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Roche’s Tecentriq improves disease-free survival in early lung cancer

Roche’s PD-L1 inhibitor Tecentriq significantly improved disease-free survival (DFS) in patients with resectable, early stage non-small cell lung cancer (NSCLC), according to newly published Phase III data.

 

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The IMpower010 study compared Tecentriq (atezolizumab) with best supportive care (BSC) in Stage II-IIA NSCLC patients.

At the interim analysis, Tecentriq showed a statistically significant improvement in DFS as adjuvant therapy following surgery and chemotherapy in all randomised Stage II-IIA populations with NSCLC.

According to Roche, DFS benefit was particularly noticeable in the PD-L1-positive population.

The study will continue with planned analyses of DFS in the overall intent-to-treat population and of overall survival data, which was immature at the time of the interim analysis.

Tecentriq is already approved in a number of lung cancer indications, including in NSCLC as either a single agent or in combination with targeted therapies and/or chemotherapies.

The checkpoint inhibitor is also approved for the front-line treatment of adults with extensive-stage small cell lung cancer (SCLC) in combination with the chemotherapies carboplatin and etoposide.

“With these landmark results, Tecentriq has become the first cancer immunotherapy to help many people with resectable early lung cancer live longer without their cancer returning,” said Levi Garraway, chief medical officer and head of global product development, Roche.

“We’re excited by the clinical benefit adjuvant Tecentriq may bring to lung cancer patients, particularly in the PD-L1-positive population. We will submit these data to regulatory authorities as soon as possible,” he added.

Proscia and Ibex strike partnership to support prostate cancer detection

Proscia, a provider of digital and computational pathology solutions, and Ibex Medical Analytics, an artificial intelligence (AI)-based cancer diagnostics firm, have entered into a strategic partnership to support pathologists in detecting prostate cancer. 

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Through the collaboration, the partners will advance the use of computationally enabled workflows leveraging AI, to drive accuracy, efficiency, and quality gains in routine diagnostic pathology workflows.  

The standard of care for diagnosing cancer is the pathologist’s assessment of tissue biopsies using the microscope. Diagnosing prostate cancer from a biopsy is challenging given that it requires the pathologist to review a large number of samples to find tumour foci that are often subtle, minute, and dependent on a qualitative grading system to assess disease severity. This review process can lead to an increased utilisation of pathologists, missed diagnoses, reliance on ancillary tests, and reduced confidence in treatment decisions.

Proscia and Ibex have joined forces to deliver a unified software solution that powers AI-enabled workflows for prostate cancer diagnosis, helping laboratories to drive meaningful productivity and quality gains. The joint product integration will bring together Ibex’s Galen Prostate solution with Proscia’s Concentriq image and data management platform, introducing AI-powered triaging, cancer detection, and grading of prostate core needle biopsies into routine workflows. Galen Prostate is already deployed in laboratories worldwide and supports pathologists with real-time quality control by alerting on misdiagnosed and mis-graded cancers. 

Joseph Mossel, CEO and co-founder, Ibex Medical Analytics, said: “As prostate cancer impacts millions of patients each year, and as pathologists face ever-increasing challenges, it is paramount that we empower laboratories with clinical-grade AI solutions that provide accurate, timely diagnosis and ultimately improve patient outcomes. We are excited to partner with Proscia to accelerate development and rollout of end-to-end digital pathology solutions that utilize the full potential of our AI technology.”

Proscia’s Concentriq is used by laboratories and health systems for routine image viewing, management, and analysis and serves as a launchpad for computational applications. The deeply integrated solution will make Galen Prostate available to users of Concentriq, starting with select customers in the United States and Europe. As Concentriq also works with scanners and laboratory information systems (LIS), offering integrations with Philips, Leica, 3DHISTECH, and Hamamatsu, it will incorporate AI insights delivered by Galen Prostate into laboratories’ connected digital ecosystems.  

