Lifescience Industry Magazine Issue 20

DISCOVERING HEALTH TECHNOLOGY

Value vs Cost in the NHS Improving the value of NHS treatments through value-based procurement

Future Watch

Clinical Need

Going Global

People & Places

Regulatory

Money

New technology and innovations

Meeting unmet clinical needs

Cracking international markets

Influential people and places in the industry

Updates and expert advice

Finance and funding news

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Value vs Cost in the NHS Improving the value of NHS treatments through value-based procurement

4-5

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Developing a smart-patch vaccine to measure effectiveness

Clearing the air in operating theatres

Sustainable biomaterial face shield system developed for the NHS

App helps reduce hospital admissions in Midlands

18 42 Lifescience Industry online – visit www.lifescienceindustrynews.com for the latest news

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A message from the editor Welcome to Lifescience Industry magazine This edition begins with a look at valuebased procurement in the NHS, exploring how exactly value can be defined and evidenced.

Future Watch puts a spotlight on new innovations in development, such as a smart-patch vaccine and a trauma procedure tray. The Clinical Need section

includes sustainable PPE made in the UK, enteral access technology to prevent feeding tube misplacement, and a security system that saves time on busy wards.

Going Global features a Midlands company helping with unique clinical trials in the US, while the People and Places section highlights a Welsh company who faced a double

challenge when their factory was flooded just before the UK’s first lockdown.

Finally, the Money section brings attention to life science firms who have recently received significant funding, and Regulatory updates focus on data and IP.

Sophie Davies Editor

Future Watch

Clinical Need

Going Global

Money

11 Hospital Services

16 Creating an effective solution

26 Clinical trial monitoring goes mobile to help

38 Business booms for Welsh

28 Introducing Medilink’s International

39 Cresco celebrates funding wins

Limited partners with Zoom to deliver integrated virtual healthcare platforms

12 Study reveals

positive results for trauma procedure tray

13 Developing a

smart-patch vaccine to measure effectiveness

15 Online programme

to equip healthcare workers for the genomics revolution

to tackle the burden of medical documentation

with COVID-19

Resource Service

17 Clearing the air in operating

Issue 5

theatres

18 Sustainable biomaterial face shield system developed for the NHS

20 Precision medicine biomarkers for early detection of ‘immunofrailty’

22 Innovative medicine management technology releases nursing time for patient care

29 PHARMASEAL’s Engility platform selected

by US medical device company

30 International expansion for 270 Vision

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Jess Fisher Editor

24 Enteral access device says never to ‘never events’

25 Optimising CAR-T and

2012 ISSUE 4

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36 App helps reduce hospital admissions in Midlands

T-cell antibody engagers in haematological and solid tumours

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to market

Published by Teamworks. www.teamworksdesign.com Editor: Sophie Davies, editor@lifescienceindustrynews.com Executive Editor: Gwyn Tudor, gwyn@lifescienceindustrynews.com Advertising Sales: sam@lifescienceindustrynews.com Art direction: Lee Gillum.

Produced by MediWales for Medilink UK 7 Schooner Way, Atlantic Wharf, Cardiff CF10 4DZ Designed by Teamworks Design & Marketing www.lifescienceindustrynews.com Tel: 029 2047 3456 Web: www.mediwales.com Contact: The views expressed in this publication do not necessarily represent the Editor: Jess Fisher opinions of individual partners unless explicitly stated.jess@uklifescienceindustry.com © Teamworks. 2021

Supported by

The views expressed in this publication do not necessarily represent the opinions of individual Medilink UK members unless explicitly stated. © MediWales Ltd. 2012

DISCOVERING HEALTH TECHNOLOGY

Advertising: Charlotte Tyson

www.medilinkuk.com

healthcare firm during pandemic to start 2021

40 Funding to support growth

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41 Cancer diagnostics firm

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Regulatory 42 Data: supporting health and wealth

43 What does the expiry of the

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47 Events Calendar 2021

Value vs Cost in the NHS The unprecedented difficulty that healthcare organisations experienced in maintaining essential equipment supplies during the Covid-19 pandemic instantly shone a spotlight on the value of health technology, as well as the need for agile specialist suppliers with the ability to rapidly adjust to meet this demand.

Gwyn Tudor Lifescience Industry Executive Editor For those of us who are closer to the medical technology sector, the desire to move to more value-based selection of products and suppliers is a mature refrain. Demographic drivers push healthcare costs ever upwards. The World Health Organisation notes that between 2015 and 2050, the proportion of the world’s population over 60 years old will nearly double from 12 per cent to 22 per cent. This will increase demands on healthcare systems. Common conditions in older age include hearing loss, deteriorating eyesight, back and neck pain, osteoarthritis, heart disease, type 2 diabetes, depression and dementia.

Meanwhile obesity, an underlying cause or contributing factor for many diseases, has nearly tripled since 1975. These drivers go some way to explaining why total current healthcare expenditure in the UK accounts for 10 per cent of gross domestic product, compared with just 6.9 per cent in 1997.

Value

4

= Issue 20

Conversely, healthcare also has the ability to drive economic growth. The UK life science sector sector, comprising of medical technology, diagnostics, pharmaceuticals and digital health, generates over £80bn in annual turnover for the UK and employs over a quarter of a million people. The UK has a long-established world-leading role in medical research, and the NHS is a trusted healthcare brand recognised across the globe.

A whole system approach To meet the demands of our changing population, to address the challenge of rising healthcare costs, and to grasp the opportunities presented by new research and technology advances, a whole system approach is needed. Reduction in product costs (which typically represent just 10-15 per cent of procedure costs) will not address the big challenges that society is facing.

Health Outcomes

£

Cost of Delivery

Value-Based Healthcare is defined by the Centre for Evidence-Based Medicine at the University of Oxford as “the equitable, sustainable and transparent use of available resources to achieve better outcomes and experiences for every person”. Value-Based Healthcare addresses the wider definition of value of a procedure, rather than focusing simply on the cost.

Value-Based Procurement An essential part of realising Value-Based Healthcare is Value-Based Procurement. The Value in Health team at NHS Wales defines Value-Based Procurement as “assessing the value and measuring what matters, using outcome divided by cost, and placing clinical and patient reported outcomes at the heart of the procurement decision making process”.

NHS Supply Chain, who manage the sourcing, delivery and supply of healthcare products, services for healthcare organisations across England and Wales, explain that “Value-Based Procurement is an approach that delivers tangible, measurable financial benefit to the health system over and above a reduction in purchase price; and/or a tangible and measurable, improved patient outcome derived through the process of procurement.”

Expressed as an equation, value looks simple to define. The problem, however, is understanding which outcomes are most important to us as a society and how we measure these outcomes.

Also, what costs should be considered – product cost, procedure cost, whole life cost?

And cost to whom – to the patient, to the healthcare provider, or to the economy and society as whole?

Efficiency Savings To take full advantage of a value-based approach, we might factor in efficiency savings like reduced theatre time, length of hospital stay, after care costs, repeat appointments, waiting times and administrative costs, the effects of improved outcomes on repeat appointments and procedures, and ongoing chronic disease management costs. Supplier selection criteria might include engagement with innovation and collaborative R&D projects, or willingness to support clinical trials and evaluations. At a society level, the environmental impact of production, transportation, use and disposal of a product are important. Highlighted by the effects of the Covid-19 pandemic, supply chain resilience may also be an important criteria in procurement choices, favouring closer suppliers who can guarantee reliable supply if transportation links are disrupted.

to the new, disruptive solutions that may deliver the innovative products required.

For purchasers, the challenge is that while price is easy to use as a selection criteria, most of these value-based criteria are difficult to quantify, difficult to rank, and difficult to predict at the beginning of a relationship with a new supplier.

For the manufacturer, the challenge is providing the evidence to meet these criteria. Many medical products won’t generate the returns needed to fund extensive evidence gathering, and often the health economics case is not easy to demonstrate at any cost. Track record, post market data and customer experience are often relied upon, but this route is not open

Bridging the gap between the need for evidence and the challenge in defining what evidence to gather and collecting it at a reasonable cost requires commitment from both sides. Healthcare purchasers need to be clear about value-based selection criteria and they need to reward suppliers who meet these criteria.

Manufacturers need to provide robust evidence that new products and processes will deliver outcomes that address valuebased criteria.

Deciding which outcomes we value most as a society will be a much wider debate, but even small steps towards a more value-based healthcare procurement process should deliver a positive impact on healthcare, society and the economy.

For daily lifescience news visit www.lifescienceindustrynews.com 5

ADVERTORIAL

Protection, clarity, and vision Bollé Safety, world leader in the design and manufacture of protective and sports eyewear, has developed their unique and exclusive PLATINUM® lens coating providing all healthcare professionals with the highest levels of protection, clarity and vision.

For the first time in history, a health crisis has shut down the entire global economy, demonstrating how inseparable healthcare and the economy have become. The COVID-19 pandemic

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keeps making a tremendous impact in healthcare work environments. The need to keep patients from mingling together and a scarcity of PPE have had continued effects on hospital and healthcare business operations throughout the pandemic response.

Wearing full personal protective equipment (PPE) makes it difficult to clearly see and hear patients and the surrounding environment.

This becomes a safety issue when providing care and doing precise work, such as charting or filling medications. Wearing safety eyewear that fogs can lead to disastrous results.

The healthcare industry has one of the highest rates of work-related injuries and illnesses.

Healthcare workers (HCWs) continue to provide care and save lives during the pandemic, despite exhaustion, increased rates of infections, and deaths of patients and loved ones.

