when lung cancer diagnosed, and the scans taken during immunotherapy treatment.

Besides Immunotherapy, AI Algorithms to find use for Tissue biopsy

Besides this, the researchers have been training AI algorithms for tissue biopsy images of cancer patients. This involves use of the algorithms to study patterns of tissue biopsy images of these patients and to identify the possibility of favorable response to treatment. The algorithms are being trained for use beyond lung cancer. Meanwhile, computational approaches for predicting immunotherapy response of gynecologic cancers showcased at the American Society of Clinical Oncology meeting in May, 2020.

While the benefit of immunotherapy for cancer patients established, the quest of researchers now is beyond this. They are seeking an improved way to identify patients who are most likely to respond to this treatment.

Source: TMR Blog

Hospital robotics: democratising global healthcare

Robotics and digital automation are beginning to sweep through several major industry segments, but perhaps one of the most fascinating is healthcare.

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Whilst advanced machinery capable of performing the most delicate surgeries was once the domain of science-fiction or simply a goal to aspire towards, the reality is that we are now living in an era where health services are on the verge of being transformed in very exciting ways. The COVID-19 pandemic has illustrated the necessity for integrating digital technologies such as robotic process automation (RPA) and artificial intelligence (AI) software into everyday business operations and it is in this regard that hospital robotics forms a timely focus. Far from being a competitor to human workers, robots in healthcare are a unique opportunity to combine the abilities of both humans and people to achieve significantly better outcomes for patients. 

In addition to featuring insights from McKinsey, PwC and Deloitte, we spoke with Christophe Assenmacher, Head of Urology at Clinics of Europe (Cliniques de l’Europe) St Elizabeth’s and Trainer in Robotic Surgery at Intuitive Surgical, to get an informed perspective from the frontline of this topic.

How is robotic automation benefitting hospitals?

Assenmacher states that hospitals are demonstrating the key advantages of robotic automation, namely the enhanced service level which comes from combining the consistent, tireless and fast operational pace of machines with the creativity, empathy and quality controlling abilities of human staff. “Take the surgeon,” he explains. “While they spend years studying, their ability to function under pressure, make precise movements and many other skills can be augmented by a robot to significant impact.” Indeed, whilst some patients might still feel hesitant to undergo surgery that is entirely automated, having a highly-trained and competent surgeon at the helm aided by a robot’s precision could reassure them they are receiving optimal treatment throughout.

Costs for protracted hospital stays, the unavailability of hospital beds and the overall effectiveness of treatment are all aspects which can have a deleterious effect on healthcare generally. Making improvements to patient care is obviously the name of the game, yet the benefits to robotic-optimised surgery go beyond the operating theatre and ultimately impact the entire hospital: “From my own practice, I’ve seen that robot-assisted surgery typically halves the length of hospital stays, reduces bleeding and blood transfusions, shrinks the risk of infection, lessens the requirement for painkillers and ultimately improves the standard of care for our patients,” Assenmacher states. Furthermore, of particular relevance during incidences of highly infectious disease such as COVID-19, robots can be deployed to perform essential tasks that would otherwise place people at risk, such as disinfecting rooms and dispensing medication. Assenmacher intimates that these capabilities could simply be the tip of the automation iceberg: “We certainly expect to see an evolution of nanorobots in the bloodstream, digital pills and social companion robots.”  

Assenmacher states that he personally uses the da Vinci Surgical System when performing specialised urological procedures, although the same equipment can be used for general surgery as well as cardiac, colorectal, gynaecological, head and neck and thoracic procedures too. 

The company’s website points out that a common misunderstanding of current surgical robotics is that machines carry out procedures independently of surgeons. This is incorrect: the da Vinci system functions as a tool or instrument by which the operator carries out the procedure using a control panel.

“The da Vinci system translates your surgeon’s hand movements at the console in real-time, bending and rotating the instruments while performing the procedure. The tiny wristed instruments move like a human hand, but with a greater range of motion. The da Vinci vision system also delivers highly magnified, 3D high-definition views of the surgical area.”

How could robotics change healthcare?

Cost

Although it might seem counter-intuitive to spend significant sums of money on robotics in healthcare with the aim of making healthcare universally cheaper, Assenmacher states that this is exactly what could happen given investment, both in public and private healthcare settings. “There may be short-term dislocations or discrepancies but I think it’s unlikely that these divergences will remain,” he posits. “Robots can improve patient care and reduce costs in the long-term, meaning both public and private healthcare systems will benefit in terms of patient care and finances.” This isn’t to say that efforts won’t need to be made in order to effect such change: the initial capital expenditure on equipment, ongoing maintenance and training will still need to be factored in, as well as upgrading the robots themselves, “I also believe that there will need to be dramatic reductions in size and a shift from cable-driven electromechanical systems to more purely digital systems.”

Further to this point, Deloitte points out in ‘Taking the robot out of the human: Meet the health care workforce of the future’ that “labour is a major part of healthcare costs. Among hospitals, labour is typically the largest line item in any hospital’s budget and accounts for almost 60% of non capital costs.

“Health plans and life sciences companies also employ many people, with a variety of jobs. Some of these are highly focused on complex and innovative work, but many of these have aspects that are routine and repetitive.” It is through automating the latter that Deloitte believes health service professionals will finally be able to focus on the strictly qualitative aspects of business – “robots could make us less robotic”. 

Accelerated performance through improved design

In its article ‘The era of exponential improvement in healthcare?’, McKinsey listed robotics and RPA as among the nine technologies most likely to transform the financial and operation standards of health services by generating “between USD$350bn and $410bn in annual value by 2025 (out of the $5.34trn in healthcare spending projected for that year.” Also, in ‘How a McKinsey co-designed robot is creating a better future for minimally invasive surgery’, the organisation found that development on a surgical robots’ instrumentation to make it less complex and more intuitive when used by surgeons: “Seamlessly integrating robotic and laparoscopic processes also lowers the barriers to mastering robot-assisted surgery. Historically, learning robotic surgery has meant needing to be well-versed in all aspects of robotics. When the switch between robotics and manual laparoscopy is quick and easy, the threshold for feeling comfortable is much lower, making the adoption of the robotic system faster.” Indeed, Assenmacher verifies that the increasing sophistication of surgical robots in conjunction with easier controls makes them a highly practical solution. “The required training time for competency on the use of a robot makes them very attractive because a talented junior surgeon can expect to reach a high degree of proficiency in just a few months,” he says.

PwC’s eight highlights of how robotics and AI are transforming healthcare:

  • Helping people maintain a healthy lifestyle.
  • Early detection capabilities.
  • Enhanced diagnostics.
  • Improved healthcare decision-making.
  • Better therapies and treatments.
  • End of life care and the capacity for vulnerable people to remain independent for longer.
  • Streamlined research.
  • Advanced training.

Sanitation

Perhaps one of the most important aspects of robotics-based healthcare is the reduced incidence of transmitted infection between patients and healthcare professionals. This applies not just to surgery but also to more routine procedures like dispensing pharmaceuticals and disinfecting medical devices and equipment. Assenmacher adds, “Robots have reduced the role of fomites (inanimate objects which can lead to infection) in the spread of disease while maintaining the quality of the healthcare system. These are an indispensable part of a modern healthcare system.”

Improving quality of life

In ‘No longer science fiction, AI and robotics are transforming healthcare’, PwC presents an interesting benefit of robotics within health services that is easy to overlook: enhanced end of life care. Enabling people to remain in their own homes for longer by automating core tasks or even being programmed with AI to ‘converse’ with patients to ease their loneliness, this application of robotics could reduce the need for hospitalisation in many instances, thus opening up availability for beds and lowering operational costs for hospitals and care facilities. 

Assenmacher summarises this by stating that advanced robotics will simply lead to better yet lower-cost health services in hospitals. In fact, he claims, the effect could be of such a magnitude that it dramatically alters how average people receive healthcare. “Lower-cost healthcare enabled by advanced robotics will have a democratising effect for the entire world’s population,” he concludes. By making complex surgical procedures easier and faster, reducing the spread of infection which leads to even further associated costs and by liberating medical staff from repetitive tasks in order to refocus on value-adding services, applying robotics in hospitals could herald the beginning of a dramatically more affordable system of healthcare for everyone. “There should be no question of who deserves a complex or expensive surgery. By virtue of being a human being, we are all deserving and robotics will help us get there.

Source: Healthcare Global

AI capable of detecting prostate cancer with ‘near perfect’ accuracy

Prostate biopsy with cancer probability (blue is low, red is high). This case was originally diagnosed as benign but changed to cancer upon further review. The AI accurately detected cancer in this tricky case. CREDIT Ibex Medical Analytics, via Eureka

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Artificial intelligence (AI) has identified prostate cancer with its highest accuracy to date, demonstrating how the technology could successfully catch cases that may otherwise be missed.

Researchers from the University of Pittsburgh trained an AI system on more than one million images of tissue slides taken from patient biopsies which had been labelled by human experts to distinguish between healthy and unhealthy tissue.

The team tested the algorithm on another set of 1,600 slides collected from 100 patients treated at the university’s medical centre for suspected prostate cancer.

Source: inews

Scientists Use 3D Printers to Make Miniature Organs for Testing Potential COVID-19 Drugs

A few months ago, Science Times featured a 9-year-old boy who used his 3D printer to create face shields. He was able to produce over a thousand face shields and now continues to create more.

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Indeed, 3D printers have become a helpful tool in this fight against the pandemic. Now, scientists are looking into using it to bioprint miniature human organs that they can use to test drugs to treat COVID-19 and other diseases such as cancer.

Bioprinting Miniature Human Organs

Anthony Atala, the director of the Wake Forest Institute for Regenerative Medicine, and his team are using 3D printers to create pinhead-sized replicas of human organs to test drugs for COVID-19.

His institute has been printing tiny clusters of organs in the past few years to test drug efficacy against bacteria and infectious diseases.

They constructed miniature lungs and colons, two of the most affected organs by the coronavirus, and send them to a laboratory at George Mason University. Initially, the team made miniature organs by hand using a pipette, but they recently used 3D printers for research.

3D printing human tissues is a form of bioprinting. Scientists are developing this method to test drugs and eventually create skin and full-size organs for transplanting. They plan on making skin tissues for burn victims, manage diabetes where wound healing proves to be challenging, and for testing of cosmetics without harming animals or humans.

The importance of bioprinting for pharmaceutical analysis is at its peak now not only for COVID-19 treatments but as well as to other diseases. Dr. Atala noted that organoids would help researchers analyze the effects of drugs on an organ “without the noise” of a person’s metabolism.

Moreover, testing on bioprinted miniature organs will tell which drugs that work on animals might not perform well in people. An important guideline that cosmetic companies should remember, especially when the European Union banned them from testing products on animals since 2013.

Parts of the Bioprinted Organ

The parts of the bioprinted organs include the scaffold to act as its foundation, which is made of biodegradable materials. Scientists included 50-micron microscopic channels to the framework to provide nutrition for the organoid.

Once it is completed, a “bioink” or a combination of cells and hydrogel that turns into gelatin is printed onto the scaffold that looks like a layer of a cake.

Of course, the organ is not yet done without the blood vessels in it. Assistant professor of chemical and biological engineering Pankaj Karande from the Rensselaer Polytechnic Institute recently had success in this step.

Karande used a cell known as fibroblast that helps with growth, and collagen as the scaffold. The researchers printed the epidermis and dermis, the two layers of the skin. Together with two other researchers, Dr. Karande begins experimenting on human endothelial cells and human pericyte cells.

After some trial and error, the researchers were able to integrate the blood vessels with the skin and discovered that there were new connections between the new and existing blood vessels.

While their experiment is still on its preliminary stage, Dr. Karande was hopeful that it will succeed and would set the stage for future successful grafting in humans.

Source: The Science Times

How plastics are transforming the implantable medical devices space

Research.jpg

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Why digital healthtech is more important than ever

digital healthtech.jpg

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Manchester life sciences campus reaches practical completion

The next stage of a Manchester-based life sciences campus has reached practical completion, despite the COVID-19 pandemic.

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African women are leading biotechnology’s advance across the continent

How unlocking the secrets of African DNA could change the world ...

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Make a vaccine? I’m trying to teach my kids the alphabet

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A generation of UK researchers could be lost in a funding crisis

Medical worker taking blood from a patient

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‘The wondrous map’: how unlocking human DNA changed the course of science

Thanks to the success of the Human Genome Project, 20 years ago this week, scientists can track biology and disease at a molecular level

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The study demonstrates the feasibility of hologram technology in liver tumour ablation

liver

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7 Advantages of Hosting Virtual Events

As Aventri’s CEO Jim Sharpe says, “we know nothing beats the value of face-to-face meetings,” however, what happens when in-person meetings and events are restricted because of events like the coronavirus? Should meeting and event professionals just cancel their events altogether? The answer for many will be no, thanks to technology, like virtual event platforms.

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The accelerating adoption of emerging technology

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During this time of Covid-19 virus lockdown, many people and industries are in a state of stasis with the hope that coming out of lockdown will recover everything quickly. Many commentators and economic advisors worry about the future, as the impact on jobs and companies could be damaging for many years to come.

The emerging technology industries of Blockchain, AI and some areas of Cleantech are still moving at a fast pace. Although many say these industries have been around for a long time, the investment and application of these technologies are still taking time to move into the mainstream, therefore still emerging. It can’t be said that all companies in these sectors are doing well during this challenging time, but many have solutions that will work well in the future when we try to reduce the risk of further infection. Physical money, ink signatures, physical medical services and many other areas of business and day to day life can be replaced by digital versions that not only make life easier but safer, in this new world we live in.

As we all work from our homes and spend time in lockdown, we are already using less paper money and spending money digitally with contactless payments and online shopping. As business and customers see the benefit of this, there will only be greater adoption of this going forward. The next phase of digital money is CBDC (Central Bank Digital Currency), and in recent news on the 14th of May 2020, the digital euro has been successfully tested for the first time by France’s central bank. Countries around the world are working on projects with Blockchain and CBDC. China has also been vocal and has confirmed that it has begun testing its digital yuan in four cities. Central bank, corporate and public digital currencies will become more mainstream over the next few years, and many companies supporting these initiatives will thrive.

In the Finance sector in Europe, processing of payments and authorisations have moved to digital (e-signatures) with so much of Europe in lockdown. Some banks have made announcements in some jurisdictions that they will want to go back to handwritten signatures when we come out of the lockdown, but there is already a movement from the banks’ customers to insist that solutions are used to streamline these processes going forward. Let’s see who wins this battle. It is likely that some jurisdictions and banks will be progressive, and others will not, but it will only be a matter of time before everything moves to digital.

Another exciting area is medical services that have been forced to use digital services and are likely to keep these processes in place as the customer service is improved and saves money for hospitals/GPs. Projects in this area will succeed off the back of the way the services are now delivered.

Investment professionals are starting to realise that one obvious outcome is that more investment will come into the emerging technology sector to bring these technologies to the mainstream. This investment will generate sales and revenue for these companies, and we will start to see companies rise as they did after the internet boom. This makes it an exciting time for the emerging technology sector. Companies will be born out of this tough economic time that makes the most of these opportunities.

Appold is launched today to realise these business opportunities. We are carefully selecting companies to help those that we think have the best chance of success. Appold is an emerging technology advisory and investment company whose main focus is to assist:

Emerging Technology firms expand their businesses through strategic management and capital solutions

Investment groups seeking returns within the Emerging Technology sector

Corporates and Institutions looking to utilise and implement new technologies

Some of the companies we have selected are well known in the industry and have strong management and market presence already. We predict them to be fast growth and Appold is set up to support this. Here are some of the first of our clients:

CryptoCompare – A Global leader in Digital Market data with major corporate clients and deals with the potential for significant growth.

Cygnetise – Authorised Signatory Management on the Blockchain with major corporate clients and deals with the potential for significant growth.

SupraFin – A smart WealthTech platform for crypto-assets with a focus on financial inclusion, pre-revenue but great potential.

ByteTree – A leading provider of institutional-grade crypto-asset data. Their investor terminal tracks over 80 metrics for bitcoin in real-time.

Please see https://www.appold.com/  for more information on the company

Your legal rights for going back to work safely after lockdown

As the country heads back to work, bosses have a greater duty than ever to keep workers safe.

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Offices and workplaces across England are making adaptations to make sure their staff don’t contract coronavirus.

Despite the changes to daily life, health and safety principles for employers have not changed.

Employers have a duty to do everything that is “reasonably practicable” to safeguard their employees and those affected by their operations under the Health and Safety at Work Act 1974.

 
Staff at a fish and chip shop in Northumberland wearing PPE as they put out social distancing signs (Image: PA)

“Whilst these may be extraordinary times, the guiding principle for employers has not changed,” Leigh Day associate solicitor Ross Whalley says.

“Employers must therefore assess the risks that are present in their workplace and act accordingly.

“This now includes making provision for employees against the risk of coronavirus infection.

“Employers owe a duty to identify and take appropriate measures to lessen this risk, which must also take into account any particular vulnerabilities amongst their staff such as pregnancy or people with underlying health issues.

“The general Government guidance for employers on coronavirus stresses that employers should make sure workplaces are clean and hygienic, promote regular and thorough hand-washing, and promote good respiratory hygiene.

“Whilst this and other steps such as social distancing and self-isolating may prove effective preventive measures, what consideration is given to those workers at greater risk?”

According to Mr Whalley, the Personal Protective Equipment Regulations 2002 and the Personal Protective Equipment at Work Regulations 1922 set out the main requirements in respect of protective equipment at work.

They state that PPE must be supplied where there remain unavoidable occupational risks to health and safety that cannot be adequately controlled in other ways.

 
(Image: Copyright Unknown)

The Personal Protective Equipment at Work Regulations 1992 requires that ‘every employer shall ensure that suitable personal protective equipment is provided to his employees who may be exposed to a risk to their health…’

The PPE must be ‘effective to prevent or adequately control the risk or risks involved’.

This mandatory duty too cannot be evaded by a claim of ineptitude on the part of the employer in failing to order the PPE in time.

Examples of breaching these requirements will vary depending on the job.

“What may be appropriate in one employment context may not be the same in others,” Mr Whalley says.

“An employer should give very careful consideration of the extent and nature of the risk of coronavirus to their employees. What is required in a healthcare setting, where gloves, aprons and screens may be proportionate to the risk, may not be the same as what is required by supermarket workers.”

Employers are also required to review a risk assessment already in place if there is any reason to suspect it is no longer valid or there has been a significant change.

If an employer was being investigated, lawyers would look at workplace documentation and witness testimony or – in more serious cases – the Health and Safety Executive may carry out an investigation.

In cases where an employee has died as a result, the coroner may call an inquest or investigation to consider the facts of how an employee came to their death.

Legal experts believe that causation will be harder to prove than a breach for Covid-19 claims. Potential claimants will need to prove that their Covid-19 transmission occurred in the workplace, rather than anywhere else.

But the test to do so is only on the balance of probabilities – 51 per cent likelihood or more – so each case will turn on its own facts.

Claimants would also be required to provide evidence of the illness suffered or the death and any consequent loss or financial expense and apply a legal valuation.

How does global talent mobility function during a pandemic?

How does global talent mobility function during a pandemic?

The COVID-19 pandemic has grounded even the most mobile talent. Where do we go from here?

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Topia delivers the world’s leading Global Talent Mobility platform which enables organizations to mobilize thousands of employees around the world. The COVID-19 pandemic has grounded even the most mobile talent. Where do we go from here?

COVID-19’s Market Impact Will be Transient for Life Sciences

As the COVID-19 outbreak has halted the world, we are witnessing the life sciences industry come together and aggressively react to one of the gravest threats of our lifetime.

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UK life sciences industry sees ‘unprecedented’ growth

Life sciences

Life science incubator BioCity, has released its biennial publication, the UK Life Science Start-Up Report, documenting an unprecedented period of growth for life sciences across the UK.

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Source: European Pharmaceutical Manufacturer

3D visualisation tech launched for UK cancer patients

The Mixed Reality Viewer allows clinicians and patients to see, interpret and interact with a patient’s medical data in realistic 3D visualisations. Credit: Shutterstock

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genesiscare brainlab vr

Source: Verdict Medical Devices

UK life sciences regulation begins to diverge – the Medicines and Medical Devices Bill

As the UK looks forward to its future outside the EU, we are gradually seeing more structure and shape begin to emerge.

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An important development for life science businesses is the publication of the Medicines and Medical Devices Bill. As expected, this draft legislation will provide for the UK Government to take over the rulebook for human and veterinary medicines, clinical trials and medical devices after the end of the transition period on 31st December 2020. Currently very closely harmonised at EU level, the legislation is not expected to diverge rapidly from EU law. However, there are clear signals in the Bill and Explanatory Notes that a separate approach is likely to evolve.

Legislation in this area has previously been updated at EU level, with the changes flowing through into UK law. The Medicines and Medical Devices Bill will allow the Health Secretary to take over that task.

Human medicines regulation, clinical trials and medical devices

The Bill proposes to give broad powers to the Health Secretary (or Northern Ireland Department of Health) to make regulations amending or supplementing the law relating to human medicines and clinical trials. This allows for a wide range of possible changes. When the Bill was foreshadowed in the new UK Government’s Queen’s Speech, the stated aim was to

“ensure that our NHS and patients can have faster access to innovative medicines, while supporting the growth of our domestic sector.”

References in the Queen’s Speech briefing to policy aims such as:

  • “Removing unnecessary bureaucracy for the lowest risk clinical trials, to encourage rapid introduction of new medicines” and
  • “Enabling our regulators… to develop innovative regulatory approaches to respond quickly to developments such as artificial intelligence in treatments and ensure the UK can break new ground in complex clinical trials”

are not played out in full in the Bill, but actions to implement these would be enabled by the extensive powers it gives to the Health Secretary.

The Bill mentions the possibility of changes to reflect the new EU Clinical Trials Regulation. Although that legislation is already in force, its application is currently suspended pending full rollout of the EU clinical trials portal and database. On current timetable estimates, the new EU clinical trials system will not be introduced before the end of the Brexit transition period and so will be too late for automatic inclusion in UK law. (The latest EMA website update indicates that the audit of the Clinical Trials Information System will begin in December 2020, while the Brexit transition period is due to end that same month.)

The Bill proposes similar powers to amend or supplement the medical devices legislation. Of course, the existing EU directives in this area are due to be replaced by two new Regulations:

 

  • Regulation 2017/745 on medical devices (applicable from 26 May 2020)
  • Regulation 2017/746 on in vitro diagnostic medical devices (applicable from 26 May 2022)

The second of these is expected to apply after the end of the transition period, and so will not be automatically included in UK law. The Bill’s Explanatory Notes state that the UK will need to make its own decisions about the future regulation of IVDs, raising the prospect of a divergent approach.

Note that, any regulations made under this Bill must take account of the following factors:

  • the safety of human medicines/medical devices
  • the availability of human medicines/medical devices
  • the attractiveness of the UK as a place in which to conduct clinical trials, supply human medicines or develop or supply medical devices

The third of these is an interesting addition to the usual policy considerations in this area, and reflects the UK Government’s current approach to the future relationship. A prior consultation process is also required so that those affected will have an opportunity to comment.

Medical devices enforcement

The Bill includes extensive provisions on enforcement of the medical devices regime. The intention here is to bring together in one place enforcement rules affecting medical devices – they are currently scattered across several different pieces of legislation. The Bill proposes a scheme of enforcement notices: compliance notices, suspension notices, safety notices and information notices, with a specific criminal offence for breach of these enforcement notices. A due diligence defence may be available for those accused of an offence.

The Bill also provides for a method for affected individuals to bring civil proceedings if they are affected by a breach of medical devices legislation. This raises the prospect of a clear path to damages claims, without resorting to general product safety legislation.

Watch this space

The Government’s powerful position in Parliament suggests that the Bill will become law with few changes. The next stage will be tracking, and where necessary intervening, as the Health Secretary begins to make of the powers it confers.

Source:Mills & Reeve

By Isabel Teare

 

Drug-device combinations under the new EU medical devices regime

Many healthcare products are sold as a combination of medicine with a medical device. Examples include drug-eluting cardiac stents and pre-filled injector pens.

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Products like these offer safety and convenience benefits for the clinician and the patient, but they often involve additional regulatory hurdles for producers. Because medicines and medical devices are regulated separately under different laws and through separate bodies and procedures, it can be difficult for manufacturers to understand how to navigate the path to market efficiently.

EU law reforms on the regulation of medical devices are due to take effect in May 2020. Among the changes is a new requirement for Notified Body involvement where a combination of products falls within the regulatory system for medicines. Applicants for marketing authorisation will have to include details of the conformity assessment carried out in relation to the device element when preparing a marketing authorisation dossier for the combination product. More information on this can be found in a Q&A document issued jointly by the EMA and CMDh, available here.

In order to help applicants understand the new system, the EMA is currently consulting on detailed guidance for producers of drug-device combinations. These are intended to assist those filing a marketing authorisation application once the new medical devices regime takes effect.

Products classed as “drug-device combinations” include:

  • devices which are integral to the medicinal product (pre-filled syringes, pens and injectors, drug-releasing intrauterine devices and dry powder inhalers, etc).
  • non-integral devices, where a specific device is co-packaged with the medicinal product or referred to in the product information (oral administration devices, injection needles, pumps, nebulisers, etc).

The draft guidelines envisage the inclusion within the marketing authorisation dossier for an integral DDC of evidence that the device element of the combination meets the relevant safety and performance requirements (GSPRs). Depending on the type of device, this may be the manufacturer’s declaration of conformity, or a certificate issued by a notified body. Where these are not available, the applicant will need to provide other evidence that the device element meets the GSPRs.

The guidance explains

“The core precept of this guideline is that the Competent Authority for the regulation of medicines (CA) will evaluate the device specific aspects of safety and performance relevant to the quality, safety and efficacy of the medicinal product, and that, as applicable, the NB will assess the relevant GSPRs.”

Note that Advanced Therapy Medicinal Products involving genes, cells or tissues are not covered. A separate set of rules cover ATMPs and these include situations where a device forms part of the active substance or formulation of an ATMP.

Source: Life Science Law

By Isabel Teare, Senior Legal Adviser

The Global Regulatory And Quality Environment For Biopharma Outsourcing

The topic of rising healthcare costs isn’t just a first-world issue anymore. Global healthcare expenditures are rising, and spending is increasing at an annual rate of 5.4 per cent between 2017-2022, from $7.724 trillion to $10.059 trillion, according to Deloitte’s 2019 Global Healthcare Outlook. 

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The global drug market will continue to grow, driven in part by double-digit economic growth in India and China and by downward pricing pressures in the U.S. The new regulatory frameworks now deployed in China are fueling growth in the Asia Pacific.

While the U.S. and Western Europe still make up more than half of the global market, China has replaced Western Europe as the second-largest marketplace. Harmonization of standards is inevitable as the socioeconomic statuses of these markets converge. Therefore, it is critical that organizations looking to engage an external contract service provider be aware of these newly established regulations to align their programs with the latest expectations for each relevant market. Let’s examine these in detail.

EUROPEAN UNION

The EU is undergoing major changes in the pharma, clinical data, and medical device arenas (Figure 1).

Several new regulations are worth noting:

Identification of Medicinal Products (IDMP): Data Standards

The European Medicines Agency (EMA) is implementing the ISO IDMP standards for the identification of medicinal products in a phased program, based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organization, and referential (SPOR) data. Under the IDMP standards, pharmaceutical companies will be required to electronically submit detailed product data and maintain it on an ongoing basis.

The goals of this new standard are to:

  • help facilitate the creation of global drug dictionaries and product dossiers
  • link product and safety information across global regulatory agencies
  • increase the industry’s signal detection capabilities to quickly identify product risks and issues, including coordinating product, recalls
  • connect critical product information within healthcare systems

The new framework consists of five ISO standards, shown in Figure 2. Becoming IDMP-compliant will drive pharmaceutical companies and full-service contract service providers to make significant changes to current product-related processes and systems, in a new era of cross-functional collaboration that paves the way for transformational benefits that extend beyond compliance.

CMOS NEED TO UNDERSTAND:

  • evolving regulations, implementation guidelines, and iterations
  • the compliance timeline and consequences of not meeting regulations
  • the IDMP data model and where data resides in the organization

Medical Device Regulation (MDR)

In June 2016, the European Parliament and the Council of the European Union adopted the far-reaching EU Medical Device Regulation following calls for greater control and stringent monitoring of medical devices, triggered by the Poly Implant Prothèse (PIP) breast implant scandal, a widespread hip replacement recall, and other incidents that revealed the system’s regulatory weaknesses. This regulation goes into effect in May 2020 and will transform both the medical device classification and the approval process. The MDR regulation will supersede all prior device approvals within the EU, with no grandfather clause for the former regulation. Compliance for reclassified devices must be in place by May 2020, or the product must be withdrawn from the market.

Key changes within this new regulation involve:

  • Scrutiny process: The European Commission (EC) will be able to review recommendations for Conformité Européenne (French) (CE) marking prior to approval.
  • Common technical specifications (CTS): The EC’s ability to create common technical specifications will be expanded to all devices.
  • New rules for notified bodies: Only newly created special notified bodies will be able to issue CE certificates for high-risk devices such as implants.
  • Audits for notified bodies: Notified bodies will be audited for compliance with the new regulations jointly by two competent authorities (i.e., the regulatory body for each member state). Also, manufacturers will be subject to unannounced audits by notified bodies.
  • Reclassification of medical devices: Spinal implants, devices that control and monitor active implants, nanomaterials, apheresis machines, and combination products will be reclassified as Class III devices requiring design dossiers.
  • Identification and traceability of devices: A unique device identification (UDI) system will be required for labelling, and the European Databank on Medical Devices (EUDAMED) will be expanded. Manufacturers will need to provide a summary of safety and clinical performance for Class III devices and also for implants of lower classification.
  • Clinical evaluation and investigations: The new MDR regulation will put in place a regimen for clinical investigations with mandatory post-market and clinical follow-up (PMCF) and periodic safety update reports.
  • Post-market surveillance (PMS), vigilance, and market surveillance: Under the regulation, PMS and vigilance requirements will be revisited, and manufacturers will consequently need to amend their procedures.
  • Change in the format of technical files: Formatting declarations of conformity and technical files is revised under the new regulation. This requires manufacturers to create a summary document for each section instead of providing complete protocols and reports.

CHINA NMPA

China’s regulatory framework is moving into close alignment with global regulatory practice, and few regulatory bodies have encountered as much change in a short period of time as China’s National Medical Products Administration (NMPA).

As ICH guidelines become China’s standard, China is increasingly willing to accept global clinical data in support of local product registrations, with priority for products that serve Chinese patients’ unmet medical needs.

China has implemented several key changes to accelerate a clinical trial and drug approval timelines.

  • Inclusion of data from clinical trials undertaken outside China. Drug sponsors and CROs that are attentive to the NMPA’s requirements will be well-positioned for access to the Chinese market.
  • Streamlined clinical trial approvals (CTAs). Specifically, the NMPA is allowing clinical trial materials to be tested by the sponsor or a trusted third-party testing lab, rather than having to be tested by a government-accredited testing lab.
  • Lifting of restrictions on the involvement of Chinese sites in multicenter Phase 1 studies. This changes the dynamic when selecting a CMO or CRO for multicenter Phase 1 studies.
  • Fast-track approval for drugs and devices. Specifically, new drugs and devices in development that meet urgent clinical needs in China can be approved for marketing conditions if data from early- or mid-stage trials show promising clinical value. Further, new drugs or devices for rare diseases can be approved for marketing in China if they have been approved for marketing overseas.

What’s more, China’s revised Drug Administration Law (DAL) entered into effect in December 2019. Under the new DAL, the market authorization holder (MAH) system applies equally to imported and domestic drugs, with MAH responsibility for the entire life cycle of a drug. Marketing authorizations can be transferred from one company to another without changing contract manufacturers, subject to NMPA approval. The amended regulation will enable Chinese MAHs to work with overseas CMOs. Likewise, foreign MAHs may choose to work with CMOs in China and restructure their supply chains accordingly.

INDIA

The Indian health ministry announced that certain drugs approved for use in major markets (such as the EU and the U.S.) will be automatically approved in India without a further native clinical trial having to take place, to give patients faster access to new medicines. The Ministry of Health & Family Welfare (MHFW) announced the new Drugs and Clinical Trials Rules 2019 in March 2019, to improve the ethical and quality standards of clinical trials in India. New guidance consists of 13 chapters (including 107 rules) and eight schedules that apply to all new drugs, as well as investigational new drugs for human use, clinical trials, bioequivalence and bioavailability studies, and ethics committees.

The new clinical trial rules include:

  • approval for clinical trials in 30 working days for indigenous drugs to speed up the trial process and encourage local drug development
  • provision for accelerated product approval, with some conditions, adding pre- and post-submission meetings with authorities to increase regulatory engagement.

The new framework is designed to stimulate the local clinical research industry, allowing more global clinical studies in India and promoting Indian indigenous drug development. These comprehensive new rules should improve the ethical and quality standards of clinical trials in India, aiding patients and industry.

The one constant we can count on changes. It has taken time, but the regulatory philosophies of the major markets are converging, creating avenues that accelerate access to new drug therapies while providing a solid, structured framework for clinical trial and regulatory oversight. Drug sponsors pursuing an outsourcing strategy will have to make sure the necessary processes and systems are in place — both internally and with their contract service providers — to ensure compliance in a new decade of modernized market regulatory expectations.

BIKASH CHATTERJEE is president and chief science officer for Pharmatech Associates. He has over 30 years’ experience in the design and development of pharmaceutical, biotech, medical device, and IVD products.

Source: Life Science Leader

By Bikash Chatterjee.

Scientists to improve heart attack treatment by blocking heart damaging molecules

Scientists in Cambridge are to investigate how the treatment of heart attacks could be improved. 

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In the UK, most heart attacks are treated with an angioplasty – a procedure to quickly unblocked the coronary artery. 

This has helped to improve the survival of patients who experience a heart attack. However, the sudden restoration of blood flow to the heart – called reperfusion – can damage it. 

When fresh blood re-enters the heart tissue it produces a burst of damaging molecules called free radicals. These can permanently damage the heart, leading to a weakening of the heart muscle and, ultimately, to heart failure. 

Now, Dr Thomas Krieg and his team at the University of Cambridge have been awarded £349,477 by the BHF to see if the release of these damaging molecules can be blocked using a drug they have developed. 

Previous research by Dr Krieg discovered how the free radicals are produced, enabling them to design new and simple drugs to stop their production and release. If this was to prove successful, it could reduce the risk of heart attack survivors developing heart failure. 

Improving treatment

Dr Thomas Krieg said: “Angioplasty is a life-saving treatment, so it is deeply frustrating for doctors that we do not yet have a therapy that can stop the heart being injured by reperfusion. 

“Having identified how these damaging molecules are produced, we now want to explore the underlying mechanisms and develop new types of drugs further to see if they will also work in patients and improve their long-term survival. 

“In addition, as similar types of injury occur during stroke, operations or organ transplantation these new types of drugs could be used as a treatment in many other important medical situations.”

Heart attacks are caused when the flow of blood to part of the heart is stopped. This block in the oxygen and nutrient supply causes cells in the heart to die.

In the UK, over 100,000 angioplasty procedures are carried out each year. During the procedure, a special kind of balloon is gently inflated to stretch the narrowed or blocked coronary artery. Many people also have a stainless steel mesh called a stent positioned within the artery which allows blood to flow normally again.

Simple solution

Our Research Adviser, Dr Tian Yu, said: “If this project is successful, it would point towards a relatively simple solution to a decades old problem. One that could improve the lives of tens of thousands of heat attack survivors each year. 

“Worryingly, the ability of the BHF to fund crucial projects like this is under threat. Coronavirus had had a devastating impact on our fundraising. That’s why – together with other medical research charities – we are calling on the Government to commit to a Life Sciences Charity Partnership Fund. 

“This will ensure that the BHF and other charities can continue to invest in the science that produces the breakthroughs that save and improve lives.”

UK Government launches international trade hub in Scottish capital | Edinburgh biotech set to scale up | Research project boost

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A new trade hub dedicated to helping businesses in Scotland grow internationally has been launched today, providing “much-needed support for thousands of companies in economically challenging times”.

Based in Edinburgh’s Queen Elizabeth House, a UK Government HQ opened last month which will house 3,000 civil servants from multiple departments, it is claimed the UK Department for International Trade’s new Scotland Hub will provide businesses with greatly increased trade support.

Through the trade hub, businesses will be able to utilise the UK Government’s global networks, expertise and influence, as well as a world-leading credit agency, UK Export Finance (UKEF), to grow their overseas trade and build back from the impact of coronavirus, the government said.

Leveraging the strength and reach of the UK Government, the hub will “deliver effective services for people and businesses in Scotland”, it declared.

UK Government Exports Minister, Graham Stuart, met with Scottish businesses and representative organisations, including FSB Scotland, NFU Scotland and the Scottish Council for Development to discuss the support available for companies in the region.

Graham Stuart MP, UK Minister for Exports, said: “One of the UK Government’s key priorities is to champion all four parts of the UK and demonstrate how beneficial a strong Union is for all. This specialist Hub for Scotland will provide businesses with the support and guidance needed to boost their profits and harness their full potential.

“Trade is crucial to the UK’s recovery from coronavirus and will be the foundation of our relationships across the globe after the transition period ends this year. I want to ensure that businesses in Scotland benefit from our new trade deals with the world’s biggest markets, as we remove barriers that they previously faced.”

HeraldScotland:

David Duguid, UK Government Minister for Scotland, said: “This new UK Government Trade Hub in Edinburgh is fantastic news for Scottish businesses. It will help them make the very most of the global trade opportunities once the EU transition period ends.

“I urge Scottish businesses to work with the Trade Hub to expand their export business, especially Scotland’s famous food and drink sector. This is a real boost for Scottish produce. Recovering our economy from coronavirus is a national effort. We are working as one United Kingdom to support businesses in Scotland.

“The Trade Hub will be based in Queen Elizabeth House, the UK Government’s new flagship building in Edinburgh. It is a clear demonstration of our commitment to strengthening the Union and delivering for people in Scotland.”

UKEF has appointed a specialist to focus on renewable exports and to support the energy transition in Scotland, further demonstrating the continued commitment to supporting energy companies across Scotland and helping them succeed abroad.

Having previously worked to strengthen the outreach of UKEF’s regional network of Export Finance Managers, Alistair McMillan takes up this new role.

In Queen Elizabeth House, DIT will be joining the Office of the Secretary of State for Scotland, Office of the Advocate General, HMRC, HM Treasury, Cabinet Office, the Office for Statistics Regulation, the Information Commissioner’s Office, and the Government Actuary’s Department. Additional UK Government departments are expected to confirm occupancy in the coming months.

The UK Government building will be fully occupied as soon as it is safe to do in a COVID-secure way.

Work is also underway to set up a flagship UK Government building in Glasgow.

Edinburgh biotechnology firm IntelliDigest is primed to scale up its efforts in tackling food waste after being supported by Royal Bank of Scotland’s Entrepreneurial Accelerator programme.

Combining the latest developments in biotech, deeptech, agritech and foodtech, the company, which was founded in 2016 by Dr Ifeyinwa Kanu, is pioneering the elimination of food waste through the promotion of a circular economy, by preventing edible food going to waste, and by converting inedible food waste into sustainable chemicals.

These chemicals can then be used for food packaging, cosmetics and growing food.

Royal Bank of Scotland’s 18-month Accelerator programme provides support systems for business owners, allowing them time to focus on developing their company through one-to-ones and networking opportunities.

Through the Accelerator, industry experts worked with IntelliDigest on direction and commercialisation, leading seasoned scientific lawyer Patricia Barclay to take on the role of chairperson with the company.

Set to graduate from the programme in January, Dr Kanu has refocused her efforts on strategic restructuring and positioning the company as the go-to-market brand for addressing the food waste challenge.

IntelliDigest was also financially supported through Royal Bank of Scotland’s “Back Her Business” fund-matching scheme, which provided an additional £10,000 towards funds raised by the company.

Ifeyinwa Kanu, IntelliDigest founder, said: “The Entrepreneur Accelerator has been incredibly useful, giving me the opportunity to network and build lasting relationships with other budding entrepreneurs and experts from world-class organisations.

“The opportunity to spend time focusing on business development has been invaluable, as is the bank’s support in other ways – from funding to signing up to our initiatives.”

Royal Bank of Scotland accelerator manager, Matthew Teague said: “Dr Kanu developed an innovative, sustainable business which drew our attention, but ultimately, her mindset, drive, and enthusiasm were key to her enrolment. It’s been great to see IntelliDigest continue to grow, and I’m looking forward to seeing what’s in store in the years to come.”

A new Scottish research project has been awarded funding from the Royal Society to improve existing technology with benefits for health and safety in industry, healthcare and the COVID-19 pandemic.

University of the West of Scotland’s (UWS) Institute of Thin Films, Sensors and Imaging and Novosound will work together to improve the efficiency of ultrasonic sensors and imaging devices.

Dr Carlos García Nuñez, a lecturer in physics at UWS, has been awarded almost £25,000 in funding through the Royal Society’s Short Industry Fellowship scheme to undertake the project alongside award-winning sensors company Novosound.

The Royal Society Short Industry Fellow García Nuñez said: “The Royal Society’s Short Industry Fellowship brings academia and industry together to improve knowledge and work on solutions to current, real-world problems.

“I am thrilled to have been awarded the Fellowship, and look forward to working with Novosound on this exciting project.”

Novosound Ltd, UWS’s first spin-out company, has rapidly revolutionised ultrasound technology, which has remained largely unchanged for 40 years, by replacing conventional sensor materials with a flexible piezoelectric thin-film material. This has resulted in significant cost reduction and improved flexibility, providing 3D ultrasonic imaging and sensing capabilities for applications in oil and gas, aerospace, energy and many more.

Dr García Nuñez’s research will seek to further improve the capabilities of the device, utilising UWS-patented microwave plasma-assisted sputter deposition processes, developed at the University’s Institute of Thin Films, Sensors and Imaging, enhancing the piezoelectric thin films’ acoustic properties utilised in the Novosound transducers.

Dr García Nuñez added: “Ultrasonic transducers can be used in a range of different ways, and recently, we have seen increased interest in their application, especially in terms of non-destructive testing. By using microwave plasma-assisted sputter deposition, the project seeks to improve the performance of the Novosound technology, expanding use for societal benefit.”

Professor Dave Hughes, founder of Novosound and visiting professor at UWS’s Institute of Thin Films, Sensors and Imaging, commented: “As the first-spin out company to emerge from UWS, I am looking forward to revisiting Novosound’s research and development roots to work with Dr García Nuñez on this exciting project.

“The prestigious Royal Society Short Industry Fellowship allows Novosound and UWS to build on our existing, world-class, research to enable advancements and improved performance of Novosound’s product offering.”

Novosound’s current products have a broad range of applications, including non-destructive testing and monitoring in industry, medical imaging, and wearables. In the current COVID-19 pandemic, Novosound has also developed a lung ultrasound system for monitoring of acute respiratory failure.

The six-month project between UWS and Novosound will make use of both industry facilities and the University’s Institute of Thin Films, Sensors and Imaging laboratory, which launched earlier this year.

The £12 million lab, recognised a centre of excellence in the UK, will help the Institute continue to build on its successes, which, over the past five years, has won £7 million worth of external research and enterprise grants, as well as securing five patents and creating a new masters programme in advanced thin films technology.

Professor Des Gibson, Director of the Institute of Thin Films, Sensors and Imaging at UWS, said: “At UWS, we are committed to impactful, relevant research, and Dr García Nuñez’s collaboration with Novosound is a fantastic example of how we are working with industry to achieve this. The Royal Society Short Industry Fellowship enables dynamic engagement between universities and businesses to make a real impact – I look forward to seeing the outcome of this project.”

GSK establishes AI hub in London to discover new drugs

GlaxoSmithKline (GSK) has opened a £10m research hub in King’s Cross, London to leverage artificial intelligence (AI) for the discovery of new drugs to treat cancer and other diseases.

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GlaxoSmithKline (GSK) has opened a £10m research hub in King’s Cross, London, UK, to leverage artificial intelligence (AI) for the discovery of new drugs to treat cancer and other diseases.

Initially, the research base will have 30 scientists and engineers, who will work with their new neighbouring hubs, including the Francis Crick and Alan Turing research institutes.

The aim is to partner with other pharma companies using AI for the drug discovery process, such as analysis of genes that could cause disease and screening for potential drugs.

The company’s chief executive Emma Walmsley said that the move is expected to help enter the ‘huge London tech talent pool’ and attract scientists to GSK, according to London Evening Standard.

Walmsley was quoted as saying: “Using technologies like AI is a critical part of helping us to discover and develop medicines for serious diseases.”

US-based tech giant NVIDIA will also send a team of engineers to the new GSK research hub to explore ways of working together to find new drugs.

GSK is also expected to announce a collaboration with another US company, Cerebras, which has an AI supercomputer with the largest chip and is said to be a thousand times faster than conventional machines.

Scientists at the new hub will be part of an 80-member team of AI experts worldwide at GSK.

In a statement, GSK said: “We’ve announced our new AI hub in London, which will help us reimagine how new medicines are discovered for cancer and other serious diseases.”

Last month, Merck, known as MSD in Europe, announced plans to build a $1.3bn (£1bn) research hub on a 25,000m² site in London.

The hub, named London Discovery Research Centre, is the first early research centre by Merck outside of the US.

Scientists develop new compound which kills both types of antibiotic-resistant superbugs

Scientists develop new compound which kills both types of antibiotic resistant superbugs

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Researchers at the University of Sheffield have developed a new compound that is able to kill both gram-positive and gram-negative antibiotic-resistant bacteria.

Gram-positive and gram-negative bacteria have different cell wall structures, but the new antibiotic compound is able to pass through the cell wall of both forms of bacteria and then bind to the DNA.

The findings, published in Chemical Science, pave the way for developing new treatments for all kinds of antibiotic-resistant bacteria, including the gram-positive MRSA and gram-negative E.Coli.

The team from the University of Sheffield has previously developed new compound leads that specifically target gram-negative bacteria, but this new compound is a broad-spectrum antimicrobial which means it is just as effective in both types of bacteria.

Gram-negative bacteria strains are particularly difficult to treat as their cell wall prevents drugs from getting into the microbe, they can cause infections including pneumonia, urinary tract infections and bloodstream infections.

The team worked with colleagues at the Science and Technology Facilities Council’s (STFC) Rutherford Appleton Laboratory (RAL).

Professor Jim Thomas, Principal Investigator of the research from the University of Sheffield, said: “Antimicrobial resistance is an increasing problem with many studies predicting a medical global emergency, so broad-spectrum antimicrobials which work against resistant pathogens are urgently needed. As the compound is luminescent it glows when exposed to light. This means we were able to follow the uptake and effect on bacteria using advanced microscopy techniques available at STFC’s Rutherford Appleton Lab.”

Antimicrobial resistance is already responsible for 25,000 deaths in the EU each year, and unless this rapidly emerging threat is addressed, it’s estimated by 2050 more than 10 million people could die every year due to antibiotic-resistant infections.

Doctors have not had a new treatment for gram-negative bacteria in the last 50 years, and no potential drugs have entered clinical trials since 2010.

Anticancer Immunotherapy Response Predicted Using New Imaging Tool

Scientists at the University of Bath have developed a diagnostic tool that can predict whether a cancer patient is likely to respond to immune checkpoint inhibitor therapy. The method uses an imaging technique, iFRET, to directly assess the interaction between programmed death ligand-1 (PD-L1) ligand with its receptor programmed death receptor-1 (PD-1), in patients’ tumour samples.

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The team hopes that the technique will allow clinicians to tailor treatments to individual patients and avoid treatment paths that are unlikely to be successful.

“Currently, decisions on whether to proceed with checkpoint inhibitor treatment are based simply on whether PD-1 and PD-L1 are present in biopsies, rather than their functional state,” stated Banafshé Larijani, PhD, director of the Centre for Therapeutic Innovation (CTI-Bath). “However, our work has shown it is far more important to know that the two proteins are actually interacting and therefore likely to be having a functional impact on tumor survival.” Larijani and colleagues reported on the new tool in Cancer Research, in a paper titled, “High PD-1/PD-L1 Checkpoint Interaction Infers Tumor Selection and Therapeutic Sensitivity to Anti-PD-1/PD-L1 Treatment.”

Immunotherapy is a type of cancer treatment that helps a patient’s immune system fight cancer, and is having a profoundly positive impact on cancer treatment for many patients. Cancers can evade detection by the immune system, making themselves invisible to the natural anti-tumor response and actively blocking it. Antibody-based immune checkpoint inhibitor therapy effectively removes the brakes that tumors can put on the immune system, and so reactivates the patients’ natural anticancer response, which then destroys the tumor. Checkpoint inhibitors have been hugely successful for some subsets of cancer patients, but for many this type of treatment has little or no effect, and “notwithstanding some remarkable successes with immune checkpoint inhibitors, the majority of patients display primary or acquired resistance to treatment,” the authors wrote.

Co-author José I López, PhD, from the department of pathology, Cruces University Hospital, in Bilbao, noted, “Immune checkpoint blockade is becoming a therapeutic milestone in some cancers in the last years. Patients are selected for this treatment option using immunohistochemistry, however, this technique does not reliably detect all of the candidates that would potentially benefit. Actually, up to 19% of patients supposedly negative do respond to this therapy.”

So, given the inherent toxicity risks associated with immunotherapy, there is a real need to define which patients are most likely to benefit from treatment, and avoid unnecessary exposure for those patients who won’t respond. As the researchers commented, “There is, therefore, an unmet clinical need to identify biomarkers that distinguish potential responders from nonresponders to ensure that nonresponders are not exposed to the side-effects of these drug for no therapeutic benefit.”

The team in Bath led by Larijani, working with colleagues in the U.K. and Spain, including the company FASTBASE Solutions, has now developed a prognostic tool that uses an advanced microscopy platform to identify immune cell interactions with tumor cells, and also reported on the activation status of immune-checkpoints that dampen the antitumor response. The scientists used the technique to evaluate the immune checkpoint involving PD-1, which is present on immune cells called T lymphocytes, and PD-L1, which is present on other types of immune cells and on the surface of many different types of tumors. When PD-1 on the surface of T lymphocytes engages with PD-L1 on the surface of other immune cells, it effectively switches off the immune function of the T cell. In a healthy individual, these checkpoints tightly regulate the body’s immune response, acting as an off-switch to prevent autoimmune and inflammatory disease. Tumor cells essentially hijack this mechanism by expressing PD-L1 on their surface, enabling them to activate PD-1 on the T lymphocyte, thus switching off its antitumor function, allowing survival and growth of the tumor.

Immunotherapy checkpoint inhibitors work by disrupting the interaction between PD-L1 expressed on the tumor and PD-1 on the T cell, and thus re-establish the patient’s antitumor activity. “Conceptually, it is surmised that a high degree of PD-1/PD-L1 interaction infers tumor selection in patients, indicating that the patient’s tumor may be reliant on PD-1/PD-L1 interaction to facilitate immune evasion. It is precisely this group of patients that would be expected to respond to immune checkpoint inhibition,” the investigators explained.

The new iFRET imaging tool developed by the Bath researchers can quantify the extent of PD-1/PD-L1 interaction in a biopsy of the tumor, to help predict whether the checkpoint inhibitor therapy is likely to have significant clinical benefit. Results from tests with the system on tumor biopsy samples confirmed that immunotherapy-treated patients with metastatic non-small cell lung cancer (NSCLC) who displayed a low extent of PD-1/PD-L1 interaction showed significantly worse outcome than those with a high interaction.

The team hopes that the same approach could be used to monitor other immune cell interactions in cancer. “iFRET can be exploited to monitor other intercellular protein interactions and there are ongoing developments designed to capture related immune modulatory interactions pertinent to cancer and emerging cancer treatments,” the scientists noted. “This provides the potential for iFRET to become a useful predictive tool informing on the nature of the tumor immune-privileged state.’

Stephen Ward, PhD, vice-chair of CTI-Bath and a co-author of the study, said, “The tool we have developed is an important step towards personalized medicine. By using it, we can precisely select who will benefit from immunotherapy. It will also show which patients are unlikely to respond well before they start a long course of treatment, and these patients can be offered a different treatment route … “It should make treatment with these expensive biotherapeutics much more efficient for the NHS.”

Tests in additional patients are now being planned, according to Eunate Arana, PhD, scientific coordinator of BioCruces Health Research Institute. “We find this technology and its application in the field of immunotherapy truly interesting. Therefore, we are going to carry out a clinical trial in three hospitals of BioCruces and BioDonostia, the Basque Public Health network, that will allow us to evaluate the predictive capacity of this quantitative imaging platform, to improve patient stratification for lung cancer immunotherapy.”

The authors concluded, “The exemplification of iFRET in tumor settings opens up exciting and powerful new opportunities to move beyond the cataloguing of cell phenotypes in situ and add functional attributes to our patient data inventory, impacting clinical decisions … This is a routine parameter for small-molecule inhibitors targeted at driver mutations, and we suggest it should become a routine for these more complex biotherapeutic interventions.”

Virtual reality a rising force in the global healthcare industry

An image from the FeM Surgery VR video showing the vacuum assisted breast biopsy VR procedure.

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SINGAPORE – Virtual reality (VR) has commonly been associated with gaming and entertainment, but it has also been making waves in hospitals and clinics across the world in recent years.

Doctors are increasingly applying this technology across a spectrum of uses, from medical training to diagnosing and treating different conditions, to easing a patient’s anxiety before and during a medical procedure.

The global market for virtual reality in healthcare was valued at US$2.14 billion (S$2.92 billion) in 2019 and is projected to reach US$33.72 billion by 2027, according to a Verified Market Research report in July.

In a pilot study done last year, patients undergoing wide-awake surgery at St George’s Hospital in London had the option to use a VR headset before and during their operation to view calming landscapes.

All the participants reported that their overall hospital experience was improved by wearing the headset, while 94 per cent said they felt more relaxed.

Furthermore, 80 per cent said they felt less pain after wearing the headset and 73 per cent reported feeling less anxious.

Consultant orthopaedic surgeon Shamim Umarji, who led the study, said: “Many patients feel quite anxious about the prospect of being awake during surgery, so it’s fantastic to see the positive impact virtual reality can have on the patient experience. As surgeons we occasionally lose sight of how daunting the operating theatre can be.”

A research team at the University of Utah in the United States has also found VR to be useful in building balance skills in patients with Parkinson’s disease.

The technology has successfully improved patients’ obstacle negotiation and balance, as well as their confidence in moving around in their environment, according to their findings published in peer-reviewed journal Experimental Biology.