Dave West, CEO of Proscia, said: “Computational pathology is poised to make the biggest impact on the field since the introduction of the microscope over a century ago. Our partnership with Ibex helps laboratories to capitalise on this promise by seamlessly deploying a solution backed by great science and proven customer success into workflows at scale.”

The future of the UK’s life science industry post COVID-19

From the latest edition of Lifescience Industry magazine.

 

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As 2020 comes to an end, most of us will be glad to see the back of a totally unprecedented year. At the start of 2020, global markets were growing and the investment market in life sciences was in good health. Investors were backing advanced therapeutics (ATMP), precision medicine and diagnostics, digital healthcare and AI. But even at that time, there were warning signs that COVID-19 was approaching.

Health technology companies were needed to respond to the COVID-19 challenge. Manufacturers of products as diverse as masks and gowns, hand sanitiser, in-vitro and point of care diagnostics, ventilators and respiratory products, and digital tracking and monitoring faced unprecedented demand. The urgent need for supplies encouraged numerous companies new to the sector to pivot their production facilities in an attempt to support the NHS. They tried to meet this challenge while keeping their own workforce safe.

Not all health technology companies experienced unprecedented demand. Many PPE, digital, diagnostics and respiratory products were selling stock as fast as they could manufacture, but other companies (those involved in scheduled procedures that were being cancelled and postponed across the country) had to meet a very different challenge, to ensure their businesses would be in good health when the NHS restores normal services.

In September, Lifescience Industry held its first Spotlight event – showcasing how the life science and health technology sector has worked, collaborated and persevered to meet the challenges presented by COVID-19. The national and regional trade associates and networks who make up the partners behind Lifescience Industry led the event. During the early days of the pandemic, these organisations provided vital contact with UK manufacturers through daily liaison with the NHS, UK and devolved governments, in some case through full-time secondment of key staff. Between them, they coordinated thousands of offers of critical PPE, testing and medical technology supplies, and brought together businesses from across the UK to collaborate on the development of new essential products, new supply chains and support for companies who were new to the health technology sector. They provided business support, guidance and grant support, and also delivered events and publications to showcase the remarkable efforts made by UK manufacturers during the pandemic.

The Spotlight event focused on some of the numerous examples of companies which have delivered critical solutions at the pace required. Sensyne Health presented their successful work in app development, allowing patients to self-monitor vital signs; Abingdon Health spoke about their antibody test development and collaboration with other businesses as part of the UK Rapid Test Consortium; Hospital Direct showcased new patient handling solutions, as well as the design and development support they were able to provide for new manufacturers; Inspiration Healthcare Group demonstrated the essential work they have been doing to meet ventilator demand during the pandemic; Somnus Scientific presented their work in novel, real-time blood propofol monitoring during anaesthesia; Indoor Biotechnologies showcased their Innovate UK funded work developing a novel cellular immunity test for COVID-19; Aptus Clinical demonstrated new patient wearables and AI applications for COVID-19 patient management; and XenoGesis presented their personal COVID-19 journey and their efforts to provide business continuity in exceptional times. These examples, along with an NHS presentation from Barts Health NHS Trust, highlighted the diversity of projects and contributions that industry has made and continues to make to meet the challenge.

Looking forward to the post COVID-19 landscape, our partner networks and their members, who make up the UK’s medical technology, diagnostics, pharmaceutical and digital health sectors, have stressed the need to retain and build on the accelerated development and adoption of products and digital solutions seen during the crisis. They see a need to reshore the lost manufacturing capability of critical supplies back to the UK, in order to ensure the continuity of supplies, as well as a need to build in resilience throughout the supply chain of critical supplies and specialist expertise. They are unanimous in believing that the contribution UK manufacturers can make to the continued health of our NHS supply chain needs to be properly recognised as part of the procurement process. Our sector is at a crossroads. The choice: return to pre COVID-19 practices, or grasp the opportunities that now appear far more achievable to accelerate product development, trials and adoption, and to support and nurture a strong, robust, indigenous manufacturing base.