Eyewear fogging can be dangerous and even deadly in healthcare environments The current guidance for PPE from WHO has several categories depending on the level of risk. The focus is on contact and droplet precautions to prevent exposure of the nose, eyes and mouth. The required PPE, for example, during hospital care of COVID-19 patients includes gowns, gloves, medical masks, and eye protection. Safety eyewear needs to be relied on to provide protection and ensure safety -- a clear vision field must be maintained at all times.

The fogging effect on eyewear is a result of rising body temperature and environmental factors such as heat and humidity. Glasses can fog while exerting effort, such as turning intubated patients or walking upstairs.

Going from cold to hot environments or vice versa, such as leaving an airconditioned place into summer heat outside (temporary hospitals) or going from winter coldness to a warm place, can completely fog over your vision.

When wearing a mask and eyewear, warm exhaled air from the mouth lands on the cooler lens of the glass and creates the formation of small water droplets. This condensation reduces visual acuity, scatters light, and negatively affects vision.

Researchers interviewed medical staff at a hospital in Wuhan, China, who explained that their goggles fogging was a problem when caring for COVID-19 patients. They noted that fogging can hinder work efficiency and be dangerous.

Fogging is such a challenge for people who wear safety eyewear that manufacturers strive to make advances in anti-fog coatings and lens technologies for improved performance.

Innovative protective coatings for safety eyewear Innovative protective coatings can keep safety eyewear fog-free all day. It is important to ensure that the eyewear is comfortable, and that vision is not impaired.

The unique and exclusive EN166 K and N permanent double sided anti-fog and anti-scratch PLATINUM® coating is available on safety glasses and goggles, including prescription glasses. Bolle Safety is the first company in the world to supply all their prescription lenses with PLATINUM® coating, giving all eyewear a high resistance to scratching, to the most aggressive chemicals and delays the onset of fogging. In all circumstances and at all times, the PLATINUM® lens innovation ensures your eyes improved protection and guarantees greater safety, reliability, and comfort.

Anti-fog coating incorporates hydrophilic materials that absorb moisture and hydrophobic techniques that divert excess moisture to the sides of the lens. Most protective eyewear on the market only protects the inside of the lens against fogging and the outside against scratching but this does not account for all the types of fogging up that can occur. Other technology like the PLATINUM® Coating by Bollé Safety offers more comprehensive

protection from fogging up by applying a scratch-and-fog-resistant coating on both the inside and outside of the lens.

Anti-fog eyewear solutions for hard-working healthcare professionals Medical staff is exceptional for what they do every day to save lives, so they deserve the best and most comfortable protection.

While fogging can have detrimental effects in a healthcare environment, including accidents and injuries, there are now anti-fog innovations that allow clear vision while wearing safety eyewear for long periods of time.

It is Bollé Safety’s shared commitment to provide the highest quality protection for all healthcare professionals. Ultrainnovative, materials, lenses and accessories of the complete Bollé Safety range have a simple goal: to prevent eye injuries, provide maximum comfort to users with design and performance, and reduce cost in use.

Ensuring that PPE eyewear is comfortable and free from fog and scratches allows healthcare workers to continue to do what they do best -- providing essential care.

IMAGES © BOLLE SAFETY - A. CHILDERIC

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MedTech

International EXPO & CONFERENCE

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Friday 8th October 2021

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The SME focused healthcare event for driving collaborations between Academics, Business, Care & Clinicians Devices, Diagnostics, Digital At one EVENT & in one DAY

8

Issue 18

ADVERTORIAL

Changing lives, transforming careers How apprenticeships can help us rebuild

Over the past year, many people have reassessed their life goals, and thought deeply about what really matters to them.

In the UK, it’s inspired a significant rise in applications for healthcare careers.

Employers can now benefit from a larger talent pool through structured education with a strong focus on the skills needed in the workplace.

UCAS reports a 32% rise in applications for nursing courses starting in autumn 2021 compared to 2020. Of those, applications from men are up 40%, with applicants aged 35 and over rising above 10,000 for the first time.

But in a time of economic uncertainty for businesses, what are the best ways to recruit staff?

Apprenticeships: enhance your business For health and social care providers, apprenticeships are a great way to retain and train high-quality staff. They also bring in passionate, committed employees at the beginning of their careers. Training is tailored to the real workplace, and typically takes up one day in five each week. With extensive government support from the Apprenticeships Levy, they could also be a cost-effective option.

Despite common misconceptions about apprenticeships, there’s no upper age limit.

Coventry University apprentices range from 18 to mid-50s, and there’s around a 50/50 split between new employees and workers upskilling from a long-term role.

Range of courses • Eight health and social care programmes available, with four more from September 21 • Nursing, occupational therapy, physiotherapy and more from levels 5 to 7 • 1800 apprentices enrolled this year, working with 550 employers Flexible locations • Campuses in Coventry and Scarborough, with further facilities in London • Hybrid in-workplace training available for many courses • Direct support for apprentices and employers Quality • No.1 for Nursing and Midwifery in the Midlands • No.1 for Social Work in the Midlands • Top ten across the UK for social work, physiotherapy and occupational therapy (Coventry University - Guardian University Guide 2021)

“COVID-19 has not only shown us we need more health and care workers; in addition, we need to be flexible in how we deliver our health education.

I am very proud of how our faculty has responded to the apprenticeship agenda in developing these exciting health and care roles, helping us to attract values-driven individuals into these important professions.”

Lisa Bayliss-Pratt, Pro-Vice-Chancellor Coventry University, Faculty of Health and Life Sciences

Take the next step To find out more about becoming an industry partner or supporting your employees to train with us, get in touch today.

T: 02477 654960 E: apprenticeships@coventry.ac.uk W: www.coventry.ac.uk/apprenticeships

9

Future watch

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Issue 18

Future watch

Hospital Services Limited partners with Zoom to deliver integrated virtual healthcare platforms

Hospital Services Limited (HSL), a specialist distributor of telehealth solutions for hospitals and medical practices across the UK and Ireland, has announced an agreement with Zoom which will allow their customers to deliver integrated virtual care services for clinicians and patients.

T

he agreement will enable provision of seamless, highly secure and user-friendly telehealth services for a wide range of healthcare implementations. HSL is the first healthcare partner with Zoom in the UK and Ireland. This partnership will provide HSL with an option to expand the availability and adoption of virtual consultations through a widely known app, so that the broadest possible range of patients and the general public can access different parts of the healthcare system.

Telehealth solutions have been widely embraced by healthcare providers and patients alike during the pandemic, and this new way of providing and accessing patient care is expected to endure within the local healthcare sector post-pandemic. The team at HSL predicts that within a year, every hospital across the UK and Ireland will be using Zoom in some part of their operations, and the availability of Zoom through a healthcare partner removes the risks of investing in this technology in many more parts of healthcare development and delivery.

“The opportunity to work with Zoom, and to embed their services with the solutions that we have been delivering to healthcare providers across the UK and Ireland, brings together the power and capacity of the world’s largest provider in this space with dedicated specialists, products and services that we at HSL already supply to our customer base. The addition of this service to our growing portfolio of telehealthenabled practices and solutions empowers our customers to deliver integrated virtual health platforms as part of their Covid management plans, in a way that they will remain as part of the health service beyond this pandemic.”

Dominic Walsh CEO, Hospital Services Limited Ron Emerson, Global Healthcare Lead at Zoom Video Communications, added: “We are excited by the prospect of working with

Hospital Services Limited to create more uses for Zoom in healthcare in the UK and Ireland, in ways that will exploit the fantastic capabilities, current and future, that Zoom provides. I know and have worked with the HSL Telehealth team for many years and understand the specialist skills and experience they provide, which can help healthcare providers to embrace and use Zoom to deliver benefit to clinicians and patients alike.”

Sam McMaster, Director of Telehealth for HSL, added: “The option to leverage the Zoom services as part of telehealth applications and virtual healthcare platforms offered by HSL brings a new and dynamic dimension to the market for these services.

Zoom is the app of choice for many people and has been used extensively in medical education for many years. Our ability to provide Zoom as a service for our customers in health and to integrate this with the clinical workflows that drive the health service to deliver secure, private safe virtual consultations will help our customers to transform the health service.” www.hsl.ie

For daily lifescience news visit www.lifescienceindustrynews.com 11

Future watch

Study reveals positive results for trauma procedure tray Uvamed Ltd, manufacturer of the popular Rainbow Trays and Tamper Evident Rainbow Trays for anaesthetic drugs, has won an Innovate UK award to develop the Trauma Tray procedure-pack/crash-box.

T

rauma Trays are secure and auditable complete procedure packs for use away from regular hospital environments such as rescue services, ambulances, field hospitals, care homes and in emergency departments. The secure tray packs will contain all equipment, supplies and, where appropriate, the drugs required to perform procedures in remote locations.

A usability study led by TM-MIC/MD-TEC (Trauma Management MedTech Cooperative / Medical Devices Testing and Evaluation Centre), sought specialist opinion from a select group of healthcare professionals working within the field of anaesthesia, regarding imagined use of the product outside of their typical working environment for RSI (Rapid Sequence Induction) procedures. The study suggested a good level of demand and acceptance for the Trauma Tray concept, yielding many key insights for consideration.

Valuable feedback on the requirements of Trauma Trays for RSI will feed into the R&D for the packs, which are designed for professional use to support human factor principles in reducing cognitive loads during administration. All participants mentioned that the inconsistency of drug availability and equipment between locations was a concern and so the Trauma Tray would be of benefit.

Other healthcare professionals have provided significant and effective feedback into the Trauma Tray design, use, function and suitability, the value of which has been fundamental to creating a product that will address the needs of healthcare professionals in their working environments.

in ambulances, hospitals and communities, especially where surroundings are unfamiliar and communication is restricted.”