VR has also been effective in training surgeons as well as teaching medical students.

Last year, a study from Harvard Business Review showed that training using VR technology improved participants’ overall surgical performance by 230 per cent compared with traditional training methods.

The participants from the David Geffen School of Medicine at University of California, Los Angeles, were able to complete procedures on average 20 per cent faster and more accurately.

“Synthetic lethality” kills cancer by blocking DNA repair mechanism

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Three dimensional culture of human breast cancer cells.
Photo credit: NCI Center for Cancer Research.

With advances in genome sequencing, cancer treatments have increasingly sought to leverage the idea of “synthetic lethality,” exploiting cancer-specific genetic defects to identify targets that are uniquely essential to the survival of cancer cells.

Synthetic lethality results when non-lethal mutations in different genes become deadly when combined in cells. In a new paper published online July 27, 2020 in the Proceedings of the National Academy of Sciences (PNAS), researchers at the San Diego branch of Ludwig Institute for Cancer Research and University of California San Diego School of Medicine report that inhibiting a key enzyme caused human cancer cells associated with two major types of breast and ovarian cancer to die and in mouse studies reduced tumor growth.

The research team, led by senior study author Richard D. Kolodner, PhD, Distinguished Professor of Medicine and Cellular and Molecular Medicine and member of the Ludwig Institute for Cancer Research San Diego Branch, studied Saccharomyces cerevisiae, a species of yeast used in basic research, to search for synthetic lethal relationships.

They zeroed in on Flap Endonuclease 1 (FEN1), a DNA structure-specific endonuclease involved in DNA replication and repair. Turning their attention to cancer cells, they found that when they blocked functions of FEN1 using either a small molecule inhibitor or genetic ablation, BRCA1 and BRCA2 mutant cancer cell lines were preferentially killed. Notably, normal cells were able to recover from FEN1 inhibition.

BRCA1 and BRCA2 genes normally act to prevent breast and ovarian cancer as well as other cancers, but when mutated, may cause a person to be more likely to develop breast or ovarian cancer or develop cancer at a younger age. Less than 10 percent of women diagnosed with breast cancer have a BRCA mutation, but it’s estimated that 55 to 65 percent of women with the BRCA1 mutation will develop breast cancer before age 70 while approximately 45 percent of women with a BRCA2 mutation will develop breast cancer by age 70, according to the National Breast Cancer Foundation.

Similarly, women with inherited BRCA mutations have an increased risk of developing ovarian cancer and men with inherited BRCA mutations have increased risk of developing breast and prostate cancer.

Breast cancer is the most common type of cancer in the United States, with approximately 276,000 new cases per year, according to the National Cancer Institute. Prostate cancer is the fourth most common, with 191,930 new cases and ovarian is 17th, with an estimated 21,750 new cases annually, according to the National Cancer Institute.
Kolodner and colleagues then tested the approach in an immune-compromised mouse xenograft model, and found that FEN1 inhibition significantly reduced tumor growth.

The researchers say their findings are significant in two ways: They underscore the value of using S. cerevisiae yeast as a genetics tool for discovering synthetic lethality relationships and identify FEN1 inhibitors as a possible therapeutic agent to further develop for treating certain cancers with targeted vulnerabilities.

Co-authors of the study include: Elaine Guo, Yuki Ishii, James Mueller, Anjana Srivatsan, Ludwig Institute for Cancer Research, San Diego Branch; Timothy Gahman, Ludwig Institute for Cancer Research; Christopher D. Putnam and Jean Y.J. Wang, Ludwig Institute for Cancer Research, San Diego Branch and UC San Diego.

Funding for this research came, in part, from the Ludwig Institute for Cancer Research and the National Institutes of Health (grant GM26017).

Deep learning (AI) – enhancing automated inspection of medical devices?

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Integrated quality inspection processes continue to make a significant contribution to medical device manufacturing production, including the provision of automated inspection capabilities as part of real-time quality control procedures. Long before COVID-19, medical device manufacturers were rapidly transforming their factory floors by leveraging technologies such as artificial intelligence (AI), machine vision, robotics, and deep learning.

These investments have enabled them to continue to produce critical and high-demand products during these current times, even ramping up production to help address the pandemic. Medical device manufacturers must be lean, with high-speeds, and an ability to switch product variants quickly and easily, all validated to ‘Good Automated Manufacturing Practice’ (GAMP). Most medical device production processes involve some degree of vision inspection, generally due to either validation requirements or speed constraints (a human operator will not keep up with the speed of production). Therefore, it is critical that these systems are robust, easy-to-understand and seamlessly integrate within the production control and factory information system.

Deep learning

Historically, such vision systems have used traditional machine vision algorithms to complete some everyday tasks: such as device measurement, surface inspection, label reading and component verification. Now, new “deep learning” algorithms are available to provide an ability for the vision system to “learn”, based on samples shown to the system – thus allowing the quality control process to mirror how an operator learns the process. So, these two systems differ: the traditional system being a descriptive analysis, and the new deep learning systems based on predictive analytics.

Innovative machine and deep learning processes ensure more robust recognition rates. Medical device manufacturers can benefit from enhanced levels of automation. Deep learning algorithms use classifiers, allowing image classification, object detection and segmentation at a higher speed. It also results in greater productivity, reliable identification, allocation, and handling of a broader range of objects such as blister packs, moulds and seals. By enhancing the quality and precision of deployed machine vision systems, this adds a welcome layer of reassurance for manufacturers operating within this in-demand space.

Deep learning has other uses in medical device manufacturing too. As AI relies on a variety of methods, including machine learning and deep learning, to observe patterns found in data, deep learning is a subfield of machine learning that mimics the neural networks in the human brain by creating an artificial neural network (ANN). Like the human brain solving a problem, the software takes inputs, processes them, and generates an output. Not only can it help identify defects, but it can, as an example, help identify missing components from a medical set. Additionally, deep learning can often classify the type of defect, enabling closed-loop process control.

Deep learning can undoubtedly improve quality control in the medical device industry by providing consistent results across lines, shifts, and factories. It can reduce labour costs through high-speed automated inspection. It can help manufacturers avoid costly recalls and resolve product issues, ultimately protecting the health and safety of those towards the end of the chain.

AI limitations

However, deep learning is not a silver bullet for all medical device and pharmaceutical vision inspection applications. It may be challenging to adopt in some applications due to the Food and Drugs Administration (FDA)/GAMP rules relating to validation.

The main issue is the limited ability to validate such systems. As the vision inspection solution utilising AI algorithms needs sample data, both good and bad samples – it makes validating the process extremely difficult, where quantitative data is required. Traditional machine vision will provide specific outputs relating to measurements, grey levels, feature extraction, counts etc. which are generally used for validating a process. With deep learning, the only output is “pass” or “fail”.

This is a limiting capability of deep learning enabled machine vision solutions – the user has to accept the decision provided by the AI tool blindly, providing no detailed explanation for the choice. In this context, the vision inspection application should be reviewed in advance, to see if AI is applicable and appropriate for such a solution.

Conclusion

In conclusion, deep learning for machine vision in industrial quality control is now widely available. Nevertheless, each application must be reviewed in detail – to understand if the most appropriate solution is to utilise traditional machine vision with quantifiable metrics or the use of deep-learning with its decision based on the data pool provided. As AI and deep learning systems continue to develop for vision system applications, we will see more novel ways of adapting the solutions to replace traditional image processing techniques.

Source: Med-Tech Innovation News

How has COVID-19 changed the NHS customer landscape?

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Oli Hudson, content director at Wilmington Healthcare, explores the rapid and startling changes to the NHS customer landscape – and how it will affect medtech.

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Two months ago, the NHS had a customer environment that was often challenging, sometimes frustrating, but largely predictable.

Change appeared at a stately pace and in line with the NHS Long Term Plan, which set out to foster gentle collaboration rather than competition.

So integrated care systems were emerging, but yet to contract officially with integrated providers; some hospitals within trusts were being divided into ‘hot’ (emergency or specialist) and ‘cold’ (elective) sites; limited partnership between trusts and joint purchasing strategies were being developed, but slowly; and pilot programmes for pathway change, specialisation, and digital adoption seemed the norm, rather than the wholesale transformation desired.

Some elements of the plan, such as a move away from long-term hospital bed use towards care in social, community, primary and home settings, were well intentioned but happening sporadically in areas where all the players within an ICS could agree.

Smart medtech companies were watching, with a view that organisational relationships between their customers, and between their customers and them could change, albeit slowly; perhaps the most crucial thing was the change in the national procurement model.

Two months later, the Coronavirus outbreak has made all these assumptions null and void.

Integration

The crisis has forced the pace with integration – with all the players within integrated care systems including acute, primary, community, specialist, ambulance and social care, as well as representation of local housing, transport, education and police, having to come together to make decisions on resource and capacity. Meanwhile, the Long Term Plan’s drive to create more coherent governance models in the shape of CCG mergers is ahead with increased fervour. This lays a baseline for a more integrated stakeholder map, with some ICS representatives saying they have achieved more in seven day timelines than had previously happened in 18 months. The learning? ICSs will be the standard operating unit of the NHS after the outbreak, and their decisions will affect which hospitals do which procedures and how pathways that involve medtech are managed.

Acute care

Within acute care, we are seeing changes to the purpose of hospitals– with whole units given over to COVID-19. Operating theatres have been turned into ICUs, and staff not previously specialising in respiratory or critical care requisitioned for this emergency. Departmental structures that previously existed within large hospitals have been shaken up beyond recognition, with clinicians working well beyond their normal disciplines. In places like London, a reconfiguration is underway between hospitals dealing with COVID-19 patients, and ones which are specialising in other areas, with Royal Brompton and Harefield forming a ‘hub’ model for heart disease, the Royal Marsden for cancer, and St Bartholomew’s for emergency elective treatment. The NHS has even enlisted the entire private sector to increase its critical care capacity. As a landscape, it is unrecognisable.

There is also developing a backlog of long-term conditions treatment, outpatients and elective care. The medtech products used to treat them will be needed at some point, but when? Acute care will be a confusing and challenging customer environment for medtech during the outbreak – and industry may have to change its approach, determining the route to engagement – for example, via digital and remote channels.

It is unlikely that hospitals will revert to the pre-COVID working-in-a-vacuum strategy. There will be trade-offs and resource sharing. This is likely to foster closer collaboration in procurement in the future.

Long-term conditions

The emphasis on COVID-19 has detracted from other groups of patients – vulnerable groups such as respiratory, diabetes, cancer, heart and autoimmune conditions. How are these patients now being catered for and will the outbreak mean changes to care pathways? Cancer surgery has been affected, with patients being risk-stratified into four groups. Some groups will not receive treatment, depending on the likely outcome, whether it has a clinically meaningful aim, whether the patient is likely to gain significant extra life, and whether operating will expose the patient to a COVID-19 risk that is greater than not operating. Such measures have been outlined across most therapy areas by NICE in its series of rapid response guides, and will affect operations performed that use medtech for some time.

Industry impact

Hardly anything industry does with the NHS will be unaffected by this pandemic. It is important that industry stays well informed, prepares to be agile, offers solutions that deliver value and address issues of rapid, reliable and consistent supply and distribution – and act as a partner to the local and national NHS during this crisis.

Source: Med-Tech News

Partnership aims to advance cybersecurity practices in medical devices

Two medical device organisations have announced a new collaboration to advance cybersecurity practices across the entire medical device lifecycle.

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How 3D printing is used to create patient-specific jaw restorations

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Hay fever: Grass pollen DNA study could help sufferers

Trees, grass and weeds all produce pollen that can cause hay fever

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BD Receives Order from U.K. Government for 65 Million Injection Devices to Support COVID-19 Vaccination Campaign

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Biotech Venture Capitalist Picked to Run U.K. Vaccine Taskforce

The U.K. government has appointed biotech venture capitalist Kate Bingham to chair a task force that will coordinate efforts to find a viable vaccine for Covid-19 and make it widely available to the public.

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The Future of Drug Discovery: AI, Automation and Beyond

The Future of Drug Discovery: AI, Automation and Beyond

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Women in science are battling both Covid-19 and the patriarchy

A black female scientist working in a lab

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Can This Biotech Shed New Light on Cancer Immunotherapies?

T cells attacking cancer cells

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Can This Biotech Shed New Light on Cancer Immunotherapies?

5 tips for retaining top talent

5 tips for retaining top talent

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Top 10 Biotech and Pharmaceutical Stocks to Watch in 2020

Here’s an overview of the top 10 biotech and pharmaceutical stocks to watch in 2020. This biotech stocks list consists of companies that are actively developing drugs to fight diseases and even the coronavirus pandemic.

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Swallowing a Pill Filled With Light Could Be The Key to Ingestible Medical Devices

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Urology robot tech first for Harley Street

King Edward VII’s Hospital has become the first hospital in the Harley Street Medical Area to introduce the latest da Vinci surgical system, the da Vinci Xi© robot…

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King Edward VII’s Hospital has become the first hospital in the Harley Street Medical Area to introduce the latest da Vinci surgical system, the da Vinci Xi© robot, currently the most technologically advanced robotic system. As well as offering increased flexibility and versatility, the system provides multi-quadrant anatomical access – increasing the range in which surgeons can operate and creating room for more complex and challenging procedures.

Designed with enhanced ergonomics and precision, the da Vinci Xi© robot is at the forefront of surgical technology, with novel architecture, extended instrument reach and integrated auxiliary technology.

It is the first of its kind both at the hospital and within the famous Harley Street Medical Area, London – an area famed for its medical excellence in treating complex and life-threatening conditions.

Kate Farrow, Director of Operations at King Edward VII’s Hospital, said:

“We chose the Xi as we are committed to providing the highest standards of treatment available, and it is the currently the most technologically advanced robotic system. It allows the surgeon to operate on multi–quadrants, meaning that unlike previous models, the range in which a surgeon can operate within the patient is larger and a wider range of complex procedures can be done. We look forward to expanding our robotic programme to include colorectal, general and gynaecological surgery.”

With the addition of its new robotic technology, the hospital has also recently announced a new range of services to provide diagnostics and treatment for a variety of conditions and urological disorders, including pelvic reconstruction; erectile dysfunction; female urology; urinary incontinence; female functional urological reconstruction; kidney stones; male infertility; and prostate, bladder and kidney cancer.

Focal therapy is one of the new services offered at King Edward VII’s Hospital for treating prostate cancer, using High Intensity Focussed Ultrasound (HIFU) or electroporation (Nanoknife). This minimally-invasive treatment is offered to men who have medium (intermediate) risk prostate cancer. The side effects of this type of treatment, which treats only the cancer and a small area around it, are rendered much less than those for traditional prostate cancer surgery or radiotherapy

The hospital has also expanded their team of leading urology specialists with the appointment of new consultants, including Professor Caroline Moore MBBS, MD, FRCS(Urol) – the first woman in the UK to be a Professor of Urology; Professor Mark Emberton BSc, MBBS, FRSC (Urol), MD, FMedSci; Mrs. Sian Allen MBChB, MRCS(Eng), MD(Res), FRCS Urol; and Mr. Paul Cathcart MBBS, MD, FRCS (Urol).

Lindsey Condron, Chief Executive, added:

“We are committed to providing the best care to our patients and having expanded our urology team, we are in a position to offer a complete range of urological services. Our ambition is to be the leading independent urological centre in the UK.”

King Edward VII’s Hospital is one of the UK’s leading centres for urology, bringing together an exceptional multidisciplinary team of consultant urologists – leaders in their specialist field. With the very latest in diagnostic and surgical technology at their fingertips, they work together to provide outstanding personalised, patient-centred care at the cutting edge of modern medicine.

The hospital is located within the world-famous Harley Street Medical Area. Managed by long-term landlord The Howard de Walden Estate, the area is home to a community of world-renowned medical professionals.

Source: Life Science Industry News

How S.O.F.T. Skills Can Help Close The Talent Gap

In 1972, the U.S. Continental Army Command (CONARC) at Fort Bliss, TX, coined the phrase “soft skills,” in order to distinguish job behaviours that characterize human interactions with machines…

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…(“hard skills,” evident in situations with clear, measurable processes) from equally important job behaviours that characterize human interactions with other people (soft skills, occurring in situations of high uncertainty and consequences). In contrasting the two types of skills, the Army’s Soft Skills Training Conference report admitted, “in other words, those job functions about which we know a good deal are hard skills, and those about which we know very little are soft skills.”

In the decades since the conference, even as the military’s “machines” have transformed into ubiquitous computer networks and daily interaction with computational tools has become routine, workplace interactions with colleagues can seem just as mysterious as they did to CONARC back in 1972.

MAPPING S.O.F.T. SKILLS FOR LIFE SCIENCES

In our recent research paper for the Massachusetts Biotechnology Education Foundation (MassBioEd), my colleagues, Karla Talanian, Luke Haubenstock, and I attempted to remove some of the mystery surrounding these skills, by mapping nontechnical job behaviours most essential to the life sciences industry. In the process, we repurposed the word “soft” to define the four axes of this behaviour map as “S.O.F.T.,” for Self — Others — Feeling — Thinking. We concluded that life science enterprises urgently need to accelerate the development of S.O.F.T. skills in order to decrease the talent gap that threatens the industry’s success in providing innovative therapies for patients in need.

Happily, numerous individual companies are rising to the challenge of expanding S.O.F.T. skills development across their workforces: Effective approaches are underway at organizations of all sizes across the life sciences ecosystem.

PRACTICAL APPROACHES TO ACCELERATE S.O.F.T. SKILLS

A first step in accelerating S.O.F.T. skills is to name them. At a leading global life sciences company, all employees, from entry-level associates to C-suite executives, are asked to pick one soft skill and one technical skill each year for individual development. Employees can choose to take classes to improve, obtain opportunities to practice internally, and find content available for reinforcement. “We put these things on calendars to see how people progress. We make it tangible. It’s a great program,” says a senior engineer.

Telling a succinct story is a crucial, yet often underdeveloped, soft skill among scientific professionals. A department of quantitative researchers addresses this skill gap directly through an elevator pitch competition: Each member of the group uses their phone to record a 30- to 60-second video description of their individual work projects and goals. They then refine and share it with peers who watch the brief videos and reply by sending their own. The group schedules an annual dinner to view and award the best elevator pitches. A senior member of the group reports, “I use my elevator speech four to six times a year to explain what I do to cross-functional colleagues.”

At one CMO, S.O.F.T. skills training focuses on increasing motivational conversations. As their VP of HR explains, “We teach people to inquire ‘How do you motivate your team? What are your best conversations, and what are your toughest conversations?’ and we challenge them on the answers.”

FEEDBACK AND COACHING ARE FOUNDATIONAL S.O.F.T. SKILLS

Role-playing can remove some of the uncertainty and anxiety that surrounds challenging conversations. As a leader at a growing biotech company explained, “People sometimes get data paralysis. The muscle memory of role-playing for skill-building can help in these situations.” Building this muscle memory requires continued practice to develop new habits. By identifying peer coaches to offer feedback and reinforcement to colleagues, life sciences companies provide opportunities for employees to practice building S.O.F.T. skills in giving and receiving feedback; asking thought-provoking questions; improving listening skills; and appreciating others’ strengths.

When a senior executive at a biotech company was challenged to develop her direct report — a renowned technical expert whose lack of interpersonal skills had stalled his career progression — continued feedback and coaching proved essential. The senior executive employed a two-step coaching approach with the expert that included:

  • giving continued direct and specific feedback
  • connecting the expert with peers who provided him with real-time feedback, providing consistent, frequent check-ins

After many months of committed focus, the technical expert had changed his mindset and behaviours to become a highly collaborative contributor, with the satisfying result that one of his strongest critics became a strong supporter, and the expert’s career trajectory took off.

Learning the S.O.F.T. skills of giving and receiving feedback is foundational to elevating other essential workplace behaviours. Gaining commitment across the organization to practice building feedback expertise is, therefore, a best practice. At one life sciences organization, the peer feedback process includes four related components:

  • Bringing junior colleagues to team meetings and debriefing with them immediately afterwards, while memories are still fresh, on how they and other participants showed up to the group.
  • Identifying senior people who excel in S.O.F.T. skills to weigh in on good practice and interaction with teams, analogous to a distinguished scientist role for technical topics.
  • Separating technical work from S.O.F.T. skills for presentations and meetings, with the goal of separating the scientific review from asking “What went well with the team meeting? Did we reach the right people? Did we make the right points? What active listening behaviours were evident?”
  • Asking peers in advance of meetings and presentations to provide feedback on specific areas of interaction at the event.

THE S.O.F.T. SKILLS OF LISTENING

Feedback is inextricably linked to another S.O.F.T. skill: active listening. At a fast-growing biotech company, employees receive coaching in mentoring others through active listening. They learn how to answer questions by listening first, in order to motivate and enrol others effectively. Explained a senior scientist, “The toughest thing to learn on a project is mirroring what people say, for example, by pausing before inserting your own ideas, and offering, ‘So if I understand what you’re saying, …’ and ‘If I hear you correctly, the implication would be, …’ in order to validate, by listening and rewording what they hear.”

Another foundational S.O.F.T. skill involves attentive listening — to oneself. Developing the practice of reflection provides access to deeper creativity, greater focus, and an elevated sense of calm. As a senior biotech executive explained, “Quieting the external static gives me space to hear myself more clearly.” This heightened sense of clarity and awareness provides an internal environment for the S.O.F.T. skill of self-awareness to flourish, so that acknowledgement and development of other needed workplace behaviours can then follow. Meetings can include reflection time by building short bursts of individual contemplation into an agenda as part of the routine workflow, for example, by asking participants to consider a topic or question quietly for as little as 60 seconds, before opening the discussion up for group comment and responses.

By committing to identifying, developing, and practising essential S.O.F.T. skills such as storytelling, giving and receiving feedback, coaching, and listening, life sciences companies are providing employees with the requisite tools to elevate organizational effectiveness. Adopting best practices that improve S.O.F.T. skills will help to close the industry’s talent gap and — most importantly — accelerate successful results by life sciences organizations to serve patients.

JENNIFER LAWRENCE is associate director, human resources business partner at Blueprint Medicines

By Jennifer Lawrence

Source: Life Science Leader

Making Progress on a Micro-Budget

Startup investors come in a variety pack. On one end of the continuum are the generalists — folks with the common traits of money on their hands and an eagerness to put it into anything bespoken as hot.

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On the other end are highly informed, motivated people who study, understand, and enthusiastically support the industry in which they invest. Biopharma investors are often among the most motivated by personal factors, from family medical crises to pure idealism.

Fortunately, industry companies such as Eikonizo Therapeutics, which must start out with scarce financial support for entry into risky therapeutic territories, may sometimes rely on the latter group. Before the friendly investors step forward, however, the company must master the art of making do. That means, for starters, making the most of its natural advantages.

Eikonizo’s natural advantages include solid scientific origins in the Broad Institute and other MIT/ Harvard-community research centres, and industry-savvy management team, modest but early VC funding, and longer-term prospects for both private and public, non-dilutive investment. Dr Janice Kranz, cofounder and CEO, bridges the academic and industry foundations of the company.

FIELD OF BATTLE

Eikonizo entered a tough area at a tough time. Beginning operation only in 2017, its chosen field is a neurodegenerative disease. It is now targeting primarily ALS, but also has Alzheimer’s and others in its pipeline — all occupying an area beset in recent times by clinical disappointments, mechanistic debates, and even conspiracy theories. Yet, in that short period, and on an initial budget of just $2 million, Eikonizo has made substantial progress. It has already advanced candidates to the brink of Phase 1 trials, brought along several other programs close behind and taken its companion PET tracer diagnostic into early clinical trials.

The company’s research roots, however, reach further back to its academic co-founder, Dr Jacob Hooker, and his work at the Massachusetts General Hospital/Harvard Medical School’s Martinos Center for Biomedical Imaging. Hooker had developed new diagnostic neuroimaging tools for HDAC (histone deacetylase) enzymes, one of which, HDAC6, became the lead therapeutic target for Eikonizo. Other champions of the science Eikonizo employs are cofounder and head of R&D Frederick “Al” Schroeder, who comes from Hooker’s lab; director of medicinal chemistry Florence Wagner, from the Broad Institute; and company advisor Stuart Schreiber, at Harvard and co-founder of the Broad Institute.

Another benefit of academic roots is human capital, in-play both before and after the company takes form. Although the others on the Eikonizo team are notable, Kranz sets the pattern.

She had followed a path only revealed to her as she stepped along it. Beginning early on the industry side as a newly minted Harvard Ph.D., Kranz picked up the phone when her lab received a cold call from the first Cubist scientist, which led to her joining the new antimicrobial company, initially assigned to starting a new program in yeast assays. She remained at the company for the next five years. “Being at Cubist satisfied me in so many ways — the intellectual curiosity, the scientific pursuit of creating something completely new, building a team from scratch, working with investors.”

But Kranz preferred the startup scenario. “I liked the first couple of years at Cubist more than I did the later years after an IPO and after it had grown from a dozen people to more than a hundred. I knew I was more attracted to the creative, early-stage startup mode. Sometimes you can find that environment in academia or in a nonprofit.” After a two-year stint at Proteome (Biobase/Incyte), she moved on to the ALS Therapy Development Institute, her first foray into the neurodegenerative area.

“I knew I was more attracted to the creative, early-stage startup mode. Sometimes you can find that environment in academia or in a non-profit.”

Dr Janice Kranz Cofounder and CEO, Eikonizo Therapeutics

Kranz later joined the Broad Institute, a further step in the integration of her academic and industry sides. “The people at the Broad Institute pride themselves on having a foot in each camp of the academic and the industry model to make it the best of both worlds. Ed Scolnick, who had come from Merck, was trying to set up a mini startup within the Institute, the Stanley Center, focused on identifying new targets and getting significant treatments for psychiatric disease. That took me deeper into neuroscience, including biology and some of the targets as well as some of the people now in this company.”

As the second in command at the Stanley Center, Kranz began to experience the desire to found and lead a company of her own. She first investigated forming a group of people to discuss the idea, but soon realized she would need to focus on a specific field and a concept for addressing a related medical need. At about the same time, she had met Hooker while he collaborated with the Broad Institute and began to entertain his HDAC imaging work as a possible seed for commercial science.

“I understood the science immediately because it was related to some of the science I had learned at the Stanley Center. Jacob brought in a scientist from his lab and a businessperson who runs the Martinos Center. So the four of us met every couple of weeks, just kicking the tires on the idea and also testing how well we got along, what our objectives were, what our values were, and what the scientists in us were trying to figure out — meanwhile, trying to find holes in the plan to see if it was worthwhile.”

FUNDS TO PURPOSE

The first order of business, of course, was funding. Kranz and Hooker had a lot of experience with grant writing, so they set to work on a proposal to the Alzheimer’s Drug Discovery Foundation (ADDF), the group headed by Dr Howard Fillit (“Industry Explorers Blaze On,” March 2019). The experience was enjoyable and further united them behind the goal of forming a company. But the grant funding alone would prove disappointing as a jumpstart.

“We had a plan, and we honestly thought we would initially avoid venture capital and could bootstrap the company using non-dilutive funding, but such funding always has a time lag,” Kranz says. While they were submitting grants, she and Hooker also had fortuitous encounters with people in their networks. Hooker was connected to Stacie Weninger, head of the Fidelity Biosciences Research Initiative (FBRI), part of F-Prime Capital, which had made a grant to Hooker’s academic lab. FBRI focuses only on neurodegeneration, and Weninger primarily invests in seed-stage companies. Hooker and Kranz also both knew Schreiber of the Broad Institute, whose lab also had done seminal work related to the proposed company’s target, HDAC6. Schreiber introduced the two budding entrepreneurs to Kevin Kinsella of Avalon Ventures, who was the founding investor of Vertex.

“Kevin was tough, with a lot of questions and probing, but after all, he bought into our idea,” says Kranz. “Since helping start an Alzheimer’s-focused company, Athena Neurosciences, in his early days, he had been looking for another opportunity in the neurodegeneration space. He likes to have things move fast, and he pushed us to produce a term sheet. We were excited about the opportunity to get things rolling before we even heard back about our submitted grants. We closed on our seed round with him, and we did get the ADDF funding later.”

Sometimes, the science and technology manifested at the academic level does not get the credit it deserves for launching companies with novel approaches. Almost in passing, scribes may herald the seminal role of university research in the origins of biopharma enterprises and bio hubs. But no one should underestimate the value carried over from Harvard and other academic centres into the bio business sector. Those sources of special knowledge and application are worth real money, and to reproduce them exclusively inside a company would eat up large chunks of time and capital.

Source: Life Science Leader

By Wayne Koberstein, Executive Editor, Life Science Leader magazine.

Employee claims for inventor compensation – what is the impact of Shanks v Unilever?

The UK Supreme Court has given a surprise boost to employed inventors. Going against the decision of the patents tribunal, and both intermediate levels of appeal, the UK’s top judges sided with a talented research scientist.

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The result – a payment of £2 million from the researcher’s former employer as a reward for a particularly valuable invention. This decision raises the prospect of fresh claims brought against employers, with the potential for substantial undefined payment awards. We consider the risk to employers and what to look out for.

Professor Shanks and his outstanding invention

Talented scientist Professor Shanks came up with an invention for a glucose biosensor in the 1980s. This coincided with his employment by Unilever group company CRL. The invention was not directly applicable to the projects he was working on – his area of focus was biosensors for process control and process engineering. Later on, the glucose testing market took off and the biosensor technology became highly desirable. Most equipment producers in the field turned to Unilever for licences of the Professor Shanks patents. Unilever gained windfall licence fees of around £20 million. It also sold its medical diagnostics business, Unipath, with about £5 million attributable to the Shanks patents.

Under UK law, the invention belonged automatically to CRL. Patents were duly applied for by Unilever and granted, although not put into practice. So far so good. However, a rarely-used rule allows an employee to claim a compensatory payment where a patent or an invention turns out to be of “outstanding benefit” to his or her employer. This is looked at in context, with attention paid to the size and nature of the employer’s business and the overall fairness of the situation. The inventiveness of the claimed technical advance is not relevant – it is the benefit accruing to the inventor’s employer that is paramount. Professor Shanks applied for an award under this rule.

Was Unilever too big to pay?

Professor Shanks’s employer, CRL, was a relatively small research unit within the wider Unilever group. Its role was to generate inventions for use within the businesses of other group companies. What should be the correct context for assessing the value of the invention – CRL or the entire group?

The patents tribunal looked at the Unilever group, meaning that the value of the Shanks patents was a drop in the ocean. In contrast, the Supreme Court focused on the flow of inventions from CRL, and the value that Unilever derived from its patent portfolio. Alongside direct benefit to CRL as the employing company, relevant considerations were:

  • the contribution of the Shanks patents, as compared to other patent families, to the success of the wider group.
  • the extent to which patents were responsible for value creation within the group business. Much of Unilever’s revenue derived from the sale of consumer goods reliant on branding and marketing spend rather than patented technology. The assessment of the contribution made by the Shanks patents should be compared to value generation from other patented technologies rather than group revenues as a whole.
  • the role played by the wider group in terms of manufacturing capacity, sales and distribution facilities, goodwill, licensing muscle and patent enforcement activity.

In that context, the Shanks patents were exceptional and should trigger an award for compensation.

A change in 2004

Employees’ prospects under this rule were enhanced by a change made in 2004. This extended the scope of the “outstanding benefit” test to include value flowing from the invention itself, as well as any patents obtained. This change came too late for the Shanks patents, but could support a wider group of claimants now that the outstanding benefit test has been altered.

How much did Professor Shanks get?

The law does not specify how the employee’s reward should be calculated, beyond giving broad guidelines as to factors the court should consider. The Supreme Court was happy to accept the assessment of the patents tribunal that 5% was appropriate.

The calculation should ignore any corporation tax paid on the revenues generated by the patents, and should benefit from an uplift to take account of inflation since Unilever realised the benefit of the invention. A sum of £2 million was considered a fair reward.  

The international perspective

The Supreme Court’s ruling applies to individuals who are mainly employed in the UK. It can also apply to staff who are not fixed to any particular location, but who have an attachment to their employer’s UK business premises. So what about staff who are based elsewhere?

 

This is not an area of law that has been harmonised internationally and so organisations cannot look to a consistent set of principles.

There are similar rules in other countries, although unfortunately, the detail varies considerably. Employers will need to take advice locally in the jurisdiction where an individual is employed.

Take away points

The Shanks ruling makes an important change to UK law. Employees who are UK-based may now be encouraged to bring new compensation claims. This does present a new risk to employers, but one which, we believe, is limited.

Although the standard of what amounts to “outstanding benefit” has been lowered, it is still a difficult one to reach. Most research staff working in project teams on their assigned areas of work will still be unlikely to qualify.

Context is all-important. Organisations that are very active in generating patented technology may be less exposed as an employee will have to show that their invention is exceptional compared to revenues derived from other inventions.

The percentage of the relevant revenue that was awarded to Professor Shanks was not large – 5%. It is, of course, possible that larger percentages could be considered appropriate in other situations.

However, the award of 5% provides a starting point likely to influence a court looking at these cases in future.

Employee revenue-sharing policies, widespread in many research institutions, are likely to be a relevant factor. Where a member of staff has access to this kind of benefits scheme, a further award under the “outstanding benefit” rule looks less probable.

If you do receive claims triggered by this ruling, it makes sense to take legal advice to assess their likelihood of success and assemble relevant information to guide any negotiations.

By James Fry, Partner

Source: Mills & Reeve

Food for Insect Pollinators in Towns and Cities

The Friends of the University of Bristol Botanic Garden welcomed 3rd-year UoB PhD student Nick Tew to discuss his findings on “Food for Insect Pollinators in Towns and Cities”.

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Nick focused on an optimistic outlook on the effects of urbanisation on pollinator species numbers in Bristol, and the unique conservation opportunities we can do in the city. He began by showing the plant experts, gardeners and local enthusiasts alike the delights of the ‘Bee Movie’, with a clip from the film representing our love for bees and apparent fast approaching doom as their numbers continue to dwindle.

Nick began with an interesting thought that media representations of plant pollinating species tend to focus on bees. ‘Pollinator Movie’ is a criminally underappreciated film idea, with other amazing pollinator species of wasp, fly, beetle and many more not enjoying the same media attention. The importance of pollinators in the sexual reproduction of flowering plants affects our natural world from our day to day lives to the scope of an entire ecosystem. For example, 76% of leading food crops have some degree of reliance on animal pollinators and is often key in producing good quality food rich in micronutrients. Plants have their own intrinsic value, and pollinators are vital in preserving the high diversity of plant species for future generations.

And this is why the figures showing a decline in our pollinator species are so impactful, with some habitats in Britain having a measured 55% drop in the number of pollinator species. Nick focused on the impact of land-use change, where natural wild grassland is converted for other, human-specific use. The most extreme land-use change is urbanisation. The building of cities leads to the removal of native plant species, warmer temperatures, and impervious surfaces. In general, land-use change is a hard and fast method in destroying biodiversity.

Nick’s own passion for allotment gardening and animal behaviour led him to his PhD thesis. Though urbanisation will negatively affect some pollinator species, bees appear to be particularly resilient to land-use change and can even find new opportunities. He theorises that this is because the larval and adult forms in bees feed on the same food sources, therefore do not need a specific plant to survive the juvenile stages. As generalised feeders, they can extract nectar and pollen from a variety of plants.

Nick began the first steps of his research in 2018 and measured the nectar content of over 200 flower species, including in the university’s own botanical garden. The measurements revealed that most of the nectar in urban areas are provided for by gardens. He found that urban areas had a more diverse array of pollinator species than farmland and nature reserves.

The second stage of his research found Nick visiting 59 different gardens in Bristol and measuring an estimated nectar production in individual gardens for each season. The gardens highly differed from one another, from their species types to the densities of plants. Generally, July was found to have the highest nectar production, with a drop in production starting in October.

However, Nick’s results showed the continuity of nectar when combining gardens together. As people plant different flowers from native and non-native species, a bee that may be able to forage in over 1000 gardens will likely be able to source nectar at each point of the year from at least a few gardens, even if the average output is minimal. The vivid pink and purple flowers of Fuchsia are a popular staple of UK gardens and are incredibly important in producing nectar in the Summer to Autumn months. In their native Americas, Fuchsia is pollinated by hummingbirds, so they produce high quantities of nectar. For UK insect pollinators, they present an absolute buffet. With this, Nick is able to present how the unique opportunity of gardens with a diverse range of flowering plants and non-native species in urban areas can actually lead to a more stable food source for pollinators.

So, what can people in cities do to help conserve our pollinator species? The opportunities presented by gardens in urban areas ride on a high diversity of flowering plants. Plant unusual flowers, ones that flower at different types of year. Think about planting 3D structure flowering plants, such as Fuchsia shrubs which can produce many flowers in one season. And, perhaps the easiest option, save your weeds! This means not pulling dandelions, clovers, and daisies that pop up in your lawn. If each available garden, green and allotment spaces are cared for with these points in mind, and with Nick’s expert opinion on which plants are best arranged together, we can help sustain our pollinators.

By Written by Nicky Kobayashi-Boyd, Biology (BSc)

Source: University of Bristol – Biological Sciences Blog

 

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Avrobio tracks improvements in first patient treated with Gaucher gene therapy

DNA helix forming inside a test tube

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Avrobio has shared data on the first Gaucher disease patient to receive its gene therapy AVR-RD-02. The patient, who was stable on enzyme replacement therapy at baseline, experienced a 22% drop in a toxic metabolite after receiving AVR-RD-02 and stopping taking the standard of care.

Gaucher, like the Fabry disease targeted by Avrobio’s lead prospect, is currently treated using enzyme replacement therapies sold by Sanofi and Takeda, which entered the market through its takeover of Shire. However, a significant minority of patients experience physical limitations despite treatment. Negative outcomes include bone pain and spleen enlargement. Johnson & Johnson’s Zavesca offers an oral alternative, but there remain unmet medical needs.

Avrobio is developing AVR-RD-02 to address those needs. The data shared as part of Avrobio’s R&D day mark the start of the effort to show AVR-RD-02 performs as hoped in the clinic.

The first patient to receive AVR-RD-02 discontinued enzyme replacement therapy one month before taking the gene therapy. Three months after receiving the gene therapy, levels of Gaucher biomarker lyso-Gb1 had fallen 22%. The patient’s level of plasma chitotriosidase, a biomarker of cells associated with severe organ damage, was down 17%. Hemoglobin and platelets were in the normal range.

AVR-RD-02 triggered those changes without causing serious adverse events. The data drop offers an early indication that Avrobio may be able to improve outcomes by harvesting hematopoietic stem cells, adding a gene that encodes for glucocerebrosidase and reinfusing the cells back into the same patient. With enzyme replacement therapies costing healthcare systems up to $400,000 a year per patient, there is scope for AVR-RD-02 to cut the cost of treating Gaucher disease.

Avrobio shared the early look at clinical data on AVR-RD-02 alongside updates about other assets. There is now more than three years of data on some Fabry patients treated with Avrobio’s lead asset, putting the company in a position to plot a path to accelerated approval. Avrobio plans to submit its briefing book to the FDA by the end of the year to align on an accelerated approval strategy. 

The update also covered cystinosis candidate AVR-RD-04. The first patient to receive the candidate is off oral and eye drop cysteamine 12 months after receiving the gene therapy. The number of crystals in the patient’s skin are down 56%, leading Avrobio to posit they may have gained the ability to make their own functional cystinosin protein.  

 

Biotechnology timeline: Humans have manipulated genes since the ‘dawn of civilization’

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Historically, biotech has been primarily associated with food, addressing such issues as malnutrition and famine.

Today, biotechnology is most often associated with the development of drugs. But drugs are hardly the future of biotech. We’ve entered the Fourth Industrial Revolution, and genetics are on a new level. Biotech is paving a way for a future open to imagination, and that’s kind of scary.

The next ten years will surely prove exciting as artificial intelligence and biotechnology merge man and machine…

The history of biotechnology can be divided into three distinct phases:

  1. Ancient Biotechnology

  2. Classical Biotechnology

  3. Modern Biotechnology

1. Ancient Biotechnology (Pre-1800)

Most of the biotech developments before the year 1800 can be termed as ‘discoveries’ or ‘developments’. If we study all these developments, we can conclude that these inventions were based on common observations about nature.

 
  • Humans have used biotechnology since the dawn of civilization.
  • After domestication of food crops (corn, wheat) and wild animals, man moved on to other new observations like cheese and curd.  Cheese can be considered as one of the first direct products (or by-product) of biotechnology because it was prepared by adding rennet (an enzyme found in the stomach of calves) to sour milk.
  • Yeast is one of the oldest microbes that have been exploited by humans for their benefit. The oldest fermentation was used to make beer in Sumeria and Babylonia as early as 7,000BCE.
  • By 4,000BCE, Egyptians used yeasts to bake leavened bread.

 

  • Another ancient product of fermentation was wine, made in Assyria as early as 3,500BCE.
  • The Chinese developed fermentation techniques for brewing and cheese making.
  • 500 BCE: In China, the first antibiotic, moldy soybean curds, is put to use to treat boils.
  • Hippocrates treated patients with vinegar in 400 BCE.
  • In 100BCE, Rome had over 250 bakeries which were making leavened bread.

 

  • A.D. 100: The first insecticide is produced in China from powdered chrysanthemums.
  • The use of molds to saccharify rice in the koji process dates back to at least A.D. 700.
  • 13th century: The Aztecs used Spirulina algae to make cakes.
  • One of the oldest examples of crossbreeding for the benefit of humans is mule. Mule is an offspring of a male donkey and a female horse. People started using mules for transportation, carrying loads, and farming, when there were no tractors or trucks.
  • By the 14th century AD, the distillation of alcoholic spirits was common in many parts of the world.

 

  • Vinegar manufacture began in France at the end of the 14th century.
  • 1663: Cells are first described by Hooke.
  • 1673-1723: In the seventeenth century, Antonie van Leeuwenhoek discovered microorganisms by examining scrapings from his teeth under a microscope.
  • 1675: Leeuwenhoek discovers protozoa and bacteria.
  • 1761: English surgeon Edward Jenner pioneers vaccination, inoculating a child with a viral smallpox vaccine.

nucleus

 

2. Classical Biotechnology (1800-1945)

  • The Hungarian Károly Ereky coined the word “biotechnology” in Hungary during 1919 to describe a technology based on converting raw materials into a more useful product. In a book entitled Biotechnologie, Ereky further developed a theme that would be reiterated through the 20th century: biotechnology could provide solutions to societal crises, such as food and energy shortages.
  • 1773-1858: Robert Brown discovered the nucleus in cells.
  • 1802: The word “biology” first appears.
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  • 1822-1895: Vaccination against small pox and rabies developed by Edward Jenner and Louis Pasteur.
  • In 1850, Casimir Davaine detected rod-shaped objects in the blood of anthrax-infected sheep and was able to produce the disease in healthy sheep by inoculation of such blood.
  • 1855: The Escherichia coli bacterium is discovered. It later becomes a major research, development, and production tool for biotechnology.
  • In 1868, Fredrich Miescher reported nuclein, a compound that consisted of nucleic acid that he extracted from white blood cells.
  • 1870: Breeders crossbreed cotton, developing hundreds of varieties with superior qualities.cotton
  • 1870: The first experimental corn hybrid is produced in a laboratory.
  • By 1875, Pasteur of France and John Tyndall of Britain finally demolished the concept of spontaneous generation and proved that existing microbial life came from preexisting life.
  • 1876: Koch’s work led to the acceptance of the idea that specific diseases were caused by specific organisms, each of which had a specific form and function.
  • In 1881, Robert Koch, a German physician, described bacterial colonies growing on potato slices (First ever solid medium).

 

  • In 1888, Heinrich Wilhelm Gottfried Von Waldeyer-Hartz, a German scientist, coined the term ‘Chromosome.’
  • In 1909, the term ‘Gene’ had already been coined by Wilhelm Johannsen (1857-1927), who described ‘gene’ as carrier of heredity. Johannsen also coined the terms ‘genotype’ and ‘phenotype.’
  • 1909: Genes are linked with hereditary disorders.
  • 1911: American pathologist Peyton Rous discovers the first cancer-causing virus.
  • 1915: Phages, or bacterial viruses, are discovered.
  • 1919: The word “biotechnology” is first used by a Hungarian agricultural engineer.
  • Pfizer, which had made fortunes using fermenting processes to produce citric acid in the 1920s, turned its attention to penicillin. The massive production of penicillin was a major factor in the Allied victory in WWII.

 

  • 1924: start of Eugenic Movement in the US.
  • The principle of genetics in inheritance was redefined by T.H. Morgan, who showed inheritance and the role of chromosomes in inheritance by using fruit flies. This landmark work was named, ‘The theory of the Gene in 1926.”
  • Alexander Fleming discovered ‘penicillin’ the antibacterial toxin from the mold Penicillium notatum, which could be used against many infectious diseases. Fleming wrote, “When I woke up just after dawn on September 28, 1928, I certainly didn’t plan to revolutionize all medicine by discovering the world’s first antibiotic, or bacteria killer.

 

  • 1933: Hybrid corn is commercialized.
  • In 1940, a team of researchers at Oxford University found a way to purify penicillin and keep it stable.
  • 1941: The term “genetic engineering” is first used by a Danish microbiologist.
  • 1942: The electron microscope is used to identify and characterize a bacteriophage- a virus that infects bacteria.
  • 1942: Penicillin is mass-produced in microbes for the first time.

DNA

 

3. Modern Biotechnology (1945-present)

The Second World War became a major impediment in scientific discoveries. After the end of the second world war some, very crucial discoveries were reported, which paved the path for modern biotechnology.

The origins of biotechnology culminated with the birth of genetic engineering. There were two key events that have come to be seen as scientific breakthroughs beginning the era that would unite genetics with biotechnology: One was the 1953 discovery of the structure of DNA, by Watson and Crick, and the other was the 1973 discovery by Cohen and Boyer of a recombinant DNA technique by which a section of DNA was cut from the plasmid of an E. coli bacterium and transferred into the DNA of another. Popularly referred to as “genetic engineering,” it came to be defined as the basis of new biotechnology.
  • In Britain, Chaim Weizemann (1874–1952) developed bacterial fermentation processes for producing organic chemicals such as acetone and cordite propellants. During WWII, he worked on synthetic rubber and high-octane gas.

 

  • 1950s: The first synthetic antibiotic is created.
  • 1951: Artificial insemination of livestock is accomplished using frozen semen.
  • In 1953, JD Watson and FHC Crick for the first time cleared the mysteries around the DNA as a genetic material, by giving a structural model of DNA, popularly known as, ‘Double Helix Model of DNA.’
  • 1954: Dr. Joseph Murray performs the first kidney transplant between identical twins.
  • 1955: An enzyme, DNA polymerase, involved in the synthesis of a nucleic acid, is isolated for the first time.
  • 1955: Dr. Jonas Salk develops the first polio vaccine. The development marks the first use of mammalian cells (monkey kidney cells) and the first application of cell culture technology to generate a vaccine.
  • 1957: Scientists prove that sickle-cell anemia occurs due to a change in a single amino acid in hemoglobin cells
  • 1958: Dr. Arthur Kornberg of Washington University in St. Louis makes DNA in a test tube for the first time.
  • Edward Tatum (1909–1975) and Joshua Lederberg (1925–2008) shared the 1958 Nobel Prize for showing that genes regulate the metabolism by producing specific enzymes.

 

  • 1960: French scientists discover messenger RNA (mRNA).
  • 1961: Scientists understand genetic code for the first time.
  • 1962: Dr. Osamu Shimomura discovers the green fluorescent protein in the jellyfish Aequorea victoria. He later develops it into a tool for observing previously invisible cellular processes.
  • 1963: Dr. Samuel Katz and Dr. John F. Enders develop the first vaccine for measles.
  • 1964: The existence of reverse transcriptase is predicted.
  • At a conference in 1964, Tatum laid out his vision of “new” biotechnology: “Biological engineering seems to fall naturally into three primary categories of means to modify organisms. These are: 1. The recombination of existing genes, or eugenics. 2. The production of new genes by a process of directed mutation, or genetic engineering. 3. Modification or control of gene expression, or to adopt Lederberg’s suggested terminology, euphenic engineering.”
  • 1967: The first automatic protein sequencer is perfected.
  • 1967: Dr. Maurice Hilleman develops the first American vaccine for mumps.
  • 1969: An enzyme is synthesized in vitro for the first time.
  • 1969: The first vaccine for rubella is developed.

 

  • 1970: Restriction enzymes are discovered.
  • 1971: The measles/mumps/rubella combo-vaccine was formed.
  • 1972: DNA ligase, which links DNA fragments together, is used for the first time.
  • 1973: Cohen and Boyer perform the first successful recombinant DNA experiment, using bacterial genes.
  • In 1974, Stanley Cohen and Herbert Boyer developed a technique for splicing together strands of DNA from more than one organism. The product of this transformation is called recombinant DNA (rDNA).
  • Kohler and Milestein in 1975 came up with the concept of cytoplasmic hybridization and produced the first ever monoclonal antibodies, which has revolutionized diagnostics.
  • Techniques for producing monoclonal antibodies were developed in 1975.
  • 1975: Colony hybridization and Southern blotting are developed for detecting specific DNA sequences.
  • 1976: Molecular hybridization is used for the prenatal diagnosis of alpha thalassemia.
  • 1978: Recombinant human insulin is produced for the first time.
  • 1978: with the development of synthetic human insulin the biotechnology industry grew rapidly.
  • 1979: Human growth hormone is synthesized for the first time.

 

  • In the 1970s-80s, the path of biotechnology became intertwined with that of genetics.
  • By the 1980s, biotechnology grew into a promising real industry.
  • 1980: Smallpox is globally eradicated following 20-year mass vaccination effort.
  • In 1980, The U.S. Supreme Court (SCOTUS), in Diamond v. Chakrabarty, approved the principle of patenting genetically engineered life forms.
  • 1981: Scientists at Ohio University produce the first transgenic animals by transferring genes from other animals into mice.
  • 1981: The first gene-synthesizing machines are developed.
  • 1981: The first genetically engineered plant is reported.
  • 1982: The first recombinant DNA vaccine for livestock is developed.
  • 1982: The first biotech drug, human insulin produced in genetically modified bacteria, is approved by FDA. Genentech and Eli Lilly developed the product. This is followed by many new drugs based on biotechnologies.
  • 1983: The discovery of HIV/AIDS as a deadly disease has helped tremendously to improve various tools employed by life-scientist for discoveries and applications in various aspects of day-to-day life.
  • In 1983, Kary Mullis developed polymerase chain reaction (PCR), which allows a piece of DNA to be replicated over and over again. PCR, which uses heat and enzymes to make unlimited copies of genes and gene fragments, later becomes a major tool in biotech research and product development worldwide.
  • 1983: The first artificial chromosome is synthesized.
  • In 1983, the first genetic markers for specific inherited diseases were found.
  • 1983: The first genetic transformation of plant cells by TI plasmids is performed.
  • In 1984, the DNA fingerprinting technique was developed.
  • 1985: Genetic markers are found for kidney disease and cystic fibrosis.
  • 1986: The first recombinant vaccine for humans, a vaccine for hepatitis B, is approved.
  • 1986: Interferon becomes the first anticancer drug produced through biotech.
  • 1986: University of California, Berkeley, chemist Dr. Peter Schultz describes how to combine antibodies and enzymes (abzymes) to create therapeutics.
  • 1988: The first pest-resistant corn, Bt corn, is produced.corn
  • 1988: Congress funds the Human Genome Project, a massive effort to map and sequence the human genetic code as well as the genomes of other species.
  • In 1988, chymosin (known as Rennin) was the first enzyme produced from a genetically modified source-yeast-to be approved for use in food.
  • In 1988, only five proteins from genetically engineered cells had been approved as drugs by the United States Food and Drug Administration (FDA), but this number would skyrocket to over 125 by the end of the 1990s.
  • In 1989, microorganisms were used to clean up the Exxon Valdez oil spill.

 

  • 1990: The first successful gene therapy is performed on a 4-year-old girl suffering from an immune disorder.
  • In 1993, The U.S. Food and Drug Administration (FDA) declared that genetically modified (GM) foods are “not inherently dangerous” and do not require special regulation.
  • 1993: Chiron’s Betaseron is approved as the first treatment for multiple sclerosis in 20 years.
  • 1994: The first breast cancer gene is discovered.
  • 1995: Gene therapy, immune-system modulation and recombinantly produced antibodies enter the clinic in the war against cancer.
  • 1995: The first baboon-to-human bone marrow transplant is performed on an AIDS patient.
  • 1995: The first vaccine for Hepatitis A is developed.
  • 1996: A gene associated with Parkinson’s disease is discovered.
  • 1996: The first genetically engineered crop is commercialized.
  • 1997: Ian Wilmut, an Irish scientist, was successful in cloning an adult animal, using sheep as a model and naming the cloned sheep ‘Dolly.’
  • 1997: The first human artificial chromosome is created.
  • 1998: A rough draft of the human genome map is produced, showing the locations of more than 30,000 genes.
  • 1998: Human skin is produced for the first time in the lab.
  • 1999: A diagnostic test allows quick identification of Bovine Spongiform Encephalopathy (BSE, also known as “mad cow” disease) and Creutzfeldt-Jakob Disease (CJD).
  • 1999: The complete genetic code of the human chromosome is deciphered.

 

  • 2000: Kenya field-tests its first biotech crop, virus-resistant sweet potato.
  • Craig Venter, in 2000, was able to sequence the human genome.
  • 2001: The sequence of the human genome is published in Science and Nature, making it possible for researchers all over the world to begin developing treatments.
  • 2001: FDA approves Gleevec® (imatinib), a gene-targeted drug for patients with chronic myeloid leukaemia. Gleevec is the first gene-targeted drug to receive FDA approval.
  • 2002: EPA approves the first transgenic rootworm-resistant corn.
  • 2002: The banteng, an endangered species, is cloned for the first time.
  • 2003: China grants the world’s first regulatory approval of a gene therapy product, Gendicine (Shenzhen SiBiono GenTech), which delivers the p53 gene as a therapy for squamous cell head and neck cancer.
  • In 2003, TK-1 (GloFish) went on sale in Taiwan, as the first genetically modified pet.
  • 2003: The Human Genome Project completes the sequencing of the human genome.
  • 2004: UN Food and Agriculture Organization endorses biotech crops, stating biotechnology is a complementary tool to traditional farming methods that can help poor farmers and consumers in developing nations.
  • 2004: FDA approves the first antiangiogenic drug for cancer, Avastin®.
  • 2005: The Energy Policy Act is passed and signed into law, authorizing numerous incentives for bioethanol development.
  • 2006: FDA approves the recombinant vaccine Gardasil®, the first vaccine developed against human papillomavirus (HPV), an infection implicated in cervical and throat cancers, and the first preventative cancer vaccine.
  • 2006: USDA grantsDow AgroSciences the first regulatory approval for a plant-made vaccine.
  • 2006: The National Institutes of Health begins a 10-year, 10,000-patient study using a genetic test that predicts breast-cancer recurrence and guides treatment.
  • In 2006, the artist Stelarc had an ear grown in a vat and grafted onto his arm.
  • 2007: FDA approves the H5N1 vaccine, the first vaccine approved for avian flu.
  • 2007: Scientists discover how to use human skin cells to create embryonic stem cells.
  • 2008: Chemists in Japan create the first DNA molecule made almost entirely of artificial parts.
  • 2009: Global biotech crop acreage reaches 330 million acres.
  • In 2009, Sasaki and Okana produced transgenic marmosets that glow green in ultraviolet light (and pass the trait to their offspring).
  • 2009: FDA approves the first genetically engineered animal for production of a recombinant form of human antithrombin.
  • In 2010, Craig Venter was successful in demonstrating that a synthetic genome could replicate autonomously.