Expert opinion:

Kevin Kiely, CEO of Medilink UK

The resilience of the UK’s life sciences manufacturing and supply chain has been challenged during COVID-19. Governments across the world paused the export of essential products, leaving the UK temporarily without key equipment and parts, as scarce resources were directed to the highest bidder.

As many countries were chasing the same suppliers, the UK needed to exploit its existing manufacturing capabilities to increase its level of self-sufficiency in the production of strategically important products e.g. PPE, ventilators, diagnostic test kits and vaccines. In certain instances, this required manufacturing companies in other sectors to repurpose their production almost overnight.   

Put simply, the UK was too reliant on a globalised supply chain, which hampered our response. To learn from this experience, we need to better understand our manufacturing and supply chain capabilities, identify potential risks and vulnerabilities, and use these insights to inform decision making and optimise future investment in UK manufacturing.  

Nick Rodgers, Chair of SEHTA

The extraordinary period since March 2020 has shown that we can reset the way we use technology in health and social care settings. We have seen what’s possible with the clever use of new technology, deployed at speed and sometimes at scale. I hope that this reset is a permanent change for the better and that, moving forward, the NHS and Social Care will continue to be more open to adopting our members’ new technologies. 

I am concerned that Government and the NHS may treat the last 8 months of rapid technology adoption to be an aberration, and will wish to go back to old and tried ways. But on balance, I think that there are enough good news stories and examples of technology delivering healthcare and cost improvements to show the benefits of technology adoption. So I am optimistic that the new improved practices will continue. As a sector, Medtech must welcome the changes with open arms and we must work with our NHS partners to continue the good work.

Andrew Davies, Digital Health Lead, ABHI

The COVID-19 pandemic has accelerated the use of remote monitoring technologies and online tools to help support patients, whilst freeing-up healthcare capacity.

The use of technology in monitoring patients with long-term conditions has also improved. We have seen the creation and adoption of platforms that support remote video consultations, with multi-disciplinary teams if required, and virtual tools, all linked through to the patient’s record and data. Increasingly sophisticated, these platforms can integrate vital sign monitoring devices and highlight any decline in a patient’s status, enabling clinicians to intervene early and remotely, before a need for admission.

This use of virtual platforms is certainly one that will endure beyond COVID-19. By providing access to care outside of the hospital, and empowering patients to better self-care through access to their own results, the move will lead to fewer unnecessary A&E visits, an improved patient experience and a reduction in the overall cost to the health system.

Cari-Anne Quinn, CEO of Life Sciences Hub Wales

The life sciences sector can take pride in its response to tackling the COVID-19 pandemic. The widespread collaboration, innovative thinking and agility has highlighted the best of what our industry can offer.

While the outbreak has delivered unprecedented challenges, the truth is that our health and social care system faced pressures long before its arrival, and these haven’t gone away. Rising patient numbers, fiscal pressures and the complexities brought by an ageing population. Life science companies will continue to play a crucial role in tackling these issues. Companies who are working hard to develop new technologies that will not only address the problems of today, but also ensure that our health and social care system is better prepared for our future needs. 

The response to COVID-19 has demonstrated that our homegrown businesses, and the multinationals that have joined us, can innovate with agility and pace to provide urgently needed solutions. As well as helping improve the health and wellbeing of people all over the world, their innovations will be key to fuelling our economic recovery and long term sustainability.

Precision Medicine Platform Aims to Advance Cancer Gene Therapies

The platform will help speed the development of cancer gene therapies and accelerate precision medicine in cancer care.

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 – A team from Cleveland Clinic has developed a precision medicine platform designed to accelerate cancer gene therapies and genome-informed drug discovery.

In a study published in Nature Genetics, researchers describe the My Personal Mutanome (MPM) platform. The platform features an interactive database that offers insight into the role of somatic mutations in cancer – acquired mutations that can’t be passed to offspring – and prioritizes mutations that may be responsive to drug therapy.

“Although advances in sequencing technology have bestowed a wealth of cancer genomic data, the capabilities to bridge the translational gap between large-scale genomic studies and clinical decision making were lacking,” said Feixiong Cheng, PhD, assistant staff in the Genomic Medicine Institute, and the study’s lead author.