Procedures identified that could benefit from a Trauma Tray include routine IV cannulation, arterial/central line insertion, tracheotomy, RSI or basic suturing kits. Potential users include military field/ remote hospital facilities, humanitarian organisations (MSF/Red Cross), ambulance services (NHS and private), emergency departments, care homes for the elderly or vulnerable, and home medication e.g. haemophilia.

State-of-the-art crash carts in ICU and A&E are extensively equipped, but the provision of comparable equipment in remote facilities is both costly and inappropriate. However, it is imperative that relevant and suitable equipment and drugs are made readily available immediately for patients. Trauma Trays will provide curated procedure packs, centrally dispensed and securely sealed with auditable labels, providing a means to get essential and appropriate equipment, supplies and drugs

to patients remotely hospitalised quickly and safely. They will be presented in a manner that promotes ease-of-use, especially when undertaken by professionals working outside of their customary scope of practice.

Funding from the Innovate UK project has allowed Uvamed to develop Trauma Trays to a level where they have two pioneer tray types ready for evaluation by end users. An IV cannulation tray for use in a wide range of applications, and a more complex Central Venous Catheter tray to demonstrate the robustness of the design for both simple and complex procedures. Moving forward, the company plans to design trays for more procedures including RSI and tracheostomy.

The COVID-19 pandemic has evidenced a reliance on medical plastics and the benefits they provide in reducing infection and keeping patients safe. In recognition of this dependency, Uvamed is working within its Innovate UK funded project to establish a safe and commercially viable option for the recycling of medical plastics and packaging, in order to support a positive end-of-life solution.

Bev Fawdington, Director at Uvamed Ltd, said, “The feedback we have received from healthcare professionals will augment the basic principles of the Rainbow Trays, including the Tamper Evident version, to include colour coding, compartmentalisation, order of progression and secure tamper-proofing with chain of custody auditable labelling. Our Trauma Trays aim to support professionals when stressed or fatigued at work, providing comprehensive procedure packs which include all equipment, supplies and drugs for use www. uvamed.net

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Issue 20

Future watch

Developing a smart-patch vaccine to measure effectiveness Researchers at Swansea University are developing the world’s first smart vaccine device that will both deliver the COVID-19 vaccine and measure its efficacy through monitoring the body’s associated response.

T

he research, from the Institute for Innovative Materials, Processing and Numerical Technologies (IMPACT), will produce the vaccine through the use of microneedles to create a smartpatch. This device will simultaneously measure a patient’s inflammatory response to the vaccination by monitoring biomarkers in the skin.

The project will be led by a team of researchers with expertise in the use of microneedle arrays for transdermal therapeutic drug delivery and diagnostic applications. The team will build on these distinct technologies by developing the first dual functionality microneedle-based COVID-19 smart-patch, capable of delivering a vaccine and measuring the immune response in the form of protein biomarkers, thus establishing the efficacy of vaccination.

“The real-time nature of the platform will mean rapid results, allowing faster containment of the COVID-19 virus. This low-cost vaccine administration device will ensure a safe return to work and management of subsequent outbreak waves. Beyond the pandemic, the scope of this work could be expanded to apply to other infectious diseases, as the nature of the platform allows for quick adaptation to different infectious diseases.

Microneedles are tiny needles (their tips are measured in millionths of a metre) designed to break the skin barrier and deliver medicines in a minimally invasive manner. A classic example is the transdermal nicotine patch that delivers nicotine through skin to help people give up smoking.

Dr Sharma, the project lead at Swansea University, explains:“Skin vaccination using microneedles has been described as a superior immunisation approach due to its potential to overcome immune tolerance observed in pregnancy, and lower vaccination costs through antigen dose-sparing, which is especially relevant in underserved countries.

“We are currently getting the platform ready and we hope to do human clinical studies on transdermal delivery with our existing partners at Imperial College London, in preparation for final implementation.”

They provide a safe and effective method to deliver vaccines with added attributes of requiring lower vaccine doses, permitting low-cost manufacturing, and enabling simple distribution and administration. A microneedle delivery patch is easy to apply and minimally invasive, so combined with the proposed measurement capabilities, this new vaccine system would enable a personalised vaccination approach.

“The primary goal of this project is to create a prototype smart vaccine delivery device which can not only deliver the COVID-19 vaccine transdermally, but also monitor biomarkers in the skin compartment in a minimally invasive way, offering real-time information on the efficacy of the vaccination. The new method would change the way in which vaccine efficacy trials are performed from a statistical assessment to a scientific measurement of patient inflammatory response to vaccination.

A team led by Professor Nikolaj Gadegaard at the University of Glasgow’s James Watt School of Engineering has developed an injection-moulding process to enable large-scale production of the microneedle smart patches.

They expect to produce many thousands of patches to help support Dr Sharma’s research and allow the clinical studies to progress.

The project is funded by the Welsh Government Sêr Cymru funding programme. The IMPACT operation is part-funded by the European Regional Development Fund through the Welsh Government and Swansea University.

“Measuring vaccine efficacy is extremely important, as it indicates the protective effects of vaccination on an individual via the level of reduction of infection risk in a vaccinated person relative to that of a susceptible, unvaccinated individual. This measure of vaccination effectiveness will address an unmet clinical need and would provide an innovative approach to vaccine development.”

Dr Sanjiv Sharma Swansea University

www.swansea.ac.uk

For daily lifescience news visit www.lifescienceindustrynews.com 13

Future watch

Online programme to equip healthcare workers for the genomics revolution Medics.Academy has collaborated with Guy’s and St Thomas’ NHS Foundation Trust to launch Nucleus, a new online programme to future proof the medical workforce for the genomics generation.

“We are proud to be collaborating with Guy’s and St Thomas’ NHS Foundation Trust on such an important programme of learning. Nucleus will allow members of all healthcare professions to upskill their knowledge of genomics to directly benefit patients in communities worldwide.”

Dr Emma Cox Chief Product Officer Medics.Academy

T

wo decades on since the human genome was first sequenced, routine integration of genomics is poised to play an integral part in everyday healthcare.

From individualised medicine, to the rapid expansion of translational biomedical research, an understanding of genomics is now an essential piece of any health worker’s armoury.

Nucleus will fulfil an unmet clinical and educational need, bringing the face-to-face training delivered by world-leading experts at Guy’s and St Thomas’ NHS Foundation Trust onto an innovative educational platform. By providing greater accessibility through high quality digital content, the widest possible cohort of health professionals will improve their competencies in the field of genomics.

Healthcare professionals often have varying levels of experience in utilising genomics to guide patient management and interpreting the results of genomic investigations. Nucleus will not only provide a foundation in the biological underpinnings of such analyses, but also cover

the crucial psychosocial skills required to counsel patients for specific tests.

Dr Toby Garrood, Clinical Director for Specialist Ambulatory Services at Guy’s and St Thomas’ NHS Foundation Trust, said: “Rapid advances in technology and understanding mean genomics is more relevant than ever before. As genomics increasingly becomes a part of mainstream NHS care, all healthcare professionals need to have a good understanding of its relevance and potential to impact the diagnosis, treatment and management of people being cared for. At Guy’s and St Thomas’ NHS Foundation Trust, we pride ourselves on being at the forefront of the genomics revolution, as evidenced by our lead role in delivering the 100,000 Genomes Project in South London and our contribution to the ‘Genome UK: the future of healthcare’ 2020 publication setting out the UK strategy for genomics.”

Starting with a focus on cancer genomics, Nucleus provides an interactive, CPD accredited learning platform for forward-thinking professionals. Its virtual nature means it can

rapidly iterate in response to the expanding nature of genomic knowledge, allowing members of the community to tailor their educational needs, learning at their own pace anytime, anywhere.

In the long term, Medics.Academy will also be working with Guy’s and St Thomas’ NHS Foundation Trust to foster a community of healthcare professionals who will become the thought leaders of this genomic generation.

Learners will have access to world-leading experts in genomics at their fingertips, as well as a community of like-minded professionals with which to share best practice, ask questions and continue their professional development.

More than ever, the COVID-19 pandemic has brought the importance of remote learning to the fore, prompting educators to rapidly adapt to the demands of the learner. It has also highlighted the crucial role genomics plays in protecting our society. Novel vaccines have been created from the implementation of mRNA techniques, while rapid surveillance of new viral variants has been made possible by huge sequencing efforts from collaborations like the COVID-19 Genomics UK (COG-UK) Consortium. www.medics.academy

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Issue 20

ADVERTORIAL

New programme to support South West life science start-ups

The Health Tech Hub has launched a new programme to support SMEs in the South West region.

What the programme offers: l Technical support for product development l Technical experts and laboratory facilities l Sector specialist support Support available: l Proof of principle laboratory projects

“The real asset of the Health Tech Hub is the creativity, enthusiasm and knowledge of the staff. The practical support shown at all levels has been second to none. Using the facilities has been very useful in terms of gaining access to professional, state-ofthe-art lab and workshop facilities to conduct initial tests and experiments in a highly sensitive, controlled environment. As a start-up SME with limited capabilities, such resources are invaluable for us to be able conduct high quality and competitive R&D to develop our ideas further.”

Habib Patel, Founder of Fullfat Technologies

l Prototype development l Product testing and validation l Near real-world technology testing l Technical and market reviews Who can apply?

“The Health Tech Hub’s expertise and support helped our design team to improve our enclosure designs. They also facilitated the successful 3D printing of our first prototypes.”