 

  • 2010: Dr.  J. Craig Venter announces completion of “synthetic life” by transplanting synthetic genome capable of self-replication into a recipient bacterial cell.
  • 2010: Harvard researchers report building “lung on a chip” – technology.
  • 2011: Trachea derived from stem cells transplanted into human recipient.
  • 2011: Advances in 3-D printing technology lead to “skin-printing.”
  • 2012: For the last three billion years, life on Earth has relied on two information-storing molecules, DNA and RNA. Now there’s a third: XNA, a polymer synthesized by molecular biologists Vitor Pinheiro and Philipp Holliger of the Medical Research Council in the United Kingdom. Just like DNA, XNA is capable of storing genetic information and then evolving through natural selection. Unlike DNA, it can be carefully manipulated.
  • 2012: Researchers at the University of Washington in Seattle announced the successful sequencing of a complete fetal genome using nothing more than snippets of DNA floating in its mother’s blood.
  • 2013: Two research teams announced a fast and precise new method for editing snippets of the genetic code. The so-called CRISPR system takes advantage of a defense strategy used by bacteria.

crispr

  • 2013: Researchers in Japan developed functional human liver tissue from reprogrammed skin cells.
  • 2013:  Researchers published the results of the first successful human-to-human brain interface.
  • 2013: Doctors announced that a baby born with HIV had been cured of the disease.
  • 2014: Researchers showed that blood from a young mouse can rejuvenate an old mouse’s muscles and brain.
  • 2014: Researchers figured out how to turn human stem cells into functional pancreatic β cells—the same cells that are destroyed by the body’s own immune system in type 1 diabetes patients.
  • 2014: All life on Earth as we know it encodes genetic information using four DNA letters: A, T, G, and C. Not anymore! In 2014, researchers created new DNA bases in the lab, expanding life’s genetic code and opening the door to creating new kinds of microbes.
  • 2014: For the first time ever, a woman gave birth to a baby after receiving a womb transplant.
  • In 2014, team of scientists reconstructed a synthetic and fully functional yeast chromosome. A breakthrough seven years in the making, the remarkable advance could eventually lead to custom-built organisms (human organisms included).
  • 2014 & Ebola: Until this year, ebola was merely an interesting footnote for anyone studying tropical diseases. Now it’s a global health disaster. But the epidemic started at a single point with one human-animal interaction — an interaction which has now been pinpointed using genetic research. A total of 50 authors contributed to the paper announcing the discovery, including five who died of the disease before it could be published.
  • 2014: Doctors discovered a vaccine that totally blocks infection altogether in the monkey equivalent of the disease — a breakthrough that is now being studied to see if it works in humans.
  • 2015: Scientists from Singapore’s Institute of Bioengineering and Nanotechnology designed short strings of peptides that self-assemble into a fibrous gel when water is added for use as a healing nanogel.
  • 2015 & CRISPR: scientists hit a number of breakthroughs using the gene-editing technology CRISPR. Researchers in China reported modifying the DNA of a nonviable human embryo, a controversial move. Researchers at Harvard University inserted genes from a long-extinct woolly mammoth into the living cells — in a petri dish — of a modern elephant. Elsewhere, scientists reported using CRISPR to potentially modify pig organs for human transplant and modify mosquitoes to eradicate malaria.
  • 2015: Researchers in Sweden developed a blood test that can detect cancer at an early stage from a single drop of blood.
  • 2015: Scientists discovered a new antibiotic, the first in nearly 30 years, that may pave the way for a new generation of antibiotics and fight growing drug-resistance. The antibiotic, teixobactin, can treat many common bacterial infections, such as tuberculosis, septicaemia, and C. diff.
  • 2015: A team of geneticists finished building the most comprehensive map of the human epigenome, a culmination of almost a decade of research. The team was able to map more than 100 types of human cells, which will help researchers better understand the complex links between DNA and diseases.
  • 2015: Stanford University scientists revealed a method that may be able to force malicious leukemia cells to change into harmless immune cells, called macrophages.
  • 2015: Using cells from human donors, doctors, for the first time, built a set of vocal cords from scratch. The cells were urged to form a tissue that mimics vocal fold mucosa – vibrating flaps in the larynx that create the sounds of the human voice.
  • 2016: A little-known virus first identified in Uganda in 1947—Zika—exploded onto the international stage when the mosquito-borne illness began spreading rapidly throughout Latin America. Researchers successfully isolated a human antibody that “markedly reduces” infection from the Zika virus.
  • 2016: CRISPR, the revolutionary gene-editing tool that promises to cure illnesses and solve environmental calamities, took a major step forward this year when a team of Chinese scientists used it to treat a human patient for the very first time.
  • 2016: Researchers found that an ancient molecule, GK-PID, is the reason single-celled organisms started to evolve into multicellular organisms approximately 800 million years ago.
  • 2016: Stem Cells Injected Into Stroke Patients Re-Enable Patient To Walk.
  • 2016:  Cloning does not cause long-term health issues, study finds
  • 2016: For the first time, bioengineers created a completely 3D-printed ‘heart on a chip.’
  • 2017: Researchers at the National Institute of Health discovered a new molecular mechanism that might be the cause of severe premenstrual syndrome known as PMDD.
  • 2017: Scientists at the Salk Institute in La Jolla, CA, said they’re one step closer to being able to grow human organs inside pigs. In their latest research they were able to grow human cells inside pig embryos, a small but promising step toward organ growth.pig embryo
  • 2017: First step taken toward epigenetically modified cotton.

 

  • 2017: Research reveals different aspects of DNA demethylation involved in tomato ripening process.
  • 2017: Sequencing of green alga genome provides blueprint to advance clean energy, bioproducts.
  • 2017: Fine-tuning ‘dosage’ of mutant genes unleashes long-trapped yield potential in tomato plants.
  • 2017: Scientists engineer disease-resistant rice without sacrificing yield.
  • 2017: Blood stem cells grown in lab for the first time.
  • 2017: Researchers at Sahlgrenska Academy – part of the University of Gothenburg, Sweden – generated cartilage tissue by printing stem cells using a 3D-bioprinter.
  • 2017: Two-way communication in brain-machine interface achieved for the first time.

Today, biotechnology is being used in countless areas including agriculture, bioremediation and forensics, where DNA fingerprinting is a common practice. Industry and medicine alike use the techniques of PCR, immunoassays and recombinant DNA.

Genetic manipulation has been the primary reason that biology is now seen as the science of the future and biotechnology as one of the leading industries.

Source: Biotechnology timeline: Humans have manipulated genes since the ‘dawn of civilization’ –  Brian Colwell

Modernising pharma patents: can AI be an inventor?

Modernising pharma patents: can AI be an inventor?

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AI has revolutionised healthcare by dramatically speeding up drug discovery and development. Despite this, patent offices have made it clear that because AI is it not human, it cannot be classed as an inventor in its own right. Allie Nawrat talks to Potter Clarkson IP attorney Peter Finnie about how patent law needs to be brought up to date to reflect the important contribution AI makes to inventions in pharma.

Patents are used to grant exclusive property rights to an inventor and prevent their discovery from being copied by others. The main requirements for a patent are that the invention must be novel, non-obvious and be useful or have an industrial application.

Patents are a central part of how pharma does business. Pharma products require longer and more complex research and development (R&D) cycles than products in other industries. Consequently, companies invest significant amounts of money into their new products early on in their development. Patent protection enables companies to recoup R&D investment and continue to produce innovative, new drugs in the future.

Throughout history, the entity listed as an inventor on a patent application has been a ‘natural person’, or a human, who then might decide to assign those rights to the invention to their employer. For instance, in the pharma industry, the so-called ‘inventor’ is usually the pharmacologist who works for a specific company.

However, as technology – particularly artificial intelligence (AI) – becomes increasingly useful in speeding up innovation and discoveries, a team led by University of Surrey professor Ryan Abbott decided to test whether AI could be an inventor.

Can AI be an inventor?

As part of the Artificial Inventor Project, in mid-2019, Abbott filed patents on behalf of Imagination Engines’ Stephen Thaler for a warning light and a food container to the European Patent Office (EPO) and United Kingdom Intellectual Property Office (UKIPO).

On the patent application, the inventor was listed as DABUS AI, not Thaler, because these were deemed to be so-called AI-generated inventions: “inventions generated autonomously by AI under circumstances, in which we believe that no natural person, as traditionally defined, qualifies as an inventor,” explained Abbott in an article for the World Intellectual Property Organization (WIPO). The application then argued that Thaler, as the AI’s owner, would be the owner of any issued patents.

Although the EPO and UKIPO accepted that these inventions were patentable, in December 2019, both rejected the application because the inventor was not human.

A related issue is that “only a natural person can convey the rights that they would otherwise own as an inventor, such as to their employer,” explains Potter Clarkson partner and patent attorney Peter Finnie.

The EPO’s decision states: “The designation of an inventor… bears a series of legal consequences, notably to ensure that the designated inventor is the legitimate one and that he or she can benefit from rights linked to this status. To exercise these rights, the inventor must have a legal personality that AI systems or machines do not enjoy.”

The bottom line then, according to the EPO and UKIPO’s decision on DABUS sends is that AI cannot be an inventor.

What implications could this have on AI’s contribution to patentable inventions, particularly in the pharma industry where AI’s use is becoming commonplace and patents are central to financial viability?

Implications for AI-assisted discoveries

Finnie is very clear that AI-generated innovation, such as the DABUS example, is not currently mainstream in any industry, and particularly in pharma.

AI has undoubtedly revolutionised the pharma industry. It has drastically accelerated drug discovery, development and repurposing, and thereby brought drugs to at-need patients much more quickly. Life and medical sciences are one of the top three sectors where AI is most employed, according to the WIPO.

Finnie classes the way AI is used in pharma as AI-assisted, rather than generated, invention. “I don’t see a compelling case yet that the use of AI and machine learning in the pharma industry is anything more than a very sophisticated number crunching,” he explains. “There is still an awful lot of inventive effort required to train it and use the results to work out sensible solutions.”

Where AI only assists in discoveries it would not be designated as an inventor – the human who programmed it or performed the related lab work would be. AI-assisted invention “doesn’t change who the inventors are, it just speeds up the process”, notes Finnie.

However, AI “is likely to have, increasingly in the future, a significant impact on the creation, production and distribution of economic and cultural goods and services”, according to a WIPO Secretariat discussion document.

There is a possibility and “risk that AI-assisted innovation in pharma will be assessed to a different [and perhaps higher] standard”. Also, it is possible that “exclusion of the AI contribution will mean there are no true inventors under the current patent system”, notes Finnie.

The obviousness test

Finnie explains: “If it starts to get into people’s minds that somehow computer-assisted innovation should be treated differently from human-generated innovation, then you start to get a challenge.”

He is particularly concerned about people starting to “buy into the anthropomorphic properties of computers”, which could lead to them turn around and say “well if the computer told you to do it, it must be obvious”.

This would threaten pharma’s ability to get a patent for that invention because, for something to be patentable, legally, it must be deemed to be novel and non-obvious. The test for obviousness is whether it would be obvious or not to a ‘person skilled in the relevant art’.

The WIPO Secretariat is aware of this challenge; in a discussion paper, it asks if when looking at AI-assisted or generated inventions, “is it necessary to retain the traditional requirements of inventive step or non-obviousness, which are fundamentally associated with human acts of invention?” and “should the art be the field of technology of the product or process that emerges as the invention from the AI application?”

Making the patent system fit for purpose

There is a need to ensure that “drugs discovered or re-purposed using AI areas patentable as if they were derived without the use of AI”, Finnie states. “The patent system must not evolve to penalise the use of AI by removing or weakening the available protection.” Patents are sacred to the pharma industry: “In the pharma space, if you can’t get a patent then you won’t do it.”

If there becomes a credibility gap about who invented something – particularly around the obviousness of that invention – this could lead to a situation where pharma is disincentivised from using AI to support its inventions, which could have dramatic consequences for drug discovery and, ultimately at-need patients.

Instead, to encourage people to innovate by rewarding that through patents, Finnie argues “we need to recognise that… AI is a contributor to the invention”; currently, regulators do not recognise them as having a contribution, a viewpoint that is increasingly outdated given AI’s important contribution to discoveries in the pharma industry.

The next step would be to give AI as an entity “legal rights in the same way as we give companies legal rights”. “You have natural persons and legal persons, so maybe you could have a third person, which is an electronic person. This could plug the [credibility] gap” and mean you haven’t got a missing contributor to the invention or inventor, notes Finnie.

Finnie also says there needs to be a modification of the definition of a ‘person skilled in the art’ to include an AI platform, as this would deal with the non-obviousness argument. He states: “One way of dealing with this is to raise the bar slightly and say where machine learning is involved the invention has to have a little extra quality to it because it has used these special powers that we [as humans] don’t have.”

Global patent offices are aware of and open to this need to re-evaluate and modernise patent laws so they are fit for purpose in a world with AI. This discussion was already in the process over the past few years, but the DABUS decision in late 2019 has pushed it further up the agenda.

Indeed, the largest five patent offices in the world – the EPO, Korean Intellectual Property Office, Japan Patent Office, China National Intellectual Property Administration and the United States Patent and Trademark Office – collectively known as IP5, are creating a joint task force to look into new emerging technologies, such as AI, and discuss the challenges and potential solutions.

Source: Pharmaceutical-Technology.com

 

Revolutionary Life Sciences and Healthcare solutions for early investors unveiled at MedTech

Early bird families, private wealth holders, healthcare corporations and venture capitalists will access cutting-edge life science innovations at Campden Wealth’s milestone 30th MedTech Investing Europe Conference, only a month away on 21-22 October, 2020.

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Belgian company AuXin Surgery said it was the first and only company to launch medical devices for chemically assisted dissection to aid such operations as spine surgery, ear surgery, musculoskeletal surgery and hand surgery while preserving such critical organs as nerves, muscles or vessels. Its fully innovative dissection system, named CADISS, was already being used by several surgeons and the company was signing multiple distribution contracts around the world.

Benoît Verjans, chief executive of AuXin SurgeryInvented by surgeons for surgeons, AuXin Surgery said the benefits of CADISS were numerous for the patient with fewer side-effects and relapses. The surgeon benefitted with faster and easier surgery, no equipment investment, no change of practice. The healthcare system benefitted with the reduction of costs linked to side-effects and relapses, better success rate for the surgery and better quality of life for the patient.

Benoit Verjans (right) is chief executive of AuXim Surgery.

Based in Denmark, Biomodics devised a new catheter to prevent and treat urinary tract infections, a relief to 20,000 patients who suffer a urinary tract infection every year while they are admitted to a Danish hospital, mainly because they have a catheter inserted.

The balloon that sits at the tip of the Biomodics catheter is made with a new type of permeable silicone material. This meant that some types of liquid, such as liquid antibiotics, could penetrate it. The new catheter has been tested on pigs, which have the same sensitivity to bacteria in the bladder as humans. During six months of tests, the bladders of the pigs that received the new catheter were completely free of bacteria, whereas all the control pigs that had had a regular catheter had cystitis, Biomodics said. It expected to be able to begin testing the catheter on humans later this year then put the device into production upon approval.

Peter Thomsen (below) is chief executive of Biomedics.

Peter Thomsen, chief executive of Biomodics

ORamaVR said it was working to revolutionise medical and surgical education through intelligent virtual reality training simulations. The Swiss company wanted to bridge the skills gap, modernise standards and foster remote access using MAGES, its hyper-realistic, virtual-reality simulation-based proprietary software platform for accelerated medical training and assessment.

ORamaVR said the cohort of medics which used its technology demonstrated greater improvement in all score categories compared to the standard group in a clinical trial. Proficiency increased 8% after only two 20-minute VR sessions, the company said.

ORamaVR said it is one year ahead of the $680 billion medical and surgical education market. Its target customers included medical universities, hospital systems, surgical training centres and non-governmental organisations.

Paolo Alejandro Catilo (below) is chief commercial officer of ORamaVR.

US industry experts who worked in endoscopy visual optics for years and successfully introduced impactful devices for physicians and their patients founded their own medtech company 270Surgical in 2016. The first 270Surgical product was the SurroundScope System, which consisted of a hardware, software and electro-optic solution that incorporated a myriad of lenses at the distal end of the scope. The result was a specialty laparoscopic system that addressed three long-standing challenges in laparoscopy, including restricted field-of-view, surgical smoke (plume), and lens fogging.

Paolo Alejandro Catilo, chief commercial officer of ORamaVR

The SurroundScope was the first marketable laparoscope that offered up to a 270-degree field-of-view, which was an increase of 200% compared to other laparoscopes in the market. The company said this expanded field-of-view would considerably benefit general surgery, trauma, OBGYN, and thoracic surgery.

The venture was backed by leading surgeons and by investment funds specialised in medical devices.

Visit MedTechInvesting.com for more information, to download the brochure and to register for the Campden Wealth 30th MedTech Investing Europe Conference on 21-22 October, 2020.

Source: campden FB

Researchers Vie To Employ AI For Cancer Immunotherapy

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In the bid to develop tools for the fight against cancer, artificial intelligence (AI) tools being developed at Case Western Reserve University have to be established in strict human clinical trials. The validation of the tool may be a step close following two recent agreements a bioengineering pioneer at New York University and select large pharmaceutical companies.

“The step is an important one for validating the research, and for further advancing efforts to get the right treatment for patients who will benefit most,” stated the research associate. The potential of AI, computational imaging tools to predict an individual response of cancer patient to immunotherapy is shown, added the research associate.

Meanwhile, recent research at the Center for Computational Imaging and personalized Diagnostics demonstrates that AI and ML can be employed in the fight against cancer. These technologies can predict patients who will benefit from immunotherapy.

To use AI and ML, researchers intrinsically teach computers to seek and detect changes in patterns of CT scans. It involves detecting changes in patterns of CT scans taken at the time when lung cancer diagnosed, and the scans taken during immunotherapy treatment.

Besides Immunotherapy, AI Algorithms to find use for Tissue biopsy

Besides this, the researchers have been training AI algorithms for tissue biopsy images of cancer patients. This involves use of the algorithms to study patterns of tissue biopsy images of these patients and to identify the possibility of favorable response to treatment. The algorithms are being trained for use beyond lung cancer. Meanwhile, computational approaches for predicting immunotherapy response of gynecologic cancers showcased at the American Society of Clinical Oncology meeting in May, 2020.

While the benefit of immunotherapy for cancer patients established, the quest of researchers now is beyond this. They are seeking an improved way to identify patients who are most likely to respond to this treatment.

Source: TMR Blog

Hospital robotics: democratising global healthcare

Robotics and digital automation are beginning to sweep through several major industry segments, but perhaps one of the most fascinating is healthcare.

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Whilst advanced machinery capable of performing the most delicate surgeries was once the domain of science-fiction or simply a goal to aspire towards, the reality is that we are now living in an era where health services are on the verge of being transformed in very exciting ways. The COVID-19 pandemic has illustrated the necessity for integrating digital technologies such as robotic process automation (RPA) and artificial intelligence (AI) software into everyday business operations and it is in this regard that hospital robotics forms a timely focus. Far from being a competitor to human workers, robots in healthcare are a unique opportunity to combine the abilities of both humans and people to achieve significantly better outcomes for patients. 

In addition to featuring insights from McKinsey, PwC and Deloitte, we spoke with Christophe Assenmacher, Head of Urology at Clinics of Europe (Cliniques de l’Europe) St Elizabeth’s and Trainer in Robotic Surgery at Intuitive Surgical, to get an informed perspective from the frontline of this topic.

How is robotic automation benefitting hospitals?

Assenmacher states that hospitals are demonstrating the key advantages of robotic automation, namely the enhanced service level which comes from combining the consistent, tireless and fast operational pace of machines with the creativity, empathy and quality controlling abilities of human staff. “Take the surgeon,” he explains. “While they spend years studying, their ability to function under pressure, make precise movements and many other skills can be augmented by a robot to significant impact.” Indeed, whilst some patients might still feel hesitant to undergo surgery that is entirely automated, having a highly-trained and competent surgeon at the helm aided by a robot’s precision could reassure them they are receiving optimal treatment throughout.

Costs for protracted hospital stays, the unavailability of hospital beds and the overall effectiveness of treatment are all aspects which can have a deleterious effect on healthcare generally. Making improvements to patient care is obviously the name of the game, yet the benefits to robotic-optimised surgery go beyond the operating theatre and ultimately impact the entire hospital: “From my own practice, I’ve seen that robot-assisted surgery typically halves the length of hospital stays, reduces bleeding and blood transfusions, shrinks the risk of infection, lessens the requirement for painkillers and ultimately improves the standard of care for our patients,” Assenmacher states. Furthermore, of particular relevance during incidences of highly infectious disease such as COVID-19, robots can be deployed to perform essential tasks that would otherwise place people at risk, such as disinfecting rooms and dispensing medication. Assenmacher intimates that these capabilities could simply be the tip of the automation iceberg: “We certainly expect to see an evolution of nanorobots in the bloodstream, digital pills and social companion robots.”  

Assenmacher states that he personally uses the da Vinci Surgical System when performing specialised urological procedures, although the same equipment can be used for general surgery as well as cardiac, colorectal, gynaecological, head and neck and thoracic procedures too. 

The company’s website points out that a common misunderstanding of current surgical robotics is that machines carry out procedures independently of surgeons. This is incorrect: the da Vinci system functions as a tool or instrument by which the operator carries out the procedure using a control panel.

“The da Vinci system translates your surgeon’s hand movements at the console in real-time, bending and rotating the instruments while performing the procedure. The tiny wristed instruments move like a human hand, but with a greater range of motion. The da Vinci vision system also delivers highly magnified, 3D high-definition views of the surgical area.”

How could robotics change healthcare?

Cost

Although it might seem counter-intuitive to spend significant sums of money on robotics in healthcare with the aim of making healthcare universally cheaper, Assenmacher states that this is exactly what could happen given investment, both in public and private healthcare settings. “There may be short-term dislocations or discrepancies but I think it’s unlikely that these divergences will remain,” he posits. “Robots can improve patient care and reduce costs in the long-term, meaning both public and private healthcare systems will benefit in terms of patient care and finances.” This isn’t to say that efforts won’t need to be made in order to effect such change: the initial capital expenditure on equipment, ongoing maintenance and training will still need to be factored in, as well as upgrading the robots themselves, “I also believe that there will need to be dramatic reductions in size and a shift from cable-driven electromechanical systems to more purely digital systems.”

Further to this point, Deloitte points out in ‘Taking the robot out of the human: Meet the health care workforce of the future’ that “labour is a major part of healthcare costs. Among hospitals, labour is typically the largest line item in any hospital’s budget and accounts for almost 60% of non capital costs.

“Health plans and life sciences companies also employ many people, with a variety of jobs. Some of these are highly focused on complex and innovative work, but many of these have aspects that are routine and repetitive.” It is through automating the latter that Deloitte believes health service professionals will finally be able to focus on the strictly qualitative aspects of business – “robots could make us less robotic”. 

Accelerated performance through improved design

In its article ‘The era of exponential improvement in healthcare?’, McKinsey listed robotics and RPA as among the nine technologies most likely to transform the financial and operation standards of health services by generating “between USD$350bn and $410bn in annual value by 2025 (out of the $5.34trn in healthcare spending projected for that year.” Also, in ‘How a McKinsey co-designed robot is creating a better future for minimally invasive surgery’, the organisation found that development on a surgical robots’ instrumentation to make it less complex and more intuitive when used by surgeons: “Seamlessly integrating robotic and laparoscopic processes also lowers the barriers to mastering robot-assisted surgery. Historically, learning robotic surgery has meant needing to be well-versed in all aspects of robotics. When the switch between robotics and manual laparoscopy is quick and easy, the threshold for feeling comfortable is much lower, making the adoption of the robotic system faster.” Indeed, Assenmacher verifies that the increasing sophistication of surgical robots in conjunction with easier controls makes them a highly practical solution. “The required training time for competency on the use of a robot makes them very attractive because a talented junior surgeon can expect to reach a high degree of proficiency in just a few months,” he says.

PwC’s eight highlights of how robotics and AI are transforming healthcare:

  • Helping people maintain a healthy lifestyle.
  • Early detection capabilities.
  • Enhanced diagnostics.
  • Improved healthcare decision-making.
  • Better therapies and treatments.
  • End of life care and the capacity for vulnerable people to remain independent for longer.
  • Streamlined research.
  • Advanced training.

Sanitation

Perhaps one of the most important aspects of robotics-based healthcare is the reduced incidence of transmitted infection between patients and healthcare professionals. This applies not just to surgery but also to more routine procedures like dispensing pharmaceuticals and disinfecting medical devices and equipment. Assenmacher adds, “Robots have reduced the role of fomites (inanimate objects which can lead to infection) in the spread of disease while maintaining the quality of the healthcare system. These are an indispensable part of a modern healthcare system.”

Improving quality of life

In ‘No longer science fiction, AI and robotics are transforming healthcare’, PwC presents an interesting benefit of robotics within health services that is easy to overlook: enhanced end of life care. Enabling people to remain in their own homes for longer by automating core tasks or even being programmed with AI to ‘converse’ with patients to ease their loneliness, this application of robotics could reduce the need for hospitalisation in many instances, thus opening up availability for beds and lowering operational costs for hospitals and care facilities. 

Assenmacher summarises this by stating that advanced robotics will simply lead to better yet lower-cost health services in hospitals. In fact, he claims, the effect could be of such a magnitude that it dramatically alters how average people receive healthcare. “Lower-cost healthcare enabled by advanced robotics will have a democratising effect for the entire world’s population,” he concludes. By making complex surgical procedures easier and faster, reducing the spread of infection which leads to even further associated costs and by liberating medical staff from repetitive tasks in order to refocus on value-adding services, applying robotics in hospitals could herald the beginning of a dramatically more affordable system of healthcare for everyone. “There should be no question of who deserves a complex or expensive surgery. By virtue of being a human being, we are all deserving and robotics will help us get there.

Source: Healthcare Global

AI capable of detecting prostate cancer with ‘near perfect’ accuracy

Prostate biopsy with cancer probability (blue is low, red is high). This case was originally diagnosed as benign but changed to cancer upon further review. The AI accurately detected cancer in this tricky case. CREDIT Ibex Medical Analytics, via Eureka

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Artificial intelligence (AI) has identified prostate cancer with its highest accuracy to date, demonstrating how the technology could successfully catch cases that may otherwise be missed.

Researchers from the University of Pittsburgh trained an AI system on more than one million images of tissue slides taken from patient biopsies which had been labelled by human experts to distinguish between healthy and unhealthy tissue.

The team tested the algorithm on another set of 1,600 slides collected from 100 patients treated at the university’s medical centre for suspected prostate cancer.

It detected prostate cancer with 98 per cent sensitivity and 97 per cent specificity – rates significantly higher than previous studies concentrating on algorithms trained on tissue slides, their report, published in The Lancet Digital Health, claimed.

Besides cancer detection, the algorithm was also able to grade and assess the size of tumours and surrounding nerve invasion to a high degree of performance.

It also highlighted six slides that had not been identified by pathologists as being of interest.

While the algorithm could be useful in overcoming pathologists’ own biases or conclusions drawn from past experience, the findings don’t necessarily prove that the AI’s diagnosis is superior to humans’, Rajiv Dhir, the report’s senior author, said.

Practised pathologists may have seen malignant cells elsewhere in a patient’s samples before recommending treatment, he pointed out, adding that the algorithm could be used to spot potential cases that may have escaped the attention of less-experienced staff.

Using such a system could help to standardise care across different institutions and even across the world.

“Algorithms like this are especially useful in lesions that are atypical,” Mr Dhir said. “A non-specialised person may not be able to make the correct assessment. That’s a major advantage of this kind of system.”

The algorithm could be adjusted to detect other kinds of cancer by training it on different sample databases, meaning the same system could flag potential breast, lung or throat cancer cases.

Human and AI diagnosis

Medical experts have been increasingly experimenting with AI as a detective and diagnostic cancer tool in recent years, including using the technology to predict patient survival rates and to predict how symptoms may develop over time.

A report from the British Medical Journal earlier this year cautioned against studies claiming AI is superior or as good as humans in interpreting medical images.

The researchers suggested that over-promising language “leaves studies susceptible to being misinterpreted by the media and the public, and as a result the possible provision of inappropriate care that does not necessarily align with patients’ best interests”.

“Many arguably exaggerated claims exist about [the AI’s] equivalence with (or superiority over) clinicians, which presents a potential risk for patient safety and population health at the societal level,” the report’s authors said.

Source: inews

Scientists Use 3D Printers to Make Miniature Organs for Testing Potential COVID-19 Drugs

A few months ago, Science Times featured a 9-year-old boy who used his 3D printer to create face shields. He was able to produce over a thousand face shields and now continues to create more.

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Indeed, 3D printers have become a helpful tool in this fight against the pandemic. Now, scientists are looking into using it to bioprint miniature human organs that they can use to test drugs to treat COVID-19 and other diseases such as cancer.

Bioprinting Miniature Human Organs

Anthony Atala, the director of the Wake Forest Institute for Regenerative Medicine, and his team are using 3D printers to create pinhead-sized replicas of human organs to test drugs for COVID-19.

His institute has been printing tiny clusters of organs in the past few years to test drug efficacy against bacteria and infectious diseases.

They constructed miniature lungs and colons, two of the most affected organs by the coronavirus, and send them to a laboratory at George Mason University. Initially, the team made miniature organs by hand using a pipette, but they recently used 3D printers for research.

3D printing human tissues is a form of bioprinting. Scientists are developing this method to test drugs and eventually create skin and full-size organs for transplanting. They plan on making skin tissues for burn victims, manage diabetes where wound healing proves to be challenging, and for testing of cosmetics without harming animals or humans.

The importance of bioprinting for pharmaceutical analysis is at its peak now not only for COVID-19 treatments but as well as to other diseases. Dr. Atala noted that organoids would help researchers analyze the effects of drugs on an organ “without the noise” of a person’s metabolism.

Moreover, testing on bioprinted miniature organs will tell which drugs that work on animals might not perform well in people. An important guideline that cosmetic companies should remember, especially when the European Union banned them from testing products on animals since 2013.

Parts of the Bioprinted Organ

The parts of the bioprinted organs include the scaffold to act as its foundation, which is made of biodegradable materials. Scientists included 50-micron microscopic channels to the framework to provide nutrition for the organoid.

Once it is completed, a “bioink” or a combination of cells and hydrogel that turns into gelatin is printed onto the scaffold that looks like a layer of a cake.

Of course, the organ is not yet done without the blood vessels in it. Assistant professor of chemical and biological engineering Pankaj Karande from the Rensselaer Polytechnic Institute recently had success in this step.

Karande used a cell known as fibroblast that helps with growth, and collagen as the scaffold. The researchers printed the epidermis and dermis, the two layers of the skin. Together with two other researchers, Dr. Karande begins experimenting on human endothelial cells and human pericyte cells.

After some trial and error, the researchers were able to integrate the blood vessels with the skin and discovered that there were new connections between the new and existing blood vessels.

While their experiment is still on its preliminary stage, Dr. Karande was hopeful that it will succeed and would set the stage for future successful grafting in humans.

Source: The Science Times

How plastics are transforming the implantable medical devices space

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Innovation has long been a driving factor in the progression of various industrial sectors across the globe. The healthcare sector, particularly with regards to medical devices, is likely to gain lucrative benefits from novel solutions and technology, be it through the modification of existing devices, or the implementation of strategic alliances and initiatives for product development. In recent years, this innovative drive has been increasingly apparent in the implantable medical devices industry.

Implantable medical devices, also known as IMDs or medical implants, are devices created using synthetic materials, designed to be placed inside the human body for medical purposes, often for a long-term duration. These devices can be used as replacements for body parts such as knees or hips, for delivery of medication like pain relief, for supervision and regulation of regular body functions including heart rate, as well as for offering support to tissues and organs.

Implants can be either inert or active, depending on their purpose. The inert ones are intended for use as structural support, generally in the form of stents or surgical meshes. On the other hand, active medical implants are built to interact with the body, for instance by responding to changes in heart rhythm via electrical shocks.

Certain implantable medical devices are designed to be “smart”, in that, they can connect to and communicate with systems outside of the body, these include devices such as neurostimulators, pacemakers, and implantable defibrillators, among others, which can monitor and deliver treatment automatically in response to any changes in the body.

The implantable medical devices market growth is mainly characterised by steady evolution and the emergence of advanced techniques and devices. A notable example of this is the progress of the cardiac pacing field. Pacemakers have undergone decades of transformation and have become progressively smaller in size, whilst featuring added functional capabilities.

In the quest to develop smaller and more sophisticated medical implant technologies, entities in the medical device domain are rapidly adopting various materials that can help reduce device profiles without any compromise on durability, flexibility, strength, and biocompatibility. One such material currently in use is plastic.

Plastics and their use in IMDs

Polymers have been suitable alternatives for metal components in medical applications for several years. This burgeoning popularity is attributed to a host of beneficial characteristics, the most significant being the biocompatibility of the material. The human body’s extracellular fluid, which comprises of isotonic saline solution, often displays extreme hostility to metal materials, which can lead to their degradation. However, this degrading effect is not largely associated with polymers, which is why many synthetic high-molecular-weight polymers are used extensively in the development of modern medical devices.

In terms of weight, thermoplastics account for almost 90% of global plastic usage. Unlike their thermoset counterparts, thermoplastics for medical devices can undergo processing sans loss of properties, making them highly sought-after materials for the development of implantable medical devices in recent years. Some of the most common thermoplastics used for medical applications include:

  • Polyethylene, also known as polythene, which demonstrates strong potential for use in prosthetics development, especially in the form of Ultra-High Molecular Weight Polyethylene (UHMWP).
  • Polypropylene, which is used for applications that require radiation stabilisation and autoclave sterilisation, given the product’s resistance to high temperatures.
  • Acrylonitrile Butadiene Styrene (ABS), which can be used as metal substitutes in structural parts, owing to features such as rigidity and high resistance to both impact and heat.
  • Polycarbonate, which is used for the development of medical tubing and other devices, due to strong UltraViolet (UV) and heat-resistant properties as well as transparency.

The impact of polymers on the medical device industry

Metal was considered the preferred material for healthcare applications for decades, as conventional plastic materials could not offer the same combination of chemical resistance, high modulus, and sterilisation process-compatibility that metal provided. Polymer technology has come a long way since then, however, with numerous plastic materials delivering metal-like properties and facilitating the fabrication of more integrated and complex medical device parts.

Healthcare OEMs are also becoming more attuned to the merits of using thermoplastics for medical devices and are rapidly making the shift from metal to plastic, by investing heavily to bring more polymer-based advanced medical devices to market.

Some high-performance plastics are now able to deliver similar strength properties as that of metals at ambient temperature, in addition to further advantages such as better aesthetics, cost-benefits as well as ergonomic enhancements like robust grip options.

To illustrate, high-performance medical polymers such as PolyEther Ether Ketone (PEEK) are used extensively in the production of implantable medical devices, showing particularly high potential in orthopaedic implants. PEEK is a strong, flexible, safe, and bioinert thermoplastic, which is suitable for medical applications and is a superior alternative to metal, ceramic, and other resorbable materials.

ith this in mind, Germany-based specialty chemicals firm Evonik, in 2020, introduced its new range of implant-grade PEEK filament, dubbed Vestakeep i4 3DF, as a part of its 3D printing materials portfolio. The new material, which complies with ASTM F2026 standards for surgical implants, facilitates the manufacturing of 3D plastic medical implants, via Fused Filament Fabrication (FFF) technology, and demonstrates superior application potential in the maxillofacial and orthopaedic surgery domains.

The rising focus on silicone as a suitable implantable medical device material

Medical device producers have also shown considerable interest in silicone as an ideal medical implant material for a long time, given the ease of moulding, vast temperature range, high tensile strength, durability, and wide range of available durometers, among other characteristics. However, what truly makes silicone the ideal match for medical devices, especially combination products, is its robust biocompatibility. Silicone is highly compatible with body fluids and tissue, demonstrates low tissue response once implanted, and helps deter the growth of bacteria and other contaminants. Furthermore, medical-grade silicone materials are subjected to strict biocompatibility and purity testing, which makes them suitable for integration in long-term medical implants.

A major application area for medical-grade silicones like Lliquid Silicone Rubber (LSR) is in drug-eluting implantable medical devices. These silicones can be compounded with Active Pharmaceutical Ingredients (APIs) such as hormones or cancer drugs, prior to moulding. These APIs can then be released steadily over time into targeted areas of the patient’s body, once the moulded implant is placed. Drug-eluting silicone-based IMDs can sustain the required API level in the patient’s body at a consistent pace and for longer durations of time, as compared to delivery through injection or pills. Additionally, since these implants are generally placed close to the targeted tissue or organ, relatively lower API concentrations are required since they can reach the targeted area directly.

There have been several prolific advancements over the years in silicone-based IMDs, including the creation of a novel technology by noted additive manufacturing company Spectroplast, which has transformed the industrial landscape for 3D printed products by using silicone as a key material in high-precision 3D printing for medical devices. The technology, which addresses the ever-growing need for time and cost-effective prototyping and mass manufacturing of customisable silicone-based medical devices, can be used to create next-gen products such as customised hearing aids, dental implants, bespoke silicon-based IMDs for heart valves as well as anatomically accurate medical models for surgical training purposes.

How the use of bioplastics is making medical devices more eco-friendly

Sustainability is the need of the hour across the globe. Plastic is considered to be one of the most notorious contributors to environmental degradation, with major global shifts taking place to ban fossil-based plastics, single-use disposable plastics such as plastic bags and straws, as well as the use of plastics that develop longer-lasting microplastic residues.

In the medical sector, however, the role of plastics is highly integral, which has prompted massive research efforts worldwide to develop more sustainable polymer technologies, designed for use in medical applications. Studies suggest that between the period of 2030-2040, nearly 25-30% of plastics across the world will be bio-based.

Given these circumstances, many global medical industry players are leaning towards adopting more environmentally friendly products, thus opening lucrative avenues for innovative efforts by companies such as Arctic Biomaterials. An example of such an effort is the company’s 2016 breakthrough in medical device innovation, with the development of a material combining the strengths of plastic and glass fibres, by fusing the two together using a proprietary adhesion layer. The resulting material established the entity as a leading presence in the medical devices’ domain, by demonstrating high heat resistance and superior strength for medical and technical purposes.

A team of researchers from the University of Birmingham made similar progress, with the development of a novel thermoplastic biomaterial, which possesses not just high toughness and strength properties, but is also easier to shape and process compared to its counterparts. The material, which is a type of nylon equipped with shape memory characteristics, can be moulded and stretched as needed, returning to its original shape upon application of heat, making it ideal for bio-based medical implants such as bone replacements, where the flexibility of implant materials plays a key role in minimally invasive surgical procedures.

Technological advancements are triggering the invention of novel materials, technologies, and ideas across the medical industry, designed to surpass the existing concepts. With plastics held in such high regard as key medical-grade materials, alongside the emergence of modern techniques such as insert moulding, injection moulding, and the like, it is becoming easier and easier for medical device manufacturers to create precision tools that can be mass-produced without compromising on efficiency or quality. This widespread adoption and acceptance of various material technologies in the implantable medical devices industry are thus indicative of revolutionary innovations that have changed and will continue to change the healthcare landscape even in the years to come.

Source: Medical Plastic News

Why digital healthtech is more important than ever

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 We talk a lot about the role of digital tech in healthcare – its ability to speed up diagnosis, manage conditions and improve both patient care and the way in which healthcare professionals connect with patients, for example. In these testing times, it is also becoming apparent that the role of digital has an increasingly important part to play in the way we continue to care for the elderly population.

Despite lockdown easing measures, the threat from coronavirus is far from over, particularly for more vulnerable sections of society. As the younger population and those with no underlying health conditions start to move back into a pre-COVID-19 existence, however that may look, it’s important we look to ways to keep the elderly and vulnerable connected, safe and involved.

Digital technology is the obvious way to achieve this. There are all manner of solutions making their way to market – some will be better suited to individual needs than others. The Essence Group for example, offers connected smart devices for elderly care, medical settings, and home security, and claims to have formed a core part of governmental and private efforts around the world to safeguard the health of seniors whilst allowing them to live as independently as possible during COVID-19. The company’s telecare solution, Essence SmartCare, has been adapted to support seniors in lockdown by providing a non-obtrusive, 24/7 care system. AI and voice-based remote monitoring solutions means carers and loved ones know their relatives remain connected and safe.

A favourite company of mine is Spirit Digital, part of the Spirit Health Group. The business is continually innovating, which I love. Following NHS England and NHS Improvement Guidance calling for steps to implement a clinical service model for care home support during COVID-19, remote monitoring has been highlighted as vital to this process.

Spirit Digital’s CliniTouch Vie is a digital, remote monitoring platform is designed to connect care homes, carers and nurses with their patients’ GPs. Carers can check patients’ vital signs and answer health questions via a tablet, as frequently as needed. GPs can then connect remotely with carers and patients to provide health and wellbeing advice and intervene where and when more urgent care is needed.

It’s exactly the sort innovation that’s needed at the moment and underlines the pivotal role that digital technology has in this section of our community. It is of course, just one way that digital technology can provide huge benefit to the healthcare system but one which is highly relevant given the pandemic and how we address health and care going forward.

On a separate note, this is my last issue of MTI. I’m off to a new exciting venture. It’s been great working in this industry and getting to know all of the innovative and forward-thinking companies. At a time when so many sectors are suffering, medtech and heathtech are still showing promise, innovation and that they have a key role in the future success of the UK and Irish economies. Keep up the great work!

Source: MedTech Innovation News

Manchester life sciences campus reaches practical completion

The next stage of a Manchester-based life sciences campus has reached practical completion, despite the COVID-19 pandemic.

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A joint venture between Manchester University NHS Foundation Trust (MFT) and Manchester Science Partnerships (MSP), Citylabs has been designed as a campus targeting companies within fields such as precision medicine and medtech.

The first phase of the development at MFT’s Oxford Road hospital campus – Citylabs 1.0 – is already home to a number of life sciences businesses.

Now the next stage of the project has reached completion. Citylabs 2.0 is a £25 million, 92,000 sq ft build located directly opposite the Royal Manchester Children’s Hospital, within the MFT campus. It’s hoped that the new building will help support up to 1,500 jobs, while also adding an estimated £150 million to Manchester’s economy over the next decade.

It forms part of a £95 million expansion which will also see the addition of Citylabs 4.0 to the campus sometime in 2022 – adding a further 1,200 jobs when complete.

The aim is to make the Citylabs campus a new national hub for precision medicine and data analytical businesses, helping bring diagnostics and treatments into Manchester’s health system.

Businesses based at Citylabs have access to clinical and academic collaborators located on the campus, as well as business support such as advice on funding sources and professional services.

Life sciences company QIAEGN will occupy the whole of Citylabs 2.0 for its Global Centre of Excellence for Precision Medicine, relocating from its current location at the nearby Manchester Science Park.

The completion of Citylabs 2.0 represents another addition to Manchester’s Oxford Road Corridor Innovation district. The district is home to 50% of Manchester’s life science businesses and generates £3.6 billion gross valued added (GVA) every year.

Tom Renn, managing director of MSP and Bruntwood SciTech – Manchester, said: “Our long-term vision for the Citylabs campus is now one step closer in realising its goal to become a world-class centre for diagnostics and health innovation.

“The last few months have showcased the importance of the life sciences sector and particularly diagnostics to society, the jobs it creates and its role in driving the UK forward globally. QIAGEN has been at the forefront of the fight against COVID-19 as a leading developer and manufacturer of test kits to help track the virus. Their expansion into Citylabs 2.0 will act as a magnet for complementary businesses – from start-ups to scale-ups and R&D centres of excellence – helping strengthen the ecosystem of the Oxford Road Corridor innovation district. 

“Despite the current challenges we’re pleased to have reached practical completion at Citylabs 2.0 with minimal delay and can now swiftly progress QIAGEN’s fit out. I’d like to thank all of the teams who have worked on Citylabs 2.0 for their ability to quickly adapt at the beginning of the pandemic to enable construction to continue, with a fantastic end result.”

Sir Richard Leese, leader of Manchester City Council, added: “The development of this new health innovation and precision medicine campus and the practical completion of Citylabs 2.0 helps confirm Manchester as a world leader in this vital industry, creating a raft of highly skilled health science jobs and providing an all important economic boost to the city. Manchester’s future success depends on building on our distinctive strengths of which life sciences is definitely one.”

Source: MedTech Innovation News

African women are leading biotechnology’s advance across the continent

How unlocking the secrets of African DNA could change the world ...

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Women researchers are strongly influencing the adoption of agricultural biotechnology in Africa.

“As African women, we are the ones who suffer most whenever drought and food shortages strike, despite the availability of technological solutions to these problems,” said Dr. Felister Makini, deputy director general in charge of crops at the Kenya Agricultural and Livestock Research Organization (KALRO).

“We are looking for new solutions and how we can use technology to give our people and ourselves better and improved crop varieties to fight hunger and improve the quality of living,” said Dr. Priver Namanya Bwesigye, who leads Uganda’s banana research program at the National Agricultural Research Laboratories (NARL) at Kawanda.  “We also need varieties that can give us more in terms of nutrients.”

Throughout Africa, women are in labs developing crops that produce high yields and can tolerate or resist disease, as well as healthier, more productive livestock. They are also found in meeting rooms and gardens informing the public about their innovations and how these improved crops can aid the fight against hunger across both the continent and the globe.

“It is time to tell the public about the positive side of biotechnology,” said Professor Caroline Thoruwa, chairperson for African Women in Science and Engineering.

In Uganda, where bananas are an important staple food and cash crop, Bwesigye is in charge of developing varieties that offer farmers better options.

She and her team are using the tools of genetic engineering to develop banana varieties that are resistant to nematodes, bacterial wilt and weevils. The most advanced of these genetically modified varieties is a banana biofortified to provide vitamin A. It should reach farmers immediately after Uganda implements a legal biosafety framework guiding the use of GMOs.

“We have trialled the technology in multiple locations — all the four banana planting regions of Uganda — and it will be ready by the time we have a legal framework,” Bwesigye said. “We have to do this [multi-location field trials] before we can give it to the farmers. We want to be sure that different farmers across the country can plant the variety and have similar results. In this case, all the banana yields should be rich in pro-vitamin A.”

But Bwesigye’s program does much more than develop improved bananas using biotechnology. It also employs conventional plant breeding tools to produce heartier varieties, including a banana resistant to black sigatoka disease. When she’s not in the lab, Bwesigye conducts extensive outreach to farmers and young people to explain agricultural biotechnology and why Uganda, Africa and the world need this tool.

Dr. Barbara Mugwanya Zawedde is also championing the adoption of agricultural biotechnology in Africa. She’s currently director for research at Uganda’s Zonal Agricultural Research and Development Institute in Mukono, which is under the jurisdiction of the National Agricultural Research Organization (NARO).

But before that, she was the coordinator for the Uganda Biosciences Information Center (UBIC) — NARO’s knowledge and information-sharing hub. It champions an appreciation of modern biosciences research for agricultural development and works to educate stakeholders on the importance of biosafety.

In that role, Zawedde engaged religious leaders, local communities, farmers, extension agents, legislators, public ministries, “women in agriculture,” students and others to raise awareness about new technologies and their safety.

After earning a doctorate in plant breeding, genetics and biotechnology from Michigan State University, Zawedde returned home to Uganda in 2013 to discover “we had gaps in communication as well as in regulation,” she recalled.

So, she worked with Dr. Yona Baguma, now deputy director general for NARO, to set up the biosciences information center. Their goal was to “bring to the fore these new technologies that people were not talking about” and to emphasise the importance of regulating them.

“The regulatory framework [we have been calling for] is not just for the introduction of these new technologies, but for their regulation as well,” Zawedde said.

To an extent, Zawedde and UBIC have been successful.

Parliament passed the National Biotechnology and Biosafety Bill on two occasions, though President Yoweri Museveni has yet to sign it into law. Additionally, more Ugandans now appreciate the science and what it can do to improve their lives. Biotechnology and biosafety elements also have been included in the country’s school curriculums.

“It will be easier to adopt these technologies [once we have a regulatory framework] because more people today understand these technologies and how they can help improve agriculture and food security in Uganda and the region,” Zawedde said

Similarly, the Women in Biosciences Forum is working in Kenya to make everyone sure knows about the value of biotechnology and the role that women are playing to advance the science.

“We need to raise the status of women in biotechnology and also encourage women to network in order to achieve the noble goal of sharing their science,” Thoruwa said. “Women must be involved for Africa to advance in agri-biotech.”

Several African countries have approved the cultivation of GMO crops and others have conducted trials for GM crop varieties. But in many of the countries that are conducting research, GM seeds have yet to reach farmers and consumers because the political leadership is swayed by opposition and remains “afraid” to adopt biotechnology, the women scientists observed.

“We need to speak with one voice and advocate for a predictable policy environment,” said KALRO’s Makini.

“The detractors will always be there,” Bwesigye said. “But we need to understand that these technologies, pretty much like everything else in life, have advantages and disadvantages. We just have to harness the advantages.”

One such advantage is being able to develop a staple food crop, like a banana, that delivers vitamin A, a crucial nutrient that is lacking in almost 30 percent of Uganda children below the age of 5. “It is a no brainer,” Bwesigye said about the value of adopting the pro-vitamin A banana.

Despite the political obstacles, Bwesigye and her colleagues remain undiscouraged.  Zawedde said that women will continue to conduct communication and outreach, calling on governments to give farmers a chance to plant some of these improved crops.

“We only need awareness, awareness and more awareness,” Bwesigye said. “Then mind-sets will change and adoption of these technologies will be easier.”

Source: Alliance for Science

Make a vaccine? I’m trying to teach my kids the alphabet

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LONDON/BERLIN/MILAN (Reuters) – It’s tough to do any useful work when you’re stuck at home, struggling to home-school bickering kids, let alone when you’re trying to produce a COVID-19 vaccine.

British drugmaker AstraZeneca had spent years preparing for a pandemic, but when the moment finally came it was caught cold on a crucial front: stressed parents working from home struggled to focus.

So the company recruited up to 80 teachers to run online lessons and repurposed a car parking app to book virtual classes. It also lined up personal tutoring and helped to locate some childcare spaces for those battling to adapt to the abrupt change to their lives.  

The move by Britain’s biggest drugmaker, and similar efforts by companies the world over to host everything from magic classes to yoga for children, shows the lengths businesses are going to to help staff work through the coronavirus crisis.

“It was quite apparent that it was going to be really challenging for those with small kids and with two parents working,” AstraZeneca’s HR chief Fiona Cicconi told Reuters.

“People were starting to say they were feeling really anxious, I’ve got so much to do, how am I going to get it done?”

The new corporate attitude towards home-working could help lead to higher productivity and loyalty, according to experts, and ease moves towards more flexible working as companies rethink whether staff need to be in the office, and as schools take time to return to normal.

 

‘I’M DISTRACTED FOR SURE’

The march of the pandemic has upended normal life, forcing companies to shut offices, schools to close and grandparents and childcare providers to stay away.

That has left many exhausted parents juggling work demands while helping their children with school work to prevent them from falling behind or spending too much time online, not to mention having to feed, entertain and care for them.

German business software company SAP provided online lessons on magic, coding, yoga, guitar and break dancing for children of staff.

It is now working on a more formalised schooling scheme with a partner organisation, which will pair children of staff with students, and also offer activities through the summer holiday.

Thomas Angerstein, EMEA head of the SAP department responsible for providing “mission critical” support to customers, said the magic classes had helped his eight-year-old son, and consequently helped him too.

“I could focus on my team,” he said. “Usually he is hovering around and looking at my screen and I’m distracted for sure.”

In Italy, tyre maker Pirelli teamed up with local company Radiomamma.it to provide online education and entertainment for children, with classes in English, creativity and technology the most popular.

Rosaria Demma Carà, who works in Pirelli’s Financial Statements division, said the classes had helped her 10-year-old son and 5-year-old daughter interact with their peers, relieving the social blackout of lockdown.

“(It also helped) us get on with some work.”

‘THEY’RE OFFERING – WHY AREN’T YOU?’

Esther Canónico, from the London School of Economics, said companies needed to prioritise supporting their staff in different ways because any return to normality would take time, and flexible, long-distance working was likely here to stay.

Chris McGillicuddy from EB Education Services hosts an online tutoring session during the coronavirus disease (COVID-19) outbreak in Manchester, Britain July 2, 2020. EB Education Services/Handout via REUTERS

Supportive measures should, however, not be seen as an attempt to persuade staff to work harder, especially when those working from home can struggle to manage boundaries with work life, and end up working for much longer, she added.

“There is not a clear differentiating line between work and home,” she said of the new environment. “The advice is for employees to actively manage their boundaries.”

Companies, for their part, see offering such services as good business sense in terms of operational resilience.

AstraZeneca, for example, knew it had to act when a survey found that 1,100 of its 8,300 staff in the country needed help with childcare.

A plan to recruit freelance teachers was inspired by a former teacher who worked in the company’s HR department and it was backed by CEO Pascal Soriot, with the whole process signed off in a matter of hours.

Launched in May, it offers four lessons a day to up to 1,300 children who have registered. Separately it has lined up a tutoring company that provides one-on-one sessions.

The tutoring firm, EB Education, said it had since been asked by another company in the drugmaker’s home town of Cambridge if they could provide a similar service.

“The other company have had a few of their workers saying: AstraZeneca are offering this so why aren’t you? So they put something in place,” EB’s Karen McGillicuddy told Reuters.

For now AstraZeneca, which has been licensed to produce a potential vaccine for COVID-19, is expanding its support. It has introduced new classes for different age groups and is looking at a summer school.