“MPM is a powerful tool that will aid in the identification of novel functional mutations/genes, drug targets and biomarkers for cancer, thus accelerating the progress towards cancer precision medicine.”

The team used clinical data to integrate nearly 500,000 mutations from over 10,800 tumor exomes – the protein-coding part of the genome – across 33 cancer types into the platform. The team then systematically mapped the mutations to over 94,500 protein-protein interactions (PPIs) and over 311,000 functional protein sites where proteins physically bind with one another. Researchers then incorporated patient survival and drug response data.

The platform analyzes the relationships between genetic mutations, proteins, PPIs, protein functional sites, and drugs to help users easily search for clinically actionable mutations. The MPM database includes three interactive visualization tools that offer two- and three-dimensional views of somatic mutations and their associated survival and drug responses.

According to the researchers, previous studies have linked disease pathogenesis and progression to mutations and variations that disturb the human interactome, the complex network of proteins and PPIs that impact cellular function. Mutations can disrupt the network by directly changing the normal function of a protein, known as nodetic effect, or by altering PPIs, known as edgetic effect.

Additionally, in a separate, previous study, a team of researchers found that somatic mutations were highly enriched where PPIs occurred. The group also demonstrated that PPI-perturbing mutations were significantly correlated with drug sensitivity or resistance as well as poor survival rate in cancer patients.

“The results from another study published in Nature Genetics, which was a collaboration between Cleveland Clinic and several other institutions, motivated us to develop the mutanome platform,” said Cheng.

“Our Nature Genetics findings, along with previous research, provide proof-of-concept of both nodetic and edgetic effects of somatic mutations in cancer. What we learned from that study inspired us to develop a systems biology tool that, by mapping mutations to PPI interfaces and protein functional sites and integrating survival and drug response data, identifies cancer-driving and actionable mutations to guide personalized treatment and drug discovery.”

Researchers expect that MPM will lead to a better understanding of mutations at the human interactome network level. This could lead to new insights in cancer genomics and treatments, ultimately achieving the goal of cancer precision medicine.

The team will continue to update MPM annually in order to provide researchers and physicians with the most comprehensive, complete data available. Researchers also plan to apply advanced analytics technologies to their insights to improve treatment development for other conditions.

“Our Nature Genetics study also demonstrates the nodetic and edgetic effects of mutations/variations in other diseases,” said Cheng.

“As a next step, we are developing new artificial intelligence algorithms to translate these genomic medicine findings into human genome-informed drug target identification and precision medicine drug discovery (i.e., protein-protein inhibitors) for other complex diseases, including heart disease and Alzheimer’s disease.”

Boehringer Ingelheim and Enara Bio join forces to discover cancer immunotherapies

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Boehringer Ingelheim has entered a strategic collaboration with UK biotech Enara Bio to research and discover novel targeted cancer immunotherapies.

The agreement will leverage Enara’s Dark Antigen discovery platform to identify and validate novel dark antigens in up to three tumour types across the lung and gastrointestinal cancer areas.

Dark antigens are a new class of cancer-associated antigens that derive from genomic dark matter – the portion of the human genome that is normally not expressed as protein.

In healthy cells, dark antigen-encoding sequences are usually silenced but are activated and presented on tumour cells – they are often associated with specific cancer types and are shared across patients.

Within the collaboration, Boehringer and Enara will aim to discover shared antigens that could lead to the development of vaccines that can be used in a broad group of cancer patients.

Under the terms of the agreement, Boehringer has the option to license dark antigens discovered and validated by Enara.

In addition, Boehringer will be responsible for all non-clinical and clinical development, as well as commercialisation of associated cancer immunotherapies – including therapeutic vaccines and T cell redirecting biologics.

In return, Enara will be eligible to receive an undisclosed upfront payment, as well as research, preclinical milestone and licensing fees for each tumour type explored as part of the collaboration.

On top of that, Enara could receive over €876m in clinical, regulatory and commercial milestones, in addition to royalties on future product sales.