Neciah Dorh, CEO & Co-Founder of FluoretiQ

l Entrepreneurs, founders/managers of newly formed businesses or mature small to medium businesses based in the Heart of the South West region l SMEs who are looking to translate current products or services to the health and life science sector

Apply now: To find out more about the Health Tech Hub – South West Programme, go to www.healthtechhub.co.uk or email julie.maggs@uwe.ac.uk

For daily lifescience news visit www.lifescienceindustrynews.com 15

Clinical Need

Creating an effective solution to tackle the burden of medical documentation Dr Mohamed Alibashe, CEO and Co-Founder of HealthMe Ltd, explains why there is an urgent need to tackle the burden of medical documentation – the leading cause of doctor’s burnout.

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edical documentation is an important part of clinical activity. It plays a critical role in describing and updating a patient case, maintaining their follow-up, evaluating the risks and benefits of the proposed intervention, and documenting the patient consent. The process of medical documentation has been changed by the widespread use of electronic medical record systems (EMRS), bringing a positive impact but also new challenges along with it.

The development of EMRS has helped transition from handwritten notes and prescription to electronic forms. The rationale behind the use of computer-based systems was to provide a better quality of care and to decrease the incidence of medical errors.

Nevertheless, a recent study has shown that the time spent by doctors on the EMRS, doing clerical activities such as documentation, order entry, billing and other administrative tasks, represents almost 50 per cent of their workday.

In this regard, doctors spend more time on the EMRS than with their patients with the latter representing only 28 per cent of their time compared to 44 per cent. Moreover, the time spent on the EMRS is associated with a significant increase in doctor workload, generating dissatisfaction, loss of productivity that can be as high as 50 per cent, and loss of revenue. Increasing use of EMRS, at the expense of the patients, changes

doctor priorities. To avoid overtime, hospital doctors might prioritise clerical activities instead of care delivery.

The development of new technologies such as cloud computing, artificial intelligence (AI) and machine learning (ML) is already disrupting multiple industries. In the healthcare industry, AI is progressively entering the field of biomedical research and diagnostics.

At HealthMe, we are leveraging the power of AI and ML to tackle the burden of medical documentation and provide every doctor with a tool that is reliable, easy to use and secure.

An important consideration when designing our tool was to not create any workload or data overload. The way HealthMe tackles the burden of medical documentation is by automatically generating medical reports for doctors in real time during consultations. Our solution interferes with neither the clinician workflow nor the way the consultation takes place.

HealthMe is on a mission: 1) to provide doctors with a tool that will relieve them from the burden of medical documentation 2) to reconnect doctors with their patients and re-establish the patientdoctor relationship 3) to guarantee the highest security, privacy and confidentiality standards

HealthMe is solving this significant unmet global need and has already partnered with a number of hospitals and clinics.

Properly managing the process of medical documentation reduces the burden on hospital workforces, decreases doctor burnout, increases patient safety, and improves patient care and satisfaction.

We passionately believe that the application of AI can significantly improve the experience of clinicians, the decision-making process, and in our case the process of medical documentation. Our mission is to give back time to doctors and improve the patient-doctor relationship. We want doctors to focus on their patients and enjoy their work.

We also want patients to spend quality time with their doctors, as this is a much needed and critical characteristic of the therapeutic process.

www.healthme.ai

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Issue 20

Clinical Need

Clearing the air in operating theatres

Brandon Medical, a Leeds-based medical equipment designer and manufacturer, offers a new operating theatre ultraclean ventilation system with an added layer of infection control.

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he company’s latest Mediclean Ultra Clean Ventilation (UCV) with Continuous Particle Monitoring (CPM) provides a unique monitoring feature, as well as automatic cleaning of surgical smoke and airborne particles.

Mediclean uses an innovative air curtain technology to constrain the flow of clean air within the clean zone and to separate it from entrainment by the surrounding “dirty air” in the rest of the room. The diffuser surface is completely flush with the suspended ceiling, without any protrusion from the UCV unit into the room. The air curtain eliminates the requirement for side screens and coanda effect air flow deflectors that would normally protrude below the ceiling.

Advantageously, Mediclean does not obstruct the movement and positioning of operating lights, medical pendants or medical imaging equipment. It is easier for designers to create ergonomic equipment

layouts and easier for staff to position equipment during surgery. In addition, damage from collisions with the UCV side screens and air deflectors is eliminated.

The Continuous Particle Monitoring (CPM) system measures airborne particles in realtime and uses simple visual alarms. Clinical staff can “see” when the air isn’t clean due to entrainment or surgical smoke and can take steps to protect themselves and their patients. It is impossible to see clean air with the naked eye, so CPM samples the air to accurately measure the number of particles present during surgery and displays the results as visible signals.

Smoke from electro-surgery is known to be hazardous. It can contain as many as 72 harmful contaminants, including known carcinogens and intact viable DNA. CPM detects harmful particles of smoke as well as dirty air. Mediclean reacts with a visual warning of the risk to the surgical team

and, by increasing the airflow to clear the smoke away from the clean zone, it protects surgeons and staff from inhaling smoke. CPM supplements the annual UCV validation tests done in empty theatres to indicate that the UCV is working efficiently during real live operating conditions.

When particles are detected, the CPM system automatically increases the airflow from the UCV to quickly flush the contamination away from the safety-critical area, for the benefit of both patients and surgical staff.

The system automatically returns to normal operation when safe operating conditions are restored.

www.brandon-medical.com

For daily lifescience news visit www.lifescienceindustrynews.com 17

Clinical Need

Sustainable biomaterial face shield system developed for the NHS

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Issue 20

Clinical Need

A West Midlands manufacturer is leading the field in the development of sustainable high-quality, British-made PPE with Optec – a new biomaterial reusable face shield system designed to help the NHS reach its carbon emission reduction targets.

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t the start of COVID-19, the urgent need for safe and comfortable PPE to protect frontline healthcare workers enabled British manufacturing to demonstrate incredible agility. But it simultaneously raised concerns about the environmental impact of more disposable commodities. In fact, in a recent survey carried out

by Tecman, 90 per cent of the 156 healthcare workers surveyed communicated growing concerns about the environmental impact of PPE. Tecman’s product lines help to address these concerns, due to their compact packaging and innovative processes saving tonnes of waste compared to other products on the market. All of their products are underpinned by their Four Pillars of Comfort, which ensure comfort to the wearer across four key areas – feel, performance, sustainability and cost.

However, Tecman’s latest development goes one step further and tackles sustainability concerns head on. The Optec reusable face shield system from the Leamington-based company uses biomaterials made from sustainably forested trees, manufactured with low carbon footprint processes. This biomaterial reusable design with cleanable screens vastly reduces plastic waste.

With this new, more sustainable protective face shield system, Tecman has responded to the government’s recommendations for reusable PPE and has been developing the eco-friendly face shield alongside the NHS.

Benefits of Tecman’s new biomaterial reusable face shields include: l

Supports NHS targets for carbon reduction

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Reusable biomaterials reduce plastic use and environmental impact of PPE

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Sustainably managed solution reduces pressure on waste management

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Easy to clean whilst minimising bacteria build-up

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New ergonomic design for improved wearer comfort and protection

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Cost-effective with a low price per wear

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Cleanable screens for a more sustainable product

Leading the way in Britishmade PPE Since spring 2020, the Tecman team has been on a mission to make Britishengineered protective visors the number one choice for NHS workers and has been working closely with the NHS ever since.

As part of this drive, the company invested over £500,000 in state-of-the-art machinery which enabled them to boost production of their protective face shields to over 1 million units per week. Their efforts were rewarded when, in June 2020, their original face shield became one of the first to receive the sought-after category III complex design PPE level.

In recognition of the product’s quality and comfort, the company’s face shield is specified by the NHS in its product framework and catalogue, and has already been used by hundreds of thousands of frontline healthcare workers.

Tecman have been running hospital trials for Optec and incorporating wearer feedback on comfort, safety and durability into its final round of improvements, ensuring it is optimised for the best possible wearer experience.

A boost for the UK economy The West Midlands-based company currently exports its protective face shields throughout Europe, and has been working with global organisations such as UNICEF and the World Health Organization (WHO) to ensure production remains at peak levels.

“We’ve worked hard alongside the NHS to develop a more sustainable reusable faceshield system which is competitive on price and quality whilst providing ecological benefits, and we’re delighted with the results. Optec has been well received by the healthcare sector and we’re working closely with the DHSC to ensure it’s fairly considered in their next procurement process. Optec addresses rising concerns about the environmental impact of PPE, provides value to the NHS, and prioritises wearer comfort and the safety of our vital healthcare workers.”

Kevin Porter, Tecman’s Technical Director

www.tecmanuk.com

For daily lifescience news visit www.lifescienceindustrynews.com 19

Clinical Need

Precision medicine biomarkers for early detection of ‘immunofrailty’ Nina Skorytchenko and Dr Daryl Fernandes, CEO and CSO of medtech startup Avenna, discuss a novel approach to prediction of serious inflammatory episodes in inflammatory bowel disease (IBD) and COVID-19 using prodromal glycomics signals from blood immune system glycoproteins.

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OVID-19 and IBD are inflammatory diseases (IDs) that cause considerable sickness and death across the globe. COVID-19 deaths now exceed 2.4 million while diagnosed IBD patients total around 11 million, with both numbers increasing. Neither disease has a cure, nor are there any dependable tests for either condition that allow medics to predict which patients will suffer the worst health outcomes.

Consequently, medical intervention for these IDs is largely reactive, kicking in only after tissue and organ damage has occurred. The illnesses do run with very different timeframes.

COVID-19 is an acute ID that kills within weeks, while IBD is a chronic ID that exerts progressive damage to the gut over many years.