HR chief Cicconi said staff had been incredibly grateful, during what is an extraordinary time.

“They know it’s not normal for us to run three primary schools,” she added.

Source: Reuters

A generation of UK researchers could be lost in a funding crisis

Medical worker taking blood from a patient

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The discovery of new cancer treatments could be delayed, research institutes shut, and a whole generation of upcoming scientists lost because of a funding crisis in medical research, charities have warned.

Covid-19 has caused fundraising to plummet, with events cancelled and charity shops shut because of the lockdown. The upshot is a dire financial situation that could have a severe impact on research crucial to finding new ways to diagnose, manage and treat diseases from cancer to neurological conditions and heart disease.

“The current pandemic has put the future of charity-funded research at significant risk,” said Aisling Burnand, chief executive of the Association of Medical Research Charities (AMRC).

While some charities have furloughed staff, Burnand said the government’s £750m charity support package does not provide cash for medical research.

As a result of the AMRC and its 151 member organisations, including Parkinson’s UK, the British Heart Foundation (BHF) and Cancer Research UK (CRUK), are calling on the government to set up a “life sciences-charity partnership fund” to support research that, they stress, saves lives.

The proposed scheme would be a matched funding programme, lasting at least three years, with the government contributing £310m over the financial year 2020-21 to bridge the funding shortfall from medical research charities. Burnand said that could be tapered down in subsequent years as fundraising picked up, with the hope that government support could galvanise donations from the public.

Medical research charities together spent £1.9bn on research last year – over half of the non-commercial medical research funding – with another £1.1bn spent on activities including patient services and support. But, because of the impact of Covid-19, many charities have warned that, without government support, medical research funding will be slashed.

The impact is already being felt. “At the end of April, 74% of clinical trials and studies funded by AMRC charities had been paused,” said Burnand, adding that more than two-thirds of its member charities are deferring upcoming grant rounds and withdrawing future funding.

Breast Cancer Now has already announced it could be making redundancies following the outbreak of Covid-19 and has cancelled two forthcoming research grant funding rounds.

While Burnand said some research was to resume now lockdown has been eased, other projects were not. For research spending by medical research charities to return to pre-COVID-19 levels, it could take four to five years, she warned.

Dr Charmaine Griffiths, BHF’s chief executive, said even with some staff furloughed the charity is losing £10m a month and is facing an unprecedented research funding crisis.

“We anticipate our net income this year falling by 50% and consequently we will have to halve our investment in new research from £100m this year to £50m,” she said, adding that could have a catastrophic impact on UK cardiovascular research.

Michelle Mitchell, chief executive of CRUK, said the charity is expecting a 30% drop in income this year because of Covid-19, meaning research funding could be cut by £150m a year.

“This would be devastating for people with cancer today, and our families and future generations of people, devastating for our science base and devastating for the economy,” she said. “It could mean a major contraction in CRUK’s infrastructure and potential closure of centres and institutes,” Mitchell added, noting it could also affect plans for clinical trials and hence, potentially, hold back new cancer treatments.

The charities warn funding cuts could also be a disaster for early career researchers, including PhD students.

“We believe we could potentially lose a generation of researchers because of this shock and the reduction in our funding,” said Griffiths.

Mitchell said it had not been possible to access research and development support that is available for businesses and made a direct plea to Boris Johnson.

“If you believe, prime minister, in improving cancer survival, if you believe in ensuring the UK retains its position as a global scientific power, if you believe in protecting infrastructure and our talented people, you absolutely must commit to supporting the UK’s research charities at a time of our need and give us time to recover and get research back on track.”

A Department of Health and Social Care spokesperson said: “The UK is home to globally recognised medical research charities, which are an integral part of our world-leading life sciences sector.

“We are working closely with medical research charities to understand the impact of the pandemic on the sector and identify how we can work together, ensuring patients continue benefiting from charity-funded research.”

Source: The Guardian

‘The wondrous map’: how unlocking human DNA changed the course of science

Thanks to the success of the Human Genome Project, 20 years ago this week, scientists can track biology and disease at a molecular level

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Human x chromosomes, illustration

‘A mission to unravel the molecular essence of humanity’: a computer illustration of human X chromosomes. Illustration: Sebastian Kaulitzki/Getty Images/Science Photo Library

Twenty years ago this week, an international group of scientists announced it had put together the first genetic blueprint of a human being. After 10 years of effort, the team – made up of thousands of scientists working on both sides of the Atlantic – revealed it had pinpointed all 3bn units of DNA that make up the human genome.

The result was “the most wondrous map ever created by humankind”, US President Bill Clinton told a special White House ceremony to mark the event. A parallel event, hosted by Tony Blair in Downing Street, also featured glittering praise for the effort.

The $2.7bn (£2.2bn) Human Genome Project remains one of science’s greatest feats of investigation. It was described, at the time, as biology’s answer to the Apollo space programme. It took researchers on a very different journey – not of outward exploration, but an inward voyage: a mission to unravel the molecular essence of humanity.

Armed with the resulting “wondrous map”, scientists would soon, it was assumed, isolate the genes for height, eye colour, intelligence and myriad other human attributes. However, this simple goal has been confounded by the fact that a great many individual human attributes are determined by dozens, if not hundreds of genes. We are too complex for reductionism.

Nevertheless, the biological revolution let loose on 25 June 2000 has had remarkable results. The draft genome published that day was later followed up with more and more accurate “maps” of our DNA until the project was officially closed in 2003 with the publication of a final, full human genome. Ever since gene sequence studies set up in the project’s wake have been involved in growing numbers of remarkable discoveries.

For example, DNA studies have shown our species once mated with Neanderthals while other projects have pinpointed mutated genes that cause cancers and melanomas. Others have helped to develop new drugs for conditions ranging from cystic fibrosis to asthma.

A visualisation of genomic data from a DNA test.
A visualisation of genomic data from a DNA test. Photograph: Getty Images

These successes have been achieved because gene sequencing, over the decades, has become a highly automated and incredibly cheap process. “It took a decade of intense effort to create that first rough draft of a human genome,” said Cordelia Langford, of the Wellcome Sanger Institute, near Cambridge, where UK scientists played a prime role in Britain’s involvement in the Human Genome Project. “Today, we sequence around 3,000 full genomes a week. It has become a simple, straightforward process.”

Not all these genomes belong to humans. Some belong to other animals and others to our mortal enemies – such as the organisms responsible for malaria and cholera, a list of foes that has now been expanded to include Sars-Cov-2, the virus that causes Covid-19. Sequencing its tiny genome is now providing doctors and public authorities with critically important information about the disease.

“We are sequencing samples of Sars-Cov-2 from different sources to see if the virus is mutating significantly,” said Dominic Kwiatkowski, director of the Centre for Genomics and Global Health at Oxford University. “The jury is still out on that. However, we are also using sequencing technology to highlight tiny variations in samples from different places, and that should help us pinpoint the locations of new outbreaks.”

A very different use of sequencing technology is being pursued by Sarah Teichmann, leader of the Human Cell Atlas project. “Devices are now so sensitive that we can analyse DNA from a single cell and at the same time compare our findings with DNA from millions of other comparable cells,” she said.

That data tells researchers what the cells in our bodies are doing at a very high resolution and at a specific time, information that has led to the discovery of many new types of cells, many in the immune system and others in the body’s various tissues.

“This work has triggered a major revolution in understanding our bodies’ cells and their organisation in tissue and organs,” said Teichmann, who is also based at the Wellcome Sanger Institute. “By comparing healthy tissue with diseased tissue in this way, we are getting incredible new insights into the mechanisms of those diseases. This is a very powerful technique.”

Such insights have included pinpointing cells involved in the development of cystic fibrosis, asthma and certain human tumours. The discoveries have opened up the prospect of developing therapies for these conditions.

The Human Genome Project is clearly having a big impact on medicine and research, but its progress was not without controversy during the course of its work, which began in 1990. “We were in a race. It was as simple as that,” said Langford, who is now the Sanger’s director of science operation but who worked as a research assistant during the project’s early days. “We were out to stop people from putting patents on human DNA that was being sequenced elsewhere.”

At the time, a rival outfit to the Human Genome Project – known as Celera – had been set up with the maverick researcher Craig Venter as its head. “They wanted to put patents on the DNA they were uncovering. We wanted to make sure everyone could use the data and were putting every sequence we found into the public domain to block any attempt to privatise the genome. And in the end we succeeded.”

Source: The Guardian

The study demonstrates the feasibility of hologram technology in liver tumour ablation

liver

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Data from one of the first clinical uses of augmented reality guidance with electromagnetically tracked tools shows that the technology may help doctors quickly, safely, and accurately deliver targeted liver cancer treatments, according to a research abstract presented during a virtual session of the Society of Interventional Radiology’s 2020 Annual Scientific Meeting on June 14. The technology provides a three-dimensional holographic view inside a patient’s body, allowing interventional radiologists to accurately burn away tumours while navigating to avoid organs and other critical structures.

“Converting traditional two-dimensional imaging into three-dimensional holograms which we can then utilize for guidance using augmented reality helps us to better view a patient’s internal structures as we navigate our way to the point of treatment,” said Gaurav Gadodia, MD, lead author of the study and radiology resident at Cleveland Clinic. “While conventional imaging like ultrasound and CT is safe, effective, and remains the gold-standard of care, augmented reality potentially improves the visualization of the tumour and surrounding structures, increasing the speed of localization and improving the treating physician’s confidence.”

In this initial in-human pilot study, the technology was used to deliver a treatment known as percutaneous thermal ablation of solid liver tumours. To apply this technology, the physicians use multi-phase CT to record coordinate markers placed on a patient’s body. This imaging data is added to a software application that allows for segmentation of the tumour and nearby structures within the marked coordinate space. This information is fed into a proprietary augmented reality application, which utilizes Microsoft’s HoloLens technology, a virtual reality headset with transparent lenses, to project a segmented hologram of the patient’s imaged anatomy directly onto the patient. The hologram is registered to the coordinate markers to ensure accurate location of the relevant anatomy.

Utilizing electromagnetic tracking, instruments including the ablation probe can also be visualized in the augmented reality space during the procedure, thus allowing for true holographic intraprocedural guidance. Interventional radiologists can then use the combination of the holographic images of the patient’s anatomy and tracking tools to find the tumour in the patient’s liver quickly, check for optimal targeting of the tumour by the ablation probe, and avoid key structures.

The study included five patients who were selected for microwave ablation of their liver tumours. For safety during this IRB-approved study, the gold standard of ultrasound was used for primary clinical decision making and probe guidance, with direct comparison to holographic guidance. Following ablation, images and video from post-procedural sonography, cone beam and multi-detector row CT, and HoloLens recordings were evaluated. In all five cases, intra-procedural holographic guidance was in agreement with the standard ultrasound-based guidance. Post-procedural imaging showed adequate tumour ablation, and no patients experienced tumour recurrence at the three-month follow-up. In this early phase pilot study, the authors anecdotally observed that the speed of tumour localization was faster with holographic guidance and that their confidence in optimal ablation and critical structure avoidance was improved over standard imaging guidance. They are further attempting to quantify these findings as they continue to enrol patients in the study.

Beyond its use during treatments, interventional radiologists also see value in using this tool for clinicians’ planning purposes and for improving patient engagement and understanding of the condition and treatment.

“This technique can be used intra-procedurally to check the accuracy and quality of the treatment, as well as pre-procedurally to engage with the patient in their own care,” said Charles Martin, III, MD, FSIR, an interventional radiologist at Cleveland Clinic who is the principal investigator of the IRB and the senior author of the study. “We can change 2-D images into holograms of a patient’s distinct anatomy so that both the physician and the patient get a better understanding of the tumour and treatment.”

Researchers continue to test this technology for ablations in the abdominal area with plans to expand to other types of procedures and in other areas of the body. The technology has only been tested for feasibility and therefore cannot yet be used as a standalone method for delivering treatment.

Additional information about the clinical trial is available at ClinicalTrials.gov, using the identifier NCT03500757. This work was funded through internal enterprise grants from Cleveland Clinic, as well as the Ohio-based biotechnology startup, MediView.

Source: Medical Press

7 Advantages of Hosting Virtual Events

As Aventri’s CEO Jim Sharpe says, “we know nothing beats the value of face-to-face meetings,” however, what happens when in-person meetings and events are restricted because of events like the coronavirus? Should meeting and event professionals just cancel their events altogether? The answer for many will be no, thanks to technology, like virtual event platforms.

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In this guide, we will discuss some of the benefits of switching your in-person event to a virtual one. But first…

What are Virtual Events?

business professional gathered around a conference table having a virtual meeting

Virtual events, in its simplest definition, are events held online. Virtual events use web-based platforms to connect dozens to thousands of attendees from across the globe and often include interactive engagement features such as polling, Q&A, chat boxes, etc. Some of the top virtual event providers include Digitell, Evia, Intrado,ON24, Zoom, GoToMeeting and more.

Virtual events, like in-person events, can cover anything, but typically there are four types of virtual events: virtual conferences, webinars, internal hybrid events, and external hybrid events.

In light of the coronavirus, going virtual has become an increasingly more popular option as it helps organizations save money and all the hard work they put into their in-person events. Some examples of events that made the decision to go virtual during the outbreak include Salesforce’s World Tour Sydney Reimagined, Facebook’s F8 Developer Conference, and Microsoft Build.

Instead of Cancelling, Let Aventri Help You Go Virtual: It’s hard to deny that coronavirus is having a serious impact on the world and live events. Rather than cancelling your events altogether, save time and enjoy the flexibility of a fully integrated virtual event platform. Contact Us.

7 Benefits of Hosting Virtual Conferences

1. It’s Less Expensive

Meeting and event planners are always looking to save money, with shrinking budgets. Thanks to virtual events, the overall cost of putting on your event will be greatly reduced, 75 percent less expensive to be specific. Planners will save on staff, venue, setup and takedown, attendee’s hotels, meals, travel costs, and so much more. The only thing planners have to worry about paying is the costs of the virtual meeting platform.

2. It Saves Time

businesswoman checking the time on her wristwatch

Because your event is virtual, you’ll also save yourself, your staff, and your attendees so much time. Although virtual events do require some setup time (e.g. event website, registration, event marketing, and promotion, etc.) it’s tremendously less than that of an in-person event. They also require no travel time! So, your employees and attendees can use that time to work on all the other important things that need their attention.

3. It’s Global

Planners are always trying to increase their event’s reach to engage more people. With virtual events, that’s easy! You can easily promote your event by sharing the link to your website and social media channels. People from across the world can join instantly without thinking about travel. Hosting a virtual event allows planners to grow their audience and get everyone to participate, no matter where they live.

4. It’s Flexible and Variable

Because virtual events take place online, you have a lot of flexibility in how you broadcast your event. Whether you’re hosting a thought leadership conference, a virtual town hall, a sales kickoff, or another type of event, you can choose to make the sessions interactive, offer different language options, invite guest speakers and more.

5. It’s Easier to Make Connections

Because virtual events tend to be faster-paced since attendees don’t have to move from session to session or booth to booth, it can be easier to make connections with other attendees and speakers than an in-person event. And since everything is online, attendees can easily record important information, like people’s names, titles, etc., right on their tablet or computer.

6. It’s Easy to Collect Feedback

businessman taking a survey on his mobile phone

Like in-person events, feedback is crucial for virtual events. But unlike in-person events, attendees are constantly online at virtual events, which means they can easily answer real-time polls or surveys in sessions. Not only will this real-time feedback help presenters gauge how their session is going (which is especially valuable since these presenters cannot see attendees’ faces during some virtual events), but it will also be useful to measure the overall success of your virtual event.

7. It’s Easy to Measure Results

Although the data that virtual events produce varies depending on what platform and event management software you use, it should be easier to gather certain data on your event and attendees during your virtual event than an in-person event. Why? Because everything is done online, so it can be easily tracked. For instance, you can know when your attendees logged on, from where, the number of people attending, how they are paying, and so much more.

Conclusion

While the interest in virtual events has certainly spiked since the coronavirus pandemic, these benefits can be applied to the world of meetings and events long after the end of travel bans and gathering restrictions. If you’re new to virtual, consider adding a virtual component to your future in-person events as a starting point and seeing how it goes. You’re bound to discover a new way to expand and reach your audience.

Source: Aventri

The accelerating adoption of emerging technology

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During this time of Covid-19 virus lockdown, many people and industries are in a state of stasis with the hope that coming out of lockdown will recover everything quickly. Many commentators and economic advisors worry about the future, as the impact on jobs and companies could be damaging for many years to come.

The emerging technology industries of Blockchain, AI and some areas of Cleantech are still moving at a fast pace. Although many say these industries have been around for a long time, the investment and application of these technologies are still taking time to move into the mainstream, therefore still emerging. It can’t be said that all companies in these sectors are doing well during this challenging time, but many have solutions that will work well in the future when we try to reduce the risk of further infection. Physical money, ink signatures, physical medical services and many other areas of business and day to day life can be replaced by digital versions that not only make life easier but safer, in this new world we live in.

As we all work from our homes and spend time in lockdown, we are already using less paper money and spending money digitally with contactless payments and online shopping. As business and customers see the benefit of this, there will only be greater adoption of this going forward. The next phase of digital money is CBDC (Central Bank Digital Currency), and in recent news on the 14th of May 2020, the digital euro has been successfully tested for the first time by France’s central bank. Countries around the world are working on projects with Blockchain and CBDC. China has also been vocal and has confirmed that it has begun testing its digital yuan in four cities. Central bank, corporate and public digital currencies will become more mainstream over the next few years, and many companies supporting these initiatives will thrive.

In the Finance sector in Europe, processing of payments and authorisations have moved to digital (e-signatures) with so much of Europe in lockdown. Some banks have made announcements in some jurisdictions that they will want to go back to handwritten signatures when we come out of the lockdown, but there is already a movement from the banks’ customers to insist that solutions are used to streamline these processes going forward. Let’s see who wins this battle. It is likely that some jurisdictions and banks will be progressive, and others will not, but it will only be a matter of time before everything moves to digital.

Another exciting area is medical services that have been forced to use digital services and are likely to keep these processes in place as the customer service is improved and saves money for hospitals/GPs. Projects in this area will succeed off the back of the way the services are now delivered.

Investment professionals are starting to realise that one obvious outcome is that more investment will come into the emerging technology sector to bring these technologies to the mainstream. This investment will generate sales and revenue for these companies, and we will start to see companies rise as they did after the internet boom. This makes it an exciting time for the emerging technology sector. Companies will be born out of this tough economic time that makes the most of these opportunities.

Appold is launched today to realise these business opportunities. We are carefully selecting companies to help those that we think have the best chance of success. Appold is an emerging technology advisory and investment company whose main focus is to assist:

Emerging Technology firms expand their businesses through strategic management and capital solutions

Investment groups seeking returns within the Emerging Technology sector

Corporates and Institutions looking to utilise and implement new technologies

Some of the companies we have selected are well known in the industry and have strong management and market presence already. We predict them to be fast growth and Appold is set up to support this. Here are some of the first of our clients:

CryptoCompare – A Global leader in Digital Market data with major corporate clients and deals with the potential for significant growth.

Cygnetise – Authorised Signatory Management on the Blockchain with major corporate clients and deals with the potential for significant growth.

SupraFin – A smart WealthTech platform for crypto-assets with a focus on financial inclusion, pre-revenue but great potential.

ByteTree – A leading provider of institutional-grade crypto-asset data. Their investor terminal tracks over 80 metrics for bitcoin in real-time.

Please see https://www.appold.com/  for more information on the company

Source: City A.M

Your legal rights for going back to work safely after lockdown

As the country heads back to work, bosses have a greater duty than ever to keep workers safe.

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Offices and workplaces across England are making adaptations to make sure their staff don’t contract coronavirus.

Despite the changes to daily life, health and safety principles for employers have not changed.

Employers have a duty to do everything that is “reasonably practicable” to safeguard their employees and those affected by their operations under the Health and Safety at Work Act 1974.

 
Staff at a fish and chip shop in Northumberland wearing PPE as they put out social distancing signs (Image: PA)

“Whilst these may be extraordinary times, the guiding principle for employers has not changed,” Leigh Day associate solicitor Ross Whalley says.

“Employers must therefore assess the risks that are present in their workplace and act accordingly.

“This now includes making provision for employees against the risk of coronavirus infection.

“Employers owe a duty to identify and take appropriate measures to lessen this risk, which must also take into account any particular vulnerabilities amongst their staff such as pregnancy or people with underlying health issues.

“The general Government guidance for employers on coronavirus stresses that employers should make sure workplaces are clean and hygienic, promote regular and thorough hand-washing, and promote good respiratory hygiene.

“Whilst this and other steps such as social distancing and self-isolating may prove effective preventive measures, what consideration is given to those workers at greater risk?”

According to Mr Whalley, the Personal Protective Equipment Regulations 2002 and the Personal Protective Equipment at Work Regulations 1922 set out the main requirements in respect of protective equipment at work.

They state that PPE must be supplied where there remain unavoidable occupational risks to health and safety that cannot be adequately controlled in other ways.

 
(Image: Copyright Unknown)

The Personal Protective Equipment at Work Regulations 1992 requires that ‘every employer shall ensure that suitable personal protective equipment is provided to his employees who may be exposed to a risk to their health…’

The PPE must be ‘effective to prevent or adequately control the risk or risks involved’.

This mandatory duty too cannot be evaded by a claim of ineptitude on the part of the employer in failing to order the PPE in time.

Examples of breaching these requirements will vary depending on the job.

“What may be appropriate in one employment context may not be the same in others,” Mr Whalley says.

“An employer should give very careful consideration of the extent and nature of the risk of coronavirus to their employees. What is required in a healthcare setting, where gloves, aprons and screens may be proportionate to the risk, may not be the same as what is required by supermarket workers.”

Employers are also required to review a risk assessment already in place if there is any reason to suspect it is no longer valid or there has been a significant change.

If an employer was being investigated, lawyers would look at workplace documentation and witness testimony or – in more serious cases – the Health and Safety Executive may carry out an investigation.

In cases where an employee has died as a result, the coroner may call an inquest or investigation to consider the facts of how an employee came to their death.

Legal experts believe that causation will be harder to prove than a breach for Covid-19 claims. Potential claimants will need to prove that their Covid-19 transmission occurred in the workplace, rather than anywhere else.

But the test to do so is only on the balance of probabilities – 51 per cent likelihood or more – so each case will turn on its own facts.

Claimants would also be required to provide evidence of the illness suffered or the death and any consequent loss or financial expense and apply a legal valuation.

Source: Manchester Evening News

How does global talent mobility function during a pandemic?

How does global talent mobility function during a pandemic?

The COVID-19 pandemic has grounded even the most mobile talent. Where do we go from here?

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Topia delivers the world’s leading Global Talent Mobility platform which enables organizations to mobilize thousands of employees around the world. The COVID-19 pandemic has grounded even the most mobile talent. Where do we go from here?

Paradoxically, over the last few weeks, Topia has been at the forefront of actively curtailing the movement of people. We’re helping customers cancel their planned assignments. We’ve mandated work from home for our employees. No travel. No large gatherings. All in support of curtailing the spread of this deadly virus. 

As a company that thrives on the free movement of talent — and particularly since we just acquired a business travel compliance company — you’re probably wondering- what were you thinking? Granted the timing may not be ideal, but it doesn’t change the fact that companies have and will continue to benefit from global talent mobility. 

We all feel the pain of a temporary setback on the global economy.  However, we see this pandemic as an affirmation of the need for great technology to help manage and support global employees and ensure their health and safety. 

To put it simply: the harder the times, the more critical it is to know where your people are, where they are planning to be, and how you can most efficiently get them where they need to be.

Events like Brexit, the 2017 Trump travel ban, the European refugee crisis, the 2020 Coronavirus outbreak, all show us that many circumstances can cause someone to wake up in the morning and not know where they even can travel to. In a globally interconnected world – where health situations, border regimes, and flight schedules are changing by the hour – you need accurate data and technological help to make the right decisions to keep your people safe and productive.

Especially in a rapidly evolving situation like the COVID-19 pandemic, there is news every day about different restrictions on the movement of people. That’s where the right technology can help you understand where you can go, what kind of documentation you may need to file for, and will this have a tax implication on you or your employees. 

Topia’s Global Talent Mobility platform serves some of the largest enterprises on the planet, with hundreds of thousands of employees scattered in dozens of countries. Let me share three recent anecdotes we’ve heard over the past few weeks, as customers are faced with COVID-19, and how data and technology can help them address these issues proactively.

1. What we heard:

“We allowed some ex-pats to return to their home country before the travel bans, while technically keeping them ‘on assignment.’ So we now need to keep track of how long they are going to be in the home country to make sure there is no impact on tax residency or other compliance issues.”

How technology can help: Customers are leveraging Topia’s platform to create a new profile to track those employees working remotely while on assignment. Having a row on an Excel sheet saying, “Mary is on an assignment in Argentina for nine months” is not enough. To stay compliant, you need an accurate yet privacy-preserving trail of their actual physical location during this time.

2. What we heard:

“We have a lot of mobility-related issues currently because of travel bans & quarantines. e.g., people from Korea can’t be moved to Israel, so they have to be quarantined elsewhere.”

How technology can help: The more volatile the situation around the world, the more dynamic your employee mobility needs to be. You might have started with a plan to send key people to a sales office, factory, or onsite for a customer project. But now you’re faced with needing to sort out how to keep your people safe in a location you don’t know much about. Tools like Topia Go allow customers to provide location information to employees instantly, and business travel solutions that are kept up to date on current travel restrictions can inform organizations through which routes they can mobilize people. 

3. What we heard:

“I am reading the news and following the John Hopkins COVID-19 dashboard, trying to see changes in specific new outbreaks where we might have assignees. It takes a lot of manual effort.”

How technology can help: If you have accurate data about your employees already stored in a modern, data-driven technology platform, it’s possible to layer in COVID-19 outbreak incidents on the same map to spot risky overlaps between emerging problems and your mobile employees. Here’s what that looks like for one of our customers:

We live in a global economy, and no matter how difficult the short-term impacts of COVID-19, that isn’t going to change long-term. Business continues around the world, even at the worst moments in time: European consumers are using an American video calling tool over the internet while working from home. Italians are welcoming a shipment of face masks from China. Food and toilet paper is being trucked to stores with empty shelves.

And gradually international borders will reopen and people will once again be back on planes, and life as we know it will be back to some new kind of “normal” level. It will be different in many ways, but businesses will once again look to global economies for hiring key skill sets, provide international experience to retain top talent, and move people around the world to take advantage of business opportunities and gain competitive advantage.

What is inevitably changing is the “how” of it all. Data and technology will help us better track, report, and respond more quickly to evolving global threats.

Those that embrace the right technology sooner will be the ones best positioned for success.

Source: HR Grapevine

COVID-19’s Market Impact Will be Transient for Life Sciences

As the COVID-19 outbreak has halted the world, we are witnessing the life sciences industry come together and aggressively react to one of the gravest threats of our lifetime.

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The stock market’s reaction to the outbreak has been unprecedented with daily 1,000 point moves in the Dow Jones Industrial Average (DJIA) becoming standard fare, and market volatility levels not seen since the height of the global financial crisis in late 2008.

Regardless of current uncertainties, it is clear that COVID-19’s long-term market impact on the life science sector will be transient, as the industry remains on the forefront of value creation. Along with addressing a growing aging population, life sciences companies’ innovations remain key in driving future global economic growth.

In fact, when overall markets plunged last month when the severity of the pandemic in the U.S. became clear, biopharma equities began to regain some of their valuation that was lost during the first days of the outbreak; an early indication of the industry’s strength. Regeneron saw its shares jump 10 percent throughout the month of March, a time where the company, along with multiple other multinational peers, worked vigorously to bring the world’s first COVID-19 treatments to fruition. As clinical trials, such as Gilead’s Remdesivir, quickly progress with nods of promising data, investors are already beginning to see the value in these investments when compared to the industry at-large. The DJIA has lost 17 percent of its value for the year, while various Life Science indexes are only down anywhere from 2 – 6 percent for the year.

While a plethora of uncertainty regarding near-term market performance remains, there will be strong demand and robust appetite for life science investments in the coming months, as markets continue to stabilize and the world begins to move forward. Scientific innovation and investment into next-generation medicines has never been more appreciated than now, and investors are seeing the first-hand value of developing life-saving therapies. COVID-19 has shined a light on how the life sciences industry protects the world by creating a better and safer place for all.

Rise of Impact Investing

The investment community has been galvanized by impact investing in recent years. Prior to the COVID-19 outbreak, impact investing has soared, as sustainable funds raised $20.6 billion in new capital last year, which was nearly four times larger than the prior year. Combined with increasing measures to create value for all stakeholders, life sciences companies are well positioned to benefit from this investment approach. By increasing the standards of patient care, seeking higher inclusivity thresholds for trials, supporting ethical supply chains and integrating cutting-edge data analysis into tracking metrics, life sciences companies are advancing these measures to drive greater impact, as well as returns for all stakeholders.

Advancements in medical devices and oncology will remain at the forefront of the life science impact thesis. Artificial intelligence (AI) integration and technological developments continue to propel the world into a new age of innovation, and as a result, companies are producing products that are smarter, faster and better than ever, without being so invasive to the patient. Oncology has consistently been considered an attractive investment, due to the impact of what the bioscience promises. The oncology industry has gone through several decades of learning, discovering and developing cancer therapies and is now entering into the phase of consequential improvement. Finding better ways to overcome adversities, such as platinum resistance, is good for the patient, and good for business.   

Robust Appetite for M&A Activity to Come

There will be strong opportunities on the backside of the COVID-19 crisis for companies with solid foundations. Large companies with good balance sheets will see the need for investing in opportunities to drive the demand for quality therapies, piggybacking off of a year of a significant increase in the amount of megamergers executed.

As a result, robust appetite for continued M&A activity is expected. Companies in seed rounds should be able to weather this economic storm, especially if they fundraised in 2019. For those who have recently fundraised, there is clear data that’s attractive to investors, and as the outbreak has indicated, that value will not change.

Over the past year, life science M&A activity totaled a historic $357 billion (as of Nov., 2019). It’s expected that the trend in megamergers and high-valued deals will continue, as companies look to optimize portfolios to further home in on specific therapeutic areas, increase near-term revenue and seek additional access to innovative resources. These fundamentals do not change in a post-pandemic world.

During a time where deal flow is stagnant as a result of rock-bottom market declines, biopharmaceutical companies generated over $16 billion in public and private transactions throughout the first fiscal quarter of this year. This was nearly a decade-high for the industry, with only the first quarter of 2018 raising more capital.

The ability to withstand these historic market pressures has only further propelled the industry’s value, which was already indicating encouraging projections. Over the past year, the number of drugs in the pharma pipeline grew by 6 percent, and industry R&D spend is forecasted to grow at a compounded annual growth rate of 3 percent over the next five years. Recently, two of the sector’s largest venture capital firms announced plans to invest a combined $2.5 billion in biotech companies, a testament to the value of the industry and a commitment to its future. These investments will help develop early-stage assets, as well as advance technological developments including machine learning and health security. It’s impossible to drive these innovations forward, and realize the future therapeutic benefit, without proper investment today.

The industry will remain on the forefront of finding, funding and developing the proper therapies and tools to not only fight COVID-19, but continue creating life-changing innovations day-after-day. The pandemic has further underscored this notion, as the industry has been collectively working at an unprecedented scale to discover new treatments and accelerate the clearance and delivery of existing therapies.

Source: Life Science Leader

UK life sciences industry sees ‘unprecedented’ growth

Life sciences

Life science incubator BioCity, has released its biennial publication, the UK Life Science Start-Up Report, documenting an unprecedented period of growth for life sciences across the UK.

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The report has collected, analysed and interpreted data for nearly a decade and a half.

This is thanks in part to a change in the funding landscape, expressed in a four-fold increase to £2.8 billion of investment in early-stage ventures, compared to the previous five-year period.

Authored by BioCity chairman and former CEO, Dr Glenn Crocker MBE, the report looks at the prevalence of life science start-ups in the UK over the past five years and the broader landscape in which they operate to also asses the quality of UK life science start-ups. By analysing the number of start-ups by region, area of scientific focus, funding, investment and university association, the report creates a broad picture of the current health and future of, the industry.

Multiple factors are highlighted as driving expansion, but of greatest impact was the emergence of a number of significant venture funds able and willing to make very large investments in early-stage businesses.

Also identified as a contributing factor is the increasing use of smaller companies and academia as sources of innovation by large pharmaceuticals aiming to counteract falling R&D productivity. The report documents a rise in the number of global players establishing or sponsoring accelerators and incubators and making investments through their corporate venturing arms.

Simultaneously, universities such as Bristol, Newcastle and Aberdeen introduced a gear change in spin-out formation, while a supportive local public sector reinforced the growth.

Dr Glenn Crocker said: “Both the number of companies starting up and the amount invested in them has taken off. We have seen a 50% increase in the number of companies and a four-fold increase in investment going into them; this will likely result in a substantial increase in the demand for space. We estimate that this cohort of businesses alone could require 1.4 million sq ft of specialist facilities over the next five years. One consequence of this demand growth is that real estate investors are being increasingly attracted to the sector.”

The findings of the BioCity UK Life Science Start-Up Report will be discussed in full by Dr Crocker during a key-note speech to an invited audience of industry figures at a launch event at MediCity Nottingham on Tuesday 26 November 2019.

Source: European Pharmaceutical Manufacturer

3D visualisation tech launched for UK cancer patients

The Mixed Reality Viewer allows clinicians and patients to see, interpret and interact with a patient’s medical data in realistic 3D visualisations. Credit: Shutterstock

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genesiscare brainlab vr

GenesisCare has launched the Brainlab Mixed Reality Viewer at its Oxford centre for diagnostics, oncology and wellbeing, offering cancer patients a novel way to visualise their treatment.

The technology is being rolled out as part of a £20m investment from GenesisCare, alongside a number of other state-of-the-art cancer treatments, including stereotactic radiosurgery (SRS).

The Mixed Reality Viewer allows clinicians and patients to see, interpret and interact with a patient’s medical data in realistic 3D visualisations, as if they were objects in the real world. The technology is intended to allow patients to be more involved in their care and better understand the impact of their cancer treatment plan.

The viewer also allows groups of clinicians to collaborate on different cases and treatment decisions as a multidisciplinary team, allowing insights to be shared more easily.

GenesisCare consultant neurosurgeon Puneet Plaha said: “The Mixed Reality Viewer is a truly remarkable piece of equipment – freeing patient scans from a 2D screen and bringing them to life in a room for patients to see.

“Ultimately, this allows us to make tailored treatment decisions alongside patients, empowering them in a way which was previously not possible.”

The Mixed Reality Viewer will be used in conjunction with SRS, an advanced radiotherapy technique that precisely delivers multiple beams of radiation to a tumour in one single treatment session. SRS reduces the number of treatments required in comparison with standard radiotherapy and helps to preserve healthy tissue.

Source: Verdict Medical Devices

UK life sciences regulation begins to diverge – the Medicines and Medical Devices Bill

As the UK looks forward to its future outside the EU, we are gradually seeing more structure and shape begin to emerge.

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An important development for life science businesses is the publication of the Medicines and Medical Devices Bill. As expected, this draft legislation will provide for the UK Government to take over the rulebook for human and veterinary medicines, clinical trials and medical devices after the end of the transition period on 31st December 2020. Currently very closely harmonised at EU level, the legislation is not expected to diverge rapidly from EU law. However, there are clear signals in the Bill and Explanatory Notes that a separate approach is likely to evolve.

Legislation in this area has previously been updated at EU level, with the changes flowing through into UK law. The Medicines and Medical Devices Bill will allow the Health Secretary to take over that task.

Human medicines regulation, clinical trials and medical devices

The Bill proposes to give broad powers to the Health Secretary (or Northern Ireland Department of Health) to make regulations amending or supplementing the law relating to human medicines and clinical trials. This allows for a wide range of possible changes. When the Bill was foreshadowed in the new UK Government’s Queen’s Speech, the stated aim was to

“ensure that our NHS and patients can have faster access to innovative medicines, while supporting the growth of our domestic sector.”

References in the Queen’s Speech briefing to policy aims such as:

  • “Removing unnecessary bureaucracy for the lowest risk clinical trials, to encourage rapid introduction of new medicines” and
  • “Enabling our regulators… to develop innovative regulatory approaches to respond quickly to developments such as artificial intelligence in treatments and ensure the UK can break new ground in complex clinical trials”

are not played out in full in the Bill, but actions to implement these would be enabled by the extensive powers it gives to the Health Secretary.

The Bill mentions the possibility of changes to reflect the new EU Clinical Trials Regulation. Although that legislation is already in force, its application is currently suspended pending full rollout of the EU clinical trials portal and database. On current timetable estimates, the new EU clinical trials system will not be introduced before the end of the Brexit transition period and so will be too late for automatic inclusion in UK law. (The latest EMA website update indicates that the audit of the Clinical Trials Information System will begin in December 2020, while the Brexit transition period is due to end that same month.)

The Bill proposes similar powers to amend or supplement the medical devices legislation. Of course, the existing EU directives in this area are due to be replaced by two new Regulations:

 

  • Regulation 2017/745 on medical devices (applicable from 26 May 2020)
  • Regulation 2017/746 on in vitro diagnostic medical devices (applicable from 26 May 2022)

The second of these is expected to apply after the end of the transition period, and so will not be automatically included in UK law. The Bill’s Explanatory Notes state that the UK will need to make its own decisions about the future regulation of IVDs, raising the prospect of a divergent approach.

Note that, any regulations made under this Bill must take account of the following factors:

  • the safety of human medicines/medical devices
  • the availability of human medicines/medical devices
  • the attractiveness of the UK as a place in which to conduct clinical trials, supply human medicines or develop or supply medical devices

The third of these is an interesting addition to the usual policy considerations in this area, and reflects the UK Government’s current approach to the future relationship. A prior consultation process is also required so that those affected will have an opportunity to comment.

Medical devices enforcement

The Bill includes extensive provisions on enforcement of the medical devices regime. The intention here is to bring together in one place enforcement rules affecting medical devices – they are currently scattered across several different pieces of legislation. The Bill proposes a scheme of enforcement notices: compliance notices, suspension notices, safety notices and information notices, with a specific criminal offence for breach of these enforcement notices. A due diligence defence may be available for those accused of an offence.

The Bill also provides for a method for affected individuals to bring civil proceedings if they are affected by a breach of medical devices legislation. This raises the prospect of a clear path to damages claims, without resorting to general product safety legislation.

Watch this space

The Government’s powerful position in Parliament suggests that the Bill will become law with few changes. The next stage will be tracking, and where necessary intervening, as the Health Secretary begins to make of the powers it confers.

Source:Mills & Reeve

By Isabel Teare

 

Drug-device combinations under the new EU medical devices regime

Many healthcare products are sold as a combination of medicine with a medical device. Examples include drug-eluting cardiac stents and pre-filled injector pens.

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Products like these offer safety and convenience benefits for the clinician and the patient, but they often involve additional regulatory hurdles for producers. Because medicines and medical devices are regulated separately under different laws and through separate bodies and procedures, it can be difficult for manufacturers to understand how to navigate the path to market efficiently.

EU law reforms on the regulation of medical devices are due to take effect in May 2020. Among the changes is a new requirement for Notified Body involvement where a combination of products falls within the regulatory system for medicines. Applicants for marketing authorisation will have to include details of the conformity assessment carried out in relation to the device element when preparing a marketing authorisation dossier for the combination product. More information on this can be found in a Q&A document issued jointly by the EMA and CMDh, available here.

In order to help applicants understand the new system, the EMA is currently consulting on detailed guidance for producers of drug-device combinations. These are intended to assist those filing a marketing authorisation application once the new medical devices regime takes effect.

Products classed as “drug-device combinations” include:

  • devices which are integral to the medicinal product (pre-filled syringes, pens and injectors, drug-releasing intrauterine devices and dry powder inhalers, etc).
  • non-integral devices, where a specific device is co-packaged with the medicinal product or referred to in the product information (oral administration devices, injection needles, pumps, nebulisers, etc).

The draft guidelines envisage the inclusion within the marketing authorisation dossier for an integral DDC of evidence that the device element of the combination meets the relevant safety and performance requirements (GSPRs). Depending on the type of device, this may be the manufacturer’s declaration of conformity, or a certificate issued by a notified body. Where these are not available, the applicant will need to provide other evidence that the device element meets the GSPRs.

The guidance explains

“The core precept of this guideline is that the Competent Authority for the regulation of medicines (CA) will evaluate the device specific aspects of safety and performance relevant to the quality, safety and efficacy of the medicinal product, and that, as applicable, the NB will assess the relevant GSPRs.”

Note that Advanced Therapy Medicinal Products involving genes, cells or tissues are not covered. A separate set of rules cover ATMPs and these include situations where a device forms part of the active substance or formulation of an ATMP.

Source: Life Science Law

By Isabel Teare, Senior Legal Adviser

The Global Regulatory And Quality Environment For Biopharma Outsourcing

The topic of rising healthcare costs isn’t just a first-world issue anymore. Global healthcare expenditures are rising, and spending is increasing at an annual rate of 5.4 per cent between 2017-2022, from $7.724 trillion to $10.059 trillion, according to Deloitte’s 2019 Global Healthcare Outlook. 

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The global drug market will continue to grow, driven in part by double-digit economic growth in India and China and by downward pricing pressures in the U.S. The new regulatory frameworks now deployed in China are fueling growth in the Asia Pacific.

While the U.S. and Western Europe still make up more than half of the global market, China has replaced Western Europe as the second-largest marketplace. Harmonization of standards is inevitable as the socioeconomic statuses of these markets converge. Therefore, it is critical that organizations looking to engage an external contract service provider be aware of these newly established regulations to align their programs with the latest expectations for each relevant market. Let’s examine these in detail.

EUROPEAN UNION

The EU is undergoing major changes in the pharma, clinical data, and medical device arenas (Figure 1).

Several new regulations are worth noting:

Identification of Medicinal Products (IDMP): Data Standards

The European Medicines Agency (EMA) is implementing the ISO IDMP standards for the identification of medicinal products in a phased program, based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organization, and referential (SPOR) data. Under the IDMP standards, pharmaceutical companies will be required to electronically submit detailed product data and maintain it on an ongoing basis.

The goals of this new standard are to:

  • help facilitate the creation of global drug dictionaries and product dossiers
  • link product and safety information across global regulatory agencies
  • increase the industry’s signal detection capabilities to quickly identify product risks and issues, including coordinating product, recalls
  • connect critical product information within healthcare systems

The new framework consists of five ISO standards, shown in Figure 2. Becoming IDMP-compliant will drive pharmaceutical companies and full-service contract service providers to make significant changes to current product-related processes and systems, in a new era of cross-functional collaboration that paves the way for transformational benefits that extend beyond compliance.

CMOS NEED TO UNDERSTAND:

  • evolving regulations, implementation guidelines, and iterations
  • the compliance timeline and consequences of not meeting regulations
  • the IDMP data model and where data resides in the organization

Medical Device Regulation (MDR)

In June 2016, the European Parliament and the Council of the European Union adopted the far-reaching EU Medical Device Regulation following calls for greater control and stringent monitoring of medical devices, triggered by the Poly Implant Prothèse (PIP) breast implant scandal, a widespread hip replacement recall, and other incidents that revealed the system’s regulatory weaknesses. This regulation goes into effect in May 2020 and will transform both the medical device classification and the approval process. The MDR regulation will supersede all prior device approvals within the EU, with no grandfather clause for the former regulation. Compliance for reclassified devices must be in place by May 2020, or the product must be withdrawn from the market.

Key changes within this new regulation involve:

  • Scrutiny process: The European Commission (EC) will be able to review recommendations for Conformité Européenne (French) (CE) marking prior to approval.
  • Common technical specifications (CTS): The EC’s ability to create common technical specifications will be expanded to all devices.
  • New rules for notified bodies: Only newly created special notified bodies will be able to issue CE certificates for high-risk devices such as implants.
  • Audits for notified bodies: Notified bodies will be audited for compliance with the new regulations jointly by two competent authorities (i.e., the regulatory body for each member state). Also, manufacturers will be subject to unannounced audits by notified bodies.
  • Reclassification of medical devices: Spinal implants, devices that control and monitor active implants, nanomaterials, apheresis machines, and combination products will be reclassified as Class III devices requiring design dossiers.
  • Identification and traceability of devices: A unique device identification (UDI) system will be required for labelling, and the European Databank on Medical Devices (EUDAMED) will be expanded. Manufacturers will need to provide a summary of safety and clinical performance for Class III devices and also for implants of lower classification.
  • Clinical evaluation and investigations: The new MDR regulation will put in place a regimen for clinical investigations with mandatory post-market and clinical follow-up (PMCF) and periodic safety update reports.
  • Post-market surveillance (PMS), vigilance, and market surveillance: Under the regulation, PMS and vigilance requirements will be revisited, and manufacturers will consequently need to amend their procedures.
  • Change in the format of technical files: Formatting declarations of conformity and technical files is revised under the new regulation. This requires manufacturers to create a summary document for each section instead of providing complete protocols and reports.

CHINA NMPA

China’s regulatory framework is moving into close alignment with global regulatory practice, and few regulatory bodies have encountered as much change in a short period of time as China’s National Medical Products Administration (NMPA).

As ICH guidelines become China’s standard, China is increasingly willing to accept global clinical data in support of local product registrations, with priority for products that serve Chinese patients’ unmet medical needs.

China has implemented several key changes to accelerate a clinical trial and drug approval timelines.

  • Inclusion of data from clinical trials undertaken outside China. Drug sponsors and CROs that are attentive to the NMPA’s requirements will be well-positioned for access to the Chinese market.
  • Streamlined clinical trial approvals (CTAs). Specifically, the NMPA is allowing clinical trial materials to be tested by the sponsor or a trusted third-party testing lab, rather than having to be tested by a government-accredited testing lab.
  • Lifting of restrictions on the involvement of Chinese sites in multicenter Phase 1 studies. This changes the dynamic when selecting a CMO or CRO for multicenter Phase 1 studies.
  • Fast-track approval for drugs and devices. Specifically, new drugs and devices in development that meet urgent clinical needs in China can be approved for marketing conditions if data from early- or mid-stage trials show promising clinical value. Further, new drugs or devices for rare diseases can be approved for marketing in China if they have been approved for marketing overseas.

What’s more, China’s revised Drug Administration Law (DAL) entered into effect in December 2019. Under the new DAL, the market authorization holder (MAH) system applies equally to imported and domestic drugs, with MAH responsibility for the entire life cycle of a drug. Marketing authorizations can be transferred from one company to another without changing contract manufacturers, subject to NMPA approval. The amended regulation will enable Chinese MAHs to work with overseas CMOs. Likewise, foreign MAHs may choose to work with CMOs in China and restructure their supply chains accordingly.

INDIA

The Indian health ministry announced that certain drugs approved for use in major markets (such as the EU and the U.S.) will be automatically approved in India without a further native clinical trial having to take place, to give patients faster access to new medicines. The Ministry of Health & Family Welfare (MHFW) announced the new Drugs and Clinical Trials Rules 2019 in March 2019, to improve the ethical and quality standards of clinical trials in India. New guidance consists of 13 chapters (including 107 rules) and eight schedules that apply to all new drugs, as well as investigational new drugs for human use, clinical trials, bioequivalence and bioavailability studies, and ethics committees.

The new clinical trial rules include:

  • approval for clinical trials in 30 working days for indigenous drugs to speed up the trial process and encourage local drug development
  • provision for accelerated product approval, with some conditions, adding pre- and post-submission meetings with authorities to increase regulatory engagement.

The new framework is designed to stimulate the local clinical research industry, allowing more global clinical studies in India and promoting Indian indigenous drug development. These comprehensive new rules should improve the ethical and quality standards of clinical trials in India, aiding patients and industry.

The one constant we can count on changes. It has taken time, but the regulatory philosophies of the major markets are converging, creating avenues that accelerate access to new drug therapies while providing a solid, structured framework for clinical trial and regulatory oversight. Drug sponsors pursuing an outsourcing strategy will have to make sure the necessary processes and systems are in place — both internally and with their contract service providers — to ensure compliance in a new decade of modernized market regulatory expectations.

BIKASH CHATTERJEE is president and chief science officer for Pharmatech Associates. He has over 30 years’ experience in the design and development of pharmaceutical, biotech, medical device, and IVD products.

Source: Life Science Leader

By Bikash Chatterjee.

UK Government launches international trade hub in Scottish capital | Edinburgh biotech set to scale up | Research project boost

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A new trade hub dedicated to helping businesses in Scotland grow internationally has been launched today, providing “much-needed support for thousands of companies in economically challenging times”.

Based in Edinburgh’s Queen Elizabeth House, a UK Government HQ opened last month which will house 3,000 civil servants from multiple departments, it is claimed the UK Department for International Trade’s new Scotland Hub will provide businesses with greatly increased trade support.

Through the trade hub, businesses will be able to utilise the UK Government’s global networks, expertise and influence, as well as a world-leading credit agency, UK Export Finance (UKEF), to grow their overseas trade and build back from the impact of coronavirus, the government said.

Leveraging the strength and reach of the UK Government, the hub will “deliver effective services for people and businesses in Scotland”, it declared.

UK Government Exports Minister, Graham Stuart, met with Scottish businesses and representative organisations, including FSB Scotland, NFU Scotland and the Scottish Council for Development to discuss the support available for companies in the region.

Graham Stuart MP, UK Minister for Exports, said: “One of the UK Government’s key priorities is to champion all four parts of the UK and demonstrate how beneficial a strong Union is for all. This specialist Hub for Scotland will provide businesses with the support and guidance needed to boost their profits and harness their full potential.

“Trade is crucial to the UK’s recovery from coronavirus and will be the foundation of our relationships across the globe after the transition period ends this year. I want to ensure that businesses in Scotland benefit from our new trade deals with the world’s biggest markets, as we remove barriers that they previously faced.”

HeraldScotland:

David Duguid, UK Government Minister for Scotland, said: “This new UK Government Trade Hub in Edinburgh is fantastic news for Scottish businesses. It will help them make the very most of the global trade opportunities once the EU transition period ends.

“I urge Scottish businesses to work with the Trade Hub to expand their export business, especially Scotland’s famous food and drink sector. This is a real boost for Scottish produce. Recovering our economy from coronavirus is a national effort. We are working as one United Kingdom to support businesses in Scotland.

“The Trade Hub will be based in Queen Elizabeth House, the UK Government’s new flagship building in Edinburgh. It is a clear demonstration of our commitment to strengthening the Union and delivering for people in Scotland.”

UKEF has appointed a specialist to focus on renewable exports and to support the energy transition in Scotland, further demonstrating the continued commitment to supporting energy companies across Scotland and helping them succeed abroad.

Having previously worked to strengthen the outreach of UKEF’s regional network of Export Finance Managers, Alistair McMillan takes up this new role.

In Queen Elizabeth House, DIT will be joining the Office of the Secretary of State for Scotland, Office of the Advocate General, HMRC, HM Treasury, Cabinet Office, the Office for Statistics Regulation, the Information Commissioner’s Office, and the Government Actuary’s Department. Additional UK Government departments are expected to confirm occupancy in the coming months.

The UK Government building will be fully occupied as soon as it is safe to do in a COVID-secure way.

Work is also underway to set up a flagship UK Government building in Glasgow.

Edinburgh biotechnology firm IntelliDigest is primed to scale up its efforts in tackling food waste after being supported by Royal Bank of Scotland’s Entrepreneurial Accelerator programme.

Combining the latest developments in biotech, deeptech, agritech and foodtech, the company, which was founded in 2016 by Dr Ifeyinwa Kanu, is pioneering the elimination of food waste through the promotion of a circular economy, by preventing edible food going to waste, and by converting inedible food waste into sustainable chemicals.

These chemicals can then be used for food packaging, cosmetics and growing food.

Royal Bank of Scotland’s 18-month Accelerator programme provides support systems for business owners, allowing them time to focus on developing their company through one-to-ones and networking opportunities.

Through the Accelerator, industry experts worked with IntelliDigest on direction and commercialisation, leading seasoned scientific lawyer Patricia Barclay to take on the role of chairperson with the company.

Set to graduate from the programme in January, Dr Kanu has refocused her efforts on strategic restructuring and positioning the company as the go-to-market brand for addressing the food waste challenge.

IntelliDigest was also financially supported through Royal Bank of Scotland’s “Back Her Business” fund-matching scheme, which provided an additional £10,000 towards funds raised by the company.

Ifeyinwa Kanu, IntelliDigest founder, said: “The Entrepreneur Accelerator has been incredibly useful, giving me the opportunity to network and build lasting relationships with other budding entrepreneurs and experts from world-class organisations.

“The opportunity to spend time focusing on business development has been invaluable, as is the bank’s support in other ways – from funding to signing up to our initiatives.”

Royal Bank of Scotland accelerator manager, Matthew Teague said: “Dr Kanu developed an innovative, sustainable business which drew our attention, but ultimately, her mindset, drive, and enthusiasm were key to her enrolment. It’s been great to see IntelliDigest continue to grow, and I’m looking forward to seeing what’s in store in the years to come.”

A new Scottish research project has been awarded funding from the Royal Society to improve existing technology with benefits for health and safety in industry, healthcare and the COVID-19 pandemic.

University of the West of Scotland’s (UWS) Institute of Thin Films, Sensors and Imaging and Novosound will work together to improve the efficiency of ultrasonic sensors and imaging devices.

Dr Carlos García Nuñez, a lecturer in physics at UWS, has been awarded almost £25,000 in funding through the Royal Society’s Short Industry Fellowship scheme to undertake the project alongside award-winning sensors company Novosound.

The Royal Society Short Industry Fellow García Nuñez said: “The Royal Society’s Short Industry Fellowship brings academia and industry together to improve knowledge and work on solutions to current, real-world problems.

“I am thrilled to have been awarded the Fellowship, and look forward to working with Novosound on this exciting project.”

Novosound Ltd, UWS’s first spin-out company, has rapidly revolutionised ultrasound technology, which has remained largely unchanged for 40 years, by replacing conventional sensor materials with a flexible piezoelectric thin-film material. This has resulted in significant cost reduction and improved flexibility, providing 3D ultrasonic imaging and sensing capabilities for applications in oil and gas, aerospace, energy and many more.

Dr García Nuñez’s research will seek to further improve the capabilities of the device, utilising UWS-patented microwave plasma-assisted sputter deposition processes, developed at the University’s Institute of Thin Films, Sensors and Imaging, enhancing the piezoelectric thin films’ acoustic properties utilised in the Novosound transducers.