“We are excited to partner with Enara Bio as part of our mission to bring transformative new treatments to cancer patients,” said Jonathon Sedgwick, senior vice president and global head, Cancer Immunology & Immune Modulation Research, Boehringer Ingelheim.

“Enara Bio’s unique discovery platform offers a novel and highly differentiated approach that will allow us to look beyond the known proteome to identify and characterise Dark Antigens to support the development of T Cell Receptor (TCR)-directed immunotherapies and therapeutic vaccines,” he added.

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

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Why digital healthtech is more important than ever

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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.

Changes in the Life Science Industry 2021

 

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The Life Science Sector

Since the onset of COVID-19 at the beginning of 2020 many global Life Sciences companies have positioned themselves at the forefront of fighting against the virus. With governments looking to recover their failing economies by ways of effective vaccination programs man life science companies and their suppliers have stepped up to help.. Innovation in this industry has always been the  key to success, the presence of COVID-19 and its accompanied accelerated demand for research and product have highlighted the industry’s capabilities in this crucial area. With metrics for new company formations and venture funding at an all-time high level this desire and need for an NGP pipeline remains strong.

As one of the UK’s most valuable sectors, life sciences have an annual turnover of around £73.8 billion, achieving an average gross value added (GVA) per worker of £104k per year, over twice the UK average (UK Life Sciences 2030 Skills Strategy). Researchers are now predicting a greater surge in life sciences impact on the UK economy with an expected £8.5 billion of growth by 2025.

Employment opportunities in Life Sciences

Many of the Global Pharmaceutical companies have reduced their workforces over the years as they have outsourced their R&D departments. This outsourcing of ideation has seen a flood of investment in innovative startups investing billions of pounds of venture capital and private equity. Consequently, employment within this sector has seen an 8% increase over the past 10 years, in some cases seeing internal teams and investing partners more than double. With the world’s top 25 Biopharma and top 30 Med Tech companies having operations in the UK many look to these new companies for their growth. The life sciences sector is currently responsible for 220,000 jobs in the UK alone. Employment opportunities are expected to rise considerably over the next decade, estimating an additional 133,000 jobs through replacement and growth (UK Life Sciences 2030 Skills Strategy). This rapid growth in employment is reigniting the demand for more life science talent (Life Sciences Industry Outlook, 2020).

The demand for skilled personnel is a recurring theme within life sciences and the need for dedicated professionals within research bodies continues to rise, particularly within nutraceuticals. Trade bodies have advised the industry that future success relies on a strong and sustainable environment alongside a skilled workforce, particularly when obtaining research and development (R&D) investments. Many executives from high-profile positions have since exited their roles and began start-ups or joined new companies, which has resulted in the spread of high-level expertise and professional leadership throughout the industry

Expectations for the Life Sciences Industry 2021 and beyond

Research and Development

With innovation at the forefront of industry objectives, life changing discoveries have been made in gene and cell therapy, genetic engineering, immunotherapy and precision medicine, moving towards possible cures for, once thought to be, ‘untreatable’ diseases. These developments are largely reliant on research opportunities – a main focus for 2021. With increased funding and speed of FDA drug approvals, the industry hopes to uncover emerging technologies, treatments and drugs over the coming years. Research of immunotherapy, with a focus on immune cell function, proposes to transform cancer treatment. While other developments are aimed at gene technology and gene editing, with the potential to assess and treat hereditary disorders in children. These plans for accelerated research provide hope and optimism for patients now and in the future.

Personalised Medicine

Further developments in research will allow advances to be made in genetically constructed medicines. Taking the lead in shaping the life sciences ecosystem, the use of genetics in medicine is expected to sore over the next decade (The Real Economy Industry Outlook, 2020), moving towards the personlisation of medicines with a $2.4 trillion market value by just 2022. Side effects from inaccurate medicines are responsible for 30% of acute hospital admissions each year. Precision medicines however will allow doctors to select treatments with a more in-depth understanding of the patient and disease in question, giving thought to their genetics throughout a more efficient and individualized approach. Developments in these medicines are particularly crucial in treating neurological diseases, particularly Alzheimer’s and Parkinson’s, both of which hold strong genetic correlations. Investment in this area is expected to see over a 30% increase during the next five years.