As part of our work on personalised precision medicine for IDs, we have been studying changes in the glycomics patterns of blood immune components in IBD and COVID-19 patients. The results indicate that those affected by either disease share some common underlying aetiological pathways correlating with immune dysfunctions. We call these ‘immunofrailty pathways’ and the resulting degradation of immune fitness ‘immunofrailty’.

We are now exploiting use of blood glycomics patterns as metrics of immunofrailty, with the aim of developing reliable early prognostic and predictive biomarkers for COVID-19 and IBD. The project builds on our Immunofraility Model (IFM). This uses a systems science approach to model the complex and diverse mechanisms of degradation in immune system structure and function in different IDs. IFM considers alterations to: (a) the integrity of skin, mucous membranes of the gut and respiratory systems and vascular endothelium, (b) the occurrence of chronic and acute inflammatory processes, (c) tissue and organ damage, and (d) the glycomics patterns of immune system glycoproteins.

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Issue 20

From this we propose that: (a) immunofraility is highly complex with multiple causal pathways, (b) immunofraility correlates closely with chronic inflammation, (c) chronic inflammation has both systemic and diseasespecific components, (d) both immunofraility and chronic inflammation typically rise in phases throughout progression of IBD and other chronic IDs throughout the life of each individual, and (e) the most vulnerable COVID-19 patients are immunofrail individuals who mount disordered immune responses after SARS-Cov-2 infection due to dysfunctions in their innate and humoral immune systems.

If these are true, then tracking changes in system and disease-specific chronic inflammation processes, particularly at early stages of inflammatory episodes, is key to prognosis and prediction in IBD and COVID-19.

However, current biomarkers of inflammation such as hs-CRP and interleukin-6 cannot measure chronic inflammation because of interference from acute inflammation. This is like trying to measure climate change but failing because the weather gets in the way.

GlyHealth, our family of medical glycomics biomarkers, changes this picture for ID medicine.

The glycomics patterns are prodromal signals which presage the inflammatory storms that lead to morbidity and death in IDs. This means that GlyHealth tests give early warnings of vulnerability to poor health outcomes from inflammatory diseases.

Clinical Need

The technnology is an In-vitro Diagnostic platform designed to reliably measure IF and chronic inflammation in individuals from changes in the glycomics patterns of immune components in their blood. Unlike current inflammation markers, this is done without interference from acute inflammation and seems to work reliably even at very early subclinical stages of IDs. The glycomics patterns we measure are complex, information-rich prodromal signals which presage inflammatory episodes that lead to morbidity and death. This early warning can buy critical time for patients and the medics who care for them. This is seen in GlyHealth-IBD, the most advanced of the GlyHealth variants in our development pipeline.

Avenna has been working in collaboration with its sister company, Ludger, and Translational Gastroenterology Unit (TGU) at the University of Oxford to further develop and commercialise GlyHealth technology. GlyHealth-IBD is a prognostic and predictive biomarker to support clinical decision-making in IBD. This followed our discovery that IBD patients have aberrant blood plasma glycomics patterns that correlate with IBD-specific inflammatory processes. Preliminary studies on over 400 patients showed that GlyHealth-IBD reliably estimated IBD severity, future disease course

Avenna specialises in early detection, prevention and treatment of both chronic IDs and acute IDs. In partnership with sister company Ludger, they are developing glycomic blood biomarkers to enable personalised preventative approach for inflammatory bowel disease and COVID-19. Avenna is looking to collaborate with forward-thinking clinicians and biopharma companies who are working in this field.

and future need for treatment escalation in newly diagnosed IBD patients up to 18 months from testing. The tests were able to predict IBD disease severity with ROC sensitivity and specificity scores in the range 0.88 - 0.92 (a perfect score is 1.0) compared to hsCRP and albumin with a combined score of 0.57 (0.5 is the lowest possible score). The studies and method are described in our paper ‘Serum N-Glycomic Biomarkers Predict Treatment Escalation in Inflammatory Bowel Disease’ submitted to Nature Comms.

GlyHealth-COVID is based on GlyHealth-IBD technology and is being developed to identify immunofrail individuals likely to suffer serious inflammatory episodes if they were to be infected with SARS-Cov-2 virus.

The first phase of this is being funded as part of the UKRI initiative for research addressing COVID-19 with blood samples

from individuals from the UK, Europe and the US. These include patients who have suffered COVID-19 as well as various types of control groups. The preliminary results look interesting.

However, the data is very complex and we must do much more work before we can make sense of the relationships between all the variables which include age, sex, ethnicity, blood glycomics patterns before, during and SARSCov-2 infection, health outcomes from COVID-19, known pre-existing chronic diseases and preexisting sub-clinical chronic conditions.

Our next steps involve expansion of existing work, as well as conducting detailed N-of-1 lifecourse studies on immunofrailty and health outcomes in individuals. Our study would ideally include IBD patients as well as those without IBD who either have or will contract COVID-19. The study would require access to detailed information on the development of each person’s inflammatory state to date as well as prospective longitudinal measurements of their blood GlyHealth profiles now and several years into the future. The idea is to map changes in their blood glycomics patterns that could be potential prodromal markers of future alterations to their state of immunofraility. The results of this study should allow us to update IFM and further refine our models for prognosis and predictive of inflammatory events in IBD patients. Further studies on GlyHealth-COVID and, if it is possible, developing it into a practical tool to aid clinical management of COVID-19 patients are high priorities for us. To advance these projects ,we are applying to tap into UK medical research resources such as Gut Reaction, the NIHR Health Data Research Hub for IBD, as well as expanding our network of collaboration partners including clinicians and patient groups. Financing the R&D is a critical issue too and we are exploring ways we can access funding for specific parts of these precision medicine programmes.

www.avenna.com

For daily lifescience news visit www.lifescienceindustrynews.com 21

Clinical Need

Innovative medicine management technology releases nursing time for patient care Aaron Ballard-Ridley, Healthcare Sales Manager at Abloy UK, explains how innovative, practical security systems are helping to relieve pressure and streamline the NHS.

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e’re incredibly proud of our National Health Service, but now more than ever the system is under immense pressure. NHS employees work incredibly long hours, and the operational systems in place that ensure patients receive the best possible care can only be streamlined so far.

Key security

Therefore, it stands to reason that technology is the next logical step to help increase capacity within the system, by increasing efficiency. For hospitals to invest in the latest technology, they must be shown clear benefits and a return on investment, because the NHS can’t afford to ‘gamble’ on a solution that might not succeed.

Historically, a senior nurse would be in control of a key set, and nurses would need to request the keys to open high security areas and controlled drugs cabinets. But on busy wards the keys are often misplaced, which undermines efficiency – particularly in urgent situations when nurses require instant access.

Over a period of time this detrimentally affects patient care, nursing efficiency and morale.

Issue 20

When it comes to medicine management, a system must have a high level of security at its core, and traditional mechanical keys are no longer a suitable solution for healthcare.

For example, drug cabinets naturally need to be secure, but there is always the risk with mechanical keys that they can be lost, stolen or copied.

To combat these issues, security within healthcare settings has evolved from a simple set of mechanical keys to an access control system which utilises key hierarchy. This allows individual users to have access to several areas with just one key. Each individual has their own access rights tailored to their needs, and management can have a higher level of authorisation.

Access rights and audit trails Access rights can be revoked via the web management system with ease. Management can see audit trails that can be analysed to improve working practices further. For instance, you can measure when and where increased traffic occurs during a shift and will be able to plan for these peak times. Audit trails provide objective data with valuable

Clinical Need

insight into how a ward is operating and senior nurses/pharmacists use it to save time investigating drug discrepancies.

The system allows for remote key management on locks and padlocks, and the ability to remove lost or stolen keys from the system increases the security of controlled drugs and saves costs on replacing lost keys and installing new cylinders.

It isn’t only wards that can benefit. Estate management can utilise an access control system, with contractors and maintenance staff granted access to areas within the estate. The timed access feature can also ensure access is revoked outside the allotted time to provide a high level of security.

The Abloy solution We’ve worked with healthcare providers across the country for a number of years and have seen first-hand both the solutions that they require and what types of security

systems would bring the best efficiencies.

That’s how we developed our own access control system PROTEC2 CLIQ. It uses mechanical high security disc cylinders combined with highly encrypted electronic locking and identification. Power to the lock is provided by the CLIQ key, so no batteries or wires are required for either the lock or drug cabinet, making it a costeffective and convenient retrofit solution – even for applications such as mobile drug trolleys.

Estate management requires a different solution, so eCLIQ was developed. It offers the connectivity benefits and audit trail features but without the cylinder, delivering a further level of security for lower risk areas, such as plant rooms and storage cupboards.

Building on success The CLIQ range of solutions has been making waves in the healthcare sector for a number of years, with installations at Queen Elizabeth Hospital, North Lincs. & Goole NHS Trust, Spire Hospital Manchester all benefitting from the installation of CLIQ locking solutions.

In one hospital where pre- and postinstallation results were measured, they calculated that over a year the time saved

by CLIQ would be the equivalent of having an extra 24 nurses on duty every day across the Trust. This is due to the fact that nurses were spending an average of 30 minutes per shift looking for keys, which equated to 240 minutes lost on a ward every day.

What’s more, patient satisfaction has increased. In one instance, figures from an audit of patients who felt their painkillers were given promptly jumped from 79 to 92 per cent following the installation of CLIQ. The technology has also been recognised by the Medilink West Midlands Medical & Healthcare Business Awards, taking top prize in the Delivering Innovation into Health and Care category. This recognises innovations adopted by the NHS which demonstrate an impact on efficiency, patient outcomes and system costs.