Dr García Nuñez added: “Ultrasonic transducers can be used in a range of different ways, and recently, we have seen increased interest in their application, especially in terms of non-destructive testing. By using microwave plasma-assisted sputter deposition, the project seeks to improve the performance of the Novosound technology, expanding use for societal benefit.”

Professor Dave Hughes, founder of Novosound and visiting professor at UWS’s Institute of Thin Films, Sensors and Imaging, commented: “As the first-spin out company to emerge from UWS, I am looking forward to revisiting Novosound’s research and development roots to work with Dr García Nuñez on this exciting project.

“The prestigious Royal Society Short Industry Fellowship allows Novosound and UWS to build on our existing, world-class, research to enable advancements and improved performance of Novosound’s product offering.”

Novosound’s current products have a broad range of applications, including non-destructive testing and monitoring in industry, medical imaging, and wearables. In the current COVID-19 pandemic, Novosound has also developed a lung ultrasound system for monitoring of acute respiratory failure.

The six-month project between UWS and Novosound will make use of both industry facilities and the University’s Institute of Thin Films, Sensors and Imaging laboratory, which launched earlier this year.

The £12 million lab, recognised a centre of excellence in the UK, will help the Institute continue to build on its successes, which, over the past five years, has won £7 million worth of external research and enterprise grants, as well as securing five patents and creating a new masters programme in advanced thin films technology.

Professor Des Gibson, Director of the Institute of Thin Films, Sensors and Imaging at UWS, said: “At UWS, we are committed to impactful, relevant research, and Dr García Nuñez’s collaboration with Novosound is a fantastic example of how we are working with industry to achieve this. The Royal Society Short Industry Fellowship enables dynamic engagement between universities and businesses to make a real impact – I look forward to seeing the outcome of this project.”

GSK establishes AI hub in London to discover new drugs

GlaxoSmithKline (GSK) has opened a £10m research hub in King’s Cross, London to leverage artificial intelligence (AI) for the discovery of new drugs to treat cancer and other diseases.

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GlaxoSmithKline (GSK) has opened a £10m research hub in King’s Cross, London, UK, to leverage artificial intelligence (AI) for the discovery of new drugs to treat cancer and other diseases.

Initially, the research base will have 30 scientists and engineers, who will work with their new neighbouring hubs, including the Francis Crick and Alan Turing research institutes.

The aim is to partner with other pharma companies using AI for the drug discovery process, such as analysis of genes that could cause disease and screening for potential drugs.

The company’s chief executive Emma Walmsley said that the move is expected to help enter the ‘huge London tech talent pool’ and attract scientists to GSK, according to London Evening Standard.

Walmsley was quoted as saying: “Using technologies like AI is a critical part of helping us to discover and develop medicines for serious diseases.”

US-based tech giant NVIDIA will also send a team of engineers to the new GSK research hub to explore ways of working together to find new drugs.

GSK is also expected to announce a collaboration with another US company, Cerebras, which has an AI supercomputer with the largest chip and is said to be a thousand times faster than conventional machines.

Scientists at the new hub will be part of an 80-member team of AI experts worldwide at GSK.

In a statement, GSK said: “We’ve announced our new AI hub in London, which will help us reimagine how new medicines are discovered for cancer and other serious diseases.”

Last month, Merck, known as MSD in Europe, announced plans to build a $1.3bn (£1bn) research hub on a 25,000m² site in London.

The hub, named London Discovery Research Centre, is the first early research centre by Merck outside of the US.

Scientists develop new compound which kills both types of antibiotic-resistant superbugs

Scientists develop new compound which kills both types of antibiotic resistant superbugs

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Researchers at the University of Sheffield have developed a new compound that is able to kill both gram-positive and gram-negative antibiotic-resistant bacteria.

Gram-positive and gram-negative bacteria have different cell wall structures, but the new antibiotic compound is able to pass through the cell wall of both forms of bacteria and then bind to the DNA.

The findings, published in Chemical Science, pave the way for developing new treatments for all kinds of antibiotic-resistant bacteria, including the gram-positive MRSA and gram-negative E.Coli.

The team from the University of Sheffield has previously developed new compound leads that specifically target gram-negative bacteria, but this new compound is a broad-spectrum antimicrobial which means it is just as effective in both types of bacteria.

Gram-negative bacteria strains are particularly difficult to treat as their cell wall prevents drugs from getting into the microbe, they can cause infections including pneumonia, urinary tract infections and bloodstream infections.

The team worked with colleagues at the Science and Technology Facilities Council’s (STFC) Rutherford Appleton Laboratory (RAL).

Professor Jim Thomas, Principal Investigator of the research from the University of Sheffield, said: “Antimicrobial resistance is an increasing problem with many studies predicting a medical global emergency, so broad-spectrum antimicrobials which work against resistant pathogens are urgently needed. As the compound is luminescent it glows when exposed to light. This means we were able to follow the uptake and effect on bacteria using advanced microscopy techniques available at STFC’s Rutherford Appleton Lab.”

Antimicrobial resistance is already responsible for 25,000 deaths in the EU each year, and unless this rapidly emerging threat is addressed, it’s estimated by 2050 more than 10 million people could die every year due to antibiotic-resistant infections.

Doctors have not had a new treatment for gram-negative bacteria in the last 50 years, and no potential drugs have entered clinical trials since 2010.

Anticancer Immunotherapy Response Predicted Using New Imaging Tool

Scientists at the University of Bath have developed a diagnostic tool that can predict whether a cancer patient is likely to respond to immune checkpoint inhibitor therapy. The method uses an imaging technique, iFRET, to directly assess the interaction between programmed death ligand-1 (PD-L1) ligand with its receptor programmed death receptor-1 (PD-1), in patients’ tumour samples.

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The team hopes that the technique will allow clinicians to tailor treatments to individual patients and avoid treatment paths that are unlikely to be successful.

“Currently, decisions on whether to proceed with checkpoint inhibitor treatment are based simply on whether PD-1 and PD-L1 are present in biopsies, rather than their functional state,” stated Banafshé Larijani, PhD, director of the Centre for Therapeutic Innovation (CTI-Bath). “However, our work has shown it is far more important to know that the two proteins are actually interacting and therefore likely to be having a functional impact on tumor survival.” Larijani and colleagues reported on the new tool in Cancer Research, in a paper titled, “High PD-1/PD-L1 Checkpoint Interaction Infers Tumor Selection and Therapeutic Sensitivity to Anti-PD-1/PD-L1 Treatment.”

Immunotherapy is a type of cancer treatment that helps a patient’s immune system fight cancer, and is having a profoundly positive impact on cancer treatment for many patients. Cancers can evade detection by the immune system, making themselves invisible to the natural anti-tumor response and actively blocking it. Antibody-based immune checkpoint inhibitor therapy effectively removes the brakes that tumors can put on the immune system, and so reactivates the patients’ natural anticancer response, which then destroys the tumor. Checkpoint inhibitors have been hugely successful for some subsets of cancer patients, but for many this type of treatment has little or no effect, and “notwithstanding some remarkable successes with immune checkpoint inhibitors, the majority of patients display primary or acquired resistance to treatment,” the authors wrote.

Co-author José I López, PhD, from the department of pathology, Cruces University Hospital, in Bilbao, noted, “Immune checkpoint blockade is becoming a therapeutic milestone in some cancers in the last years. Patients are selected for this treatment option using immunohistochemistry, however, this technique does not reliably detect all of the candidates that would potentially benefit. Actually, up to 19% of patients supposedly negative do respond to this therapy.”

So, given the inherent toxicity risks associated with immunotherapy, there is a real need to define which patients are most likely to benefit from treatment, and avoid unnecessary exposure for those patients who won’t respond. As the researchers commented, “There is, therefore, an unmet clinical need to identify biomarkers that distinguish potential responders from nonresponders to ensure that nonresponders are not exposed to the side-effects of these drug for no therapeutic benefit.”

The team in Bath led by Larijani, working with colleagues in the U.K. and Spain, including the company FASTBASE Solutions, has now developed a prognostic tool that uses an advanced microscopy platform to identify immune cell interactions with tumor cells, and also reported on the activation status of immune-checkpoints that dampen the antitumor response. The scientists used the technique to evaluate the immune checkpoint involving PD-1, which is present on immune cells called T lymphocytes, and PD-L1, which is present on other types of immune cells and on the surface of many different types of tumors. When PD-1 on the surface of T lymphocytes engages with PD-L1 on the surface of other immune cells, it effectively switches off the immune function of the T cell. In a healthy individual, these checkpoints tightly regulate the body’s immune response, acting as an off-switch to prevent autoimmune and inflammatory disease. Tumor cells essentially hijack this mechanism by expressing PD-L1 on their surface, enabling them to activate PD-1 on the T lymphocyte, thus switching off its antitumor function, allowing survival and growth of the tumor.

Immunotherapy checkpoint inhibitors work by disrupting the interaction between PD-L1 expressed on the tumor and PD-1 on the T cell, and thus re-establish the patient’s antitumor activity. “Conceptually, it is surmised that a high degree of PD-1/PD-L1 interaction infers tumor selection in patients, indicating that the patient’s tumor may be reliant on PD-1/PD-L1 interaction to facilitate immune evasion. It is precisely this group of patients that would be expected to respond to immune checkpoint inhibition,” the investigators explained.

The new iFRET imaging tool developed by the Bath researchers can quantify the extent of PD-1/PD-L1 interaction in a biopsy of the tumor, to help predict whether the checkpoint inhibitor therapy is likely to have significant clinical benefit. Results from tests with the system on tumor biopsy samples confirmed that immunotherapy-treated patients with metastatic non-small cell lung cancer (NSCLC) who displayed a low extent of PD-1/PD-L1 interaction showed significantly worse outcome than those with a high interaction.

The team hopes that the same approach could be used to monitor other immune cell interactions in cancer. “iFRET can be exploited to monitor other intercellular protein interactions and there are ongoing developments designed to capture related immune modulatory interactions pertinent to cancer and emerging cancer treatments,” the scientists noted. “This provides the potential for iFRET to become a useful predictive tool informing on the nature of the tumor immune-privileged state.’

Stephen Ward, PhD, vice-chair of CTI-Bath and a co-author of the study, said, “The tool we have developed is an important step towards personalized medicine. By using it, we can precisely select who will benefit from immunotherapy. It will also show which patients are unlikely to respond well before they start a long course of treatment, and these patients can be offered a different treatment route … “It should make treatment with these expensive biotherapeutics much more efficient for the NHS.”

Tests in additional patients are now being planned, according to Eunate Arana, PhD, scientific coordinator of BioCruces Health Research Institute. “We find this technology and its application in the field of immunotherapy truly interesting. Therefore, we are going to carry out a clinical trial in three hospitals of BioCruces and BioDonostia, the Basque Public Health network, that will allow us to evaluate the predictive capacity of this quantitative imaging platform, to improve patient stratification for lung cancer immunotherapy.”

The authors concluded, “The exemplification of iFRET in tumor settings opens up exciting and powerful new opportunities to move beyond the cataloguing of cell phenotypes in situ and add functional attributes to our patient data inventory, impacting clinical decisions … This is a routine parameter for small-molecule inhibitors targeted at driver mutations, and we suggest it should become a routine for these more complex biotherapeutic interventions.”

Virtual reality a rising force in the global healthcare industry

An image from the FeM Surgery VR video showing the vacuum assisted breast biopsy VR procedure.

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SINGAPORE – Virtual reality (VR) has commonly been associated with gaming and entertainment, but it has also been making waves in hospitals and clinics across the world in recent years.

Doctors are increasingly applying this technology across a spectrum of uses, from medical training to diagnosing and treating different conditions, to easing a patient’s anxiety before and during a medical procedure.

The global market for virtual reality in healthcare was valued at US$2.14 billion (S$2.92 billion) in 2019 and is projected to reach US$33.72 billion by 2027, according to a Verified Market Research report in July.

In a pilot study done last year, patients undergoing wide-awake surgery at St George’s Hospital in London had the option to use a VR headset before and during their operation to view calming landscapes.

All the participants reported that their overall hospital experience was improved by wearing the headset, while 94 per cent said they felt more relaxed.

Furthermore, 80 per cent said they felt less pain after wearing the headset and 73 per cent reported feeling less anxious.

Consultant orthopaedic surgeon Shamim Umarji, who led the study, said: “Many patients feel quite anxious about the prospect of being awake during surgery, so it’s fantastic to see the positive impact virtual reality can have on the patient experience. As surgeons we occasionally lose sight of how daunting the operating theatre can be.”

A research team at the University of Utah in the United States has also found VR to be useful in building balance skills in patients with Parkinson’s disease.

The technology has successfully improved patients’ obstacle negotiation and balance, as well as their confidence in moving around in their environment, according to their findings published in peer-reviewed journal Experimental Biology.

VR has also been effective in training surgeons as well as teaching medical students.

Last year, a study from Harvard Business Review showed that training using VR technology improved participants’ overall surgical performance by 230 per cent compared with traditional training methods.

The participants from the David Geffen School of Medicine at University of California, Los Angeles, were able to complete procedures on average 20 per cent faster and more accurately.

“Synthetic lethality” kills cancer by blocking DNA repair mechanism

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Three dimensional culture of human breast cancer cells.
Photo credit: NCI Center for Cancer Research.

With advances in genome sequencing, cancer treatments have increasingly sought to leverage the idea of “synthetic lethality,” exploiting cancer-specific genetic defects to identify targets that are uniquely essential to the survival of cancer cells.

Synthetic lethality results when non-lethal mutations in different genes become deadly when combined in cells. In a new paper published online July 27, 2020 in the Proceedings of the National Academy of Sciences (PNAS), researchers at the San Diego branch of Ludwig Institute for Cancer Research and University of California San Diego School of Medicine report that inhibiting a key enzyme caused human cancer cells associated with two major types of breast and ovarian cancer to die and in mouse studies reduced tumor growth.

The research team, led by senior study author Richard D. Kolodner, PhD, Distinguished Professor of Medicine and Cellular and Molecular Medicine and member of the Ludwig Institute for Cancer Research San Diego Branch, studied Saccharomyces cerevisiae, a species of yeast used in basic research, to search for synthetic lethal relationships.

They zeroed in on Flap Endonuclease 1 (FEN1), a DNA structure-specific endonuclease involved in DNA replication and repair. Turning their attention to cancer cells, they found that when they blocked functions of FEN1 using either a small molecule inhibitor or genetic ablation, BRCA1 and BRCA2 mutant cancer cell lines were preferentially killed. Notably, normal cells were able to recover from FEN1 inhibition.

BRCA1 and BRCA2 genes normally act to prevent breast and ovarian cancer as well as other cancers, but when mutated, may cause a person to be more likely to develop breast or ovarian cancer or develop cancer at a younger age. Less than 10 percent of women diagnosed with breast cancer have a BRCA mutation, but it’s estimated that 55 to 65 percent of women with the BRCA1 mutation will develop breast cancer before age 70 while approximately 45 percent of women with a BRCA2 mutation will develop breast cancer by age 70, according to the National Breast Cancer Foundation.

Similarly, women with inherited BRCA mutations have an increased risk of developing ovarian cancer and men with inherited BRCA mutations have increased risk of developing breast and prostate cancer.

Breast cancer is the most common type of cancer in the United States, with approximately 276,000 new cases per year, according to the National Cancer Institute. Prostate cancer is the fourth most common, with 191,930 new cases and ovarian is 17th, with an estimated 21,750 new cases annually, according to the National Cancer Institute.
Kolodner and colleagues then tested the approach in an immune-compromised mouse xenograft model, and found that FEN1 inhibition significantly reduced tumor growth.

The researchers say their findings are significant in two ways: They underscore the value of using S. cerevisiae yeast as a genetics tool for discovering synthetic lethality relationships and identify FEN1 inhibitors as a possible therapeutic agent to further develop for treating certain cancers with targeted vulnerabilities.

Co-authors of the study include: Elaine Guo, Yuki Ishii, James Mueller, Anjana Srivatsan, Ludwig Institute for Cancer Research, San Diego Branch; Timothy Gahman, Ludwig Institute for Cancer Research; Christopher D. Putnam and Jean Y.J. Wang, Ludwig Institute for Cancer Research, San Diego Branch and UC San Diego.

Funding for this research came, in part, from the Ludwig Institute for Cancer Research and the National Institutes of Health (grant GM26017).

Deep learning (AI) – enhancing automated inspection of medical devices?

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Integrated quality inspection processes continue to make a significant contribution to medical device manufacturing production, including the provision of automated inspection capabilities as part of real-time quality control procedures. Long before COVID-19, medical device manufacturers were rapidly transforming their factory floors by leveraging technologies such as artificial intelligence (AI), machine vision, robotics, and deep learning.

These investments have enabled them to continue to produce critical and high-demand products during these current times, even ramping up production to help address the pandemic. Medical device manufacturers must be lean, with high-speeds, and an ability to switch product variants quickly and easily, all validated to ‘Good Automated Manufacturing Practice’ (GAMP). Most medical device production processes involve some degree of vision inspection, generally due to either validation requirements or speed constraints (a human operator will not keep up with the speed of production). Therefore, it is critical that these systems are robust, easy-to-understand and seamlessly integrate within the production control and factory information system.

Deep learning

Historically, such vision systems have used traditional machine vision algorithms to complete some everyday tasks: such as device measurement, surface inspection, label reading and component verification. Now, new “deep learning” algorithms are available to provide an ability for the vision system to “learn”, based on samples shown to the system – thus allowing the quality control process to mirror how an operator learns the process. So, these two systems differ: the traditional system being a descriptive analysis, and the new deep learning systems based on predictive analytics.

Innovative machine and deep learning processes ensure more robust recognition rates. Medical device manufacturers can benefit from enhanced levels of automation. Deep learning algorithms use classifiers, allowing image classification, object detection and segmentation at a higher speed. It also results in greater productivity, reliable identification, allocation, and handling of a broader range of objects such as blister packs, moulds and seals. By enhancing the quality and precision of deployed machine vision systems, this adds a welcome layer of reassurance for manufacturers operating within this in-demand space.

Deep learning has other uses in medical device manufacturing too. As AI relies on a variety of methods, including machine learning and deep learning, to observe patterns found in data, deep learning is a subfield of machine learning that mimics the neural networks in the human brain by creating an artificial neural network (ANN). Like the human brain solving a problem, the software takes inputs, processes them, and generates an output. Not only can it help identify defects, but it can, as an example, help identify missing components from a medical set. Additionally, deep learning can often classify the type of defect, enabling closed-loop process control.

Deep learning can undoubtedly improve quality control in the medical device industry by providing consistent results across lines, shifts, and factories. It can reduce labour costs through high-speed automated inspection. It can help manufacturers avoid costly recalls and resolve product issues, ultimately protecting the health and safety of those towards the end of the chain.

AI limitations

However, deep learning is not a silver bullet for all medical device and pharmaceutical vision inspection applications. It may be challenging to adopt in some applications due to the Food and Drugs Administration (FDA)/GAMP rules relating to validation.

The main issue is the limited ability to validate such systems. As the vision inspection solution utilising AI algorithms needs sample data, both good and bad samples – it makes validating the process extremely difficult, where quantitative data is required. Traditional machine vision will provide specific outputs relating to measurements, grey levels, feature extraction, counts etc. which are generally used for validating a process. With deep learning, the only output is “pass” or “fail”.

This is a limiting capability of deep learning enabled machine vision solutions – the user has to accept the decision provided by the AI tool blindly, providing no detailed explanation for the choice. In this context, the vision inspection application should be reviewed in advance, to see if AI is applicable and appropriate for such a solution.

Conclusion

In conclusion, deep learning for machine vision in industrial quality control is now widely available. Nevertheless, each application must be reviewed in detail – to understand if the most appropriate solution is to utilise traditional machine vision with quantifiable metrics or the use of deep-learning with its decision based on the data pool provided. As AI and deep learning systems continue to develop for vision system applications, we will see more novel ways of adapting the solutions to replace traditional image processing techniques.

Source: Med-Tech Innovation News

How has COVID-19 changed the NHS customer landscape?

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Oli Hudson, content director at Wilmington Healthcare, explores the rapid and startling changes to the NHS customer landscape – and how it will affect medtech.

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Two months ago, the NHS had a customer environment that was often challenging, sometimes frustrating, but largely predictable.

Change appeared at a stately pace and in line with the NHS Long Term Plan, which set out to foster gentle collaboration rather than competition.

So integrated care systems were emerging, but yet to contract officially with integrated providers; some hospitals within trusts were being divided into ‘hot’ (emergency or specialist) and ‘cold’ (elective) sites; limited partnership between trusts and joint purchasing strategies were being developed, but slowly; and pilot programmes for pathway change, specialisation, and digital adoption seemed the norm, rather than the wholesale transformation desired.

Some elements of the plan, such as a move away from long-term hospital bed use towards care in social, community, primary and home settings, were well intentioned but happening sporadically in areas where all the players within an ICS could agree.

Smart medtech companies were watching, with a view that organisational relationships between their customers, and between their customers and them could change, albeit slowly; perhaps the most crucial thing was the change in the national procurement model.

Two months later, the Coronavirus outbreak has made all these assumptions null and void.

Integration

The crisis has forced the pace with integration – with all the players within integrated care systems including acute, primary, community, specialist, ambulance and social care, as well as representation of local housing, transport, education and police, having to come together to make decisions on resource and capacity. Meanwhile, the Long Term Plan’s drive to create more coherent governance models in the shape of CCG mergers is ahead with increased fervour. This lays a baseline for a more integrated stakeholder map, with some ICS representatives saying they have achieved more in seven day timelines than had previously happened in 18 months. The learning? ICSs will be the standard operating unit of the NHS after the outbreak, and their decisions will affect which hospitals do which procedures and how pathways that involve medtech are managed.

Acute care

Within acute care, we are seeing changes to the purpose of hospitals– with whole units given over to COVID-19. Operating theatres have been turned into ICUs, and staff not previously specialising in respiratory or critical care requisitioned for this emergency. Departmental structures that previously existed within large hospitals have been shaken up beyond recognition, with clinicians working well beyond their normal disciplines. In places like London, a reconfiguration is underway between hospitals dealing with COVID-19 patients, and ones which are specialising in other areas, with Royal Brompton and Harefield forming a ‘hub’ model for heart disease, the Royal Marsden for cancer, and St Bartholomew’s for emergency elective treatment. The NHS has even enlisted the entire private sector to increase its critical care capacity. As a landscape, it is unrecognisable.

There is also developing a backlog of long-term conditions treatment, outpatients and elective care. The medtech products used to treat them will be needed at some point, but when? Acute care will be a confusing and challenging customer environment for medtech during the outbreak – and industry may have to change its approach, determining the route to engagement – for example, via digital and remote channels.

It is unlikely that hospitals will revert to the pre-COVID working-in-a-vacuum strategy. There will be trade-offs and resource sharing. This is likely to foster closer collaboration in procurement in the future.

Long-term conditions

The emphasis on COVID-19 has detracted from other groups of patients – vulnerable groups such as respiratory, diabetes, cancer, heart and autoimmune conditions. How are these patients now being catered for and will the outbreak mean changes to care pathways? Cancer surgery has been affected, with patients being risk-stratified into four groups. Some groups will not receive treatment, depending on the likely outcome, whether it has a clinically meaningful aim, whether the patient is likely to gain significant extra life, and whether operating will expose the patient to a COVID-19 risk that is greater than not operating. Such measures have been outlined across most therapy areas by NICE in its series of rapid response guides, and will affect operations performed that use medtech for some time.

Industry impact

Hardly anything industry does with the NHS will be unaffected by this pandemic. It is important that industry stays well informed, prepares to be agile, offers solutions that deliver value and address issues of rapid, reliable and consistent supply and distribution – and act as a partner to the local and national NHS during this crisis.

Source: Med-Tech News

Partnership aims to advance cybersecurity practices in medical devices

Two medical device organisations have announced a new collaboration to advance cybersecurity practices across the entire medical device lifecycle.

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The Association for the Advancement of Medical Instrumentation (AAMI) and the Archimedes Centre for Medical Device Security will work together to connect their networks of medical device and health technology professionals across the country.

Robert Burroughs, AAMI senior vice president of education, said: “Cybersecurity is a major area of concern for medical device safety, and it’s an area where AAMI has been active and will be even more active in the future. Our collaboration with Archimedes will expand the reach of some of the world’s leading experts in the area of cybersecurity and lead to new education offerings and resources that will drive patient safety. We welcome them as members to the AAMI community.”

AAMI is a non-profit community of more than 9,000 professionals working to support the healthcare community in the development, management, and use of safe and effective health technology.

Archimedes was the first of its kind to bring together the different stakeholders from the medical devices industry—including healthcare providers, medical device manufacturers, security researchers, and regulators—for the purpose of solving security challenges. Housed at the University of Michigan’s Computer Science and Engineering department, the centre is funded by 17 institutional members to support graduate students and train healthcare professionals to better integrate security engineering into medical device design, procurement, and operation.

Representatives at AAMI cite a growing focus on security across the medical devices industry as a major motivation behind the collaboration.

Burroughs added: “There are a few things happening in the future that are really crucial for medical devices. In an Internet-of-Things world, cybersecurity is already here today as an issue and it’s only going to grow in importance.” 

The two organisations intend to connect their membership and stakeholder networks to work on advancing security practices for these devices. Potential outcomes of this initiative include a standardised healthcare and medical device security curriculum for manufacturers and healthcare delivery organisations.

Professor Kevin Fu, University of Michigan professor and chief scientist at the Archimedes Centre, said: “We appreciate how AAMI represents thousands of experts in healthcare technology, sterilisation, and medical device manufacturing. The Archimedes cybersecurity collaboration with AAMI will help us to significantly grow our broader impact on society for trustworthy, safe, and effective delivery of healthcare.” 

The organisations are considering additional joint activities to promote their overlapping work, including an annual innovation award for medical device security.

Source: Med-Tech News

How 3D printing is used to create patient-specific jaw restorations

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Creating and placing jaw restorations or implants for dental patients can be extremely time-intensive, with the need for manual model shaping, bone grafts and titanium meshes – to name just a few of the challenges.

3D Systems has been able to develop a design process to produce patient-specific implants (PSIs). The creation of individualised implants for complex surgical procedures is aided by utilising the advanced processes and enhanced flexibility that 3D printing enables.

Due to the highly customised nature of this process, its DICOM to PRINT (D2P) and Geomagic Freeform 3D design software allows the creation of PSIs more meticulously than ever before. Geomagic Freeform, for example, takes advantage of touch-based haptic devices, the Touch and Touch X, to help make the process extremely natural. Transforming traditional techniques into digital design with precision at the core.

But, how are the 3D Systems innovations used in real-world scenarios? To highlight how this process works, I’d like to go through the typical use case of a patient in need of a PSI from a partner of 3D Systems, Graft3D Healthcare Solutions, who create prosthetics using our technology.

The first step is for a cone-beam computed tomography scan of the patient, the data from which can be rendered in DICOM, before being converted by the 3D Systems D2P software into an STL file. For reference, D2P can also be used by surgeons, radiologists, lab technicians, and device designers for the quick realisation of digital 3D models, but here we would use it to extract the exact amount of bone exposed during a CBCT.

This provides precise information about such elements as bone density and soft tissues. The net result is a minimally invasive osteotomy, with the enhanced accuracy potentially forming less discomfort for the patient.

Implants designed to specific measurements, customised to each and every individual, can then be created. The STL file previously converted by the D2P software is now imported into our Geomagic Freeform software – which combined with our haptic-feedback devices – is used to formulate the particular location, length, depth and angles for the prosthetic replacement.

Again, here we are looking at a specific use case for Geomagic Freeform, but the flexibility of the platform means that it could also be used for different projects such as turning the hand fabrication of orthoses and prostheses (O&P) into a digital workflow or establishing functional cages for applications such as custom medical implants.

By this point, you can hopefully see the improvements in accuracy and patient comfort, and that’s before we discuss the savings in time and changes in surgical procedure.

When formulating customised PSIs, speed of creation is an important factor. The use of the Geomagic Freeform software facilities the impressions of the patient’s mouth to be overlaid with the proposed new prosthetic design, the effect being an assessment period up to 50-60% faster thanks to the eradication of multiple patient visitations.

Once the elements are created using a combination of plastic and metal additive manufacturing (AM), the surgical procedure can commence. Here, adopting our 3D printing and AM processes creates millimetre-perfect prosthetics catered to the individual’s mouth, reducing bone scraping and lessening repetitive drills during surgery.

The net result is a reduction in time, an increase in accuracy and a less inconvenienced patient. Plus, the use of 3D-printed PSIs helps reduce the chances of periodontal disease further down the line.

Clinicians being able to work interactively with patient-specific interactive models thanks to 3D Systems’ D2P and Geomagic Freeform software is truly a game-changing revelation for subperiosteal implants and we continue to work tirelessly to find new technological-breakthroughs to assist medical professionals.

Source: Med-Tech

Hay fever: Grass pollen DNA study could help sufferers

Trees, grass and weeds all produce pollen that can cause hay fever

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The lives of hay fever sufferers could be changed thanks to research to identify which grass pollen causes the most common allergic reactions.

Aberystwyth and Bangor universities are studying pollen DNA to distinguish different types of pollen.

They are examining it because even under powerful microscopes different kinds look identical. But some affects hay fever sufferers more than others.

And different grasses flower and release pollen at different times.

While it can last a long time, it disperses quickly so after a few weeks it is no longer present.

The researchers hope to identify which pollen causes the most common allergic reactions.

That would mean they could provide better information to hay fever sufferers.

Those grass species could then perhaps be avoided in fields, or grassland areas in schools and housing estates.

It is estimated there are about 13 million hay fever sufferers across the UK.

According to charity Allergy UK, people taking time off because of their symptoms costs the economy £7bn in lost productivity.

As well as the Welsh institutions, universities in Worcester and Exeter are involved and researchers are also working with the Met Office.

Prof Simon Creer is studying pollen DNA to distinguish between pollen typesImage copyright-BANGOR UNIVERSITY
Prof Simon Creer is studying pollen DNA to distinguish between different types

They have deployed collection traps across the UK to capture what type of pollen is in the air at any given time.

They can then cross-reference that information with data from GP surgeries and hospitals.

That will show when people are accessing anti-histamines to combat hay fever and have more severe symptoms.

In future, they hope weather forecasts will be able to include more detail about different kinds of pollen in the atmosphere.

Dr Gareth Griffiths, of Aberystwyth University’s biological, environmental and rural sciences institute, said: “We can guess when pollen is being realised from seeing when the different grasses are flowering.

“But our data, where we’ve caught the pollen grains from the air and analysed their DNA, this tells us exactly what proportions there are of each type of grass, and also how that varies from north to south and east to west across the British Isles.”

Collection traps have been deployed across the UK to capture pollenImage copyrightMANDY JONES
Collection traps have been deployed across the UK to capture pollen

Bangor University’s Prof Simon Creer said: “If we can identify the species of grass that are contributing more to the allergenic load, then that informs us that we can try and avoid those species whenever possible.

“If we see a spike in a particular kind of pollen at the same time that hay fever is increasing, you can work out where the hot spots are, and which pollen is in that area.”

Prof Creer said the research could extend to recommending to turf makers and grass seed producers which grass species are less associated with hay fever.

That could lead to advising developers to avoid them when building schools, hospitals or housing estates.

Source: BBC NEWS

BD Receives Order from U.K. Government for 65 Million Injection Devices to Support COVID-19 Vaccination Campaign

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WINNERSH, U.K. (July 3, 2020) – BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the receipt of a large pandemic order from the U.K. government for 65 million needles and syringes to be delivered by mid-September 2020 to support the U.K. vaccination effort for COVID-19. The first shipments of the injection devices arrived in the U.K. on June 18 and provide the first element of the government’s COVID-19 and flu response plan.

Mike Fairbourn, vice president and general manager of BD – U.K. and Ireland said, “With a 60-year history in vaccine delivery, BD is committed to producing 65 million high-quality vaccine injection devices to support the U.K. in planning for a COVID-19 vaccination campaign. BD applauds the U.K. government for its forward-thinking and coordinated approach in planning for future COVID-19 needs. This device selection will help ensure the maximum number of U.K. citizens get inoculated in the fastest possible timeframe. We thank the government for its partnership, and we look forward to continuing to work with all levels of government in the U.K., as we partner together to respond to the COVID-19 pandemic and support the re-setting of the National Health Service as core healthcare work resumes.”

Recognising the need to prepare early, the U.K. is among the first governments in the world to secure vaccine injection devices in support of a national COVID-19 vaccination campaign. BD continues to advise governments around the world that the time to act on injection devices is now to prepare for when a COVID-19 vaccine has been approved and is widely available. While many annual vaccines come ready-to-deliver in prefilled syringes, due to the rapid ramp up in production and speed necessary to deploy the COVID-19 vaccination quickly, the new vaccine is anticipated to be made available initially in single or multidose vials, which require the use of separate needles and syringes to draw the vaccine from the vial and administer it to patients.

BD is the largest manufacturer of injection devices in the world, producing billions of syringes and needles annually through its global manufacturing network. This commitment is the latest effort in the company’s multifaceted global response to this virus. In addition to ramping up manufacturing of needles and syringes, BD has been working closely with the National Health Service (NHS) and other government agencies to expand access to diagnostic testing and support treatment of COVID-19 patients. Through June, the company has supplied health care providers globally with approximately 48 million swabs for flu and COVID-19 testing, more than 2.85 million COVID-19 rapid molecular diagnostic tests on the BD MAX™ System and millions of products used in the treatment of COVID-19 patients, including infusion pumps, infusion sets and catheters. BD Biosciences instruments are also being used by researchers around the world to better understand the human immune response to COVID-19.

Source: BD.com

Biotech Venture Capitalist Picked to Run U.K. Vaccine Taskforce

The U.K. government has appointed biotech venture capitalist Kate Bingham to chair a task force that will coordinate efforts to find a viable vaccine for Covid-19 and make it widely available to the public.

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Bingham will step back from her role as managing partner of SV Health Investors to take on the position, and will report directly to U.K. Prime Minister Boris Johnson, the government said on Saturday.

The U.K. has committed £250 million ($303 million) to find a vaccine for the virus, and the task force will coordinate development efforts already underway across government, industry and academia.

The appointment comes as world leaders struggle to balance the need to motivate drug discovery while making sure that the benefits aren’t available only to those who pay the most. The World Health Organization wants to ensure broad access by asking pharmaceutical companies to voluntarily donate their COVID-related intellectual property to a common global pool.

Source: Bloomberg

The Future of Drug Discovery: AI, Automation and Beyond

The Future of Drug Discovery: AI, Automation and Beyond

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“It all started in the 1950s with the famous mathematician Alan Turing, who asked the question – Can machines think?” – Pieter Peeters, Janssen Research & Development.

In a recent interview with Technology Networks, Pieter Peeters, Leader of High Dimensional Biology and Discovery Data Sciences Group at Janssen Research & Development, discusses the evolution of artificial intelligence (AI), and how it can be used to discover, develop and test new drugs.

“Artificial intelligence is a discipline in computer science that deals with building smart computer algorithms that mimic the things we typically associate with the human brain,” explains Peeters.

“Personally, I don’t like the term artificial intelligence, because I think we still have a way to go before machines can be said to have real intelligence, but we are heading in that direction.”

So, what has changed since the 1950s, and how is AI now integrated into many industries, including drug discovery? Peeters explains that AI’s ability to influence these industries is due to developments in three main areas – data volume and accessibility, hardware, and the algorithms themselves.


“AI is affecting every aspect of the pharmaceutical industry, from the very early drug discovery aspects, all the way through to how we do clinical development and bring medicines to patients,” – Pieter Peeters, Janssen Research & Development. Peeter explains that a branch of AI, known as natural language processing, is helping scientists mine vast amounts of biomedical literature in a more effective way. This provides drug discovery teams with insight into how diseases manifest – information that can be exploited to develop treatments. AI also impacts the later stages of drug development, the way clinical trials are run, the way participants are recruited to the studies, and also the way these participants are monitored.

Watch our interview with Pieter Peeters below to discover, in more detail, how AI is affecting the way drugs are discovered, tested, and provided to patients.

VIDEO LINK

Source: Technology Networks

Women in science are battling both Covid-19 and the patriarchy

A black female scientist working in a lab

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The pandemic has worsened longstanding sexist and racist inequalities in science pushing many of us to say ‘I’m done’, write 35 female scientists 

Successful female scientists are, by definition, resilient. We have overcome well-documented barriers throughout our lives: discouragement by teachers, family and society to pursue careers in STEM fields; a lack of role models; hostile and sometimes abusive work environments; disproportionate domestic work and caring responsibilities; and biases against us in favour of men in every aspect of our professional lives – hiring, promotion, publishing, pay, service loads and grant allocation. These barriers are felt even more keenly by women of colour, who face the intersectional effects of racism and sexism.

And yet, even these lifelong battles for a place in science have left us unprepared for the gendered and racial inequalities we have experienced in the response to the Covid-19 pandemic. The worst impacts of the coronavirus will undoubtedly be the loss of lives, the collapse of economies, the disruption of humanitarian aid and the decay of democracies. But we fear that the hard-won progress for women in science will be collateral damage to this crisis.

Together, we represent scientists in North America and Europe who are working on Covid-19 both through research and in the translation of research to clinical responses, policy and public communication. We span the academic career pipeline from graduate students all the way up to senior, tenured faculty. We all share the same experience: the scientific response to Covid-19 has been characterised by an extraordinary level of sexism and racism.

In some ways, the issues we face represent an exacerbation of the inequalities we have always had to manage. But what is surprising and demoralising is seeing the fault lines of sexism that define our unequal footing with men crack into gaping chasms under the pressure of the pandemic. 

Women are advising policymakers, designing clinical trials, coordinating field studies and leading data collection and analysis, but you would never know it from the media coverage of the pandemic. More than ever before, epidemiologists, virologists, and clinicians are communicating with journalists and the public about their science. But highly visible articles in The New York Times and other media outlets about the scientists involved in the response are biased towards men, even though there are plenty of qualified women on the frontlines of the Covid-19 response that could easily be identified by checking author lists and scientific websites.

Neither epidemiology nor medicine is male-dominated fields, but women are quoted less often – sometimes not at all – in articles. What’s more, the lack of inclusion of leaders of colour is striking and disenfranchising for minority women scientists of colour, particularly as communities of colour are being hit hardest by this epidemic.

Even within our own institutions, unqualified men’s voices are being amplified over expert women because they have been identified through informal male networks, or have blustered their way into social media and TV interviews and are therefore perceived as “high profile”.

Not including women’s voices in the public discussion of the Covid-19 pandemic is a distortion of reality. It not only perpetuates the invisibility of women in science and leadership positions, undermining our ability to be taken seriously as experts and failing to provide role models for younger women, but also impacts our careers as we strive to prove the impact of our work to funding agencies, colleagues, and hiring or promotion committees.   

We have also noticed that women are more likely to be doing work that is focused on “getting shit done”–  the operational work and supporting decision-makers, for example – rather than writing scientific papers or grants.

All the while we are disproportionately supporting students and filling service or pastoral roles in our institutions; a continuation of a troubling trend of women doing the “invisible work in academia” even in the absence of a pandemic. At the same time, we see that the opportunistic but not necessarily qualified researchers who are applying for newly available Covid-19 funding are overwhelmingly male; this is not only skewed in favour of men and often fails to acknowledge junior women involved but also represents a misallocation of funds.

And then there is the potentially dangerous issue of unqualified men being listened to more than women experts, reflecting the fact that white male power structures seem unable to entrust the most important public health questions to anyone other than white men, regardless of their qualifications.

Management consultants – largely male – with negligible relevant experience are making key decisions about the health of millions. Tech sector data scientists with no prior experience in any aspect of public health, biology or disease control are being “pulled in” to task forces to discuss the finer points of contact tracing with policymakers. Senior male academics, famous for their innovations in other spheres, are giving public commentary with ill-informed modelling exercises, conjectures, or policy prescriptions with no basis in rigorous science.

For many women, the final straw is the inequality they face in domestic work, childcare, and responsibility for ageing parents and community members. There is ample evidence that women faculty spend significantly more time doing household chores and looking after children than their male counterparts. Now, with almost all of us working from home and schools closed around the world, the burden of these responsibilities – particularly childcare – falls heavily on women.

We already know how this discrepancy plays out in terms of academic productivity, where “equal” maternity and paternity leave policies come with a deficit for women and provide a boost to men. Now there is evidence of the productivity divide during the Covid-19 crisis, with fewer women submitting papers than men, which we suspect reflects both the type of academic work women are doing and the time deficit created around trying to balance work with increased domestic responsibilities. Even the crucial medical research into Covid-19 is male-centric.

As women who are deeply involved in Covid-19 science, it has become clear to us that our expertise means little when it comes to real decision-making in this public health emergency. We are frustrated that our work is being overlooked and misrepresented in the media. We’re exhausted knowing that after this is all over we will have a powerful fight on our hands to reclaim the professional ground that is slipping away from us during this emergency.

And we fear that these experiences will lead to a haemorrhaging of women from academia in the aftermath of the pandemic – particularly junior women – even with assurances of tenure clock stoppages or other mitigating policies. The disillusionment and cynicism we hear in the voices of our colleagues and friends fill us with sadness. “After this is over, I’m done” is a refrain we have heard many times in the past few months, almost exclusively from women.

We are reticent to complain about fear of being seen as weak, as if we are overly fixating on prestige or whining about being left out, when in fact the stringent filters of sexism and racism have left us all with tougher skins and greater resilience than many of our male colleagues.

Source: The World University Rankings

Can This Biotech Shed New Light on Cancer Immunotherapies?

T cells attacking cancer cells

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Can This Biotech Shed New Light on Cancer Immunotherapies?

Its new discovery in the field of cancer immunotherapy produced mixed clinical results, but it certainly has ample backing from the big players.

Over the past decade, many immunotherapies have been investigated for the treatment of cancer, with limited success. Will Compugen (NASDAQ:CGEN) become yet another casualty in an endless uphill battle?

Compugen claims a key competitive advantage: proprietary algorithms it can use to detect specific sequences within protein receptors that regulate the immune system and inhibit their activity. Normally, these receptors prevent T-cells in the body from attacking healthy tissues. Cancer cells, however, are known to evade detection by the body’s own immune system by posing as healthy cells through these receptors, a process known as peripheral tolerance. Hence, by blocking the pathways of cancerous cells disguising themselves as healthy cells, the immune system will be able to recognize them as pathogens and form an effective response.

T cells attacking cancer cells

IMAGE SOURCE: GETTY IMAGES.

Currently, immunotherapy drugs such as nivolumab, pembrolizumab, and ipilimumab target the PD-1 and CTLA-4 checkpoint inhibitors. On the other hand, Compugen claims it has discovered a new set of protein receptors responsible for peripheral tolerance.

As a result, it’s now investigating three novel immunotherapy candidates to target various types of cancer. All three therapies are undergoing phase 1 clinical trials. However, only one candidate, COM701, has data available to analyze.

Is the data as good as the theory?

COM701 is an antibody that inhibits the activity of the newly discovered (by Compugen) PVRIG receptor, which is theorized to prevent the activation of T-cells against many types of tumor activity, such as in melanoma, ovarian cancer, endometrial cancer, lung cancer, breast cancer, and colorectal cancer. The therapy is administered intravenously to patients every three to four weeks. In an interim clinical data release involving 13 patients treated with either COM701 alone or with COM701 and Opdivo (nivolumab, an approved PD-1 inhibitor), the stable disease control rate was 69%. This metric represents the percentage of patients with advanced-stage cancer who saw their condition stabilize after intervention therapies were administered in clinical trials. There are concerns in the scientific community that the metric is ambiguous and may exaggerate therapeutic effects.

A much better endpoint, in this case, would be the partial response rate, which is defined as the percentage of patients showing at least a 50% reduction in tumour size after an experimental therapy is administered. In another interim data release this April, there were two cases of partial responses among 28 patients in the COM701 and COM701-plus-Opdivo arms, resulting in a partial response rate of just 7%.

Not only did the clinical trial not have a standard-of-care comparison cohort, but patients enrolled also received a median of seven other oncological drugs before the investigation began. That makes it extremely difficult to tell whether or not COM701 works.

Does this mean the stock is no good?

Despite the uncertainty surrounding COM701, investors shouldn’t be dismayed. Usually, when investing in small-cap biotech stocks, what’s far more important in the decision-making process is to see whether the company is backed by institutional investors. Institutional investors have vast teams of doctors, pharmacists, and biology experts who conduct due diligence into whether a mechanism of action for a particular drug is promising, and who are well-informed about a company’s potential. Luckily, Compugen has the backing of Ark Investment Management — a famously bullish investor of Tesla (NASDAQ: TSLA). The firm owns over eight million shares of Compugen, accounting for more than 10% of the company’s outstanding shares.

Furthermore, the company has numerous research and development agreements with big players in the pharmaceutical sector. Bayer (OTC:BAYRY), AstraZeneca (NYSE:AZN), and Bristol Myers Squibb(NYSE:BMY) have all signed up for research and development partnerships with Compugen’s pipeline candidates, including COM701. Together, the three pharmaceutical giants have invested $50 million into the company in the form of up-front payments, with over $500 million in potential milestone payments tied to the success of its clinical trials.

Full phase 1 results from COM701 are set to be released next year. In the meantime, the company has enough capital to stay afloat, with $43 million in cash and only $27 million in expenses last year.

This may be a potential opportunity for biotech investors with high-risk tolerance. Nonetheless, it would be wise to diversify across a basket of stocks in the sector, in case Compugen’s clinical candidates show no promise.

Source: The Motley Fool

5 tips for retaining top talent

5 tips for retaining top talent

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Few things are more important to a business than retaining top talent.

Although high turnover is indicative of deeper-rooted issues within a business, assessing the surface impact of losing your talent should be worrying enough; Acas research stated that the average cost of replacing an employee within the UK is around £30,000, with £25,000 of that cost coming from a loss of productivity in the 28 weeks it takes to get a new hire up to speed.

The remaining cost comes from the logistics of sourcing the replacement such as agency costs, advertisement fees, HR and management time and even the possibility of having to hire a temp before the new starter joins. The analysis, based on figures drawn from five different industries including legal, retail, accountancy, advertising and IT, found that the total costs for these sectors combined over the course of a year were a shocking £4.3billion.

Why do people leave a company?

So, if it wasn’t already obvious, ensuring that your company promotes longevity and keeps hold of its talent is a matter of extreme importance. This, then, begs the question – why do people leave? Whilst inevitably salary plays a large role in peoples’ discontent within the workplace (16% of respondents to a Bureau of Labour Statistics (BLS) agreed that this was their key motivation), finances aren’t the be-all and end-all of retention.

Actually, far from it. The BLS put this largely down to the rise in living costs, increasing by 14% since 2015, whilst opportunities for growth or advancement opportunities came in at 11.7%, it’s unsurprising that the largest factor that pushes people to quit by a dramatic amount, is a toxic or negative company culture at 40%.

Why do they stay?

So, the above detailed why people are keen to leave an organisation. And whilst this is worrying, HR will no doubt be looking for solutions through the minefield of retention information. For this reason, here are five of the best things HR can do to keep staff and ensure that their workforce is happy and productive:

Culture 

There’s no alternative to addressing your own company culture when seeking to improve retention. Identifying the early warning signs of toxic or hostile company culture, before it starts to have a truly devastating effect on the business, can be the difference between thriving in the current volatile marketplace and losing your best staff. Forbes reported on a Gallup study which found that 70% of workers hate their job, with toxic culture identified as the biggest reason why. Staff who feel like they are micromanaged, constantly watched and given no trust are inevitably counting down their days at the company.

Inadequate investments in people

It’s the most obvious source of dissonance, yet lack of training is the number one contributing factor. An ONS study recently found that 40% of managers have had no formal training in leading teams, whilst a Shift study found that the average employee receives just 12 minutes of training every six months and 62% of employees stated that they are simply left to figure out their jobs – leading to confusion and hostility between workers and managers.

Three tips to boost staff retention in 2020   A lack of accountability

When doubts creep into the employee psyche about a company’s commitment to its core values, employees may use these as a justification for not reporting poor behaviour, as well as a reason to be less careful about their own actions. One-third of employees surveyed by Weber Shandwick stated that they believe their company doesn’t consistently hold people responsible for misconduct.

A lack of diversity 

Diversity and Inclusion within the workforce have been proven time and time again to have a drastic difference on company performance, but it also contributes largely to positive company culture. When people feel included and heard, they’re far more likely to invest in their work. Nearly eight in ten employees who left their jobs last year stated that they were victims of unfair treatment such as stereotyping, harassment, and microaggressions, according to a United Minds survey.

Poor leadership behaviours 

A 2019 survey from PwC found that CEOs are being ousted from their companies, not just for poor financial performance, but increasingly more for reasons related to poor personal conduct or other ethical issues. This is evident in the vast string of CEO departures which have hit headlines in the last year such as WeWork’s Adam Neumann and McDonald’s CEO Steve Easterbrook to the resignation of Overtstock.com’s Patrick Byrne.

Source: HR Grapevine

Top 10 Biotech and Pharmaceutical Stocks to Watch in 2020

Here’s an overview of the top 10 biotech and pharmaceutical stocks to watch in 2020. This biotech stocks list consists of companies that are actively developing drugs to fight diseases and even the coronavirus pandemic.

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Biotechnology and pharmaceutical stocks are shares in companies in the Biotech sector. Biotech focuses on the development of drugs for the treatment of infectious diseases and medical conditions. It also involves the creation of tools that aid in the detection of diseases. This sector ranges from biofuels, gene cloning, genetically modified foods, and several others.

The high demand for medicines makes biotech and pharmaceutical stocks a great class to invest in. In line with that, people may always need to take medications to improve their state of health, which is why investing in companies in this industry hold great prospects.

Despite this, there is still a level of risk involved in trading this type of stock. For instance, health products often undergo rigorous testing and also need to be approved by the U.S. Food and Drug Administration (FDA). The time and cost needed to complete these processes require that investors wait long years before they can tell if they’ve run into a profit or loss.

Here are the top biotechnology and pharmaceutical stocks to watch in 2020.

Amgen Inc.

Amgen Inc. is a biotech company that was founded in 1980. The company is focused on the discovery, development, and marketing of drugs to treat diseases. It makes this possible by taking advantage of the advancement in cellular and molecular biology.

AMGN Stock

Amgen’s shares are traded on the stock market under the ticker symbol AMGN. The company’s stock is worth about $138 billion, which gives it the largest market capitalization for any stock from a biotech company. It also ranks Amgen as the biggest company in the Biotech & Pharma industry.

Nonetheless, it is worth noting that these shares declined at the start of the year. The reason could be tied to the company’s announcement of a decline in its 2019 revenue. The reported revenue for the full year was $23.4 billion, a 2% decline from 2018.

Health Products

Amgen has manufactured several health products that have been approved by the FDA. Popular among these are the Neulasta and Enbrel. Neulasta improves the health of chemotherapy patients by keeping infections at bay. Whereas Enbrel aids in the treatment of patients with rheumatoid arthritis.

And in a bid to fight the COVID-19 pandemic, Amgen has begun clinical trials of drugs that could potentially cure the virus. It partnered with Adaptive Biotechnologies to create antibodies to fight the virus. What’s more, the company says there is no shortage of supply of its drugs despite the epidemic and its impact on supply chains.

Gilead Sciences Inc.

Gilead Sciences Inc. is a biopharmaceutical company that was founded in 1987. The California-based company develops drugs for the treatment of diverse illnesses. During its initial public offering (IPO) in the early 1990s, the company raised $86.25 million.

GILD Stock

Gilead Sciences stock operates under the ticker symbol GILD and it is listed on the Nasdaq Biotechnology Index and the S&P 500 index. GILD has a market capitalization of about $100 billion, at the time of writing. Interestingly, when the Dow Jones plummet by 1000 points, GILD came in second as the best performing stock on S&P 500. It also surged higher on Nasdaq-100.

On the other hand, there was a change in the company’s Chairman and CEO in early 2019. Daniel O’Day is now in charge with the goal of increasing the company’s sales after years of decline. The company reported a revenue of $5.9 billion in the Q4 of 2019 and it was an increase from the $5.8 billion made in Q4 of 2018.

Health Products

Gilead Sciences has developed several drugs targeted at treating hepatitis B, hepatitis C HIV, and influenza. Viread (tenofovir), for instance, was approved in 2001 and it is used in treating HIV patients. There’s also Sovaldi, an FDA approved that is used for the treatment of hepatitis C.

Interestingly, Gilead Sciences gained popularity of late thanks to its development of the drug Remdevisir. According to the World Health Organization (WHO), Remdevisir could potentially help in treating coronavirus. Gilead Sciences, however, notes that the drug has not been approved even though it has proven effective in the treatment of MERS and SARS, which are other strains of coronaviruses.

Vertex Pharmaceuticals Inc.

Vertex Pharmaceuticals Inc. is a biopharmaceutical company that was founded in 1989. The Boston-based company is reportedly among the first to have adopted an explicit strategy for rational drug design. The latter differs from the combinatorial chemistry design that was often used.

VRTX Stock

Vertex is listed under the ticker name VRTX and its shares price grew steadily within a three year period. It grew from $74 to $269 per share between 2017 and 2020. At the time of writing, VRTX has a market capitalization of about $69 billion.

Vertex recorded an increase in sales. This was $3.04 billion in 2018 significantly higher than the $500 million it had reported in 2014. What’s more, the product revenue was also a 40% increase from the $2.17 billion revenue it had generated in 2017.

Health Products

Some of the health products offered by Vertex and which have been approved include Kalydeco (ivacaftor), Orkambi (lumafavtor, ivacaftor), Symdeko (tezacaftor, ivacaftor) and Trikafta (ivacaftor, elexacaftor, tezacaftor, and ivacaftor). These drugs aid in the treatment of patients with cystic fibrosis from 12 years and above. There are currently trials to launch drugs that could potentially help in treating medical conditions like sickle cell anaemia.

Vertex Foundation, a non-profit arm of the company issued $5 million as a COVID-19 relief package. According to the Biotech company, the funds are aimed at helping organizations tailored to the provision of emergency relief to communities with Vertex employees. The foundation recently made a move to donate $50,000 CAD to charity organization Food Banks Canada.

Biogen Inc.

Biogen Inc. is a biotechnology company that was founded in 1978 as a result of a merger. The company develops drugs that help in the treatment of patients with neurological diseases. Some of these are Alzheimer’s and dementia.

BIIB Stock

Biogen’s stock is listed under the ticker name BIIB and it has a market capitalization of about 48 billion. Although Biogen had hit several milestones in 2018, it was still not enough to save its stock from tanking by over 30% in 2019.

