Search here:

The key ingredient in your recruitment

Blogs & News

The accelerating adoption of emerging technology

Read More

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.

Read More

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?

Read More

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.

Read More

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.

Read More

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

Read More

 

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.

Read More

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.

Read More

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. 

Read More

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.

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.

Read More

Can This Biotech Shed New Light on Cancer Immunotherapies?

T cells attacking cancer cells

Read More

Can This Biotech Shed New Light on Cancer Immunotherapies?

5 tips for retaining top talent

5 tips for retaining top talent

Read More

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.

Read More

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

main article image

Read More

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…

Read More

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…

 Read More

…(“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.

Read More

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.

Read More

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”.

Read More

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

 

Contact Us

Company Number: 09017439

Follow, Talk, Share