Ultimately, CLIQ encourages nurses to deliver more direct patient facing care, helping to relieve pressure and streamline the NHS.

“We’ve worked with healthcare providers across the country for a number of years and have seen first-hand both the solutions that they require and what types of security systems would bring the best efficiencies. That’s how we developed our own access control system PROTEC2 CLIQ.”

www.abloy.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 23

Clinical Need

Enteral access device says never to ‘never events’ Enteral Access Technologies (E.A.T.), has developed a device called DoubleCHEK which uses dual indicators, CO2 and pH, to prevent the misplacement of feeding tubes into the lungs.

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he misplacement of a nasogastric tube into the lung is known as a ‘never event’ in the NHS. This means it is wholly preventable if current national guidance is followed properly, but it is still surprisingly common.

Existing solutions are either too costly or too big to be compatible with all tube sizes, have accuracy problems discerning lung placement, or only provide information after the tube has been fully inserted.

DoubleCHEK combines CO2 and pH indicators with a proprietary valving system to help clinicians place tubes safely and quickly in any environment. The innovative enteral access device assists the clinicians who use it and benefits the patients who require it in their fight to survive life threatening conditions.

The Liverpool-based company recently secured £750,000 through a mix of private investment and matched funding from the British Business Bank’s Future Fund. This funding will enable E.A.T. to manufacture the device in the UK and initiate commercialisation in Q2 of 2021. The investment will also be used to obtain FDA approval ahead of the US expansion being led by the E.A.T. team in Chicago, Illinois.

Previously known as NasoGastric Feeding Solutions Ltd (NGFS), the company changed its name to Enteral Access Technologies in March 2021. The name change, which was part of an overall rebrand, was designed to more accurately reflect the company’s emphasis on technological progress and its portfolio of enteral access focused products.

“Our new company name better reflects what we do and our vision for the future. Our focus is on developing new technologies to improve enteral access, and we wanted our brand to reflect that.”

George Gallagher CEO Enteral Access Technologies

www.enteralaccesstech.com

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Issue 20

Clinical Need

Optimising CAR-T and T-cell antibody engagers in haematological and solid tumours David Mead, Director of Business Development at Isogenica and Advisory Board Member of BioPartner UK, explains how VHH single-domain antibodies are prime to become integral components of next generation CAR-T and bispecific T-cell engager therapeutics.

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he past ten years have seen a rapid evolution of therapeutic T-cell redirection immunotherapies, culminating in the approval of two important new treatment modalities: Chimeric Antigen Receptor T-cells (CAR-T) and Bispecific T-cell Engagers (BiTEs). One BiTE and three CAR-T therapies have been approved by the FDA for the treatment of haematological malignancies by direct redirection of T-cells. Despite positive clinical results, both therapies continue to face similar safety concerns due to the risk of cytokine release syndrome and neurotoxicity. CAR-T and antibody-based T-cell engager therapies are in development for solid tumours, but to date there are no approved therapies for treatment.

Significant possibilities exist to optimise both BiTEs and CAR-T through the incorporation of humanised camelid-derived single domain antibodies, commonly referred to as VHH or Nanobodies. VHH represent an attractive format for incorporation in CAR-T and T-cell engaging therapeutic format with carefully designed affinities, valencies and specificities enabling refined tumour cell targeting and modes of action. They are small, fully functional, single domain antibodies that exhibit all of the features associated with antibody specificity and have binding capacities like conventional monoclonal IgG antibodies. However, because of their smaller binding region, they can target antigens and epitopes that are considered intractable.

VHH domains are less immunogenic than other single chain constructs such as ScFv because of their high homology with human VH genes and absence of exposed hydrophobic regions making them less potent immune targets.

Their small size, approximately 1/10th the size of an IgG molecule, is likely to enable improved

tissue penetration in vivo. Because they are encoded by only a single gene, VHH can be easily covalently linked to other molecules or pro-drugs. Fusion of VHH that bind different epitopes or have different modes of action allows the creation of multivalent molecules with high affinity or potency. VHH can be engineered to tune their binding selectivity and specificity for antigen targeting, whilst their favourable biophysical properties simplify development and manufacturing.

Their small size also confers advantages for tuning the immune synapse, the interface between antigen-presenting cells and T-cells, to optimise potency and minimise toxicity of T-cell redirecting immunotherapies.

Emerging evidence of how receptors at the immune synapse must be organised to optimise signalling elements for directed T-cell mediated killing highlights the importance of small format antibodies, such as VHH, in enhancing bispecific antibody T-cell engagers and CAR-T therapies.

Isogenica’s overarching mission is to develop next-generation biotherapeutics to address unmet needs and improve clinical outcomes for patients. With a track record of delivering clinical assets through collaborative partnerships, discovery projects are tailored to achieve developable therapeutic candidate binders

identified from its hugely diverse proprietary LlamdA® single domain antibody library. Purely in vitro, Isogenica’s LlamdA Library enables speed and efficiency unmatched by animal immunisation.

Isogenica has the in-house capability to efficiently undertake and manage all discovery and development activities from programme start to completion.

From high throughput screening and hit characterisation, through to lead optimisation and safety, there is a focus on achieving clinical development and success at each stage.

The company’s extensive expertise and technologies combine together to effectively develop novel approaches to disease treatment.

Bringing these clinically proven technologies together – by the incorporation of VHH into bispecific antibody T-cell engagers and CAR-T – offers a highly promising route to next generation T-cell redirecting therapies that more effectively harness the immune system to fight cancer. www.isogenica.com

For daily lifescience news visit www.lifescienceindustrynews.com 25

Going Global

Clinical trial monitoring goes mobile to help with COVID-19 Quick-thinking engineers at Vaisala have enabled a US-based drug manufacturer to conduct clinical trials in mobile units, which had been almost unthinkable before COVID-19.

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n summer 2020, a drug manufacturer initiated an innovative project to conduct clinical trials on potential treatments for elderly COVID-19 patients.

Long-term care facilities have been especially vulnerable to COVID-19 outbreaks since the beginning of the pandemic, with some sources estimating that up to 40 per cent of novel coronavirus-related deaths in the US occur in those facilities.

To respond to this situation and ensure that elderly people living in long-term care were included in research into treating the virus, a team of clinical development, clinical supply and engineering experts came up with the idea of converting recreational vehicles (RVs) into mobile research units. Along with the mobile units, trailer trucks were customised to transport clinical research supplies.

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Issue 20

Clinical trials are one of the most complex and challenging ventures in science, and the data they produce must be painstakingly collected and protected, otherwise crucial research can be lost.

Laboratories that contain samples and other high-value research assets require storage environments that are carefully maintained in specified conditions. Records of those conditions must be complete and accurate.

The drug manufacturer conducting this clinical trial was already using Vaisala’s viewLinc system to monitor temperature, humidity and other parameters in several cGMP environments at their facility. The question was: could the viewLinc system’s data loggers be used in the new mobile research units to send monitoring data back to their existing viewLinc system and send alerts for excursions? And more importantly, could Vaisala provide such a solution quickly?

Conducting clinical trials in mobile units was almost unthinkable before COVID-19. But with the help of the VaiNet wireless monitoring technology and Vaisala’s quickthinking project engineers, the drug manufacturer was able to put its mobile research units on the road within 30 days.

Mobilising a monitoring system The drug manufacturer contacted Vaisala. They needed monitoring in the refrigerators and freezers mounted inside the RVs which had been newly outfitted as mobile research units. The RVs would be travelling the country to perform clinical

Going Global

trials in long-term care and nursing home facilities. However, due to the pandemic and the vulnerability of the residents, the implementation timeline for the monitoring system in the mobile research units was only a few weeks.

Because the fridges and freezers would be opened twenty times per day or more, it was critical to record temperatures inside the fridges and freezers every few minutes to ensure proper conditions were maintained. The temperature data history also needed to be automated, accurate, complete and easily reportable. Ideally, the data would reside in their existing viewLinc monitoring system, which was validated.

Most importantly, if any temperature excursions occurred, remote staff had to be alerted immediately by email or text message.

Leveraging modern communication technology Vaisala project engineers used simple, off-the-shelf modems to enable several VaiNet AP10 network access devices to communicate from the mobile laboratories.

This was achieved without a VPN to connect the access points in the RVs to the viewLinc server. This method requires only a modem and the inherent communication capabilities of the AP10.

The wireless RFL100 temperature and humidity data loggers use Vaisala’s proprietary VaiNet wireless technology.

The modulation technique used by VaiNet is based on LoRa chirp spread spectrum.

LoRa (Long Range) is a low-power, wide-area network (LPWAN) protocol.

VaiNet’s indoor signal range typically exceeds 100 m (300 ft) and can easily penetrate walls and other barriers.

Outdoors, the signal range is much higher.

For instance, if the research staff were to take the RFL 100 data loggers outside the

mobile labs, they could go several hundred feet from the RV and maintain connectivity to the AP10 network device. The AP10 access point functions as a base station for the VaiNet wireless data loggers.

Low power, simple and fast In the application, the RFL100 temperature probes were placed inside fridges and freezers. The AP10 was connected by Ethernet cable that included Power over Ethernet (PoE) to a network switch inside the RV. A typical PoE network switch provides roughly 48 to 50 volts along with network connectivity. This eliminated the need for DC power adapters for the AP10 network access devices. A 4G modem, which was also PoE-capable, was used.

This allowed only one outlet to power the monitoring system; the network switch uses a power outlet and provides power to both the AP10 and the modem via PoE. However, all devices are equipped with power adapters, and if needed, the AP10 could connect directly to the modem.