The decline was due to its suspension of trials pertaining to aducanumab over regulatory concerns. Aducanumab is a drug that would’ve been used for the treatment of Alzheimer’s. Nonetheless, clinical trials were held after the drug was evaluated again, however, the company is yet to submit the drug to the FDA for approval. Early this year, Biogen reported first-quarter revenue of $3.5 Billion

Health Products

Biogen has launched several drugs that have helped in combating neurological conditions. Some of these drugs include Avonex, Fampyra, Flixabi, Benepali, Tysabri, Plegridy, Imraldi, Tecfidera, and Spinraza.

Illumina Inc.

Illumina Inc. is a biotechnology company that was founded. in 1998. The California based company specializes in the development of products tailored to proteomics, genotyping, DNA sequencing, etc. The company’s technology was able to reduce the cost of human genome sequencing. This cost was reduced from $1 million to $1,000.

ILMN Stock

Illumina’s stock is listed on Nasdaq‘s index under the ticker name ILMN. ILMN has a market capitalization of about $45.37 billion and in a 52 week period, its shares have traded between $196.78 and $380.

In January 2020, the company announced its revenue for the fourth quarter of 2019. Based on the company’s report, its revenue grew by 10% in Q4 of 2019 compared to that of 2018. In this case, it recorded $953 million, a significant difference from the $867 million raised in the Q4 of the previous year.

Health Products

Illumina offers several sequencing kits including Nextera DNA Flex, TruSeq RNA Exome, MiSeq Reagent Kits v3, NextSeq 500/550 v2.5 Kits. There are also products for reproductive health application and these products are not limited to HumanCytoSNP-12 BeadChip, Infinium CytoSNP-850K v1.2 BeadChip, and HumanCytoSNP-12 BeadChip.

On the other hand, Illumina is working on tool kits for testing the SARS-CoV-2, the novel coronavirus. It launched the Illumina SARS-CoV-2 NGS Data Toolkit in a bid to accelerate the work of researchers looking for a cure for the virus. The company says these tools aid in detecting and identify COVID-19 in test samples. Hence, it could also help to add these findings to public databases.

Regeneron Pharmaceuticals Inc.

Regeneron Pharmaceuticals Inc. is a U.S. based biotech company that was founded in 1988. The company specializes in the development of drugs that reduce cholesterol, stimulate the blood vessels, and offer regenerative capabilities.

REGN Stock

Regeneron stock is listed on Nasdaq under the ticker REGN. It has a market capitalization of about $59.38 billion. The price per share has traded between $271.37 – $574.32 for the past 52 weeks. In January, the biotech company announced that it had generated a revenue of $2.17 billion in the fourth quarter of 2019. The value marked a 13% increase from its revenue in the fourth quarter of 2018.

Health Products

Regeneron offers quite a number of health products that have been approved. One of such products is EYLEA, which helps in treating eye diseases. EYLEA has also amassed more sales for the company more than any of its products. For instance, the company gets an annual revenue of about $1 billion from the sales of EYLEA in regions other than the U.S.

On the other hand, the great dependence on the company on EYLEA for its income did take a toll on it. For starters, Regeneron’s stock price declined when news of a tough competitor to EYLEA was being produced by Novartis. Despite this, the company’s price surged to and made a two year high after Novartis faced setbacks early this year.

Recently, Regeneron Pharmaceuticals Inc and Sanofi SA began a clinical trial to ascertain if their arthritis drug Kevzara can help treat patients with COVID-19. In line with that, the company wants to develop a drug that combines the antibodies of mice and humans to treat COVID-19 patients.

Alexion Pharmaceuticals Inc.

Alexion Pharmaceuticals Inc. was founded in 1992. The Boston-based company specializes in creating therapies that could potentially enhance the body’s immunity.

ALXN Stock

Alexion Pharmaceuticals, Inc. is listed on Nasdaq with the ticker name ALXN. The stock has a market capitalization of $24.556 billion. Each share has been sold between the range of $109.68 and $111.42 for the past 52 weeks.

In its financial report for the Q4 of 2019, the company revealed an increase in revenue over the Q4 of 2018. Here, it recorded $1,384.3 million in revenue, a 23% increase over the earnings of the Q4 of 2018. It may also be worth noting that since its inception, Alexion has acquired or merged with several companies including Proliferon Inc, Enobia Pharma Corp, Synageva BioPharma, Syntimmune, Achillion Pharmaceuticals, and Wilson Therapeutics.

Health Products

Alexion’s drug Soliris has gained popularity over the years. Soliris is used to treat rare diseases. The company further revealed that it will be widening the scope of its products to meet more patients.

When it comes to the treatment of coronavirus, Alexion is in the third phase of testing Ultomiris. The company hopes that Ultomiris could potentially help to fight the pandemic. The FDA has also cleared the drug to be used in testing.

Incyte Corporation

Incyte Corporation is a biopharmaceutical company that was founded in 1991.

INCY Stock

Incyte’s stock trades on Nasdaq as INCY. The stock has a market cap of $22.62 billion. The price per share has ranged between $103.45 – $104.81 for a 52 week period. The company revealed in its 2019 Q4 financial report that it has revenue of $579 million for the quarter and $2.1 billion for the whole year. These revenues were 24% and 22% increment over those generated in Q4 2018 and the whole of 2018, respectively.

Health Products

Incyte Corporation launched the drug Jakafi and the FDA has approved this drug. The company had also partnered with Eli Lilly to develop baricitinib, a drug that could help in the treatment of rheumatoid arthritis. While Incyte Corporation received approval from the EU for the drug, it was rejected by the FDA over health concerns.

That aside, the FDA approved the company’s Pemazyre, a drug for the treatment of adults that have formerly been treated with cases related to Cholangiocarcinoma. Incyte also partnered with biotech company Novartis AG to use Jakafi to treat certain symptoms that lead to complications in COVID-19 patients. Both companies intend to study the drug and put 400 patients under a test with the drug.

Novavax Inc.

Novavax Inc. is a biotech company that was founded in 1987. The Bill and Melinda Gates Foundation also gave the company $89 million as a research grant.

NVAX Stock

Novavax’s stock ticker symbol is NVAX, and the stock has a market capitalization of 1.099 billion. NVAX has been priced between $3.54 and $26.34 for a 52 week period. Novavax shares, however, tanked by 33% and traded around $8.41.

Health Products

There were also pretrials carried out in 2015 to create a vaccine for Ebola. The FDA also gave the company a Fast Track status in order to hasten the review of NanoFlu. The latter is a drug that could potentially become an influenza vaccine.

Over and above that, the company revealed that NVX-CoV2373 has been identified as a candidate for treating SARS-CoV-2. According to the company, the drug showed high immunogenicity and it also stimulated neutralizing antibodies.

Moderna Inc.

Moderna Inc. is a biotechnology company that was founded in 2010. The Massachusetts-based specializes in the discovery and development of drugs based on messenger RNA (mRNA).

MRNA Stock

Moderna’s stock is listed on Nasdaq under the ticker MRNA. The stock has a market capitalization of $16.174 billion and it has traded between the range of $11.54 to $56.38 for a 52 week period. The company revealed its revenues for the fourth quarter of 2019 and it amounted to $14.1 million. Nonetheless, it generated annual revenue of $24 billion and there are expectations that the company’s revenue for 2020 will surge to $77.6 billion.

Health Products

Moderna does not have any marketed products at the moment. Rather, it generates its revenue from partners that collaborate with the company to use its mRNA technology. The technology aids in the development of different therapies.

Moderna is also working on mRNA-1273, a vaccine candidate for COVID-19. And in February 2020, the first clinical batch was completed and a testing process began. The company also revealed its plans to test the drug on 45 healthy adults who are aged 18 to 55 years. The test will also last for approximately six weeks.

Conclusion

These are the top 10 BioTech and pharmaceutical stocks to watch in 2020 and even consider to buy. The companies themselves are actively working to develop a vaccine for the coronavirus pandemic. They also have a wide range of products tailored to treating different ailment that plaque the human. And most importantly, these companies have reported gains within the past quarter with expectations for more. Therefore, if you’re looking to trade biotech and pharmaceutical stocks, keep a close eye on these ones.

Swallowing a Pill Filled With Light Could Be The Key to Ingestible Medical Devices

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There is an increasing number of medical devices that treat us by going in through the mouth (think bariatric balloon or oesophagal stents) – but the process of getting them out again can be a lot more painful than putting them in.   New research offers an alternative – devices that can break down in your stomach after you’ve swallowed a pill of light.

Yes, you read that right. The idea is that when medical devices inserted into the gastrointestinal tract reach the end of their life they could start to break down once they come into contact with certain kinds of light. They would then be processed through the body like any other kind of waste.

Thanks to the newly developed light-sensitive hydrogel, devices could be easily removed if they weren’t working or after the course of treatment had finished – all patients would have to do is take a glowing LED pill that would trigger the dissolving process in the gut.

“We are developing a set of systems that can reside in the gastrointestinal tract, and as part of that, we’re looking to develop different ways in which we can trigger the disassembly of devices in the GI tract without the requirement for a major procedure,” says gastroenterologist Giovanni Traverso, from MIT.

The researchers tested their hydrogel in pig guts, finding that a bariatric balloon (often used to reduce appetite and treat obesity) based on the gel could be dissolved in as little as 30 minutes using an LED. These balloons are typically deflated via surgery and then removed via the mouth.

To make their device material, the researchers started with a light-sensitive polymer that includes a chemical bond that breaks when exposed to certain wavelengths of light. That was linked with stronger materials including polyacrylamide.

The end result is something that’s durable enough to last in the gut and yet still break down when exposed to light. By changing the mix of the hydrogel material, the researchers are able to vary the time it takes to break down.

light pill 2The bariatric balloon developed by the researchers. (Ritu Raman)

“You’re forming one polymer network and then forming another polymer network around it, so it’s really entangled,” says mechanical engineer Ritu Raman, from MIT. “That makes it very tough and stretchy.”

As well as being much more convenient, quicker and less painful than surgery, swallowing an LED is a very effective way of targeting ingestible devices – no light makes it down to the gastrointestinal tract naturally, so the LED doesn’t have to actually make contact with the device to start doing its work.

Different colours of light affect the degradation speed as well – ultraviolet light works faster than blue light, for example, but also carries a higher risk of causing damage to the cells in the body. All these factors will need to be tested in future research.

In the meantime, the technique shows a lot of future potential for a better way of removing devices from the body, from bariatric balloons to oesophagal stents that can be used to help treat some types of cancer.

“We’re really looking at different triggers and how they perform, and whether we can apply them to different settings,” says Traverso.

“This study is a proof of concept that we can create this kind of material, and now we’re thinking about what are the best applications for it.”

The research has been published in Science Advances.

Urology robot tech first for Harley Street

King Edward VII’s Hospital has become the first hospital in the Harley Street Medical Area to introduce the latest da Vinci surgical system, the da Vinci Xi© robot…

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King Edward VII’s Hospital has become the first hospital in the Harley Street Medical Area to introduce the latest da Vinci surgical system, the da Vinci Xi© robot, currently the most technologically advanced robotic system. As well as offering increased flexibility and versatility, the system provides multi-quadrant anatomical access – increasing the range in which surgeons can operate and creating room for more complex and challenging procedures.

Designed with enhanced ergonomics and precision, the da Vinci Xi© robot is at the forefront of surgical technology, with novel architecture, extended instrument reach and integrated auxiliary technology.

It is the first of its kind both at the hospital and within the famous Harley Street Medical Area, London – an area famed for its medical excellence in treating complex and life-threatening conditions.

Kate Farrow, Director of Operations at King Edward VII’s Hospital, said:

“We chose the Xi as we are committed to providing the highest standards of treatment available, and it is the currently the most technologically advanced robotic system. It allows the surgeon to operate on multi–quadrants, meaning that unlike previous models, the range in which a surgeon can operate within the patient is larger and a wider range of complex procedures can be done. We look forward to expanding our robotic programme to include colorectal, general and gynaecological surgery.”

With the addition of its new robotic technology, the hospital has also recently announced a new range of services to provide diagnostics and treatment for a variety of conditions and urological disorders, including pelvic reconstruction; erectile dysfunction; female urology; urinary incontinence; female functional urological reconstruction; kidney stones; male infertility; and prostate, bladder and kidney cancer.

Focal therapy is one of the new services offered at King Edward VII’s Hospital for treating prostate cancer, using High Intensity Focussed Ultrasound (HIFU) or electroporation (Nanoknife). This minimally-invasive treatment is offered to men who have medium (intermediate) risk prostate cancer. The side effects of this type of treatment, which treats only the cancer and a small area around it, are rendered much less than those for traditional prostate cancer surgery or radiotherapy

The hospital has also expanded their team of leading urology specialists with the appointment of new consultants, including Professor Caroline Moore MBBS, MD, FRCS(Urol) – the first woman in the UK to be a Professor of Urology; Professor Mark Emberton BSc, MBBS, FRSC (Urol), MD, FMedSci; Mrs. Sian Allen MBChB, MRCS(Eng), MD(Res), FRCS Urol; and Mr. Paul Cathcart MBBS, MD, FRCS (Urol).

Lindsey Condron, Chief Executive, added:

“We are committed to providing the best care to our patients and having expanded our urology team, we are in a position to offer a complete range of urological services. Our ambition is to be the leading independent urological centre in the UK.”

King Edward VII’s Hospital is one of the UK’s leading centres for urology, bringing together an exceptional multidisciplinary team of consultant urologists – leaders in their specialist field. With the very latest in diagnostic and surgical technology at their fingertips, they work together to provide outstanding personalised, patient-centred care at the cutting edge of modern medicine.

The hospital is located within the world-famous Harley Street Medical Area. Managed by long-term landlord The Howard de Walden Estate, the area is home to a community of world-renowned medical professionals.

Source: Life Science Industry News

How S.O.F.T. Skills Can Help Close The Talent Gap

In 1972, the U.S. Continental Army Command (CONARC) at Fort Bliss, TX, coined the phrase “soft skills,” in order to distinguish job behaviours that characterize human interactions with machines…

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…(“hard skills,” evident in situations with clear, measurable processes) from equally important job behaviours that characterize human interactions with other people (soft skills, occurring in situations of high uncertainty and consequences). In contrasting the two types of skills, the Army’s Soft Skills Training Conference report admitted, “in other words, those job functions about which we know a good deal are hard skills, and those about which we know very little are soft skills.”

In the decades since the conference, even as the military’s “machines” have transformed into ubiquitous computer networks and daily interaction with computational tools has become routine, workplace interactions with colleagues can seem just as mysterious as they did to CONARC back in 1972.

MAPPING S.O.F.T. SKILLS FOR LIFE SCIENCES

In our recent research paper for the Massachusetts Biotechnology Education Foundation (MassBioEd), my colleagues, Karla Talanian, Luke Haubenstock, and I attempted to remove some of the mystery surrounding these skills, by mapping nontechnical job behaviours most essential to the life sciences industry. In the process, we repurposed the word “soft” to define the four axes of this behaviour map as “S.O.F.T.,” for Self — Others — Feeling — Thinking. We concluded that life science enterprises urgently need to accelerate the development of S.O.F.T. skills in order to decrease the talent gap that threatens the industry’s success in providing innovative therapies for patients in need.

Happily, numerous individual companies are rising to the challenge of expanding S.O.F.T. skills development across their workforces: Effective approaches are underway at organizations of all sizes across the life sciences ecosystem.

PRACTICAL APPROACHES TO ACCELERATE S.O.F.T. SKILLS

A first step in accelerating S.O.F.T. skills is to name them. At a leading global life sciences company, all employees, from entry-level associates to C-suite executives, are asked to pick one soft skill and one technical skill each year for individual development. Employees can choose to take classes to improve, obtain opportunities to practice internally, and find content available for reinforcement. “We put these things on calendars to see how people progress. We make it tangible. It’s a great program,” says a senior engineer.

Telling a succinct story is a crucial, yet often underdeveloped, soft skill among scientific professionals. A department of quantitative researchers addresses this skill gap directly through an elevator pitch competition: Each member of the group uses their phone to record a 30- to 60-second video description of their individual work projects and goals. They then refine and share it with peers who watch the brief videos and reply by sending their own. The group schedules an annual dinner to view and award the best elevator pitches. A senior member of the group reports, “I use my elevator speech four to six times a year to explain what I do to cross-functional colleagues.”

At one CMO, S.O.F.T. skills training focuses on increasing motivational conversations. As their VP of HR explains, “We teach people to inquire ‘How do you motivate your team? What are your best conversations, and what are your toughest conversations?’ and we challenge them on the answers.”

FEEDBACK AND COACHING ARE FOUNDATIONAL S.O.F.T. SKILLS

Role-playing can remove some of the uncertainty and anxiety that surrounds challenging conversations. As a leader at a growing biotech company explained, “People sometimes get data paralysis. The muscle memory of role-playing for skill-building can help in these situations.” Building this muscle memory requires continued practice to develop new habits. By identifying peer coaches to offer feedback and reinforcement to colleagues, life sciences companies provide opportunities for employees to practice building S.O.F.T. skills in giving and receiving feedback; asking thought-provoking questions; improving listening skills; and appreciating others’ strengths.

When a senior executive at a biotech company was challenged to develop her direct report — a renowned technical expert whose lack of interpersonal skills had stalled his career progression — continued feedback and coaching proved essential. The senior executive employed a two-step coaching approach with the expert that included:

  • giving continued direct and specific feedback
  • connecting the expert with peers who provided him with real-time feedback, providing consistent, frequent check-ins

After many months of committed focus, the technical expert had changed his mindset and behaviours to become a highly collaborative contributor, with the satisfying result that one of his strongest critics became a strong supporter, and the expert’s career trajectory took off.

Learning the S.O.F.T. skills of giving and receiving feedback is foundational to elevating other essential workplace behaviours. Gaining commitment across the organization to practice building feedback expertise is, therefore, a best practice. At one life sciences organization, the peer feedback process includes four related components:

  • Bringing junior colleagues to team meetings and debriefing with them immediately afterwards, while memories are still fresh, on how they and other participants showed up to the group.
  • Identifying senior people who excel in S.O.F.T. skills to weigh in on good practice and interaction with teams, analogous to a distinguished scientist role for technical topics.
  • Separating technical work from S.O.F.T. skills for presentations and meetings, with the goal of separating the scientific review from asking “What went well with the team meeting? Did we reach the right people? Did we make the right points? What active listening behaviours were evident?”
  • Asking peers in advance of meetings and presentations to provide feedback on specific areas of interaction at the event.

THE S.O.F.T. SKILLS OF LISTENING

Feedback is inextricably linked to another S.O.F.T. skill: active listening. At a fast-growing biotech company, employees receive coaching in mentoring others through active listening. They learn how to answer questions by listening first, in order to motivate and enrol others effectively. Explained a senior scientist, “The toughest thing to learn on a project is mirroring what people say, for example, by pausing before inserting your own ideas, and offering, ‘So if I understand what you’re saying, …’ and ‘If I hear you correctly, the implication would be, …’ in order to validate, by listening and rewording what they hear.”

Another foundational S.O.F.T. skill involves attentive listening — to oneself. Developing the practice of reflection provides access to deeper creativity, greater focus, and an elevated sense of calm. As a senior biotech executive explained, “Quieting the external static gives me space to hear myself more clearly.” This heightened sense of clarity and awareness provides an internal environment for the S.O.F.T. skill of self-awareness to flourish, so that acknowledgement and development of other needed workplace behaviours can then follow. Meetings can include reflection time by building short bursts of individual contemplation into an agenda as part of the routine workflow, for example, by asking participants to consider a topic or question quietly for as little as 60 seconds, before opening the discussion up for group comment and responses.

By committing to identifying, developing, and practising essential S.O.F.T. skills such as storytelling, giving and receiving feedback, coaching, and listening, life sciences companies are providing employees with the requisite tools to elevate organizational effectiveness. Adopting best practices that improve S.O.F.T. skills will help to close the industry’s talent gap and — most importantly — accelerate successful results by life sciences organizations to serve patients.

JENNIFER LAWRENCE is associate director, human resources business partner at Blueprint Medicines

By Jennifer Lawrence

Source: Life Science Leader

Making Progress on a Micro-Budget

Startup investors come in a variety pack. On one end of the continuum are the generalists — folks with the common traits of money on their hands and an eagerness to put it into anything bespoken as hot.

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On the other end are highly informed, motivated people who study, understand, and enthusiastically support the industry in which they invest. Biopharma investors are often among the most motivated by personal factors, from family medical crises to pure idealism.

Fortunately, industry companies such as Eikonizo Therapeutics, which must start out with scarce financial support for entry into risky therapeutic territories, may sometimes rely on the latter group. Before the friendly investors step forward, however, the company must master the art of making do. That means, for starters, making the most of its natural advantages.

Eikonizo’s natural advantages include solid scientific origins in the Broad Institute and other MIT/ Harvard-community research centres, and industry-savvy management team, modest but early VC funding, and longer-term prospects for both private and public, non-dilutive investment. Dr Janice Kranz, cofounder and CEO, bridges the academic and industry foundations of the company.

FIELD OF BATTLE

Eikonizo entered a tough area at a tough time. Beginning operation only in 2017, its chosen field is a neurodegenerative disease. It is now targeting primarily ALS, but also has Alzheimer’s and others in its pipeline — all occupying an area beset in recent times by clinical disappointments, mechanistic debates, and even conspiracy theories. Yet, in that short period, and on an initial budget of just $2 million, Eikonizo has made substantial progress. It has already advanced candidates to the brink of Phase 1 trials, brought along several other programs close behind and taken its companion PET tracer diagnostic into early clinical trials.

The company’s research roots, however, reach further back to its academic co-founder, Dr Jacob Hooker, and his work at the Massachusetts General Hospital/Harvard Medical School’s Martinos Center for Biomedical Imaging. Hooker had developed new diagnostic neuroimaging tools for HDAC (histone deacetylase) enzymes, one of which, HDAC6, became the lead therapeutic target for Eikonizo. Other champions of the science Eikonizo employs are cofounder and head of R&D Frederick “Al” Schroeder, who comes from Hooker’s lab; director of medicinal chemistry Florence Wagner, from the Broad Institute; and company advisor Stuart Schreiber, at Harvard and co-founder of the Broad Institute.

Another benefit of academic roots is human capital, in-play both before and after the company takes form. Although the others on the Eikonizo team are notable, Kranz sets the pattern.

She had followed a path only revealed to her as she stepped along it. Beginning early on the industry side as a newly minted Harvard Ph.D., Kranz picked up the phone when her lab received a cold call from the first Cubist scientist, which led to her joining the new antimicrobial company, initially assigned to starting a new program in yeast assays. She remained at the company for the next five years. “Being at Cubist satisfied me in so many ways — the intellectual curiosity, the scientific pursuit of creating something completely new, building a team from scratch, working with investors.”

But Kranz preferred the startup scenario. “I liked the first couple of years at Cubist more than I did the later years after an IPO and after it had grown from a dozen people to more than a hundred. I knew I was more attracted to the creative, early-stage startup mode. Sometimes you can find that environment in academia or in a nonprofit.” After a two-year stint at Proteome (Biobase/Incyte), she moved on to the ALS Therapy Development Institute, her first foray into the neurodegenerative area.

“I knew I was more attracted to the creative, early-stage startup mode. Sometimes you can find that environment in academia or in a non-profit.”

Dr Janice Kranz Cofounder and CEO, Eikonizo Therapeutics

Kranz later joined the Broad Institute, a further step in the integration of her academic and industry sides. “The people at the Broad Institute pride themselves on having a foot in each camp of the academic and the industry model to make it the best of both worlds. Ed Scolnick, who had come from Merck, was trying to set up a mini startup within the Institute, the Stanley Center, focused on identifying new targets and getting significant treatments for psychiatric disease. That took me deeper into neuroscience, including biology and some of the targets as well as some of the people now in this company.”

As the second in command at the Stanley Center, Kranz began to experience the desire to found and lead a company of her own. She first investigated forming a group of people to discuss the idea, but soon realized she would need to focus on a specific field and a concept for addressing a related medical need. At about the same time, she had met Hooker while he collaborated with the Broad Institute and began to entertain his HDAC imaging work as a possible seed for commercial science.

“I understood the science immediately because it was related to some of the science I had learned at the Stanley Center. Jacob brought in a scientist from his lab and a businessperson who runs the Martinos Center. So the four of us met every couple of weeks, just kicking the tires on the idea and also testing how well we got along, what our objectives were, what our values were, and what the scientists in us were trying to figure out — meanwhile, trying to find holes in the plan to see if it was worthwhile.”

FUNDS TO PURPOSE

The first order of business, of course, was funding. Kranz and Hooker had a lot of experience with grant writing, so they set to work on a proposal to the Alzheimer’s Drug Discovery Foundation (ADDF), the group headed by Dr Howard Fillit (“Industry Explorers Blaze On,” March 2019). The experience was enjoyable and further united them behind the goal of forming a company. But the grant funding alone would prove disappointing as a jumpstart.

“We had a plan, and we honestly thought we would initially avoid venture capital and could bootstrap the company using non-dilutive funding, but such funding always has a time lag,” Kranz says. While they were submitting grants, she and Hooker also had fortuitous encounters with people in their networks. Hooker was connected to Stacie Weninger, head of the Fidelity Biosciences Research Initiative (FBRI), part of F-Prime Capital, which had made a grant to Hooker’s academic lab. FBRI focuses only on neurodegeneration, and Weninger primarily invests in seed-stage companies. Hooker and Kranz also both knew Schreiber of the Broad Institute, whose lab also had done seminal work related to the proposed company’s target, HDAC6. Schreiber introduced the two budding entrepreneurs to Kevin Kinsella of Avalon Ventures, who was the founding investor of Vertex.

“Kevin was tough, with a lot of questions and probing, but after all, he bought into our idea,” says Kranz. “Since helping start an Alzheimer’s-focused company, Athena Neurosciences, in his early days, he had been looking for another opportunity in the neurodegeneration space. He likes to have things move fast, and he pushed us to produce a term sheet. We were excited about the opportunity to get things rolling before we even heard back about our submitted grants. We closed on our seed round with him, and we did get the ADDF funding later.”

Sometimes, the science and technology manifested at the academic level does not get the credit it deserves for launching companies with novel approaches. Almost in passing, scribes may herald the seminal role of university research in the origins of biopharma enterprises and bio hubs. But no one should underestimate the value carried over from Harvard and other academic centres into the bio business sector. Those sources of special knowledge and application are worth real money, and to reproduce them exclusively inside a company would eat up large chunks of time and capital.

Source: Life Science Leader

By Wayne Koberstein, Executive Editor, Life Science Leader magazine.

Employee claims for inventor compensation – what is the impact of Shanks v Unilever?

The UK Supreme Court has given a surprise boost to employed inventors. Going against the decision of the patents tribunal, and both intermediate levels of appeal, the UK’s top judges sided with a talented research scientist.

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The result – a payment of £2 million from the researcher’s former employer as a reward for a particularly valuable invention. This decision raises the prospect of fresh claims brought against employers, with the potential for substantial undefined payment awards. We consider the risk to employers and what to look out for.

Professor Shanks and his outstanding invention

Talented scientist Professor Shanks came up with an invention for a glucose biosensor in the 1980s. This coincided with his employment by Unilever group company CRL. The invention was not directly applicable to the projects he was working on – his area of focus was biosensors for process control and process engineering. Later on, the glucose testing market took off and the biosensor technology became highly desirable. Most equipment producers in the field turned to Unilever for licences of the Professor Shanks patents. Unilever gained windfall licence fees of around £20 million. It also sold its medical diagnostics business, Unipath, with about £5 million attributable to the Shanks patents.

Under UK law, the invention belonged automatically to CRL. Patents were duly applied for by Unilever and granted, although not put into practice. So far so good. However, a rarely-used rule allows an employee to claim a compensatory payment where a patent or an invention turns out to be of “outstanding benefit” to his or her employer. This is looked at in context, with attention paid to the size and nature of the employer’s business and the overall fairness of the situation. The inventiveness of the claimed technical advance is not relevant – it is the benefit accruing to the inventor’s employer that is paramount. Professor Shanks applied for an award under this rule.

Was Unilever too big to pay?

Professor Shanks’s employer, CRL, was a relatively small research unit within the wider Unilever group. Its role was to generate inventions for use within the businesses of other group companies. What should be the correct context for assessing the value of the invention – CRL or the entire group?

The patents tribunal looked at the Unilever group, meaning that the value of the Shanks patents was a drop in the ocean. In contrast, the Supreme Court focused on the flow of inventions from CRL, and the value that Unilever derived from its patent portfolio. Alongside direct benefit to CRL as the employing company, relevant considerations were:

  • the contribution of the Shanks patents, as compared to other patent families, to the success of the wider group.
  • the extent to which patents were responsible for value creation within the group business. Much of Unilever’s revenue derived from the sale of consumer goods reliant on branding and marketing spend rather than patented technology. The assessment of the contribution made by the Shanks patents should be compared to value generation from other patented technologies rather than group revenues as a whole.
  • the role played by the wider group in terms of manufacturing capacity, sales and distribution facilities, goodwill, licensing muscle and patent enforcement activity.

In that context, the Shanks patents were exceptional and should trigger an award for compensation.

A change in 2004

Employees’ prospects under this rule were enhanced by a change made in 2004. This extended the scope of the “outstanding benefit” test to include value flowing from the invention itself, as well as any patents obtained. This change came too late for the Shanks patents, but could support a wider group of claimants now that the outstanding benefit test has been altered.

How much did Professor Shanks get?

The law does not specify how the employee’s reward should be calculated, beyond giving broad guidelines as to factors the court should consider. The Supreme Court was happy to accept the assessment of the patents tribunal that 5% was appropriate.

The calculation should ignore any corporation tax paid on the revenues generated by the patents, and should benefit from an uplift to take account of inflation since Unilever realised the benefit of the invention. A sum of £2 million was considered a fair reward.  

The international perspective

The Supreme Court’s ruling applies to individuals who are mainly employed in the UK. It can also apply to staff who are not fixed to any particular location, but who have an attachment to their employer’s UK business premises. So what about staff who are based elsewhere?

 

This is not an area of law that has been harmonised internationally and so organisations cannot look to a consistent set of principles.

There are similar rules in other countries, although unfortunately, the detail varies considerably. Employers will need to take advice locally in the jurisdiction where an individual is employed.

Take away points

The Shanks ruling makes an important change to UK law. Employees who are UK-based may now be encouraged to bring new compensation claims. This does present a new risk to employers, but one which, we believe, is limited.

Although the standard of what amounts to “outstanding benefit” has been lowered, it is still a difficult one to reach. Most research staff working in project teams on their assigned areas of work will still be unlikely to qualify.

Context is all-important. Organisations that are very active in generating patented technology may be less exposed as an employee will have to show that their invention is exceptional compared to revenues derived from other inventions.

The percentage of the relevant revenue that was awarded to Professor Shanks was not large – 5%. It is, of course, possible that larger percentages could be considered appropriate in other situations.

However, the award of 5% provides a starting point likely to influence a court looking at these cases in future.

Employee revenue-sharing policies, widespread in many research institutions, are likely to be a relevant factor. Where a member of staff has access to this kind of benefits scheme, a further award under the “outstanding benefit” rule looks less probable.

If you do receive claims triggered by this ruling, it makes sense to take legal advice to assess their likelihood of success and assemble relevant information to guide any negotiations.

By James Fry, Partner

Source: Mills & Reeve

Food for Insect Pollinators in Towns and Cities

The Friends of the University of Bristol Botanic Garden welcomed 3rd-year UoB PhD student Nick Tew to discuss his findings on “Food for Insect Pollinators in Towns and Cities”.

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Nick focused on an optimistic outlook on the effects of urbanisation on pollinator species numbers in Bristol, and the unique conservation opportunities we can do in the city. He began by showing the plant experts, gardeners and local enthusiasts alike the delights of the ‘Bee Movie’, with a clip from the film representing our love for bees and apparent fast approaching doom as their numbers continue to dwindle.

Nick began with an interesting thought that media representations of plant pollinating species tend to focus on bees. ‘Pollinator Movie’ is a criminally underappreciated film idea, with other amazing pollinator species of wasp, fly, beetle and many more not enjoying the same media attention. The importance of pollinators in the sexual reproduction of flowering plants affects our natural world from our day to day lives to the scope of an entire ecosystem. For example, 76% of leading food crops have some degree of reliance on animal pollinators and is often key in producing good quality food rich in micronutrients. Plants have their own intrinsic value, and pollinators are vital in preserving the high diversity of plant species for future generations.

And this is why the figures showing a decline in our pollinator species are so impactful, with some habitats in Britain having a measured 55% drop in the number of pollinator species. Nick focused on the impact of land-use change, where natural wild grassland is converted for other, human-specific use. The most extreme land-use change is urbanisation. The building of cities leads to the removal of native plant species, warmer temperatures, and impervious surfaces. In general, land-use change is a hard and fast method in destroying biodiversity.

Nick’s own passion for allotment gardening and animal behaviour led him to his PhD thesis. Though urbanisation will negatively affect some pollinator species, bees appear to be particularly resilient to land-use change and can even find new opportunities. He theorises that this is because the larval and adult forms in bees feed on the same food sources, therefore do not need a specific plant to survive the juvenile stages. As generalised feeders, they can extract nectar and pollen from a variety of plants.

Nick began the first steps of his research in 2018 and measured the nectar content of over 200 flower species, including in the university’s own botanical garden. The measurements revealed that most of the nectar in urban areas are provided for by gardens. He found that urban areas had a more diverse array of pollinator species than farmland and nature reserves.

The second stage of his research found Nick visiting 59 different gardens in Bristol and measuring an estimated nectar production in individual gardens for each season. The gardens highly differed from one another, from their species types to the densities of plants. Generally, July was found to have the highest nectar production, with a drop in production starting in October.

However, Nick’s results showed the continuity of nectar when combining gardens together. As people plant different flowers from native and non-native species, a bee that may be able to forage in over 1000 gardens will likely be able to source nectar at each point of the year from at least a few gardens, even if the average output is minimal. The vivid pink and purple flowers of Fuchsia are a popular staple of UK gardens and are incredibly important in producing nectar in the Summer to Autumn months. In their native Americas, Fuchsia is pollinated by hummingbirds, so they produce high quantities of nectar. For UK insect pollinators, they present an absolute buffet. With this, Nick is able to present how the unique opportunity of gardens with a diverse range of flowering plants and non-native species in urban areas can actually lead to a more stable food source for pollinators.

So, what can people in cities do to help conserve our pollinator species? The opportunities presented by gardens in urban areas ride on a high diversity of flowering plants. Plant unusual flowers, ones that flower at different types of year. Think about planting 3D structure flowering plants, such as Fuchsia shrubs which can produce many flowers in one season. And, perhaps the easiest option, save your weeds! This means not pulling dandelions, clovers, and daisies that pop up in your lawn. If each available garden, green and allotment spaces are cared for with these points in mind, and with Nick’s expert opinion on which plants are best arranged together, we can help sustain our pollinators.

By Written by Nicky Kobayashi-Boyd, Biology (BSc)

Source: University of Bristol – Biological Sciences Blog

 

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Avrobio tracks improvements in first patient treated with Gaucher gene therapy

DNA helix forming inside a test tube

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Avrobio has shared data on the first Gaucher disease patient to receive its gene therapy AVR-RD-02. The patient, who was stable on enzyme replacement therapy at baseline, experienced a 22% drop in a toxic metabolite after receiving AVR-RD-02 and stopping taking the standard of care.

Gaucher, like the Fabry disease targeted by Avrobio’s lead prospect, is currently treated using enzyme replacement therapies sold by Sanofi and Takeda, which entered the market through its takeover of Shire. However, a significant minority of patients experience physical limitations despite treatment. Negative outcomes include bone pain and spleen enlargement. Johnson & Johnson’s Zavesca offers an oral alternative, but there remain unmet medical needs.

Avrobio is developing AVR-RD-02 to address those needs. The data shared as part of Avrobio’s R&D day mark the start of the effort to show AVR-RD-02 performs as hoped in the clinic.

The first patient to receive AVR-RD-02 discontinued enzyme replacement therapy one month before taking the gene therapy. Three months after receiving the gene therapy, levels of Gaucher biomarker lyso-Gb1 had fallen 22%. The patient’s level of plasma chitotriosidase, a biomarker of cells associated with severe organ damage, was down 17%. Hemoglobin and platelets were in the normal range.

AVR-RD-02 triggered those changes without causing serious adverse events. The data drop offers an early indication that Avrobio may be able to improve outcomes by harvesting hematopoietic stem cells, adding a gene that encodes for glucocerebrosidase and reinfusing the cells back into the same patient. With enzyme replacement therapies costing healthcare systems up to $400,000 a year per patient, there is scope for AVR-RD-02 to cut the cost of treating Gaucher disease.

Avrobio shared the early look at clinical data on AVR-RD-02 alongside updates about other assets. There is now more than three years of data on some Fabry patients treated with Avrobio’s lead asset, putting the company in a position to plot a path to accelerated approval. Avrobio plans to submit its briefing book to the FDA by the end of the year to align on an accelerated approval strategy. 

The update also covered cystinosis candidate AVR-RD-04. The first patient to receive the candidate is off oral and eye drop cysteamine 12 months after receiving the gene therapy. The number of crystals in the patient’s skin are down 56%, leading Avrobio to posit they may have gained the ability to make their own functional cystinosin protein.  

 

Biotechnology timeline: Humans have manipulated genes since the ‘dawn of civilization’

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Historically, biotech has been primarily associated with food, addressing such issues as malnutrition and famine.

Today, biotechnology is most often associated with the development of drugs. But drugs are hardly the future of biotech. We’ve entered the Fourth Industrial Revolution, and genetics are on a new level. Biotech is paving a way for a future open to imagination, and that’s kind of scary.

The next ten years will surely prove exciting as artificial intelligence and biotechnology merge man and machine…

The history of biotechnology can be divided into three distinct phases:

  1. Ancient Biotechnology

  2. Classical Biotechnology

  3. Modern Biotechnology

1. Ancient Biotechnology (Pre-1800)

Most of the biotech developments before the year 1800 can be termed as ‘discoveries’ or ‘developments’. If we study all these developments, we can conclude that these inventions were based on common observations about nature.

 
  • Humans have used biotechnology since the dawn of civilization.
  • After domestication of food crops (corn, wheat) and wild animals, man moved on to other new observations like cheese and curd.  Cheese can be considered as one of the first direct products (or by-product) of biotechnology because it was prepared by adding rennet (an enzyme found in the stomach of calves) to sour milk.
  • Yeast is one of the oldest microbes that have been exploited by humans for their benefit. The oldest fermentation was used to make beer in Sumeria and Babylonia as early as 7,000BCE.
  • By 4,000BCE, Egyptians used yeasts to bake leavened bread.

 

  • Another ancient product of fermentation was wine, made in Assyria as early as 3,500BCE.
  • The Chinese developed fermentation techniques for brewing and cheese making.
  • 500 BCE: In China, the first antibiotic, moldy soybean curds, is put to use to treat boils.
  • Hippocrates treated patients with vinegar in 400 BCE.
  • In 100BCE, Rome had over 250 bakeries which were making leavened bread.

 

  • A.D. 100: The first insecticide is produced in China from powdered chrysanthemums.
  • The use of molds to saccharify rice in the koji process dates back to at least A.D. 700.
  • 13th century: The Aztecs used Spirulina algae to make cakes.
  • One of the oldest examples of crossbreeding for the benefit of humans is mule. Mule is an offspring of a male donkey and a female horse. People started using mules for transportation, carrying loads, and farming, when there were no tractors or trucks.
  • By the 14th century AD, the distillation of alcoholic spirits was common in many parts of the world.

 

  • Vinegar manufacture began in France at the end of the 14th century.
  • 1663: Cells are first described by Hooke.
  • 1673-1723: In the seventeenth century, Antonie van Leeuwenhoek discovered microorganisms by examining scrapings from his teeth under a microscope.
  • 1675: Leeuwenhoek discovers protozoa and bacteria.
  • 1761: English surgeon Edward Jenner pioneers vaccination, inoculating a child with a viral smallpox vaccine.

nucleus

 

2. Classical Biotechnology (1800-1945)

  • The Hungarian Károly Ereky coined the word “biotechnology” in Hungary during 1919 to describe a technology based on converting raw materials into a more useful product. In a book entitled Biotechnologie, Ereky further developed a theme that would be reiterated through the 20th century: biotechnology could provide solutions to societal crises, such as food and energy shortages.
  • 1773-1858: Robert Brown discovered the nucleus in cells.
  • 1802: The word “biology” first appears.
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  • 1822-1895: Vaccination against small pox and rabies developed by Edward Jenner and Louis Pasteur.
  • In 1850, Casimir Davaine detected rod-shaped objects in the blood of anthrax-infected sheep and was able to produce the disease in healthy sheep by inoculation of such blood.
  • 1855: The Escherichia coli bacterium is discovered. It later becomes a major research, development, and production tool for biotechnology.
  • In 1868, Fredrich Miescher reported nuclein, a compound that consisted of nucleic acid that he extracted from white blood cells.
  • 1870: Breeders crossbreed cotton, developing hundreds of varieties with superior qualities.cotton
  • 1870: The first experimental corn hybrid is produced in a laboratory.
  • By 1875, Pasteur of France and John Tyndall of Britain finally demolished the concept of spontaneous generation and proved that existing microbial life came from preexisting life.
  • 1876: Koch’s work led to the acceptance of the idea that specific diseases were caused by specific organisms, each of which had a specific form and function.
  • In 1881, Robert Koch, a German physician, described bacterial colonies growing on potato slices (First ever solid medium).

 

  • In 1888, Heinrich Wilhelm Gottfried Von Waldeyer-Hartz, a German scientist, coined the term ‘Chromosome.’
  • In 1909, the term ‘Gene’ had already been coined by Wilhelm Johannsen (1857-1927), who described ‘gene’ as carrier of heredity. Johannsen also coined the terms ‘genotype’ and ‘phenotype.’
  • 1909: Genes are linked with hereditary disorders.
  • 1911: American pathologist Peyton Rous discovers the first cancer-causing virus.
  • 1915: Phages, or bacterial viruses, are discovered.
  • 1919: The word “biotechnology” is first used by a Hungarian agricultural engineer.
  • Pfizer, which had made fortunes using fermenting processes to produce citric acid in the 1920s, turned its attention to penicillin. The massive production of penicillin was a major factor in the Allied victory in WWII.

 

  • 1924: start of Eugenic Movement in the US.
  • The principle of genetics in inheritance was redefined by T.H. Morgan, who showed inheritance and the role of chromosomes in inheritance by using fruit flies. This landmark work was named, ‘The theory of the Gene in 1926.”
  • Alexander Fleming discovered ‘penicillin’ the antibacterial toxin from the mold Penicillium notatum, which could be used against many infectious diseases. Fleming wrote, “When I woke up just after dawn on September 28, 1928, I certainly didn’t plan to revolutionize all medicine by discovering the world’s first antibiotic, or bacteria killer.

 

  • 1933: Hybrid corn is commercialized.
  • In 1940, a team of researchers at Oxford University found a way to purify penicillin and keep it stable.
  • 1941: The term “genetic engineering” is first used by a Danish microbiologist.
  • 1942: The electron microscope is used to identify and characterize a bacteriophage- a virus that infects bacteria.
  • 1942: Penicillin is mass-produced in microbes for the first time.

DNA

 

3. Modern Biotechnology (1945-present)

The Second World War became a major impediment in scientific discoveries. After the end of the second world war some, very crucial discoveries were reported, which paved the path for modern biotechnology.

The origins of biotechnology culminated with the birth of genetic engineering. There were two key events that have come to be seen as scientific breakthroughs beginning the era that would unite genetics with biotechnology: One was the 1953 discovery of the structure of DNA, by Watson and Crick, and the other was the 1973 discovery by Cohen and Boyer of a recombinant DNA technique by which a section of DNA was cut from the plasmid of an E. coli bacterium and transferred into the DNA of another. Popularly referred to as “genetic engineering,” it came to be defined as the basis of new biotechnology.
  • In Britain, Chaim Weizemann (1874–1952) developed bacterial fermentation processes for producing organic chemicals such as acetone and cordite propellants. During WWII, he worked on synthetic rubber and high-octane gas.

 

  • 1950s: The first synthetic antibiotic is created.
  • 1951: Artificial insemination of livestock is accomplished using frozen semen.
  • In 1953, JD Watson and FHC Crick for the first time cleared the mysteries around the DNA as a genetic material, by giving a structural model of DNA, popularly known as, ‘Double Helix Model of DNA.’
  • 1954: Dr. Joseph Murray performs the first kidney transplant between identical twins.
  • 1955: An enzyme, DNA polymerase, involved in the synthesis of a nucleic acid, is isolated for the first time.
  • 1955: Dr. Jonas Salk develops the first polio vaccine. The development marks the first use of mammalian cells (monkey kidney cells) and the first application of cell culture technology to generate a vaccine.
  • 1957: Scientists prove that sickle-cell anemia occurs due to a change in a single amino acid in hemoglobin cells
  • 1958: Dr. Arthur Kornberg of Washington University in St. Louis makes DNA in a test tube for the first time.
  • Edward Tatum (1909–1975) and Joshua Lederberg (1925–2008) shared the 1958 Nobel Prize for showing that genes regulate the metabolism by producing specific enzymes.

 

  • 1960: French scientists discover messenger RNA (mRNA).
  • 1961: Scientists understand genetic code for the first time.
  • 1962: Dr. Osamu Shimomura discovers the green fluorescent protein in the jellyfish Aequorea victoria. He later develops it into a tool for observing previously invisible cellular processes.
  • 1963: Dr. Samuel Katz and Dr. John F. Enders develop the first vaccine for measles.
  • 1964: The existence of reverse transcriptase is predicted.
  • At a conference in 1964, Tatum laid out his vision of “new” biotechnology: “Biological engineering seems to fall naturally into three primary categories of means to modify organisms. These are: 1. The recombination of existing genes, or eugenics. 2. The production of new genes by a process of directed mutation, or genetic engineering. 3. Modification or control of gene expression, or to adopt Lederberg’s suggested terminology, euphenic engineering.”
  • 1967: The first automatic protein sequencer is perfected.
  • 1967: Dr. Maurice Hilleman develops the first American vaccine for mumps.
  • 1969: An enzyme is synthesized in vitro for the first time.
  • 1969: The first vaccine for rubella is developed.

 

  • 1970: Restriction enzymes are discovered.
  • 1971: The measles/mumps/rubella combo-vaccine was formed.
  • 1972: DNA ligase, which links DNA fragments together, is used for the first time.
  • 1973: Cohen and Boyer perform the first successful recombinant DNA experiment, using bacterial genes.
  • In 1974, Stanley Cohen and Herbert Boyer developed a technique for splicing together strands of DNA from more than one organism. The product of this transformation is called recombinant DNA (rDNA).
  • Kohler and Milestein in 1975 came up with the concept of cytoplasmic hybridization and produced the first ever monoclonal antibodies, which has revolutionized diagnostics.
  • Techniques for producing monoclonal antibodies were developed in 1975.
  • 1975: Colony hybridization and Southern blotting are developed for detecting specific DNA sequences.
  • 1976: Molecular hybridization is used for the prenatal diagnosis of alpha thalassemia.
  • 1978: Recombinant human insulin is produced for the first time.
  • 1978: with the development of synthetic human insulin the biotechnology industry grew rapidly.
  • 1979: Human growth hormone is synthesized for the first time.

 

  • In the 1970s-80s, the path of biotechnology became intertwined with that of genetics.
  • By the 1980s, biotechnology grew into a promising real industry.
  • 1980: Smallpox is globally eradicated following 20-year mass vaccination effort.
  • In 1980, The U.S. Supreme Court (SCOTUS), in Diamond v. Chakrabarty, approved the principle of patenting genetically engineered life forms.
  • 1981: Scientists at Ohio University produce the first transgenic animals by transferring genes from other animals into mice.
  • 1981: The first gene-synthesizing machines are developed.
  • 1981: The first genetically engineered plant is reported.
  • 1982: The first recombinant DNA vaccine for livestock is developed.
  • 1982: The first biotech drug, human insulin produced in genetically modified bacteria, is approved by FDA. Genentech and Eli Lilly developed the product. This is followed by many new drugs based on biotechnologies.
  • 1983: The discovery of HIV/AIDS as a deadly disease has helped tremendously to improve various tools employed by life-scientist for discoveries and applications in various aspects of day-to-day life.
  • In 1983, Kary Mullis developed polymerase chain reaction (PCR), which allows a piece of DNA to be replicated over and over again. PCR, which uses heat and enzymes to make unlimited copies of genes and gene fragments, later becomes a major tool in biotech research and product development worldwide.
  • 1983: The first artificial chromosome is synthesized.
  • In 1983, the first genetic markers for specific inherited diseases were found.
  • 1983: The first genetic transformation of plant cells by TI plasmids is performed.
  • In 1984, the DNA fingerprinting technique was developed.
  • 1985: Genetic markers are found for kidney disease and cystic fibrosis.
  • 1986: The first recombinant vaccine for humans, a vaccine for hepatitis B, is approved.
  • 1986: Interferon becomes the first anticancer drug produced through biotech.
  • 1986: University of California, Berkeley, chemist Dr. Peter Schultz describes how to combine antibodies and enzymes (abzymes) to create therapeutics.
  • 1988: The first pest-resistant corn, Bt corn, is produced.corn
  • 1988: Congress funds the Human Genome Project, a massive effort to map and sequence the human genetic code as well as the genomes of other species.
  • In 1988, chymosin (known as Rennin) was the first enzyme produced from a genetically modified source-yeast-to be approved for use in food.
  • In 1988, only five proteins from genetically engineered cells had been approved as drugs by the United States Food and Drug Administration (FDA), but this number would skyrocket to over 125 by the end of the 1990s.
  • In 1989, microorganisms were used to clean up the Exxon Valdez oil spill.

 

  • 1990: The first successful gene therapy is performed on a 4-year-old girl suffering from an immune disorder.
  • In 1993, The U.S. Food and Drug Administration (FDA) declared that genetically modified (GM) foods are “not inherently dangerous” and do not require special regulation.
  • 1993: Chiron’s Betaseron is approved as the first treatment for multiple sclerosis in 20 years.
  • 1994: The first breast cancer gene is discovered.
  • 1995: Gene therapy, immune-system modulation and recombinantly produced antibodies enter the clinic in the war against cancer.
  • 1995: The first baboon-to-human bone marrow transplant is performed on an AIDS patient.
  • 1995: The first vaccine for Hepatitis A is developed.
  • 1996: A gene associated with Parkinson’s disease is discovered.
  • 1996: The first genetically engineered crop is commercialized.
  • 1997: Ian Wilmut, an Irish scientist, was successful in cloning an adult animal, using sheep as a model and naming the cloned sheep ‘Dolly.’
  • 1997: The first human artificial chromosome is created.
  • 1998: A rough draft of the human genome map is produced, showing the locations of more than 30,000 genes.
  • 1998: Human skin is produced for the first time in the lab.
  • 1999: A diagnostic test allows quick identification of Bovine Spongiform Encephalopathy (BSE, also known as “mad cow” disease) and Creutzfeldt-Jakob Disease (CJD).
  • 1999: The complete genetic code of the human chromosome is deciphered.

 

  • 2000: Kenya field-tests its first biotech crop, virus-resistant sweet potato.
  • Craig Venter, in 2000, was able to sequence the human genome.
  • 2001: The sequence of the human genome is published in Science and Nature, making it possible for researchers all over the world to begin developing treatments.
  • 2001: FDA approves Gleevec® (imatinib), a gene-targeted drug for patients with chronic myeloid leukaemia. Gleevec is the first gene-targeted drug to receive FDA approval.
  • 2002: EPA approves the first transgenic rootworm-resistant corn.
  • 2002: The banteng, an endangered species, is cloned for the first time.
  • 2003: China grants the world’s first regulatory approval of a gene therapy product, Gendicine (Shenzhen SiBiono GenTech), which delivers the p53 gene as a therapy for squamous cell head and neck cancer.
  • In 2003, TK-1 (GloFish) went on sale in Taiwan, as the first genetically modified pet.
  • 2003: The Human Genome Project completes the sequencing of the human genome.
  • 2004: UN Food and Agriculture Organization endorses biotech crops, stating biotechnology is a complementary tool to traditional farming methods that can help poor farmers and consumers in developing nations.
  • 2004: FDA approves the first antiangiogenic drug for cancer, Avastin®.
  • 2005: The Energy Policy Act is passed and signed into law, authorizing numerous incentives for bioethanol development.
  • 2006: FDA approves the recombinant vaccine Gardasil®, the first vaccine developed against human papillomavirus (HPV), an infection implicated in cervical and throat cancers, and the first preventative cancer vaccine.
  • 2006: USDA grantsDow AgroSciences the first regulatory approval for a plant-made vaccine.
  • 2006: The National Institutes of Health begins a 10-year, 10,000-patient study using a genetic test that predicts breast-cancer recurrence and guides treatment.
  • In 2006, the artist Stelarc had an ear grown in a vat and grafted onto his arm.
  • 2007: FDA approves the H5N1 vaccine, the first vaccine approved for avian flu.
  • 2007: Scientists discover how to use human skin cells to create embryonic stem cells.
  • 2008: Chemists in Japan create the first DNA molecule made almost entirely of artificial parts.
  • 2009: Global biotech crop acreage reaches 330 million acres.
  • In 2009, Sasaki and Okana produced transgenic marmosets that glow green in ultraviolet light (and pass the trait to their offspring).
  • 2009: FDA approves the first genetically engineered animal for production of a recombinant form of human antithrombin.
  • In 2010, Craig Venter was successful in demonstrating that a synthetic genome could replicate autonomously.