Smart Tech Telepractice

The industry has seen a rise in smart tech and the digitalisation of assessment, diagnostic and treatment practices, with the ability to improve the precision of medical prescriptions. These developing technologies support the ever-evolving healthcare landscape, as many doctors and medical professionals are now accredited to continue their practices on a virtual basis, post COVID. While populations around the world live and work through virtual means for the purpose of social distancing, it has since been proven that remote consultations are not only achievable but are often also easier and preferable for both parties. Claims have been made that this is just the start of Telepractice and medicine, with virtual healthcare existing and increasing well after the need for social distancing subsides.

Precision Surgery

Advancements are being made within precision surgery and the use of ‘robots’ for computer-assisted surgeries. Having been created for the purpose of overcoming limitations and enhancing the benefits of minimally invasive surgery (MIS), computer-assisted surgery uses robotic systems to execute surgical procedures, achieving a new level of stability and precision, otherwise unachieved by hand. Popular robotic procedures include the removal of cancer tissue from sensitive areas of the body and with expansion and use of this equipment expecting to rise significantly over the next decade, the value of robotic surgery is predicted to reach over $12 billion by 2030.

Nanotechnology

Developments in Nanotechnology are achieving advances in drug delivery and increasing the speed of disease diagnosis. With the introduction of a nano-pill camera, doctors can carefully study internal areas of the body and better treat patients as a result, with particular focus on assisting with cancer treatments. Further developments have been made in new nanotech devices including vibrant capsules to kick-start digestion, dose trackers and smart sensors, all providing new insights with increased precision for treatment options. The global nanotech market is expected to exceed $125B by 2024, with further research working on the development of Nanobots, offering magnetic micro-surgery within eyes, blocked arteries, during biopsies and even targeted cancer bots cutting off blood supply to tumors. Such technologies are heading towards more portable and convenient medicines with the power to improve health outcomes on a global scale.

Artificial Intelligence

Artificial Intelligence (AI) and machine learning are being brought to the forefront of advances in healthcare. Despite setbacks of COVID-19, 2020 saw significant developments being implemented into our healthcare like never before. With the ability to achieve enhanced diagnosis and treatments, AI and machine learning are breaking through barriers to achieve previously impossible results. AI will be seen to overcome healthcare obstacles throughout 2021 and beyond, with particular success in optimizing triage practices and supporting oncology. More precision in diagnosing and assessing cancer patients, means a more tailored and appropriate action plan for their treatment.

Company Collaborations

Seen more recently within the industry, a willingness to share expertise, data and technology between life science companies can enhance and speed up the discovery of innovative new treatments, technologies and best practices. Collaboration in this industry existed prior to COVID-19, with pharmaceutical companies having partnered up with universities for years on research projects. The presence of the virus however has reminded the industry of what can be achieved through this careful teamwork. A recent partnership saw Ori Biotech and Achilles Therapeutics develop the efficiency of their cell therapy manufacturing process and more collaborations of this nature are predicted for 2021, with the hope to spike innovation across the life science sector.

How does Ginger fit in?

Sitting at the heart of life sciences is innovation, research and development, we have placed hundreds of candidates in exciting roles to advance their careers. We understand the skill shortages within the sector and dedicate ourselves to carefully scoping out current and future talent in order to fill these gaps. Through our appreciation of the need for transferable skills and their importance within emerging markets and technologies, we are able to take an open-minded approach to recruiting. Investing significant time into understanding our clients and candidates, we ensure their needs and wants are put first to secure the best fit with every role. We pride ourselves on ensuring candidates are placed into a role that not only supports our clients for success, but also meets our candidates needs as the ideal next step within their career.

Join one of the UK’s most valuable sectors, taking the lead on research and innovation.

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Author: Jenna Nixon

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