The modem was used for communicating with the AP10, but also provided local internet access at a computer workstation inside the RV. The advantage to using a

3G/4G modem with the AP10 is that the AP10 uses an extremely low amount of data bandwidth. Although each AP10 can host up to 32 RFL100 data loggers, there is only a small amount of data going through the wireless modem, using very little bandwidth. Since cellular modem charges are based upon usage, this was a cost-effective solution. The modem communicates to a cell tower and allows the data to be sent over the Internet to the validated viewLinc server.

Stronger together The mobile research units created in 2020 are currently deployed to COVID-19 outbreaks at facilities across the US. This clinical trial was the first of its kind and a steep learning curve for the many scientists, project managers and engineers who worked to implement it. In a time when so many are isolated, few are as isolated or vulnerable as people living in nursing homes and long-term care. Vaisala was proud to provide a solution for a research organisation endeavouring to help in an urgent situation. www.vaisala.com

For daily lifescience news visit www.lifescienceindustrynews.com 27

Going Global

Introducing Medilink’s International Resource Service Medilink UK has launched an International Resource service to help companies identify international markets, grow their export capabilities and de-risk international expansion.

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heir team of international specialists can work with you to understand the challenges that your business faces and help complement your export team and strategy. This costeffective and low-risk additional resource can be used for projects ranging in size and scope, or for more long-term cover and additional capacity, for example maternity, absence or sickness cover.

Typical projects may include: l Market identification and research l Distributor assessment l International marketing review

Medilink’s International Advisors have over 50 years’ experience working with healthcare technology and life science businesses and have supported a huge variety of companies over the years.

They have an extensive network of professionals from across the world, with specific expertise in Europe, Africa and the Middle East. The team will use their overseas market knowledge and expertise, supplemented by refined research techniques, to assist your organisation’s international trade goals whether you are a new or experienced exporter.

There is currently regional funding spread throughout the UK for international development, and as such your project

with Medilink’s International Team could be subsidised by up to 60 per cent.

To discuss your company’s needs and requirements, and any potential funding routes as part of a free and personalised project-scoping exercise, please contact the team on the details below.

Medilink also has an extensive international healthcare event calendar, supporting UK companies to reach their exporting goals in markets including the Middle East, Germany, the US, Thailand and South Africa.

They offer cost-effective exhibition stand packages and a range of services designed to help you get the most out of your exhibiting experience.

l Exhibition participation support l Board or investment strategy l International trade training l Sales and partnership agreements

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For further information, get in touch with the team on: Email: international@medilink.co.uk Tel: 0114 232 9272

Going Global

PHARMASEAL’s Engility platform selected by US medical device company PHARMASEAL, a provider of clinical trial management and governance solutions, has secured its first Medical Device customer – an award-winning US-based company providing ultrasound technology, which selected PHARMASEAL’s Engility Trial Management Platform following review of several clinical trial management systems (CTMS).

E

ngility provides users with a higher level of productivity by allowing clinical teams to operate with one single system. Ultimately it saves time on setup, implementation, user training and validation. This allows better, more integrated workflows and a consistent user experience across both capabilities.

The platform simplifies the management and control of clinical trials for biopharmaceutical, clinical research organisations and medical device companies. It has a combined CTMS and eTMF capability offering a simplified, cost-effective process for managing, tracking and storing documents within one system. For customers who have not invested in CTMS or eTMF technology, or are unhappy with their incumbent technology, this development eliminates the need for investing in two separate

systems and having to integrate them, which can be complex. The platform utilises advanced engineering, offering enterprise management with rapid deployment, has a simple intuitive user interface and integrates easily with other eClinical applications to optimise clinical governance and trial oversight.

PHARMASEAL wants to give customers increased control of their clinical trials and product development. The company has applied industry expertise, innovative thinking and advanced automation to build and operate an integrated enterprise platform which allows biopharmaceutical and medical device companies to manage all of their clinical trials effectively.

They share a vision with innovative companies to simplify and unify clinical trial governance.

BresMed’s new global HQ at Steel City House in Sheffield is the heart of the company’s worldwide operation. Commenting on the move, CEO Nic Brereton said: “I am so proud to be expanding BresMed to these “This news is a great start to thepremium year for premises in the city.

The building verythat much PHARMASEAL. We are delighted Engility fitshas withbeen our selected brand – and it’s iconic with quirky licensed toasupport feelits and, us, it dares be different.” firstlike medical deviceto customer to improve the management and control of their device The company has come a long way since Nic trials. Furthermore, this will allow us to work moved into a one-person office in the city with more global medical device companies many years ago, adding: “Actually, it was more who have expressed an interest in Engility, a cupboard! However, it helped me launch the allowing for smarter management and business.” execution of medical device clinical trials.

We have the vision to create smarter technologies for the improvement of human health and we are excited to see what possibilities emerge from this collaboration for transforming the future of healthcare.”

Daljit Cheema Founder and CEO PHARMASEAL

www.pharmaseal.co

For daily lifescience news visit www.lifescienceindustrynews.com 29

Going Global

International expansion for 270 Vision 270 Vision has announced ambitious expansion plans, as the med-tech business seeks to raise investment to support its growth and the deployment of two new products.

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he Hampshire-based company has gone from strength to strength with BPMpathway, which offers cost-effective and reliable technology in support of remote patient assessment undertaken by clinicians. They now aim to utilise the technology to diversify into new markets in an investment raise through the Elevate investment network.

Founded in 2011, 270 Vision are developers of simple-to-use, highly accurate body analysis technology for use in injury prevention and rehabilitation in the medical, employee welfare and elite sports sectors. With six patents granted and two further applications pending, multi-award winning 270 Vision are internationally renowned as the market leaders in motion sensor design and development.

In 2016, recognising the potential of BPMpathway, international healthcare giants B. Braun first invested into 270 Vision as part of their strategy of securing access to key future technology and to take the product into patient rehabilitation post orthopaedic surgery under a global distribution agreement. In 2018, B. Braun further increased their stake in the company to support the worldwide rollout of BPMpathway which, through the partnership, has gone on to be certified in 14 countries. Of those 14 countries, it has already been successfully launched into seven, including China and India, and it is expected to be launched into Japan and South Korea later in 2021.

BresMed’s new global HQ at Steel City House in Sheffield is the heart of the company’s worldwide operation. Commenting on the move, CEO Nic Brereton said: “I am so proud to be expanding BresMed tobeen thesefantastic, premium “Our journey to date has premises in the city.

The building very and we have been extremely proudmuch to fitshave with been our brand – it’s iconic a quirky recognised with awith National feelMedilink and, likeOutstanding us, it dares toAchievement be different.”

Award, as well as securing the The company has come a long way since Nic partnership with B. Braun, without moved into a one-person office in the city whom the scale of the expansion to date many years ago, adding: “Actually, it was more would not have been possible.” a cupboard! However, it helped me launch the Martin Gossling business.”

CEO and Co-founder 270 Vision

In addition to the Medilink Award, the business has won several further accolades, including the Best Digital Health Platform award for BPMpathway at the 2018 Juniper Research Future Digital Awards.

Having successfully raised £2.9m in investment to date, the business is now seeking to raise further investment through the Elevate investment network, to aid their growth plans and support the launch of new products including WPMpro and BPMcare.

Commenting on the new products, CFO and Co-founder Jane Gossling said: “WPMpro is a cost-effective system at the forefront of the next generation of wearable sensor technology. Multiple smart, autonomous sensors detect excessive joint range

of motion to help employers identify individuals at risk of injury and, through pro-active early intervention, limit the cost and disruption caused by work-related musculoskeletal disorders.”

Jane added: “WPMpro technology is a game-changer in the world of wearables.

For the first time, far field charging of the multiple sensors can be delivered in a production solution. There is currently no commercially available solution capable of producing a complete body assessment, because manually charging even two-three sensors has been deemed impractical. With WPMpro, however, as many as 20 sensors can be distributed throughout a person’s clothing without the wearer being aware of them. These sensors are then charged overnight as they hang in the individual’s locker using patent-pending RF transmitters at regulated frequencies developed by 270 Vision.”

In addition to smart clothing, 270 Vision is also looking to develop its BPMcare technology. Jane explained: “BPMcare uses technology complementary to BPMpathway in the remote monitoring of bio-signs and urinary issues in patients in long term care, particularly those with comorbidities and catheter users. BPMcare technology is designed to detect blood and dehydration to help reduce the risk of infection and further complications”.

www.bpmpathway.com

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Issue 20

Going Global

125 years

That’s how long we’ve been improving lives.

A tradition of advancing science, medicine and diagnostics.

Then, now and in the future.

Traddodiad o datblygu gwyddoniaeth, meddyginiaeth a diagnosteg. Yn y gorffennol, heddiw ac yn y dyfodol. roche.co.uk

Roche Corporate Ad - MediWales Connect 2021 - half page.indd 1

24/03/2021 08:57:55

Going Global

SEHTA Grant Appraisal & Application Review

For most MedTech SMEs, public sector grant funding is essential to their early growth to help them develop their proof of concept, their technology and start early clinical development. Some public sector grants will also fund later stage development such as clinical trials, IP protection and help with regulatory approval.

SEHTA has a strong track record helping companies understand the funding landscape in the UK and working closely with them to secure funding. SEHTA staff also help government bodies review grant applications so have first-hand experience of what makes an application successful.

The SEHTA offer

• A Grant Appraisal Service, which provides initial feedback on the proposal and directs the SME to the most suitable funding source(s). The appraisal is based upon completion of a form by the SME articulating the technology/service they need funding for, what they want to do with the funding and how much funding they need.

• A Grant Review Service, which provides a rapid analysis of a completed draft grant application articulating ways to improve it to increase the chance of success.