 

  • 2010: Dr.  J. Craig Venter announces completion of “synthetic life” by transplanting synthetic genome capable of self-replication into a recipient bacterial cell.
  • 2010: Harvard researchers report building “lung on a chip” – technology.
  • 2011: Trachea derived from stem cells transplanted into human recipient.
  • 2011: Advances in 3-D printing technology lead to “skin-printing.”
  • 2012: For the last three billion years, life on Earth has relied on two information-storing molecules, DNA and RNA. Now there’s a third: XNA, a polymer synthesized by molecular biologists Vitor Pinheiro and Philipp Holliger of the Medical Research Council in the United Kingdom. Just like DNA, XNA is capable of storing genetic information and then evolving through natural selection. Unlike DNA, it can be carefully manipulated.
  • 2012: Researchers at the University of Washington in Seattle announced the successful sequencing of a complete fetal genome using nothing more than snippets of DNA floating in its mother’s blood.
  • 2013: Two research teams announced a fast and precise new method for editing snippets of the genetic code. The so-called CRISPR system takes advantage of a defense strategy used by bacteria.

crispr

  • 2013: Researchers in Japan developed functional human liver tissue from reprogrammed skin cells.
  • 2013:  Researchers published the results of the first successful human-to-human brain interface.
  • 2013: Doctors announced that a baby born with HIV had been cured of the disease.
  • 2014: Researchers showed that blood from a young mouse can rejuvenate an old mouse’s muscles and brain.
  • 2014: Researchers figured out how to turn human stem cells into functional pancreatic β cells—the same cells that are destroyed by the body’s own immune system in type 1 diabetes patients.
  • 2014: All life on Earth as we know it encodes genetic information using four DNA letters: A, T, G, and C. Not anymore! In 2014, researchers created new DNA bases in the lab, expanding life’s genetic code and opening the door to creating new kinds of microbes.
  • 2014: For the first time ever, a woman gave birth to a baby after receiving a womb transplant.
  • In 2014, team of scientists reconstructed a synthetic and fully functional yeast chromosome. A breakthrough seven years in the making, the remarkable advance could eventually lead to custom-built organisms (human organisms included).
  • 2014 & Ebola: Until this year, ebola was merely an interesting footnote for anyone studying tropical diseases. Now it’s a global health disaster. But the epidemic started at a single point with one human-animal interaction — an interaction which has now been pinpointed using genetic research. A total of 50 authors contributed to the paper announcing the discovery, including five who died of the disease before it could be published.
  • 2014: Doctors discovered a vaccine that totally blocks infection altogether in the monkey equivalent of the disease — a breakthrough that is now being studied to see if it works in humans.
  • 2015: Scientists from Singapore’s Institute of Bioengineering and Nanotechnology designed short strings of peptides that self-assemble into a fibrous gel when water is added for use as a healing nanogel.
  • 2015 & CRISPR: scientists hit a number of breakthroughs using the gene-editing technology CRISPR. Researchers in China reported modifying the DNA of a nonviable human embryo, a controversial move. Researchers at Harvard University inserted genes from a long-extinct woolly mammoth into the living cells — in a petri dish — of a modern elephant. Elsewhere, scientists reported using CRISPR to potentially modify pig organs for human transplant and modify mosquitoes to eradicate malaria.
  • 2015: Researchers in Sweden developed a blood test that can detect cancer at an early stage from a single drop of blood.
  • 2015: Scientists discovered a new antibiotic, the first in nearly 30 years, that may pave the way for a new generation of antibiotics and fight growing drug-resistance. The antibiotic, teixobactin, can treat many common bacterial infections, such as tuberculosis, septicaemia, and C. diff.
  • 2015: A team of geneticists finished building the most comprehensive map of the human epigenome, a culmination of almost a decade of research. The team was able to map more than 100 types of human cells, which will help researchers better understand the complex links between DNA and diseases.
  • 2015: Stanford University scientists revealed a method that may be able to force malicious leukemia cells to change into harmless immune cells, called macrophages.
  • 2015: Using cells from human donors, doctors, for the first time, built a set of vocal cords from scratch. The cells were urged to form a tissue that mimics vocal fold mucosa – vibrating flaps in the larynx that create the sounds of the human voice.
  • 2016: A little-known virus first identified in Uganda in 1947—Zika—exploded onto the international stage when the mosquito-borne illness began spreading rapidly throughout Latin America. Researchers successfully isolated a human antibody that “markedly reduces” infection from the Zika virus.
  • 2016: CRISPR, the revolutionary gene-editing tool that promises to cure illnesses and solve environmental calamities, took a major step forward this year when a team of Chinese scientists used it to treat a human patient for the very first time.
  • 2016: Researchers found that an ancient molecule, GK-PID, is the reason single-celled organisms started to evolve into multicellular organisms approximately 800 million years ago.
  • 2016: Stem Cells Injected Into Stroke Patients Re-Enable Patient To Walk.
  • 2016:  Cloning does not cause long-term health issues, study finds
  • 2016: For the first time, bioengineers created a completely 3D-printed ‘heart on a chip.’
  • 2017: Researchers at the National Institute of Health discovered a new molecular mechanism that might be the cause of severe premenstrual syndrome known as PMDD.
  • 2017: Scientists at the Salk Institute in La Jolla, CA, said they’re one step closer to being able to grow human organs inside pigs. In their latest research they were able to grow human cells inside pig embryos, a small but promising step toward organ growth.pig embryo
  • 2017: First step taken toward epigenetically modified cotton.

 

  • 2017: Research reveals different aspects of DNA demethylation involved in tomato ripening process.
  • 2017: Sequencing of green alga genome provides blueprint to advance clean energy, bioproducts.
  • 2017: Fine-tuning ‘dosage’ of mutant genes unleashes long-trapped yield potential in tomato plants.
  • 2017: Scientists engineer disease-resistant rice without sacrificing yield.
  • 2017: Blood stem cells grown in lab for the first time.
  • 2017: Researchers at Sahlgrenska Academy – part of the University of Gothenburg, Sweden – generated cartilage tissue by printing stem cells using a 3D-bioprinter.
  • 2017: Two-way communication in brain-machine interface achieved for the first time.

Today, biotechnology is being used in countless areas including agriculture, bioremediation and forensics, where DNA fingerprinting is a common practice. Industry and medicine alike use the techniques of PCR, immunoassays and recombinant DNA.

Genetic manipulation has been the primary reason that biology is now seen as the science of the future and biotechnology as one of the leading industries.

Source: Biotechnology timeline: Humans have manipulated genes since the ‘dawn of civilization’ –  Brian Colwell

Modernising pharma patents: can AI be an inventor?

Modernising pharma patents: can AI be an inventor?

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AI has revolutionised healthcare by dramatically speeding up drug discovery and development. Despite this, patent offices have made it clear that because AI is it not human, it cannot be classed as an inventor in its own right. Allie Nawrat talks to Potter Clarkson IP attorney Peter Finnie about how patent law needs to be brought up to date to reflect the important contribution AI makes to inventions in pharma.

Patents are used to grant exclusive property rights to an inventor and prevent their discovery from being copied by others. The main requirements for a patent are that the invention must be novel, non-obvious and be useful or have an industrial application.

Patents are a central part of how pharma does business. Pharma products require longer and more complex research and development (R&D) cycles than products in other industries. Consequently, companies invest significant amounts of money into their new products early on in their development. Patent protection enables companies to recoup R&D investment and continue to produce innovative, new drugs in the future.

Throughout history, the entity listed as an inventor on a patent application has been a ‘natural person’, or a human, who then might decide to assign those rights to the invention to their employer. For instance, in the pharma industry, the so-called ‘inventor’ is usually the pharmacologist who works for a specific company.

However, as technology – particularly artificial intelligence (AI) – becomes increasingly useful in speeding up innovation and discoveries, a team led by University of Surrey professor Ryan Abbott decided to test whether AI could be an inventor.

Can AI be an inventor?

As part of the Artificial Inventor Project, in mid-2019, Abbott filed patents on behalf of Imagination Engines’ Stephen Thaler for a warning light and a food container to the European Patent Office (EPO) and United Kingdom Intellectual Property Office (UKIPO).

On the patent application, the inventor was listed as DABUS AI, not Thaler, because these were deemed to be so-called AI-generated inventions: “inventions generated autonomously by AI under circumstances, in which we believe that no natural person, as traditionally defined, qualifies as an inventor,” explained Abbott in an article for the World Intellectual Property Organization (WIPO). The application then argued that Thaler, as the AI’s owner, would be the owner of any issued patents.

Although the EPO and UKIPO accepted that these inventions were patentable, in December 2019, both rejected the application because the inventor was not human.

A related issue is that “only a natural person can convey the rights that they would otherwise own as an inventor, such as to their employer,” explains Potter Clarkson partner and patent attorney Peter Finnie.

The EPO’s decision states: “The designation of an inventor… bears a series of legal consequences, notably to ensure that the designated inventor is the legitimate one and that he or she can benefit from rights linked to this status. To exercise these rights, the inventor must have a legal personality that AI systems or machines do not enjoy.”

The bottom line then, according to the EPO and UKIPO’s decision on DABUS sends is that AI cannot be an inventor.

What implications could this have on AI’s contribution to patentable inventions, particularly in the pharma industry where AI’s use is becoming commonplace and patents are central to financial viability?

Implications for AI-assisted discoveries

Finnie is very clear that AI-generated innovation, such as the DABUS example, is not currently mainstream in any industry, and particularly in pharma.

AI has undoubtedly revolutionised the pharma industry. It has drastically accelerated drug discovery, development and repurposing, and thereby brought drugs to at-need patients much more quickly. Life and medical sciences are one of the top three sectors where AI is most employed, according to the WIPO.

Finnie classes the way AI is used in pharma as AI-assisted, rather than generated, invention. “I don’t see a compelling case yet that the use of AI and machine learning in the pharma industry is anything more than a very sophisticated number crunching,” he explains. “There is still an awful lot of inventive effort required to train it and use the results to work out sensible solutions.”

Where AI only assists in discoveries it would not be designated as an inventor – the human who programmed it or performed the related lab work would be. AI-assisted invention “doesn’t change who the inventors are, it just speeds up the process”, notes Finnie.

However, AI “is likely to have, increasingly in the future, a significant impact on the creation, production and distribution of economic and cultural goods and services”, according to a WIPO Secretariat discussion document.

There is a possibility and “risk that AI-assisted innovation in pharma will be assessed to a different [and perhaps higher] standard”. Also, it is possible that “exclusion of the AI contribution will mean there are no true inventors under the current patent system”, notes Finnie.

The obviousness test

Finnie explains: “If it starts to get into people’s minds that somehow computer-assisted innovation should be treated differently from human-generated innovation, then you start to get a challenge.”

He is particularly concerned about people starting to “buy into the anthropomorphic properties of computers”, which could lead to them turn around and say “well if the computer told you to do it, it must be obvious”.

This would threaten pharma’s ability to get a patent for that invention because, for something to be patentable, legally, it must be deemed to be novel and non-obvious. The test for obviousness is whether it would be obvious or not to a ‘person skilled in the relevant art’.

The WIPO Secretariat is aware of this challenge; in a discussion paper, it asks if when looking at AI-assisted or generated inventions, “is it necessary to retain the traditional requirements of inventive step or non-obviousness, which are fundamentally associated with human acts of invention?” and “should the art be the field of technology of the product or process that emerges as the invention from the AI application?”

Making the patent system fit for purpose

There is a need to ensure that “drugs discovered or re-purposed using AI areas patentable as if they were derived without the use of AI”, Finnie states. “The patent system must not evolve to penalise the use of AI by removing or weakening the available protection.” Patents are sacred to the pharma industry: “In the pharma space, if you can’t get a patent then you won’t do it.”

If there becomes a credibility gap about who invented something – particularly around the obviousness of that invention – this could lead to a situation where pharma is disincentivised from using AI to support its inventions, which could have dramatic consequences for drug discovery and, ultimately at-need patients.

Instead, to encourage people to innovate by rewarding that through patents, Finnie argues “we need to recognise that… AI is a contributor to the invention”; currently, regulators do not recognise them as having a contribution, a viewpoint that is increasingly outdated given AI’s important contribution to discoveries in the pharma industry.

The next step would be to give AI as an entity “legal rights in the same way as we give companies legal rights”. “You have natural persons and legal persons, so maybe you could have a third person, which is an electronic person. This could plug the [credibility] gap” and mean you haven’t got a missing contributor to the invention or inventor, notes Finnie.

Finnie also says there needs to be a modification of the definition of a ‘person skilled in the art’ to include an AI platform, as this would deal with the non-obviousness argument. He states: “One way of dealing with this is to raise the bar slightly and say where machine learning is involved the invention has to have a little extra quality to it because it has used these special powers that we [as humans] don’t have.”

Global patent offices are aware of and open to this need to re-evaluate and modernise patent laws so they are fit for purpose in a world with AI. This discussion was already in the process over the past few years, but the DABUS decision in late 2019 has pushed it further up the agenda.

Indeed, the largest five patent offices in the world – the EPO, Korean Intellectual Property Office, Japan Patent Office, China National Intellectual Property Administration and the United States Patent and Trademark Office – collectively known as IP5, are creating a joint task force to look into new emerging technologies, such as AI, and discuss the challenges and potential solutions.

Source: Pharmaceutical-Technology.com

 

Revolutionary Life Sciences and Healthcare solutions for early investors unveiled at MedTech

Early bird families, private wealth holders, healthcare corporations and venture capitalists will access cutting-edge life science innovations at Campden Wealth’s milestone 30th MedTech Investing Europe Conference, only a month away on 21-22 October, 2020.

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Belgian company AuXin Surgery said it was the first and only company to launch medical devices for chemically assisted dissection to aid such operations as spine surgery, ear surgery, musculoskeletal surgery and hand surgery while preserving such critical organs as nerves, muscles or vessels. Its fully innovative dissection system, named CADISS, was already being used by several surgeons and the company was signing multiple distribution contracts around the world.

Benoît Verjans, chief executive of AuXin SurgeryInvented by surgeons for surgeons, AuXin Surgery said the benefits of CADISS were numerous for the patient with fewer side-effects and relapses. The surgeon benefitted with faster and easier surgery, no equipment investment, no change of practice. The healthcare system benefitted with the reduction of costs linked to side-effects and relapses, better success rate for the surgery and better quality of life for the patient.

Benoit Verjans (right) is chief executive of AuXim Surgery.

Based in Denmark, Biomodics devised a new catheter to prevent and treat urinary tract infections, a relief to 20,000 patients who suffer a urinary tract infection every year while they are admitted to a Danish hospital, mainly because they have a catheter inserted.

The balloon that sits at the tip of the Biomodics catheter is made with a new type of permeable silicone material. This meant that some types of liquid, such as liquid antibiotics, could penetrate it. The new catheter has been tested on pigs, which have the same sensitivity to bacteria in the bladder as humans. During six months of tests, the bladders of the pigs that received the new catheter were completely free of bacteria, whereas all the control pigs that had had a regular catheter had cystitis, Biomodics said. It expected to be able to begin testing the catheter on humans later this year then put the device into production upon approval.

Peter Thomsen (below) is chief executive of Biomedics.

Peter Thomsen, chief executive of Biomodics

ORamaVR said it was working to revolutionise medical and surgical education through intelligent virtual reality training simulations. The Swiss company wanted to bridge the skills gap, modernise standards and foster remote access using MAGES, its hyper-realistic, virtual-reality simulation-based proprietary software platform for accelerated medical training and assessment.

ORamaVR said the cohort of medics which used its technology demonstrated greater improvement in all score categories compared to the standard group in a clinical trial. Proficiency increased 8% after only two 20-minute VR sessions, the company said.

ORamaVR said it is one year ahead of the $680 billion medical and surgical education market. Its target customers included medical universities, hospital systems, surgical training centres and non-governmental organisations.

Paolo Alejandro Catilo (below) is chief commercial officer of ORamaVR.

US industry experts who worked in endoscopy visual optics for years and successfully introduced impactful devices for physicians and their patients founded their own medtech company 270Surgical in 2016. The first 270Surgical product was the SurroundScope System, which consisted of a hardware, software and electro-optic solution that incorporated a myriad of lenses at the distal end of the scope. The result was a specialty laparoscopic system that addressed three long-standing challenges in laparoscopy, including restricted field-of-view, surgical smoke (plume), and lens fogging.

Paolo Alejandro Catilo, chief commercial officer of ORamaVR

The SurroundScope was the first marketable laparoscope that offered up to a 270-degree field-of-view, which was an increase of 200% compared to other laparoscopes in the market. The company said this expanded field-of-view would considerably benefit general surgery, trauma, OBGYN, and thoracic surgery.

The venture was backed by leading surgeons and by investment funds specialised in medical devices.

Visit MedTechInvesting.com for more information, to download the brochure and to register for the Campden Wealth 30th MedTech Investing Europe Conference on 21-22 October, 2020.

Source: campden FB

Researchers Vie To Employ AI For Cancer Immunotherapy

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In the bid to develop tools for the fight against cancer, artificial intelligence (AI) tools being developed at Case Western Reserve University have to be established in strict human clinical trials. The validation of the tool may be a step close following two recent agreements a bioengineering pioneer at New York University and select large pharmaceutical companies.

“The step is an important one for validating the research, and for further advancing efforts to get the right treatment for patients who will benefit most,” stated the research associate. The potential of AI, computational imaging tools to predict an individual response of cancer patient to immunotherapy is shown, added the research associate.

Meanwhile, recent research at the Center for Computational Imaging and personalized Diagnostics demonstrates that AI and ML can be employed in the fight against cancer. These technologies can predict patients who will benefit from immunotherapy.

To use AI and ML, researchers intrinsically teach computers to seek and detect changes in patterns of CT scans. It involves detecting changes in patterns of CT scans taken at the time when lung cancer diagnosed, and the scans taken during immunotherapy treatment.

Besides Immunotherapy, AI Algorithms to find use for Tissue biopsy

Besides this, the researchers have been training AI algorithms for tissue biopsy images of cancer patients. This involves use of the algorithms to study patterns of tissue biopsy images of these patients and to identify the possibility of favorable response to treatment. The algorithms are being trained for use beyond lung cancer. Meanwhile, computational approaches for predicting immunotherapy response of gynecologic cancers showcased at the American Society of Clinical Oncology meeting in May, 2020.

While the benefit of immunotherapy for cancer patients established, the quest of researchers now is beyond this. They are seeking an improved way to identify patients who are most likely to respond to this treatment.

Source: TMR Blog

Hospital robotics: democratising global healthcare

Robotics and digital automation are beginning to sweep through several major industry segments, but perhaps one of the most fascinating is healthcare.

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Whilst advanced machinery capable of performing the most delicate surgeries was once the domain of science-fiction or simply a goal to aspire towards, the reality is that we are now living in an era where health services are on the verge of being transformed in very exciting ways. The COVID-19 pandemic has illustrated the necessity for integrating digital technologies such as robotic process automation (RPA) and artificial intelligence (AI) software into everyday business operations and it is in this regard that hospital robotics forms a timely focus. Far from being a competitor to human workers, robots in healthcare are a unique opportunity to combine the abilities of both humans and people to achieve significantly better outcomes for patients. 

In addition to featuring insights from McKinsey, PwC and Deloitte, we spoke with Christophe Assenmacher, Head of Urology at Clinics of Europe (Cliniques de l’Europe) St Elizabeth’s and Trainer in Robotic Surgery at Intuitive Surgical, to get an informed perspective from the frontline of this topic.

How is robotic automation benefitting hospitals?

Assenmacher states that hospitals are demonstrating the key advantages of robotic automation, namely the enhanced service level which comes from combining the consistent, tireless and fast operational pace of machines with the creativity, empathy and quality controlling abilities of human staff. “Take the surgeon,” he explains. “While they spend years studying, their ability to function under pressure, make precise movements and many other skills can be augmented by a robot to significant impact.” Indeed, whilst some patients might still feel hesitant to undergo surgery that is entirely automated, having a highly-trained and competent surgeon at the helm aided by a robot’s precision could reassure them they are receiving optimal treatment throughout.

Costs for protracted hospital stays, the unavailability of hospital beds and the overall effectiveness of treatment are all aspects which can have a deleterious effect on healthcare generally. Making improvements to patient care is obviously the name of the game, yet the benefits to robotic-optimised surgery go beyond the operating theatre and ultimately impact the entire hospital: “From my own practice, I’ve seen that robot-assisted surgery typically halves the length of hospital stays, reduces bleeding and blood transfusions, shrinks the risk of infection, lessens the requirement for painkillers and ultimately improves the standard of care for our patients,” Assenmacher states. Furthermore, of particular relevance during incidences of highly infectious disease such as COVID-19, robots can be deployed to perform essential tasks that would otherwise place people at risk, such as disinfecting rooms and dispensing medication. Assenmacher intimates that these capabilities could simply be the tip of the automation iceberg: “We certainly expect to see an evolution of nanorobots in the bloodstream, digital pills and social companion robots.”  

Assenmacher states that he personally uses the da Vinci Surgical System when performing specialised urological procedures, although the same equipment can be used for general surgery as well as cardiac, colorectal, gynaecological, head and neck and thoracic procedures too. 

The company’s website points out that a common misunderstanding of current surgical robotics is that machines carry out procedures independently of surgeons. This is incorrect: the da Vinci system functions as a tool or instrument by which the operator carries out the procedure using a control panel.

“The da Vinci system translates your surgeon’s hand movements at the console in real-time, bending and rotating the instruments while performing the procedure. The tiny wristed instruments move like a human hand, but with a greater range of motion. The da Vinci vision system also delivers highly magnified, 3D high-definition views of the surgical area.”

How could robotics change healthcare?

Cost

Although it might seem counter-intuitive to spend significant sums of money on robotics in healthcare with the aim of making healthcare universally cheaper, Assenmacher states that this is exactly what could happen given investment, both in public and private healthcare settings. “There may be short-term dislocations or discrepancies but I think it’s unlikely that these divergences will remain,” he posits. “Robots can improve patient care and reduce costs in the long-term, meaning both public and private healthcare systems will benefit in terms of patient care and finances.” This isn’t to say that efforts won’t need to be made in order to effect such change: the initial capital expenditure on equipment, ongoing maintenance and training will still need to be factored in, as well as upgrading the robots themselves, “I also believe that there will need to be dramatic reductions in size and a shift from cable-driven electromechanical systems to more purely digital systems.”

Further to this point, Deloitte points out in ‘Taking the robot out of the human: Meet the health care workforce of the future’ that “labour is a major part of healthcare costs. Among hospitals, labour is typically the largest line item in any hospital’s budget and accounts for almost 60% of non capital costs.

“Health plans and life sciences companies also employ many people, with a variety of jobs. Some of these are highly focused on complex and innovative work, but many of these have aspects that are routine and repetitive.” It is through automating the latter that Deloitte believes health service professionals will finally be able to focus on the strictly qualitative aspects of business – “robots could make us less robotic”. 

Accelerated performance through improved design

In its article ‘The era of exponential improvement in healthcare?’, McKinsey listed robotics and RPA as among the nine technologies most likely to transform the financial and operation standards of health services by generating “between USD$350bn and $410bn in annual value by 2025 (out of the $5.34trn in healthcare spending projected for that year.” Also, in ‘How a McKinsey co-designed robot is creating a better future for minimally invasive surgery’, the organisation found that development on a surgical robots’ instrumentation to make it less complex and more intuitive when used by surgeons: “Seamlessly integrating robotic and laparoscopic processes also lowers the barriers to mastering robot-assisted surgery. Historically, learning robotic surgery has meant needing to be well-versed in all aspects of robotics. When the switch between robotics and manual laparoscopy is quick and easy, the threshold for feeling comfortable is much lower, making the adoption of the robotic system faster.” Indeed, Assenmacher verifies that the increasing sophistication of surgical robots in conjunction with easier controls makes them a highly practical solution. “The required training time for competency on the use of a robot makes them very attractive because a talented junior surgeon can expect to reach a high degree of proficiency in just a few months,” he says.

PwC’s eight highlights of how robotics and AI are transforming healthcare:

  • Helping people maintain a healthy lifestyle.
  • Early detection capabilities.
  • Enhanced diagnostics.
  • Improved healthcare decision-making.
  • Better therapies and treatments.
  • End of life care and the capacity for vulnerable people to remain independent for longer.
  • Streamlined research.
  • Advanced training.

Sanitation

Perhaps one of the most important aspects of robotics-based healthcare is the reduced incidence of transmitted infection between patients and healthcare professionals. This applies not just to surgery but also to more routine procedures like dispensing pharmaceuticals and disinfecting medical devices and equipment. Assenmacher adds, “Robots have reduced the role of fomites (inanimate objects which can lead to infection) in the spread of disease while maintaining the quality of the healthcare system. These are an indispensable part of a modern healthcare system.”

Improving quality of life

In ‘No longer science fiction, AI and robotics are transforming healthcare’, PwC presents an interesting benefit of robotics within health services that is easy to overlook: enhanced end of life care. Enabling people to remain in their own homes for longer by automating core tasks or even being programmed with AI to ‘converse’ with patients to ease their loneliness, this application of robotics could reduce the need for hospitalisation in many instances, thus opening up availability for beds and lowering operational costs for hospitals and care facilities. 

Assenmacher summarises this by stating that advanced robotics will simply lead to better yet lower-cost health services in hospitals. In fact, he claims, the effect could be of such a magnitude that it dramatically alters how average people receive healthcare. “Lower-cost healthcare enabled by advanced robotics will have a democratising effect for the entire world’s population,” he concludes. By making complex surgical procedures easier and faster, reducing the spread of infection which leads to even further associated costs and by liberating medical staff from repetitive tasks in order to refocus on value-adding services, applying robotics in hospitals could herald the beginning of a dramatically more affordable system of healthcare for everyone. “There should be no question of who deserves a complex or expensive surgery. By virtue of being a human being, we are all deserving and robotics will help us get there.

Source: Healthcare Global

AI capable of detecting prostate cancer with ‘near perfect’ accuracy

Prostate biopsy with cancer probability (blue is low, red is high). This case was originally diagnosed as benign but changed to cancer upon further review. The AI accurately detected cancer in this tricky case. CREDIT Ibex Medical Analytics, via Eureka

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Artificial intelligence (AI) has identified prostate cancer with its highest accuracy to date, demonstrating how the technology could successfully catch cases that may otherwise be missed.

Researchers from the University of Pittsburgh trained an AI system on more than one million images of tissue slides taken from patient biopsies which had been labelled by human experts to distinguish between healthy and unhealthy tissue.

The team tested the algorithm on another set of 1,600 slides collected from 100 patients treated at the university’s medical centre for suspected prostate cancer.

It detected prostate cancer with 98 per cent sensitivity and 97 per cent specificity – rates significantly higher than previous studies concentrating on algorithms trained on tissue slides, their report, published in The Lancet Digital Health, claimed.

Besides cancer detection, the algorithm was also able to grade and assess the size of tumours and surrounding nerve invasion to a high degree of performance.

It also highlighted six slides that had not been identified by pathologists as being of interest.

While the algorithm could be useful in overcoming pathologists’ own biases or conclusions drawn from past experience, the findings don’t necessarily prove that the AI’s diagnosis is superior to humans’, Rajiv Dhir, the report’s senior author, said.

Practised pathologists may have seen malignant cells elsewhere in a patient’s samples before recommending treatment, he pointed out, adding that the algorithm could be used to spot potential cases that may have escaped the attention of less-experienced staff.

Using such a system could help to standardise care across different institutions and even across the world.

“Algorithms like this are especially useful in lesions that are atypical,” Mr Dhir said. “A non-specialised person may not be able to make the correct assessment. That’s a major advantage of this kind of system.”

The algorithm could be adjusted to detect other kinds of cancer by training it on different sample databases, meaning the same system could flag potential breast, lung or throat cancer cases.

Human and AI diagnosis

Medical experts have been increasingly experimenting with AI as a detective and diagnostic cancer tool in recent years, including using the technology to predict patient survival rates and to predict how symptoms may develop over time.

A report from the British Medical Journal earlier this year cautioned against studies claiming AI is superior or as good as humans in interpreting medical images.

The researchers suggested that over-promising language “leaves studies susceptible to being misinterpreted by the media and the public, and as a result the possible provision of inappropriate care that does not necessarily align with patients’ best interests”.

“Many arguably exaggerated claims exist about [the AI’s] equivalence with (or superiority over) clinicians, which presents a potential risk for patient safety and population health at the societal level,” the report’s authors said.

Source: inews

Scientists Use 3D Printers to Make Miniature Organs for Testing Potential COVID-19 Drugs

A few months ago, Science Times featured a 9-year-old boy who used his 3D printer to create face shields. He was able to produce over a thousand face shields and now continues to create more.

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Indeed, 3D printers have become a helpful tool in this fight against the pandemic. Now, scientists are looking into using it to bioprint miniature human organs that they can use to test drugs to treat COVID-19 and other diseases such as cancer.

Bioprinting Miniature Human Organs

Anthony Atala, the director of the Wake Forest Institute for Regenerative Medicine, and his team are using 3D printers to create pinhead-sized replicas of human organs to test drugs for COVID-19.

His institute has been printing tiny clusters of organs in the past few years to test drug efficacy against bacteria and infectious diseases.

They constructed miniature lungs and colons, two of the most affected organs by the coronavirus, and send them to a laboratory at George Mason University. Initially, the team made miniature organs by hand using a pipette, but they recently used 3D printers for research.

3D printing human tissues is a form of bioprinting. Scientists are developing this method to test drugs and eventually create skin and full-size organs for transplanting. They plan on making skin tissues for burn victims, manage diabetes where wound healing proves to be challenging, and for testing of cosmetics without harming animals or humans.

The importance of bioprinting for pharmaceutical analysis is at its peak now not only for COVID-19 treatments but as well as to other diseases. Dr. Atala noted that organoids would help researchers analyze the effects of drugs on an organ “without the noise” of a person’s metabolism.

Moreover, testing on bioprinted miniature organs will tell which drugs that work on animals might not perform well in people. An important guideline that cosmetic companies should remember, especially when the European Union banned them from testing products on animals since 2013.

Parts of the Bioprinted Organ

The parts of the bioprinted organs include the scaffold to act as its foundation, which is made of biodegradable materials. Scientists included 50-micron microscopic channels to the framework to provide nutrition for the organoid.

Once it is completed, a “bioink” or a combination of cells and hydrogel that turns into gelatin is printed onto the scaffold that looks like a layer of a cake.

Of course, the organ is not yet done without the blood vessels in it. Assistant professor of chemical and biological engineering Pankaj Karande from the Rensselaer Polytechnic Institute recently had success in this step.

Karande used a cell known as fibroblast that helps with growth, and collagen as the scaffold. The researchers printed the epidermis and dermis, the two layers of the skin. Together with two other researchers, Dr. Karande begins experimenting on human endothelial cells and human pericyte cells.

After some trial and error, the researchers were able to integrate the blood vessels with the skin and discovered that there were new connections between the new and existing blood vessels.

While their experiment is still on its preliminary stage, Dr. Karande was hopeful that it will succeed and would set the stage for future successful grafting in humans.

Source: The Science Times

How plastics are transforming the implantable medical devices space

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Innovation has long been a driving factor in the progression of various industrial sectors across the globe. The healthcare sector, particularly with regards to medical devices, is likely to gain lucrative benefits from novel solutions and technology, be it through the modification of existing devices, or the implementation of strategic alliances and initiatives for product development. In recent years, this innovative drive has been increasingly apparent in the implantable medical devices industry.

Implantable medical devices, also known as IMDs or medical implants, are devices created using synthetic materials, designed to be placed inside the human body for medical purposes, often for a long-term duration. These devices can be used as replacements for body parts such as knees or hips, for delivery of medication like pain relief, for supervision and regulation of regular body functions including heart rate, as well as for offering support to tissues and organs.

Implants can be either inert or active, depending on their purpose. The inert ones are intended for use as structural support, generally in the form of stents or surgical meshes. On the other hand, active medical implants are built to interact with the body, for instance by responding to changes in heart rhythm via electrical shocks.

Certain implantable medical devices are designed to be “smart”, in that, they can connect to and communicate with systems outside of the body, these include devices such as neurostimulators, pacemakers, and implantable defibrillators, among others, which can monitor and deliver treatment automatically in response to any changes in the body.

The implantable medical devices market growth is mainly characterised by steady evolution and the emergence of advanced techniques and devices. A notable example of this is the progress of the cardiac pacing field. Pacemakers have undergone decades of transformation and have become progressively smaller in size, whilst featuring added functional capabilities.

In the quest to develop smaller and more sophisticated medical implant technologies, entities in the medical device domain are rapidly adopting various materials that can help reduce device profiles without any compromise on durability, flexibility, strength, and biocompatibility. One such material currently in use is plastic.

Plastics and their use in IMDs

Polymers have been suitable alternatives for metal components in medical applications for several years. This burgeoning popularity is attributed to a host of beneficial characteristics, the most significant being the biocompatibility of the material. The human body’s extracellular fluid, which comprises of isotonic saline solution, often displays extreme hostility to metal materials, which can lead to their degradation. However, this degrading effect is not largely associated with polymers, which is why many synthetic high-molecular-weight polymers are used extensively in the development of modern medical devices.

In terms of weight, thermoplastics account for almost 90% of global plastic usage. Unlike their thermoset counterparts, thermoplastics for medical devices can undergo processing sans loss of properties, making them highly sought-after materials for the development of implantable medical devices in recent years. Some of the most common thermoplastics used for medical applications include:

  • Polyethylene, also known as polythene, which demonstrates strong potential for use in prosthetics development, especially in the form of Ultra-High Molecular Weight Polyethylene (UHMWP).
  • Polypropylene, which is used for applications that require radiation stabilisation and autoclave sterilisation, given the product’s resistance to high temperatures.
  • Acrylonitrile Butadiene Styrene (ABS), which can be used as metal substitutes in structural parts, owing to features such as rigidity and high resistance to both impact and heat.
  • Polycarbonate, which is used for the development of medical tubing and other devices, due to strong UltraViolet (UV) and heat-resistant properties as well as transparency.

The impact of polymers on the medical device industry

Metal was considered the preferred material for healthcare applications for decades, as conventional plastic materials could not offer the same combination of chemical resistance, high modulus, and sterilisation process-compatibility that metal provided. Polymer technology has come a long way since then, however, with numerous plastic materials delivering metal-like properties and facilitating the fabrication of more integrated and complex medical device parts.

Healthcare OEMs are also becoming more attuned to the merits of using thermoplastics for medical devices and are rapidly making the shift from metal to plastic, by investing heavily to bring more polymer-based advanced medical devices to market.

Some high-performance plastics are now able to deliver similar strength properties as that of metals at ambient temperature, in addition to further advantages such as better aesthetics, cost-benefits as well as ergonomic enhancements like robust grip options.

To illustrate, high-performance medical polymers such as PolyEther Ether Ketone (PEEK) are used extensively in the production of implantable medical devices, showing particularly high potential in orthopaedic implants. PEEK is a strong, flexible, safe, and bioinert thermoplastic, which is suitable for medical applications and is a superior alternative to metal, ceramic, and other resorbable materials.

ith this in mind, Germany-based specialty chemicals firm Evonik, in 2020, introduced its new range of implant-grade PEEK filament, dubbed Vestakeep i4 3DF, as a part of its 3D printing materials portfolio. The new material, which complies with ASTM F2026 standards for surgical implants, facilitates the manufacturing of 3D plastic medical implants, via Fused Filament Fabrication (FFF) technology, and demonstrates superior application potential in the maxillofacial and orthopaedic surgery domains.

The rising focus on silicone as a suitable implantable medical device material

Medical device producers have also shown considerable interest in silicone as an ideal medical implant material for a long time, given the ease of moulding, vast temperature range, high tensile strength, durability, and wide range of available durometers, among other characteristics. However, what truly makes silicone the ideal match for medical devices, especially combination products, is its robust biocompatibility. Silicone is highly compatible with body fluids and tissue, demonstrates low tissue response once implanted, and helps deter the growth of bacteria and other contaminants. Furthermore, medical-grade silicone materials are subjected to strict biocompatibility and purity testing, which makes them suitable for integration in long-term medical implants.

A major application area for medical-grade silicones like Lliquid Silicone Rubber (LSR) is in drug-eluting implantable medical devices. These silicones can be compounded with Active Pharmaceutical Ingredients (APIs) such as hormones or cancer drugs, prior to moulding. These APIs can then be released steadily over time into targeted areas of the patient’s body, once the moulded implant is placed. Drug-eluting silicone-based IMDs can sustain the required API level in the patient’s body at a consistent pace and for longer durations of time, as compared to delivery through injection or pills. Additionally, since these implants are generally placed close to the targeted tissue or organ, relatively lower API concentrations are required since they can reach the targeted area directly.

There have been several prolific advancements over the years in silicone-based IMDs, including the creation of a novel technology by noted additive manufacturing company Spectroplast, which has transformed the industrial landscape for 3D printed products by using silicone as a key material in high-precision 3D printing for medical devices. The technology, which addresses the ever-growing need for time and cost-effective prototyping and mass manufacturing of customisable silicone-based medical devices, can be used to create next-gen products such as customised hearing aids, dental implants, bespoke silicon-based IMDs for heart valves as well as anatomically accurate medical models for surgical training purposes.

How the use of bioplastics is making medical devices more eco-friendly

Sustainability is the need of the hour across the globe. Plastic is considered to be one of the most notorious contributors to environmental degradation, with major global shifts taking place to ban fossil-based plastics, single-use disposable plastics such as plastic bags and straws, as well as the use of plastics that develop longer-lasting microplastic residues.

In the medical sector, however, the role of plastics is highly integral, which has prompted massive research efforts worldwide to develop more sustainable polymer technologies, designed for use in medical applications. Studies suggest that between the period of 2030-2040, nearly 25-30% of plastics across the world will be bio-based.

Given these circumstances, many global medical industry players are leaning towards adopting more environmentally friendly products, thus opening lucrative avenues for innovative efforts by companies such as Arctic Biomaterials. An example of such an effort is the company’s 2016 breakthrough in medical device innovation, with the development of a material combining the strengths of plastic and glass fibres, by fusing the two together using a proprietary adhesion layer. The resulting material established the entity as a leading presence in the medical devices’ domain, by demonstrating high heat resistance and superior strength for medical and technical purposes.

A team of researchers from the University of Birmingham made similar progress, with the development of a novel thermoplastic biomaterial, which possesses not just high toughness and strength properties, but is also easier to shape and process compared to its counterparts. The material, which is a type of nylon equipped with shape memory characteristics, can be moulded and stretched as needed, returning to its original shape upon application of heat, making it ideal for bio-based medical implants such as bone replacements, where the flexibility of implant materials plays a key role in minimally invasive surgical procedures.

Technological advancements are triggering the invention of novel materials, technologies, and ideas across the medical industry, designed to surpass the existing concepts. With plastics held in such high regard as key medical-grade materials, alongside the emergence of modern techniques such as insert moulding, injection moulding, and the like, it is becoming easier and easier for medical device manufacturers to create precision tools that can be mass-produced without compromising on efficiency or quality. This widespread adoption and acceptance of various material technologies in the implantable medical devices industry are thus indicative of revolutionary innovations that have changed and will continue to change the healthcare landscape even in the years to come.

Source: Medical Plastic News

Why digital healthtech is more important than ever

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 We talk a lot about the role of digital tech in healthcare – its ability to speed up diagnosis, manage conditions and improve both patient care and the way in which healthcare professionals connect with patients, for example. In these testing times, it is also becoming apparent that the role of digital has an increasingly important part to play in the way we continue to care for the elderly population.

Despite lockdown easing measures, the threat from coronavirus is far from over, particularly for more vulnerable sections of society. As the younger population and those with no underlying health conditions start to move back into a pre-COVID-19 existence, however that may look, it’s important we look to ways to keep the elderly and vulnerable connected, safe and involved.

Digital technology is the obvious way to achieve this. There are all manner of solutions making their way to market – some will be better suited to individual needs than others. The Essence Group for example, offers connected smart devices for elderly care, medical settings, and home security, and claims to have formed a core part of governmental and private efforts around the world to safeguard the health of seniors whilst allowing them to live as independently as possible during COVID-19. The company’s telecare solution, Essence SmartCare, has been adapted to support seniors in lockdown by providing a non-obtrusive, 24/7 care system. AI and voice-based remote monitoring solutions means carers and loved ones know their relatives remain connected and safe.

A favourite company of mine is Spirit Digital, part of the Spirit Health Group. The business is continually innovating, which I love. Following NHS England and NHS Improvement Guidance calling for steps to implement a clinical service model for care home support during COVID-19, remote monitoring has been highlighted as vital to this process.

Spirit Digital’s CliniTouch Vie is a digital, remote monitoring platform is designed to connect care homes, carers and nurses with their patients’ GPs. Carers can check patients’ vital signs and answer health questions via a tablet, as frequently as needed. GPs can then connect remotely with carers and patients to provide health and wellbeing advice and intervene where and when more urgent care is needed.

It’s exactly the sort innovation that’s needed at the moment and underlines the pivotal role that digital technology has in this section of our community. It is of course, just one way that digital technology can provide huge benefit to the healthcare system but one which is highly relevant given the pandemic and how we address health and care going forward.

On a separate note, this is my last issue of MTI. I’m off to a new exciting venture. It’s been great working in this industry and getting to know all of the innovative and forward-thinking companies. At a time when so many sectors are suffering, medtech and heathtech are still showing promise, innovation and that they have a key role in the future success of the UK and Irish economies. Keep up the great work!

Source: MedTech Innovation News

Manchester life sciences campus reaches practical completion

The next stage of a Manchester-based life sciences campus has reached practical completion, despite the COVID-19 pandemic.

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A joint venture between Manchester University NHS Foundation Trust (MFT) and Manchester Science Partnerships (MSP), Citylabs has been designed as a campus targeting companies within fields such as precision medicine and medtech.

The first phase of the development at MFT’s Oxford Road hospital campus – Citylabs 1.0 – is already home to a number of life sciences businesses.

Now the next stage of the project has reached completion. Citylabs 2.0 is a £25 million, 92,000 sq ft build located directly opposite the Royal Manchester Children’s Hospital, within the MFT campus. It’s hoped that the new building will help support up to 1,500 jobs, while also adding an estimated £150 million to Manchester’s economy over the next decade.

It forms part of a £95 million expansion which will also see the addition of Citylabs 4.0 to the campus sometime in 2022 – adding a further 1,200 jobs when complete.

The aim is to make the Citylabs campus a new national hub for precision medicine and data analytical businesses, helping bring diagnostics and treatments into Manchester’s health system.

Businesses based at Citylabs have access to clinical and academic collaborators located on the campus, as well as business support such as advice on funding sources and professional services.

Life sciences company QIAEGN will occupy the whole of Citylabs 2.0 for its Global Centre of Excellence for Precision Medicine, relocating from its current location at the nearby Manchester Science Park.

The completion of Citylabs 2.0 represents another addition to Manchester’s Oxford Road Corridor Innovation district. The district is home to 50% of Manchester’s life science businesses and generates £3.6 billion gross valued added (GVA) every year.

Tom Renn, managing director of MSP and Bruntwood SciTech – Manchester, said: “Our long-term vision for the Citylabs campus is now one step closer in realising its goal to become a world-class centre for diagnostics and health innovation.

“The last few months have showcased the importance of the life sciences sector and particularly diagnostics to society, the jobs it creates and its role in driving the UK forward globally. QIAGEN has been at the forefront of the fight against COVID-19 as a leading developer and manufacturer of test kits to help track the virus. Their expansion into Citylabs 2.0 will act as a magnet for complementary businesses – from start-ups to scale-ups and R&D centres of excellence – helping strengthen the ecosystem of the Oxford Road Corridor innovation district. 

“Despite the current challenges we’re pleased to have reached practical completion at Citylabs 2.0 with minimal delay and can now swiftly progress QIAGEN’s fit out. I’d like to thank all of the teams who have worked on Citylabs 2.0 for their ability to quickly adapt at the beginning of the pandemic to enable construction to continue, with a fantastic end result.”

Sir Richard Leese, leader of Manchester City Council, added: “The development of this new health innovation and precision medicine campus and the practical completion of Citylabs 2.0 helps confirm Manchester as a world leader in this vital industry, creating a raft of highly skilled health science jobs and providing an all important economic boost to the city. Manchester’s future success depends on building on our distinctive strengths of which life sciences is definitely one.”

Source: MedTech Innovation News

African women are leading biotechnology’s advance across the continent

How unlocking the secrets of African DNA could change the world ...

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Women researchers are strongly influencing the adoption of agricultural biotechnology in Africa.

“As African women, we are the ones who suffer most whenever drought and food shortages strike, despite the availability of technological solutions to these problems,” said Dr. Felister Makini, deputy director general in charge of crops at the Kenya Agricultural and Livestock Research Organization (KALRO).

“We are looking for new solutions and how we can use technology to give our people and ourselves better and improved crop varieties to fight hunger and improve the quality of living,” said Dr. Priver Namanya Bwesigye, who leads Uganda’s banana research program at the National Agricultural Research Laboratories (NARL) at Kawanda.  “We also need varieties that can give us more in terms of nutrients.”

Throughout Africa, women are in labs developing crops that produce high yields and can tolerate or resist disease, as well as healthier, more productive livestock. They are also found in meeting rooms and gardens informing the public about their innovations and how these improved crops can aid the fight against hunger across both the continent and the globe.

“It is time to tell the public about the positive side of biotechnology,” said Professor Caroline Thoruwa, chairperson for African Women in Science and Engineering.

In Uganda, where bananas are an important staple food and cash crop, Bwesigye is in charge of developing varieties that offer farmers better options.

She and her team are using the tools of genetic engineering to develop banana varieties that are resistant to nematodes, bacterial wilt and weevils. The most advanced of these genetically modified varieties is a banana biofortified to provide vitamin A. It should reach farmers immediately after Uganda implements a legal biosafety framework guiding the use of GMOs.

“We have trialled the technology in multiple locations — all the four banana planting regions of Uganda — and it will be ready by the time we have a legal framework,” Bwesigye said. “We have to do this [multi-location field trials] before we can give it to the farmers. We want to be sure that different farmers across the country can plant the variety and have similar results. In this case, all the banana yields should be rich in pro-vitamin A.”

But Bwesigye’s program does much more than develop improved bananas using biotechnology. It also employs conventional plant breeding tools to produce heartier varieties, including a banana resistant to black sigatoka disease. When she’s not in the lab, Bwesigye conducts extensive outreach to farmers and young people to explain agricultural biotechnology and why Uganda, Africa and the world need this tool.

Dr. Barbara Mugwanya Zawedde is also championing the adoption of agricultural biotechnology in Africa. She’s currently director for research at Uganda’s Zonal Agricultural Research and Development Institute in Mukono, which is under the jurisdiction of the National Agricultural Research Organization (NARO).

But before that, she was the coordinator for the Uganda Biosciences Information Center (UBIC) — NARO’s knowledge and information-sharing hub. It champions an appreciation of modern biosciences research for agricultural development and works to educate stakeholders on the importance of biosafety.

In that role, Zawedde engaged religious leaders, local communities, farmers, extension agents, legislators, public ministries, “women in agriculture,” students and others to raise awareness about new technologies and their safety.

After earning a doctorate in plant breeding, genetics and biotechnology from Michigan State University, Zawedde returned home to Uganda in 2013 to discover “we had gaps in communication as well as in regulation,” she recalled.

So, she worked with Dr. Yona Baguma, now deputy director general for NARO, to set up the biosciences information center. Their goal was to “bring to the fore these new technologies that people were not talking about” and to emphasise the importance of regulating them.

“The regulatory framework [we have been calling for] is not just for the introduction of these new technologies, but for their regulation as well,” Zawedde said.

To an extent, Zawedde and UBIC have been successful.

Parliament passed the National Biotechnology and Biosafety Bill on two occasions, though President Yoweri Museveni has yet to sign it into law. Additionally, more Ugandans now appreciate the science and what it can do to improve their lives. Biotechnology and biosafety elements also have been included in the country’s school curriculums.

“It will be easier to adopt these technologies [once we have a regulatory framework] because more people today understand these technologies and how they can help improve agriculture and food security in Uganda and the region,” Zawedde said

Similarly, the Women in Biosciences Forum is working in Kenya to make everyone sure knows about the value of biotechnology and the role that women are playing to advance the science.

“We need to raise the status of women in biotechnology and also encourage women to network in order to achieve the noble goal of sharing their science,” Thoruwa said. “Women must be involved for Africa to advance in agri-biotech.”

Several African countries have approved the cultivation of GMO crops and others have conducted trials for GM crop varieties. But in many of the countries that are conducting research, GM seeds have yet to reach farmers and consumers because the political leadership is swayed by opposition and remains “afraid” to adopt biotechnology, the women scientists observed.

“We need to speak with one voice and advocate for a predictable policy environment,” said KALRO’s Makini.

“The detractors will always be there,” Bwesigye said. “But we need to understand that these technologies, pretty much like everything else in life, have advantages and disadvantages. We just have to harness the advantages.”

One such advantage is being able to develop a staple food crop, like a banana, that delivers vitamin A, a crucial nutrient that is lacking in almost 30 percent of Uganda children below the age of 5. “It is a no brainer,” Bwesigye said about the value of adopting the pro-vitamin A banana.

Despite the political obstacles, Bwesigye and her colleagues remain undiscouraged.  Zawedde said that women will continue to conduct communication and outreach, calling on governments to give farmers a chance to plant some of these improved crops.

“We only need awareness, awareness and more awareness,” Bwesigye said. “Then mind-sets will change and adoption of these technologies will be easier.”

Source: Alliance for Science

Make a vaccine? I’m trying to teach my kids the alphabet

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LONDON/BERLIN/MILAN (Reuters) – It’s tough to do any useful work when you’re stuck at home, struggling to home-school bickering kids, let alone when you’re trying to produce a COVID-19 vaccine.

British drugmaker AstraZeneca had spent years preparing for a pandemic, but when the moment finally came it was caught cold on a crucial front: stressed parents working from home struggled to focus.

So the company recruited up to 80 teachers to run online lessons and repurposed a car parking app to book virtual classes. It also lined up personal tutoring and helped to locate some childcare spaces for those battling to adapt to the abrupt change to their lives.  

The move by Britain’s biggest drugmaker, and similar efforts by companies the world over to host everything from magic classes to yoga for children, shows the lengths businesses are going to to help staff work through the coronavirus crisis.

“It was quite apparent that it was going to be really challenging for those with small kids and with two parents working,” AstraZeneca’s HR chief Fiona Cicconi told Reuters.

“People were starting to say they were feeling really anxious, I’ve got so much to do, how am I going to get it done?”

The new corporate attitude towards home-working could help lead to higher productivity and loyalty, according to experts, and ease moves towards more flexible working as companies rethink whether staff need to be in the office, and as schools take time to return to normal.

 

‘I’M DISTRACTED FOR SURE’

The march of the pandemic has upended normal life, forcing companies to shut offices, schools to close and grandparents and childcare providers to stay away.

That has left many exhausted parents juggling work demands while helping their children with school work to prevent them from falling behind or spending too much time online, not to mention having to feed, entertain and care for them.

German business software company SAP provided online lessons on magic, coding, yoga, guitar and break dancing for children of staff.

It is now working on a more formalised schooling scheme with a partner organisation, which will pair children of staff with students, and also offer activities through the summer holiday.

Thomas Angerstein, EMEA head of the SAP department responsible for providing “mission critical” support to customers, said the magic classes had helped his eight-year-old son, and consequently helped him too.

“I could focus on my team,” he said. “Usually he is hovering around and looking at my screen and I’m distracted for sure.”

In Italy, tyre maker Pirelli teamed up with local company Radiomamma.it to provide online education and entertainment for children, with classes in English, creativity and technology the most popular.

Rosaria Demma Carà, who works in Pirelli’s Financial Statements division, said the classes had helped her 10-year-old son and 5-year-old daughter interact with their peers, relieving the social blackout of lockdown.

“(It also helped) us get on with some work.”

‘THEY’RE OFFERING – WHY AREN’T YOU?’

Esther Canónico, from the London School of Economics, said companies needed to prioritise supporting their staff in different ways because any return to normality would take time, and flexible, long-distance working was likely here to stay.

Chris McGillicuddy from EB Education Services hosts an online tutoring session during the coronavirus disease (COVID-19) outbreak in Manchester, Britain July 2, 2020. EB Education Services/Handout via REUTERS

Supportive measures should, however, not be seen as an attempt to persuade staff to work harder, especially when those working from home can struggle to manage boundaries with work life, and end up working for much longer, she added.

“There is not a clear differentiating line between work and home,” she said of the new environment. “The advice is for employees to actively manage their boundaries.”

Companies, for their part, see offering such services as good business sense in terms of operational resilience.

AstraZeneca, for example, knew it had to act when a survey found that 1,100 of its 8,300 staff in the country needed help with childcare.

A plan to recruit freelance teachers was inspired by a former teacher who worked in the company’s HR department and it was backed by CEO Pascal Soriot, with the whole process signed off in a matter of hours.

Launched in May, it offers four lessons a day to up to 1,300 children who have registered. Separately it has lined up a tutoring company that provides one-on-one sessions.

The tutoring firm, EB Education, said it had since been asked by another company in the drugmaker’s home town of Cambridge if they could provide a similar service.

“The other company have had a few of their workers saying: AstraZeneca are offering this so why aren’t you? So they put something in place,” EB’s Karen McGillicuddy told Reuters.

For now AstraZeneca, which has been licensed to produce a potential vaccine for COVID-19, is expanding its support. It has introduced new classes for different age groups and is looking at a summer school.

HR chief Cicconi said staff had been incredibly grateful, during what is an extraordinary time.

“They know it’s not normal for us to run three primary schools,” she added.

Source: Reuters

A generation of UK researchers could be lost in a funding crisis

Medical worker taking blood from a patient

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The discovery of new cancer treatments could be delayed, research institutes shut, and a whole generation of upcoming scientists lost because of a funding crisis in medical research, charities have warned.

Covid-19 has caused fundraising to plummet, with events cancelled and charity shops shut because of the lockdown. The upshot is a dire financial situation that could have a severe impact on research crucial to finding new ways to diagnose, manage and treat diseases from cancer to neurological conditions and heart disease.

“The current pandemic has put the future of charity-funded research at significant risk,” said Aisling Burnand, chief executive of the Association of Medical Research Charities (AMRC).

While some charities have furloughed staff, Burnand said the government’s £750m charity support package does not provide cash for medical research.

As a result of the AMRC and its 151 member organisations, including Parkinson’s UK, the British Heart Foundation (BHF) and Cancer Research UK (CRUK), are calling on the government to set up a “life sciences-charity partnership fund” to support research that, they stress, saves lives.

The proposed scheme would be a matched funding programme, lasting at least three years, with the government contributing £310m over the financial year 2020-21 to bridge the funding shortfall from medical research charities. Burnand said that could be tapered down in subsequent years as fundraising picked up, with the hope that government support could galvanise donations from the public.

Medical research charities together spent £1.9bn on research last year – over half of the non-commercial medical research funding – with another £1.1bn spent on activities including patient services and support. But, because of the impact of Covid-19, many charities have warned that, without government support, medical research funding will be slashed.

The impact is already being felt. “At the end of April, 74% of clinical trials and studies funded by AMRC charities had been paused,” said Burnand, adding that more than two-thirds of its member charities are deferring upcoming grant rounds and withdrawing future funding.

Breast Cancer Now has already announced it could be making redundancies following the outbreak of Covid-19 and has cancelled two forthcoming research grant funding rounds.

While Burnand said some research was to resume now lockdown has been eased, other projects were not. For research spending by medical research charities to return to pre-COVID-19 levels, it could take four to five years, she warned.

Dr Charmaine Griffiths, BHF’s chief executive, said even with some staff furloughed the charity is losing £10m a month and is facing an unprecedented research funding crisis.

“We anticipate our net income this year falling by 50% and consequently we will have to halve our investment in new research from £100m this year to £50m,” she said, adding that could have a catastrophic impact on UK cardiovascular research.

Michelle Mitchell, chief executive of CRUK, said the charity is expecting a 30% drop in income this year because of Covid-19, meaning research funding could be cut by £150m a year.

“This would be devastating for people with cancer today, and our families and future generations of people, devastating for our science base and devastating for the economy,” she said. “It could mean a major contraction in CRUK’s infrastructure and potential closure of centres and institutes,” Mitchell added, noting it could also affect plans for clinical trials and hence, potentially, hold back new cancer treatments.

The charities warn funding cuts could also be a disaster for early career researchers, including PhD students.

“We believe we could potentially lose a generation of researchers because of this shock and the reduction in our funding,” said Griffiths.

Mitchell said it had not been possible to access research and development support that is available for businesses and made a direct plea to Boris Johnson.

“If you believe, prime minister, in improving cancer survival, if you believe in ensuring the UK retains its position as a global scientific power, if you believe in protecting infrastructure and our talented people, you absolutely must commit to supporting the UK’s research charities at a time of our need and give us time to recover and get research back on track.”

A Department of Health and Social Care spokesperson said: “The UK is home to globally recognised medical research charities, which are an integral part of our world-leading life sciences sector.

“We are working closely with medical research charities to understand the impact of the pandemic on the sector and identify how we can work together, ensuring patients continue benefiting from charity-funded research.”

Source: The Guardian

‘The wondrous map’: how unlocking human DNA changed the course of science

Thanks to the success of the Human Genome Project, 20 years ago this week, scientists can track biology and disease at a molecular level

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Human x chromosomes, illustration

‘A mission to unravel the molecular essence of humanity’: a computer illustration of human X chromosomes. Illustration: Sebastian Kaulitzki/Getty Images/Science Photo Library

Twenty years ago this week, an international group of scientists announced it had put together the first genetic blueprint of a human being. After 10 years of effort, the team – made up of thousands of scientists working on both sides of the Atlantic – revealed it had pinpointed all 3bn units of DNA that make up the human genome.

The result was “the most wondrous map ever created by humankind”, US President Bill Clinton told a special White House ceremony to mark the event. A parallel event, hosted by Tony Blair in Downing Street, also featured glittering praise for the effort.

The $2.7bn (£2.2bn) Human Genome Project remains one of science’s greatest feats of investigation. It was described, at the time, as biology’s answer to the Apollo space programme. It took researchers on a very different journey – not of outward exploration, but an inward voyage: a mission to unravel the molecular essence of humanity.

Armed with the resulting “wondrous map”, scientists would soon, it was assumed, isolate the genes for height, eye colour, intelligence and myriad other human attributes. However, this simple goal has been confounded by the fact that a great many individual human attributes are determined by dozens, if not hundreds of genes. We are too complex for reductionism.

Nevertheless, the biological revolution let loose on 25 June 2000 has had remarkable results. The draft genome published that day was later followed up with more and more accurate “maps” of our DNA until the project was officially closed in 2003 with the publication of a final, full human genome. Ever since gene sequence studies set up in the project’s wake have been involved in growing numbers of remarkable discoveries.

For example, DNA studies have shown our species once mated with Neanderthals while other projects have pinpointed mutated genes that cause cancers and melanomas. Others have helped to develop new drugs for conditions ranging from cystic fibrosis to asthma.

A visualisation of genomic data from a DNA test.
A visualisation of genomic data from a DNA test. Photograph: Getty Images

These successes have been achieved because gene sequencing, over the decades, has become a highly automated and incredibly cheap process. “It took a decade of intense effort to create that first rough draft of a human genome,” said Cordelia Langford, of the Wellcome Sanger Institute, near Cambridge, where UK scientists played a prime role in Britain’s involvement in the Human Genome Project. “Today, we sequence around 3,000 full genomes a week. It has become a simple, straightforward process.”

Not all these genomes belong to humans. Some belong to other animals and others to our mortal enemies – such as the organisms responsible for malaria and cholera, a list of foes that has now been expanded to include Sars-Cov-2, the virus that causes Covid-19. Sequencing its tiny genome is now providing doctors and public authorities with critically important information about the disease.

“We are sequencing samples of Sars-Cov-2 from different sources to see if the virus is mutating significantly,” said Dominic Kwiatkowski, director of the Centre for Genomics and Global Health at Oxford University. “The jury is still out on that. However, we are also using sequencing technology to highlight tiny variations in samples from different places, and that should help us pinpoint the locations of new outbreaks.”

A very different use of sequencing technology is being pursued by Sarah Teichmann, leader of the Human Cell Atlas project. “Devices are now so sensitive that we can analyse DNA from a single cell and at the same time compare our findings with DNA from millions of other comparable cells,” she said.

That data tells researchers what the cells in our bodies are doing at a very high resolution and at a specific time, information that has led to the discovery of many new types of cells, many in the immune system and others in the body’s various tissues.

“This work has triggered a major revolution in understanding our bodies’ cells and their organisation in tissue and organs,” said Teichmann, who is also based at the Wellcome Sanger Institute. “By comparing healthy tissue with diseased tissue in this way, we are getting incredible new insights into the mechanisms of those diseases. This is a very powerful technique.”

Such insights have included pinpointing cells involved in the development of cystic fibrosis, asthma and certain human tumours. The discoveries have opened up the prospect of developing therapies for these conditions.

The Human Genome Project is clearly having a big impact on medicine and research, but its progress was not without controversy during the course of its work, which began in 1990. “We were in a race. It was as simple as that,” said Langford, who is now the Sanger’s director of science operation but who worked as a research assistant during the project’s early days. “We were out to stop people from putting patents on human DNA that was being sequenced elsewhere.”

At the time, a rival outfit to the Human Genome Project – known as Celera – had been set up with the maverick researcher Craig Venter as its head. “They wanted to put patents on the DNA they were uncovering. We wanted to make sure everyone could use the data and were putting every sequence we found into the public domain to block any attempt to privatise the genome. And in the end we succeeded.”

Source: The Guardian

The study demonstrates the feasibility of hologram technology in liver tumour ablation

liver

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Data from one of the first clinical uses of augmented reality guidance with electromagnetically tracked tools shows that the technology may help doctors quickly, safely, and accurately deliver targeted liver cancer treatments, according to a research abstract presented during a virtual session of the Society of Interventional Radiology’s 2020 Annual Scientific Meeting on June 14. The technology provides a three-dimensional holographic view inside a patient’s body, allowing interventional radiologists to accurately burn away tumours while navigating to avoid organs and other critical structures.

“Converting traditional two-dimensional imaging into three-dimensional holograms which we can then utilize for guidance using augmented reality helps us to better view a patient’s internal structures as we navigate our way to the point of treatment,” said Gaurav Gadodia, MD, lead author of the study and radiology resident at Cleveland Clinic. “While conventional imaging like ultrasound and CT is safe, effective, and remains the gold-standard of care, augmented reality potentially improves the visualization of the tumour and surrounding structures, increasing the speed of localization and improving the treating physician’s confidence.”

In this initial in-human pilot study, the technology was used to deliver a treatment known as percutaneous thermal ablation of solid liver tumours. To apply this technology, the physicians use multi-phase CT to record coordinate markers placed on a patient’s body. This imaging data is added to a software application that allows for segmentation of the tumour and nearby structures within the marked coordinate space. This information is fed into a proprietary augmented reality application, which utilizes Microsoft’s HoloLens technology, a virtual reality headset with transparent lenses, to project a segmented hologram of the patient’s imaged anatomy directly onto the patient. The hologram is registered to the coordinate markers to ensure accurate location of the relevant anatomy.

Utilizing electromagnetic tracking, instruments including the ablation probe can also be visualized in the augmented reality space during the procedure, thus allowing for true holographic intraprocedural guidance. Interventional radiologists can then use the combination of the holographic images of the patient’s anatomy and tracking tools to find the tumour in the patient’s liver quickly, check for optimal targeting of the tumour by the ablation probe, and avoid key structures.

The study included five patients who were selected for microwave ablation of their liver tumours. For safety during this IRB-approved study, the gold standard of ultrasound was used for primary clinical decision making and probe guidance, with direct comparison to holographic guidance. Following ablation, images and video from post-procedural sonography, cone beam and multi-detector row CT, and HoloLens recordings were evaluated. In all five cases, intra-procedural holographic guidance was in agreement with the standard ultrasound-based guidance. Post-procedural imaging showed adequate tumour ablation, and no patients experienced tumour recurrence at the three-month follow-up. In this early phase pilot study, the authors anecdotally observed that the speed of tumour localization was faster with holographic guidance and that their confidence in optimal ablation and critical structure avoidance was improved over standard imaging guidance. They are further attempting to quantify these findings as they continue to enrol patients in the study.

Beyond its use during treatments, interventional radiologists also see value in using this tool for clinicians’ planning purposes and for improving patient engagement and understanding of the condition and treatment.

“This technique can be used intra-procedurally to check the accuracy and quality of the treatment, as well as pre-procedurally to engage with the patient in their own care,” said Charles Martin, III, MD, FSIR, an interventional radiologist at Cleveland Clinic who is the principal investigator of the IRB and the senior author of the study. “We can change 2-D images into holograms of a patient’s distinct anatomy so that both the physician and the patient get a better understanding of the tumour and treatment.”

Researchers continue to test this technology for ablations in the abdominal area with plans to expand to other types of procedures and in other areas of the body. The technology has only been tested for feasibility and therefore cannot yet be used as a standalone method for delivering treatment.

Additional information about the clinical trial is available at ClinicalTrials.gov, using the identifier NCT03500757. This work was funded through internal enterprise grants from Cleveland Clinic, as well as the Ohio-based biotechnology startup, MediView.

Source: Medical Press

7 Advantages of Hosting Virtual Events

As Aventri’s CEO Jim Sharpe says, “we know nothing beats the value of face-to-face meetings,” however, what happens when in-person meetings and events are restricted because of events like the coronavirus? Should meeting and event professionals just cancel their events altogether? The answer for many will be no, thanks to technology, like virtual event platforms.

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In this guide, we will discuss some of the benefits of switching your in-person event to a virtual one. But first…

What are Virtual Events?

business professional gathered around a conference table having a virtual meeting

Virtual events, in its simplest definition, are events held online. Virtual events use web-based platforms to connect dozens to thousands of attendees from across the globe and often include interactive engagement features such as polling, Q&A, chat boxes, etc. Some of the top virtual event providers include Digitell, Evia, Intrado,ON24, Zoom, GoToMeeting and more.

Virtual events, like in-person events, can cover anything, but typically there are four types of virtual events: virtual conferences, webinars, internal hybrid events, and external hybrid events.

In light of the coronavirus, going virtual has become an increasingly more popular option as it helps organizations save money and all the hard work they put into their in-person events. Some examples of events that made the decision to go virtual during the outbreak include Salesforce’s World Tour Sydney Reimagined, Facebook’s F8 Developer Conference, and Microsoft Build.

Instead of Cancelling, Let Aventri Help You Go Virtual: It’s hard to deny that coronavirus is having a serious impact on the world and live events. Rather than cancelling your events altogether, save time and enjoy the flexibility of a fully integrated virtual event platform. Contact Us.

7 Benefits of Hosting Virtual Conferences

1. It’s Less Expensive

Meeting and event planners are always looking to save money, with shrinking budgets. Thanks to virtual events, the overall cost of putting on your event will be greatly reduced, 75 percent less expensive to be specific. Planners will save on staff, venue, setup and takedown, attendee’s hotels, meals, travel costs, and so much more. The only thing planners have to worry about paying is the costs of the virtual meeting platform.

2. It Saves Time

businesswoman checking the time on her wristwatch

Because your event is virtual, you’ll also save yourself, your staff, and your attendees so much time. Although virtual events do require some setup time (e.g. event website, registration, event marketing, and promotion, etc.) it’s tremendously less than that of an in-person event. They also require no travel time! So, your employees and attendees can use that time to work on all the other important things that need their attention.

3. It’s Global

Planners are always trying to increase their event’s reach to engage more people. With virtual events, that’s easy! You can easily promote your event by sharing the link to your website and social media channels. People from across the world can join instantly without thinking about travel. Hosting a virtual event allows planners to grow their audience and get everyone to participate, no matter where they live.

4. It’s Flexible and Variable

Because virtual events take place online, you have a lot of flexibility in how you broadcast your event. Whether you’re hosting a thought leadership conference, a virtual town hall, a sales kickoff, or another type of event, you can choose to make the sessions interactive, offer different language options, invite guest speakers and more.

5. It’s Easier to Make Connections

Because virtual events tend to be faster-paced since attendees don’t have to move from session to session or booth to booth, it can be easier to make connections with other attendees and speakers than an in-person event. And since everything is online, attendees can easily record important information, like people’s names, titles, etc., right on their tablet or computer.

6. It’s Easy to Collect Feedback

businessman taking a survey on his mobile phone

Like in-person events, feedback is crucial for virtual events. But unlike in-person events, attendees are constantly online at virtual events, which means they can easily answer real-time polls or surveys in sessions. Not only will this real-time feedback help presenters gauge how their session is going (which is especially valuable since these presenters cannot see attendees’ faces during some virtual events), but it will also be useful to measure the overall success of your virtual event.

7. It’s Easy to Measure Results

Although the data that virtual events produce varies depending on what platform and event management software you use, it should be easier to gather certain data on your event and attendees during your virtual event than an in-person event. Why? Because everything is done online, so it can be easily tracked. For instance, you can know when your attendees logged on, from where, the number of people attending, how they are paying, and so much more.

Conclusion

While the interest in virtual events has certainly spiked since the coronavirus pandemic, these benefits can be applied to the world of meetings and events long after the end of travel bans and gathering restrictions. If you’re new to virtual, consider adding a virtual component to your future in-person events as a starting point and seeing how it goes. You’re bound to discover a new way to expand and reach your audience.

Source: Aventri

The accelerating adoption of emerging technology

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During this time of Covid-19 virus lockdown, many people and industries are in a state of stasis with the hope that coming out of lockdown will recover everything quickly. Many commentators and economic advisors worry about the future, as the impact on jobs and companies could be damaging for many years to come.

The emerging technology industries of Blockchain, AI and some areas of Cleantech are still moving at a fast pace. Although many say these industries have been around for a long time, the investment and application of these technologies are still taking time to move into the mainstream, therefore still emerging. It can’t be said that all companies in these sectors are doing well during this challenging time, but many have solutions that will work well in the future when we try to reduce the risk of further infection. Physical money, ink signatures, physical medical services and many other areas of business and day to day life can be replaced by digital versions that not only make life easier but safer, in this new world we live in.

As we all work from our homes and spend time in lockdown, we are already using less paper money and spending money digitally with contactless payments and online shopping. As business and customers see the benefit of this, there will only be greater adoption of this going forward. The next phase of digital money is CBDC (Central Bank Digital Currency), and in recent news on the 14th of May 2020, the digital euro has been successfully tested for the first time by France’s central bank. Countries around the world are working on projects with Blockchain and CBDC. China has also been vocal and has confirmed that it has begun testing its digital yuan in four cities. Central bank, corporate and public digital currencies will become more mainstream over the next few years, and many companies supporting these initiatives will thrive.

In the Finance sector in Europe, processing of payments and authorisations have moved to digital (e-signatures) with so much of Europe in lockdown. Some banks have made announcements in some jurisdictions that they will want to go back to handwritten signatures when we come out of the lockdown, but there is already a movement from the banks’ customers to insist that solutions are used to streamline these processes going forward. Let’s see who wins this battle. It is likely that some jurisdictions and banks will be progressive, and others will not, but it will only be a matter of time before everything moves to digital.

Another exciting area is medical services that have been forced to use digital services and are likely to keep these processes in place as the customer service is improved and saves money for hospitals/GPs. Projects in this area will succeed off the back of the way the services are now delivered.

Investment professionals are starting to realise that one obvious outcome is that more investment will come into the emerging technology sector to bring these technologies to the mainstream. This investment will generate sales and revenue for these companies, and we will start to see companies rise as they did after the internet boom. This makes it an exciting time for the emerging technology sector. Companies will be born out of this tough economic time that makes the most of these opportunities.

Appold is launched today to realise these business opportunities. We are carefully selecting companies to help those that we think have the best chance of success. Appold is an emerging technology advisory and investment company whose main focus is to assist:

Emerging Technology firms expand their businesses through strategic management and capital solutions

Investment groups seeking returns within the Emerging Technology sector

Corporates and Institutions looking to utilise and implement new technologies

Some of the companies we have selected are well known in the industry and have strong management and market presence already. We predict them to be fast growth and Appold is set up to support this. Here are some of the first of our clients:

CryptoCompare – A Global leader in Digital Market data with major corporate clients and deals with the potential for significant growth.

Cygnetise – Authorised Signatory Management on the Blockchain with major corporate clients and deals with the potential for significant growth.

SupraFin – A smart WealthTech platform for crypto-assets with a focus on financial inclusion, pre-revenue but great potential.

ByteTree – A leading provider of institutional-grade crypto-asset data. Their investor terminal tracks over 80 metrics for bitcoin in real-time.

Please see https://www.appold.com/  for more information on the company

Source: City A.M

Your legal rights for going back to work safely after lockdown

As the country heads back to work, bosses have a greater duty than ever to keep workers safe.

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Offices and workplaces across England are making adaptations to make sure their staff don’t contract coronavirus.

Despite the changes to daily life, health and safety principles for employers have not changed.

Employers have a duty to do everything that is “reasonably practicable” to safeguard their employees and those affected by their operations under the Health and Safety at Work Act 1974.

 
Staff at a fish and chip shop in Northumberland wearing PPE as they put out social distancing signs (Image: PA)

“Whilst these may be extraordinary times, the guiding principle for employers has not changed,” Leigh Day associate solicitor Ross Whalley says.

“Employers must therefore assess the risks that are present in their workplace and act accordingly.

“This now includes making provision for employees against the risk of coronavirus infection.

“Employers owe a duty to identify and take appropriate measures to lessen this risk, which must also take into account any particular vulnerabilities amongst their staff such as pregnancy or people with underlying health issues.

“The general Government guidance for employers on coronavirus stresses that employers should make sure workplaces are clean and hygienic, promote regular and thorough hand-washing, and promote good respiratory hygiene.

“Whilst this and other steps such as social distancing and self-isolating may prove effective preventive measures, what consideration is given to those workers at greater risk?”

According to Mr Whalley, the Personal Protective Equipment Regulations 2002 and the Personal Protective Equipment at Work Regulations 1922 set out the main requirements in respect of protective equipment at work.

They state that PPE must be supplied where there remain unavoidable occupational risks to health and safety that cannot be adequately controlled in other ways.

 
(Image: Copyright Unknown)

The Personal Protective Equipment at Work Regulations 1992 requires that ‘every employer shall ensure that suitable personal protective equipment is provided to his employees who may be exposed to a risk to their health…’

The PPE must be ‘effective to prevent or adequately control the risk or risks involved’.

This mandatory duty too cannot be evaded by a claim of ineptitude on the part of the employer in failing to order the PPE in time.

Examples of breaching these requirements will vary depending on the job.

“What may be appropriate in one employment context may not be the same in others,” Mr Whalley says.

“An employer should give very careful consideration of the extent and nature of the risk of coronavirus to their employees. What is required in a healthcare setting, where gloves, aprons and screens may be proportionate to the risk, may not be the same as what is required by supermarket workers.”

Employers are also required to review a risk assessment already in place if there is any reason to suspect it is no longer valid or there has been a significant change.

If an employer was being investigated, lawyers would look at workplace documentation and witness testimony or – in more serious cases – the Health and Safety Executive may carry out an investigation.

In cases where an employee has died as a result, the coroner may call an inquest or investigation to consider the facts of how an employee came to their death.

Legal experts believe that causation will be harder to prove than a breach for Covid-19 claims. Potential claimants will need to prove that their Covid-19 transmission occurred in the workplace, rather than anywhere else.

But the test to do so is only on the balance of probabilities – 51 per cent likelihood or more – so each case will turn on its own facts.

Claimants would also be required to provide evidence of the illness suffered or the death and any consequent loss or financial expense and apply a legal valuation.

Source: Manchester Evening News

How does global talent mobility function during a pandemic?

How does global talent mobility function during a pandemic?

The COVID-19 pandemic has grounded even the most mobile talent. Where do we go from here?

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Topia delivers the world’s leading Global Talent Mobility platform which enables organizations to mobilize thousands of employees around the world. The COVID-19 pandemic has grounded even the most mobile talent. Where do we go from here?

Paradoxically, over the last few weeks, Topia has been at the forefront of actively curtailing the movement of people. We’re helping customers cancel their planned assignments. We’ve mandated work from home for our employees. No travel. No large gatherings. All in support of curtailing the spread of this deadly virus. 

As a company that thrives on the free movement of talent — and particularly since we just acquired a business travel compliance company — you’re probably wondering- what were you thinking? Granted the timing may not be ideal, but it doesn’t change the fact that companies have and will continue to benefit from global talent mobility. 

We all feel the pain of a temporary setback on the global economy.  However, we see this pandemic as an affirmation of the need for great technology to help manage and support global employees and ensure their health and safety. 

To put it simply: the harder the times, the more critical it is to know where your people are, where they are planning to be, and how you can most efficiently get them where they need to be.

Events like Brexit, the 2017 Trump travel ban, the European refugee crisis, the 2020 Coronavirus outbreak, all show us that many circumstances can cause someone to wake up in the morning and not know where they even can travel to. In a globally interconnected world – where health situations, border regimes, and flight schedules are changing by the hour – you need accurate data and technological help to make the right decisions to keep your people safe and productive.

Especially in a rapidly evolving situation like the COVID-19 pandemic, there is news every day about different restrictions on the movement of people. That’s where the right technology can help you understand where you can go, what kind of documentation you may need to file for, and will this have a tax implication on you or your employees. 

Topia’s Global Talent Mobility platform serves some of the largest enterprises on the planet, with hundreds of thousands of employees scattered in dozens of countries. Let me share three recent anecdotes we’ve heard over the past few weeks, as customers are faced with COVID-19, and how data and technology can help them address these issues proactively.

1. What we heard:

“We allowed some ex-pats to return to their home country before the travel bans, while technically keeping them ‘on assignment.’ So we now need to keep track of how long they are going to be in the home country to make sure there is no impact on tax residency or other compliance issues.”

How technology can help: Customers are leveraging Topia’s platform to create a new profile to track those employees working remotely while on assignment. Having a row on an Excel sheet saying, “Mary is on an assignment in Argentina for nine months” is not enough. To stay compliant, you need an accurate yet privacy-preserving trail of their actual physical location during this time.

2. What we heard:

“We have a lot of mobility-related issues currently because of travel bans & quarantines. e.g., people from Korea can’t be moved to Israel, so they have to be quarantined elsewhere.”

How technology can help: The more volatile the situation around the world, the more dynamic your employee mobility needs to be. You might have started with a plan to send key people to a sales office, factory, or onsite for a customer project. But now you’re faced with needing to sort out how to keep your people safe in a location you don’t know much about. Tools like Topia Go allow customers to provide location information to employees instantly, and business travel solutions that are kept up to date on current travel restrictions can inform organizations through which routes they can mobilize people. 

3. What we heard:

“I am reading the news and following the John Hopkins COVID-19 dashboard, trying to see changes in specific new outbreaks where we might have assignees. It takes a lot of manual effort.”

How technology can help: If you have accurate data about your employees already stored in a modern, data-driven technology platform, it’s possible to layer in COVID-19 outbreak incidents on the same map to spot risky overlaps between emerging problems and your mobile employees. Here’s what that looks like for one of our customers:

We live in a global economy, and no matter how difficult the short-term impacts of COVID-19, that isn’t going to change long-term. Business continues around the world, even at the worst moments in time: European consumers are using an American video calling tool over the internet while working from home. Italians are welcoming a shipment of face masks from China. Food and toilet paper is being trucked to stores with empty shelves.

And gradually international borders will reopen and people will once again be back on planes, and life as we know it will be back to some new kind of “normal” level. It will be different in many ways, but businesses will once again look to global economies for hiring key skill sets, provide international experience to retain top talent, and move people around the world to take advantage of business opportunities and gain competitive advantage.

What is inevitably changing is the “how” of it all. Data and technology will help us better track, report, and respond more quickly to evolving global threats.

Those that embrace the right technology sooner will be the ones best positioned for success.

Source: HR Grapevine

COVID-19’s Market Impact Will be Transient for Life Sciences

As the COVID-19 outbreak has halted the world, we are witnessing the life sciences industry come together and aggressively react to one of the gravest threats of our lifetime.

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The stock market’s reaction to the outbreak has been unprecedented with daily 1,000 point moves in the Dow Jones Industrial Average (DJIA) becoming standard fare, and market volatility levels not seen since the height of the global financial crisis in late 2008.

Regardless of current uncertainties, it is clear that COVID-19’s long-term market impact on the life science sector will be transient, as the industry remains on the forefront of value creation. Along with addressing a growing aging population, life sciences companies’ innovations remain key in driving future global economic growth.

In fact, when overall markets plunged last month when the severity of the pandemic in the U.S. became clear, biopharma equities began to regain some of their valuation that was lost during the first days of the outbreak; an early indication of the industry’s strength. Regeneron saw its shares jump 10 percent throughout the month of March, a time where the company, along with multiple other multinational peers, worked vigorously to bring the world’s first COVID-19 treatments to fruition. As clinical trials, such as Gilead’s Remdesivir, quickly progress with nods of promising data, investors are already beginning to see the value in these investments when compared to the industry at-large. The DJIA has lost 17 percent of its value for the year, while various Life Science indexes are only down anywhere from 2 – 6 percent for the year.

While a plethora of uncertainty regarding near-term market performance remains, there will be strong demand and robust appetite for life science investments in the coming months, as markets continue to stabilize and the world begins to move forward. Scientific innovation and investment into next-generation medicines has never been more appreciated than now, and investors are seeing the first-hand value of developing life-saving therapies. COVID-19 has shined a light on how the life sciences industry protects the world by creating a better and safer place for all.

Rise of Impact Investing

The investment community has been galvanized by impact investing in recent years. Prior to the COVID-19 outbreak, impact investing has soared, as sustainable funds raised $20.6 billion in new capital last year, which was nearly four times larger than the prior year. Combined with increasing measures to create value for all stakeholders, life sciences companies are well positioned to benefit from this investment approach. By increasing the standards of patient care, seeking higher inclusivity thresholds for trials, supporting ethical supply chains and integrating cutting-edge data analysis into tracking metrics, life sciences companies are advancing these measures to drive greater impact, as well as returns for all stakeholders.

Advancements in medical devices and oncology will remain at the forefront of the life science impact thesis. Artificial intelligence (AI) integration and technological developments continue to propel the world into a new age of innovation, and as a result, companies are producing products that are smarter, faster and better than ever, without being so invasive to the patient. Oncology has consistently been considered an attractive investment, due to the impact of what the bioscience promises. The oncology industry has gone through several decades of learning, discovering and developing cancer therapies and is now entering into the phase of consequential improvement. Finding better ways to overcome adversities, such as platinum resistance, is good for the patient, and good for business.   

Robust Appetite for M&A Activity to Come

There will be strong opportunities on the backside of the COVID-19 crisis for companies with solid foundations. Large companies with good balance sheets will see the need for investing in opportunities to drive the demand for quality therapies, piggybacking off of a year of a significant increase in the amount of megamergers executed.

As a result, robust appetite for continued M&A activity is expected. Companies in seed rounds should be able to weather this economic storm, especially if they fundraised in 2019. For those who have recently fundraised, there is clear data that’s attractive to investors, and as the outbreak has indicated, that value will not change.

Over the past year, life science M&A activity totaled a historic $357 billion (as of Nov., 2019). It’s expected that the trend in megamergers and high-valued deals will continue, as companies look to optimize portfolios to further home in on specific therapeutic areas, increase near-term revenue and seek additional access to innovative resources. These fundamentals do not change in a post-pandemic world.

During a time where deal flow is stagnant as a result of rock-bottom market declines, biopharmaceutical companies generated over $16 billion in public and private transactions throughout the first fiscal quarter of this year. This was nearly a decade-high for the industry, with only the first quarter of 2018 raising more capital.

The ability to withstand these historic market pressures has only further propelled the industry’s value, which was already indicating encouraging projections. Over the past year, the number of drugs in the pharma pipeline grew by 6 percent, and industry R&D spend is forecasted to grow at a compounded annual growth rate of 3 percent over the next five years. Recently, two of the sector’s largest venture capital firms announced plans to invest a combined $2.5 billion in biotech companies, a testament to the value of the industry and a commitment to its future. These investments will help develop early-stage assets, as well as advance technological developments including machine learning and health security. It’s impossible to drive these innovations forward, and realize the future therapeutic benefit, without proper investment today.

The industry will remain on the forefront of finding, funding and developing the proper therapies and tools to not only fight COVID-19, but continue creating life-changing innovations day-after-day. The pandemic has further underscored this notion, as the industry has been collectively working at an unprecedented scale to discover new treatments and accelerate the clearance and delivery of existing therapies.

Source: Life Science Leader

UK life sciences industry sees ‘unprecedented’ growth

Life sciences

Life science incubator BioCity, has released its biennial publication, the UK Life Science Start-Up Report, documenting an unprecedented period of growth for life sciences across the UK.

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The report has collected, analysed and interpreted data for nearly a decade and a half.

This is thanks in part to a change in the funding landscape, expressed in a four-fold increase to £2.8 billion of investment in early-stage ventures, compared to the previous five-year period.

Authored by BioCity chairman and former CEO, Dr Glenn Crocker MBE, the report looks at the prevalence of life science start-ups in the UK over the past five years and the broader landscape in which they operate to also asses the quality of UK life science start-ups. By analysing the number of start-ups by region, area of scientific focus, funding, investment and university association, the report creates a broad picture of the current health and future of, the industry.

Multiple factors are highlighted as driving expansion, but of greatest impact was the emergence of a number of significant venture funds able and willing to make very large investments in early-stage businesses.

Also identified as a contributing factor is the increasing use of smaller companies and academia as sources of innovation by large pharmaceuticals aiming to counteract falling R&D productivity. The report documents a rise in the number of global players establishing or sponsoring accelerators and incubators and making investments through their corporate venturing arms.

Simultaneously, universities such as Bristol, Newcastle and Aberdeen introduced a gear change in spin-out formation, while a supportive local public sector reinforced the growth.

Dr Glenn Crocker said: “Both the number of companies starting up and the amount invested in them has taken off. We have seen a 50% increase in the number of companies and a four-fold increase in investment going into them; this will likely result in a substantial increase in the demand for space. We estimate that this cohort of businesses alone could require 1.4 million sq ft of specialist facilities over the next five years. One consequence of this demand growth is that real estate investors are being increasingly attracted to the sector.”

The findings of the BioCity UK Life Science Start-Up Report will be discussed in full by Dr Crocker during a key-note speech to an invited audience of industry figures at a launch event at MediCity Nottingham on Tuesday 26 November 2019.

Source: European Pharmaceutical Manufacturer

3D visualisation tech launched for UK cancer patients

The Mixed Reality Viewer allows clinicians and patients to see, interpret and interact with a patient’s medical data in realistic 3D visualisations. Credit: Shutterstock

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genesiscare brainlab vr

GenesisCare has launched the Brainlab Mixed Reality Viewer at its Oxford centre for diagnostics, oncology and wellbeing, offering cancer patients a novel way to visualise their treatment.

The technology is being rolled out as part of a £20m investment from GenesisCare, alongside a number of other state-of-the-art cancer treatments, including stereotactic radiosurgery (SRS).

The Mixed Reality Viewer allows clinicians and patients to see, interpret and interact with a patient’s medical data in realistic 3D visualisations, as if they were objects in the real world. The technology is intended to allow patients to be more involved in their care and better understand the impact of their cancer treatment plan.

The viewer also allows groups of clinicians to collaborate on different cases and treatment decisions as a multidisciplinary team, allowing insights to be shared more easily.

GenesisCare consultant neurosurgeon Puneet Plaha said: “The Mixed Reality Viewer is a truly remarkable piece of equipment – freeing patient scans from a 2D screen and bringing them to life in a room for patients to see.

“Ultimately, this allows us to make tailored treatment decisions alongside patients, empowering them in a way which was previously not possible.”

The Mixed Reality Viewer will be used in conjunction with SRS, an advanced radiotherapy technique that precisely delivers multiple beams of radiation to a tumour in one single treatment session. SRS reduces the number of treatments required in comparison with standard radiotherapy and helps to preserve healthy tissue.

Source: Verdict Medical Devices

UK life sciences regulation begins to diverge – the Medicines and Medical Devices Bill

As the UK looks forward to its future outside the EU, we are gradually seeing more structure and shape begin to emerge.

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An important development for life science businesses is the publication of the Medicines and Medical Devices Bill. As expected, this draft legislation will provide for the UK Government to take over the rulebook for human and veterinary medicines, clinical trials and medical devices after the end of the transition period on 31st December 2020. Currently very closely harmonised at EU level, the legislation is not expected to diverge rapidly from EU law. However, there are clear signals in the Bill and Explanatory Notes that a separate approach is likely to evolve.

Legislation in this area has previously been updated at EU level, with the changes flowing through into UK law. The Medicines and Medical Devices Bill will allow the Health Secretary to take over that task.

Human medicines regulation, clinical trials and medical devices

The Bill proposes to give broad powers to the Health Secretary (or Northern Ireland Department of Health) to make regulations amending or supplementing the law relating to human medicines and clinical trials. This allows for a wide range of possible changes. When the Bill was foreshadowed in the new UK Government’s Queen’s Speech, the stated aim was to

“ensure that our NHS and patients can have faster access to innovative medicines, while supporting the growth of our domestic sector.”

References in the Queen’s Speech briefing to policy aims such as:

  • “Removing unnecessary bureaucracy for the lowest risk clinical trials, to encourage rapid introduction of new medicines” and
  • “Enabling our regulators… to develop innovative regulatory approaches to respond quickly to developments such as artificial intelligence in treatments and ensure the UK can break new ground in complex clinical trials”

are not played out in full in the Bill, but actions to implement these would be enabled by the extensive powers it gives to the Health Secretary.

The Bill mentions the possibility of changes to reflect the new EU Clinical Trials Regulation. Although that legislation is already in force, its application is currently suspended pending full rollout of the EU clinical trials portal and database. On current timetable estimates, the new EU clinical trials system will not be introduced before the end of the Brexit transition period and so will be too late for automatic inclusion in UK law. (The latest EMA website update indicates that the audit of the Clinical Trials Information System will begin in December 2020, while the Brexit transition period is due to end that same month.)

The Bill proposes similar powers to amend or supplement the medical devices legislation. Of course, the existing EU directives in this area are due to be replaced by two new Regulations:

 

  • Regulation 2017/745 on medical devices (applicable from 26 May 2020)
  • Regulation 2017/746 on in vitro diagnostic medical devices (applicable from 26 May 2022)

The second of these is expected to apply after the end of the transition period, and so will not be automatically included in UK law. The Bill’s Explanatory Notes state that the UK will need to make its own decisions about the future regulation of IVDs, raising the prospect of a divergent approach.

Note that, any regulations made under this Bill must take account of the following factors:

  • the safety of human medicines/medical devices
  • the availability of human medicines/medical devices
  • the attractiveness of the UK as a place in which to conduct clinical trials, supply human medicines or develop or supply medical devices

The third of these is an interesting addition to the usual policy considerations in this area, and reflects the UK Government’s current approach to the future relationship. A prior consultation process is also required so that those affected will have an opportunity to comment.

Medical devices enforcement

The Bill includes extensive provisions on enforcement of the medical devices regime. The intention here is to bring together in one place enforcement rules affecting medical devices – they are currently scattered across several different pieces of legislation. The Bill proposes a scheme of enforcement notices: compliance notices, suspension notices, safety notices and information notices, with a specific criminal offence for breach of these enforcement notices. A due diligence defence may be available for those accused of an offence.

The Bill also provides for a method for affected individuals to bring civil proceedings if they are affected by a breach of medical devices legislation. This raises the prospect of a clear path to damages claims, without resorting to general product safety legislation.

Watch this space

The Government’s powerful position in Parliament suggests that the Bill will become law with few changes. The next stage will be tracking, and where necessary intervening, as the Health Secretary begins to make of the powers it confers.

Source:Mills & Reeve

By Isabel Teare

 

Drug-device combinations under the new EU medical devices regime

Many healthcare products are sold as a combination of medicine with a medical device. Examples include drug-eluting cardiac stents and pre-filled injector pens.

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Products like these offer safety and convenience benefits for the clinician and the patient, but they often involve additional regulatory hurdles for producers. Because medicines and medical devices are regulated separately under different laws and through separate bodies and procedures, it can be difficult for manufacturers to understand how to navigate the path to market efficiently.

EU law reforms on the regulation of medical devices are due to take effect in May 2020. Among the changes is a new requirement for Notified Body involvement where a combination of products falls within the regulatory system for medicines. Applicants for marketing authorisation will have to include details of the conformity assessment carried out in relation to the device element when preparing a marketing authorisation dossier for the combination product. More information on this can be found in a Q&A document issued jointly by the EMA and CMDh, available here.

In order to help applicants understand the new system, the EMA is currently consulting on detailed guidance for producers of drug-device combinations. These are intended to assist those filing a marketing authorisation application once the new medical devices regime takes effect.

Products classed as “drug-device combinations” include:

  • devices which are integral to the medicinal product (pre-filled syringes, pens and injectors, drug-releasing intrauterine devices and dry powder inhalers, etc).
  • non-integral devices, where a specific device is co-packaged with the medicinal product or referred to in the product information (oral administration devices, injection needles, pumps, nebulisers, etc).

The draft guidelines envisage the inclusion within the marketing authorisation dossier for an integral DDC of evidence that the device element of the combination meets the relevant safety and performance requirements (GSPRs). Depending on the type of device, this may be the manufacturer’s declaration of conformity, or a certificate issued by a notified body. Where these are not available, the applicant will need to provide other evidence that the device element meets the GSPRs.

The guidance explains

“The core precept of this guideline is that the Competent Authority for the regulation of medicines (CA) will evaluate the device specific aspects of safety and performance relevant to the quality, safety and efficacy of the medicinal product, and that, as applicable, the NB will assess the relevant GSPRs.”

Note that Advanced Therapy Medicinal Products involving genes, cells or tissues are not covered. A separate set of rules cover ATMPs and these include situations where a device forms part of the active substance or formulation of an ATMP.

Source: Life Science Law

By Isabel Teare, Senior Legal Adviser

The Global Regulatory And Quality Environment For Biopharma Outsourcing

The topic of rising healthcare costs isn’t just a first-world issue anymore. Global healthcare expenditures are rising, and spending is increasing at an annual rate of 5.4 per cent between 2017-2022, from $7.724 trillion to $10.059 trillion, according to Deloitte’s 2019 Global Healthcare Outlook. 

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The global drug market will continue to grow, driven in part by double-digit economic growth in India and China and by downward pricing pressures in the U.S. The new regulatory frameworks now deployed in China are fueling growth in the Asia Pacific.

While the U.S. and Western Europe still make up more than half of the global market, China has replaced Western Europe as the second-largest marketplace. Harmonization of standards is inevitable as the socioeconomic statuses of these markets converge. Therefore, it is critical that organizations looking to engage an external contract service provider be aware of these newly established regulations to align their programs with the latest expectations for each relevant market. Let’s examine these in detail.

EUROPEAN UNION

The EU is undergoing major changes in the pharma, clinical data, and medical device arenas (Figure 1).

Several new regulations are worth noting:

Identification of Medicinal Products (IDMP): Data Standards

The European Medicines Agency (EMA) is implementing the ISO IDMP standards for the identification of medicinal products in a phased program, based on the four domains of master data in pharmaceutical regulatory processes: substance, product, organization, and referential (SPOR) data. Under the IDMP standards, pharmaceutical companies will be required to electronically submit detailed product data and maintain it on an ongoing basis.

The goals of this new standard are to:

  • help facilitate the creation of global drug dictionaries and product dossiers
  • link product and safety information across global regulatory agencies
  • increase the industry’s signal detection capabilities to quickly identify product risks and issues, including coordinating product, recalls
  • connect critical product information within healthcare systems

The new framework consists of five ISO standards, shown in Figure 2. Becoming IDMP-compliant will drive pharmaceutical companies and full-service contract service providers to make significant changes to current product-related processes and systems, in a new era of cross-functional collaboration that paves the way for transformational benefits that extend beyond compliance.

CMOS NEED TO UNDERSTAND:

  • evolving regulations, implementation guidelines, and iterations
  • the compliance timeline and consequences of not meeting regulations
  • the IDMP data model and where data resides in the organization

Medical Device Regulation (MDR)

In June 2016, the European Parliament and the Council of the European Union adopted the far-reaching EU Medical Device Regulation following calls for greater control and stringent monitoring of medical devices, triggered by the Poly Implant Prothèse (PIP) breast implant scandal, a widespread hip replacement recall, and other incidents that revealed the system’s regulatory weaknesses. This regulation goes into effect in May 2020 and will transform both the medical device classification and the approval process. The MDR regulation will supersede all prior device approvals within the EU, with no grandfather clause for the former regulation. Compliance for reclassified devices must be in place by May 2020, or the product must be withdrawn from the market.

Key changes within this new regulation involve:

  • Scrutiny process: The European Commission (EC) will be able to review recommendations for Conformité Européenne (French) (CE) marking prior to approval.
  • Common technical specifications (CTS): The EC’s ability to create common technical specifications will be expanded to all devices.
  • New rules for notified bodies: Only newly created special notified bodies will be able to issue CE certificates for high-risk devices such as implants.
  • Audits for notified bodies: Notified bodies will be audited for compliance with the new regulations jointly by two competent authorities (i.e., the regulatory body for each member state). Also, manufacturers will be subject to unannounced audits by notified bodies.
  • Reclassification of medical devices: Spinal implants, devices that control and monitor active implants, nanomaterials, apheresis machines, and combination products will be reclassified as Class III devices requiring design dossiers.
  • Identification and traceability of devices: A unique device identification (UDI) system will be required for labelling, and the European Databank on Medical Devices (EUDAMED) will be expanded. Manufacturers will need to provide a summary of safety and clinical performance for Class III devices and also for implants of lower classification.
  • Clinical evaluation and investigations: The new MDR regulation will put in place a regimen for clinical investigations with mandatory post-market and clinical follow-up (PMCF) and periodic safety update reports.
  • Post-market surveillance (PMS), vigilance, and market surveillance: Under the regulation, PMS and vigilance requirements will be revisited, and manufacturers will consequently need to amend their procedures.
  • Change in the format of technical files: Formatting declarations of conformity and technical files is revised under the new regulation. This requires manufacturers to create a summary document for each section instead of providing complete protocols and reports.

CHINA NMPA

China’s regulatory framework is moving into close alignment with global regulatory practice, and few regulatory bodies have encountered as much change in a short period of time as China’s National Medical Products Administration (NMPA).

As ICH guidelines become China’s standard, China is increasingly willing to accept global clinical data in support of local product registrations, with priority for products that serve Chinese patients’ unmet medical needs.

China has implemented several key changes to accelerate a clinical trial and drug approval timelines.

  • Inclusion of data from clinical trials undertaken outside China. Drug sponsors and CROs that are attentive to the NMPA’s requirements will be well-positioned for access to the Chinese market.
  • Streamlined clinical trial approvals (CTAs). Specifically, the NMPA is allowing clinical trial materials to be tested by the sponsor or a trusted third-party testing lab, rather than having to be tested by a government-accredited testing lab.
  • Lifting of restrictions on the involvement of Chinese sites in multicenter Phase 1 studies. This changes the dynamic when selecting a CMO or CRO for multicenter Phase 1 studies.
  • Fast-track approval for drugs and devices. Specifically, new drugs and devices in development that meet urgent clinical needs in China can be approved for marketing conditions if data from early- or mid-stage trials show promising clinical value. Further, new drugs or devices for rare diseases can be approved for marketing in China if they have been approved for marketing overseas.

What’s more, China’s revised Drug Administration Law (DAL) entered into effect in December 2019. Under the new DAL, the market authorization holder (MAH) system applies equally to imported and domestic drugs, with MAH responsibility for the entire life cycle of a drug. Marketing authorizations can be transferred from one company to another without changing contract manufacturers, subject to NMPA approval. The amended regulation will enable Chinese MAHs to work with overseas CMOs. Likewise, foreign MAHs may choose to work with CMOs in China and restructure their supply chains accordingly.

INDIA

The Indian health ministry announced that certain drugs approved for use in major markets (such as the EU and the U.S.) will be automatically approved in India without a further native clinical trial having to take place, to give patients faster access to new medicines. The Ministry of Health & Family Welfare (MHFW) announced the new Drugs and Clinical Trials Rules 2019 in March 2019, to improve the ethical and quality standards of clinical trials in India. New guidance consists of 13 chapters (including 107 rules) and eight schedules that apply to all new drugs, as well as investigational new drugs for human use, clinical trials, bioequivalence and bioavailability studies, and ethics committees.

The new clinical trial rules include:

  • approval for clinical trials in 30 working days for indigenous drugs to speed up the trial process and encourage local drug development
  • provision for accelerated product approval, with some conditions, adding pre- and post-submission meetings with authorities to increase regulatory engagement.

The new framework is designed to stimulate the local clinical research industry, allowing more global clinical studies in India and promoting Indian indigenous drug development. These comprehensive new rules should improve the ethical and quality standards of clinical trials in India, aiding patients and industry.

The one constant we can count on changes. It has taken time, but the regulatory philosophies of the major markets are converging, creating avenues that accelerate access to new drug therapies while providing a solid, structured framework for clinical trial and regulatory oversight. Drug sponsors pursuing an outsourcing strategy will have to make sure the necessary processes and systems are in place — both internally and with their contract service providers — to ensure compliance in a new decade of modernized market regulatory expectations.

BIKASH CHATTERJEE is president and chief science officer for Pharmatech Associates. He has over 30 years’ experience in the design and development of pharmaceutical, biotech, medical device, and IVD products.

Source: Life Science Leader

By Bikash Chatterjee.

Scientists to improve heart attack treatment by blocking heart damaging molecules

Scientists in Cambridge are to investigate how the treatment of heart attacks could be improved. 

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In the UK, most heart attacks are treated with an angioplasty – a procedure to quickly unblocked the coronary artery. 

This has helped to improve the survival of patients who experience a heart attack. However, the sudden restoration of blood flow to the heart – called reperfusion – can damage it. 

When fresh blood re-enters the heart tissue it produces a burst of damaging molecules called free radicals. These can permanently damage the heart, leading to a weakening of the heart muscle and, ultimately, to heart failure. 

Now, Dr Thomas Krieg and his team at the University of Cambridge have been awarded £349,477 by the BHF to see if the release of these damaging molecules can be blocked using a drug they have developed. 

Previous research by Dr Krieg discovered how the free radicals are produced, enabling them to design new and simple drugs to stop their production and release. If this was to prove successful, it could reduce the risk of heart attack survivors developing heart failure. 

Improving treatment

Dr Thomas Krieg said: “Angioplasty is a life-saving treatment, so it is deeply frustrating for doctors that we do not yet have a therapy that can stop the heart being injured by reperfusion. 

“Having identified how these damaging molecules are produced, we now want to explore the underlying mechanisms and develop new types of drugs further to see if they will also work in patients and improve their long-term survival. 

“In addition, as similar types of injury occur during stroke, operations or organ transplantation these new types of drugs could be used as a treatment in many other important medical situations.”

Heart attacks are caused when the flow of blood to part of the heart is stopped. This block in the oxygen and nutrient supply causes cells in the heart to die.

In the UK, over 100,000 angioplasty procedures are carried out each year. During the procedure, a special kind of balloon is gently inflated to stretch the narrowed or blocked coronary artery. Many people also have a stainless steel mesh called a stent positioned within the artery which allows blood to flow normally again.

Simple solution

Our Research Adviser, Dr Tian Yu, said: “If this project is successful, it would point towards a relatively simple solution to a decades old problem. One that could improve the lives of tens of thousands of heat attack survivors each year. 

“Worryingly, the ability of the BHF to fund crucial projects like this is under threat. Coronavirus had had a devastating impact on our fundraising. That’s why – together with other medical research charities – we are calling on the Government to commit to a Life Sciences Charity Partnership Fund. 

“This will ensure that the BHF and other charities can continue to invest in the science that produces the breakthroughs that save and improve lives.”

UK Government launches international trade hub in Scottish capital | Edinburgh biotech set to scale up | Research project boost

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A new trade hub dedicated to helping businesses in Scotland grow internationally has been launched today, providing “much-needed support for thousands of companies in economically challenging times”.

Based in Edinburgh’s Queen Elizabeth House, a UK Government HQ opened last month which will house 3,000 civil servants from multiple departments, it is claimed the UK Department for International Trade’s new Scotland Hub will provide businesses with greatly increased trade support.

Through the trade hub, businesses will be able to utilise the UK Government’s global networks, expertise and influence, as well as a world-leading credit agency, UK Export Finance (UKEF), to grow their overseas trade and build back from the impact of coronavirus, the government said.

Leveraging the strength and reach of the UK Government, the hub will “deliver effective services for people and businesses in Scotland”, it declared.

UK Government Exports Minister, Graham Stuart, met with Scottish businesses and representative organisations, including FSB Scotland, NFU Scotland and the Scottish Council for Development to discuss the support available for companies in the region.

Graham Stuart MP, UK Minister for Exports, said: “One of the UK Government’s key priorities is to champion all four parts of the UK and demonstrate how beneficial a strong Union is for all. This specialist Hub for Scotland will provide businesses with the support and guidance needed to boost their profits and harness their full potential.

“Trade is crucial to the UK’s recovery from coronavirus and will be the foundation of our relationships across the globe after the transition period ends this year. I want to ensure that businesses in Scotland benefit from our new trade deals with the world’s biggest markets, as we remove barriers that they previously faced.”

HeraldScotland:

David Duguid, UK Government Minister for Scotland, said: “This new UK Government Trade Hub in Edinburgh is fantastic news for Scottish businesses. It will help them make the very most of the global trade opportunities once the EU transition period ends.

“I urge Scottish businesses to work with the Trade Hub to expand their export business, especially Scotland’s famous food and drink sector. This is a real boost for Scottish produce. Recovering our economy from coronavirus is a national effort. We are working as one United Kingdom to support businesses in Scotland.

“The Trade Hub will be based in Queen Elizabeth House, the UK Government’s new flagship building in Edinburgh. It is a clear demonstration of our commitment to strengthening the Union and delivering for people in Scotland.”

UKEF has appointed a specialist to focus on renewable exports and to support the energy transition in Scotland, further demonstrating the continued commitment to supporting energy companies across Scotland and helping them succeed abroad.

Having previously worked to strengthen the outreach of UKEF’s regional network of Export Finance Managers, Alistair McMillan takes up this new role.

In Queen Elizabeth House, DIT will be joining the Office of the Secretary of State for Scotland, Office of the Advocate General, HMRC, HM Treasury, Cabinet Office, the Office for Statistics Regulation, the Information Commissioner’s Office, and the Government Actuary’s Department. Additional UK Government departments are expected to confirm occupancy in the coming months.

The UK Government building will be fully occupied as soon as it is safe to do in a COVID-secure way.

Work is also underway to set up a flagship UK Government building in Glasgow.

Edinburgh biotechnology firm IntelliDigest is primed to scale up its efforts in tackling food waste after being supported by Royal Bank of Scotland’s Entrepreneurial Accelerator programme.

Combining the latest developments in biotech, deeptech, agritech and foodtech, the company, which was founded in 2016 by Dr Ifeyinwa Kanu, is pioneering the elimination of food waste through the promotion of a circular economy, by preventing edible food going to waste, and by converting inedible food waste into sustainable chemicals.

These chemicals can then be used for food packaging, cosmetics and growing food.

Royal Bank of Scotland’s 18-month Accelerator programme provides support systems for business owners, allowing them time to focus on developing their company through one-to-ones and networking opportunities.

Through the Accelerator, industry experts worked with IntelliDigest on direction and commercialisation, leading seasoned scientific lawyer Patricia Barclay to take on the role of chairperson with the company.

Set to graduate from the programme in January, Dr Kanu has refocused her efforts on strategic restructuring and positioning the company as the go-to-market brand for addressing the food waste challenge.

IntelliDigest was also financially supported through Royal Bank of Scotland’s “Back Her Business” fund-matching scheme, which provided an additional £10,000 towards funds raised by the company.

Ifeyinwa Kanu, IntelliDigest founder, said: “The Entrepreneur Accelerator has been incredibly useful, giving me the opportunity to network and build lasting relationships with other budding entrepreneurs and experts from world-class organisations.

“The opportunity to spend time focusing on business development has been invaluable, as is the bank’s support in other ways – from funding to signing up to our initiatives.”

Royal Bank of Scotland accelerator manager, Matthew Teague said: “Dr Kanu developed an innovative, sustainable business which drew our attention, but ultimately, her mindset, drive, and enthusiasm were key to her enrolment. It’s been great to see IntelliDigest continue to grow, and I’m looking forward to seeing what’s in store in the years to come.”

A new Scottish research project has been awarded funding from the Royal Society to improve existing technology with benefits for health and safety in industry, healthcare and the COVID-19 pandemic.

University of the West of Scotland’s (UWS) Institute of Thin Films, Sensors and Imaging and Novosound will work together to improve the efficiency of ultrasonic sensors and imaging devices.

Dr Carlos García Nuñez, a lecturer in physics at UWS, has been awarded almost £25,000 in funding through the Royal Society’s Short Industry Fellowship scheme to undertake the project alongside award-winning sensors company Novosound.

The Royal Society Short Industry Fellow García Nuñez said: “The Royal Society’s Short Industry Fellowship brings academia and industry together to improve knowledge and work on solutions to current, real-world problems.

“I am thrilled to have been awarded the Fellowship, and look forward to working with Novosound on this exciting project.”

Novosound Ltd, UWS’s first spin-out company, has rapidly revolutionised ultrasound technology, which has remained largely unchanged for 40 years, by replacing conventional sensor materials with a flexible piezoelectric thin-film material. This has resulted in significant cost reduction and improved flexibility, providing 3D ultrasonic imaging and sensing capabilities for applications in oil and gas, aerospace, energy and many more.

Dr García Nuñez’s research will seek to further improve the capabilities of the device, utilising UWS-patented microwave plasma-assisted sputter