Good Fair

Poor

Advert?

Contact SEHTA today for more details – info@sehta.co.uk www.sehta.co.uk

32

Issue 19

Very Good Excellent

Powered by ABHI, the UK

The platform was created out of a need to provide

Healthcare Pavilion is a unique

a single front door showcasing the strengths of UK

partnering platform helping

healthcare and life sciences. Its mission is to provide

overseas customers discover, connect and innovate with the UK’s thriving healthcare and life sciences sector. Its aim is to inspire cross-border collaborations that

overseas buyers looking for UK solutions with a simple, insightful way to identify and engage UK industry and healthcare organisations, and to support UK-based medical device, diagnostics, and digital health exporters looking to engage customers around the world.

can realise large scale impact

The UK Healthcare Pavilion provides a global platform

in response to local and global

showcasing the very best of the sector, and highlights

health challenges.

the strengths the UK has to offer.

For more information, visit ukhealthcarepavilion.com

People and Places

Medilink Midlands CEO and Board announced The newly forged Board of Directors for Medilink Midlands has appointed Dr Darren Clark as Chief Executive Officer and member of the Board of Directors. Darren previously held the position of Chief Executive Officer at Medilink East Midlands.

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arren joined Medilink East Midlands in 2004 and has over 20 years’ experience in the life science sector, the majority gained in industry, at Pharmaceutical Profiles (now Quotient Sciences), with the remainder in academic research at the University of Warwick.

Reflecting on his appointment, Darren said: “I am honoured and excited to have been selected to lead Medilink Midlands. What businesses need more than anything at the moment is reliability and assurance. As newly appointed CEO, I have a deep commitment to strengthen our support to the Midlands life science community.

“Looking forward, we will need to accelerate our strategic approach to ensure we serve all our Patrons, Members and the Midlands life science community as a whole, to the best of our ability in these ever-changing times.

Great work has been done, but we must continue to drive the Midlands forward. I am very confident we can do this because of the amazing team of people that work at Medilink Midlands, and collectively we have the desire, capabilities and knowledge to secure more new and exciting initiatives for the benefit of our members.”

As the East and West Midlands come together as Medilink Midlands, a new Board of Directors has been formed by bringing together the former boards of Medilink East and West Midlands, with Prof Martin Levermore DL appointed Chair of the Board, who previously served as Chair on the Medilink West Midlands Board of Directors.

Darren commented: “I’m delighted Martin has been appointed as Medilink Midlands Chair. Martin holds an impressive collection of professional responsibilities within the Midlands and brings with him a significant level of knowledge and exposure to the diverse life sciences and med-tech eco-system which will assist in guiding our objectives. With Martin and our Board of Directors at our side, I have no doubt Medilink Midlands has the right structure in place to progress and develop the Midlands life science offering.”

Martin responded: “As Medilink Midlands enters its next chapter, I look forward to working alongside my fellow Board members to enable bigger and better opportunities to all, and shine a light on the regions remarkable infrastructure of life sciences, med-tech and health care organisations we boast here in the Midlands. During this time of transformation, there is no better person to lead Medilink Midlands than Darren. A proven leader with a clear business vision and the ability to bring people together.”

Darren added: “Each director brings with them their unique approach and experience, and the appointment of the board represents a significant and exciting step in the growth of the Midlands, offering a new strategic direction. I’m delighted to welcome three new business leaders to our Board of Directors – Dr Arash Gadar, Technical Director of Datalink Electronics, Charles de Rohan, CEO of The Binding Site, and Mark Pettitt, former CEO now Non-Executive Director of Kimal. All well respected in the medical technology sector, bringing with them a wealth of valuable industry experiences which adds to the breadth of experience possessed by the other Board members. Collectively, this Board

represents the diversity of the life sciences sector across the Midlands and is well placed to ensure the needs of our members and the wider sector at met.”

Commenting on his appointment, Charles de Rohan from The Binding Site said: “I’m delighted to be asked to serve on the Board of this organisation, which in its expanded state should now be even better positioned to help companies develop and grow. I hope that I can provide value to members and would-be members through mentorship and advice, as well as assisting with overall direction for Medilink Midlands.”

Darren concluded: “Our members are at the forefront of everything we do. As we move into the officially formed Medilink Midlands membership, we will continue to consider the best way to move forwards and we will share our ideas with our members. Our aim is to develop more organic pathways across the Midlands, and as a single operating model this will be easier to achieve with more effective access to networks, opportunities and regional recognition of success, all for the benefit of our companies.” www.medilinkmidlands.co.uk

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Issue 20

People and Places

Gwalia Healthcare beats a double challenge 2020 presented Gwalia Healthcare with a double challenge. Whilst recovering from a flood as a result of Storm Dennis, the COVID-19 pandemic struck. With tremendous work, the UK-based pharmaceutical and medical device manufacturer has bounced back stronger.

Continuity of supply demonstrates a strong service ethos In February 2020, Gwalia Healthcare’s South Wales manufacturing site fell victim to Storm Dennis when the River Taff burst its banks. It took six weeks and an enormous amount of work to get production back up and running.

In the meantime, hand-assembly units were used to ensure that customers experienced no break in their supply chain. As recognition, the company was awarded for its exceptional customer service throughout this time. Little did they know that an even bigger challenge was on its way, with the emergence of COVID-19. Taking an opportunity to diversify the business further, Gwalia began filling locally sourced alcohol-based sanitiser gel into their own bottles and closures onsite in Treforest.

Expanding into contamination control to create the ‘Hybrisphere’ It soon became apparent that the COVID-19 pandemic needed a better solution, so Gwalia Healthcare began working with fellow MediWales member Hybrisan (a PortTalbot biotechnology company) on a range of alcohol-free antimicrobial and biocidal products. In addition to hand gel, Gwalia collaborated with Hybrisan to develop a range of decontamination products, which led them to become a key UK distributor for the Graco SaniSpray HP range of airless sprayers. Together, the collaboration has also developed the concept of the ‘Hybrisphere’ which highlights the need for all decontamination products in the workplace to be compatible, with the right balance between efficacy and safety of personnel and facilities. This has been adopted by a number of high-profile customers, including elite sporting facilities and FTSE 100 office complexes. Diversification has also seen the launch of a Decontamination Team.

Continued investment to increase capacity and sustainability The last six months has been a time of continued investment at Gwalia Healthcare, including the arrival of new machinery for their class 7 cleanrooms, as well as expanding their workforce and infrastructure. Due to recent growth, the workforce has been scaled up by 40 per cent and warehouse capacity has increased by an additional 400 pallet spaces. New high-tech moulding machinery has enabled the company to keep up with increased demand for pharmaceutical packaging and medical device manufacture at the ISO 13485 accredited site.

Gwalia Healthcare has taken delivery of 11 new machines, all of which are electric instead of hydraulic and use significantly less energy.

This development, combined with high utilisation of local supply chains, has enabled

the company to reduce their carbon footprint – a vital consideration as a single use plastics manufacturer.

www.gwaliahealthcare.com

For daily lifescience news visit www.lifescienceindustrynews.com 35

People and Places

App helps reduce hospital admissions in Midlands A digital remote care solution, including a mobile phone app, is being used by Dudley CCG to help improve the care of patients at home with COVID-19. The app, developed by Norwegian medical software company Dignio, is helping patients to stay at home safely and therefore avoid unnecessary admissions to hospital, as well as alerting clinical staff of patients more seriously ill who need prompt admission.

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atients participating in the pilot download the MyDignio app and use Bluetooth enabled medical devices, provided as part of the pilot, to monitor their temperature and oxygen levels at home. The app connects to a dashboard at the local health centre, allowing these readings to be assessed by the clinical team so they can safely keep track of patients with COVID-19 while they remain in their own home.

Users also report their symptoms through a questionnaire within the app to provide a clearer overview of their condition. The platform enables patients to become more engaged in their own health through daily monitoring and communication.

Previously, self-isolating patients would receive a call to establish symptoms, but the easy-to-use app now works as a ‘virtual ward’. Patient readings are recorded automatically and alerts are sent to healthcare staff at the first sign of any deterioration, prioritising care for patients who need it most.

Dignio has recently joined the Serendip Accelerator programme which, operating in partnership with the West Midlands Academic Health Science Network (WMAHSN), is designed to support the scaleup of digital innovations.

BresMed’s new global HQ at Steel City House in Sheffield is the heart of the company’s worldwide operation. Commenting on the move, CEO Nic Brereton said: “I am so proud to be expanding BresMed to these premium “The AHSN plays an important role premises in the city. The building very much in ensuring the NHS benefits from fits with our brand – it’s iconic with a quirky innovation, including digital solutions feel and, like us, it dares to be different.” to challenging clinical scenarios.

Early in the pandemic, the WMAHSN The company has come a long way since Nic supported Dudley CCG to find a digital moved into a one-person office in the city solution which would compliment and many years ago, adding: “Actually, it was more improve their COVID at-home service. a cupboard! However, it helped me launch the Subsequently, after the CCG settled on a business.” solution, the WMAHSN has coordinated a comprehensive evaluation of the service focusing on the digital remote care platform provided by Dignio.”

Dr Julian Sonksen WMAHSN Clinical Advisor

Following successful implementation, MyDignio could be used on a wider scale, for COVID-19 monitoring across more of the West Midlands or nationally.

Dr Ewa Truchanowicz, Managing Director of MyDignio, said: “We were delighted to be accepted for the Serendip Accelerator.

Having experienced support from the WMAHSN experts in our oximetry at home with the Dudley CCG project, we look forward to enhancing our growth in the region and beyond. Our connected care solution offers a safe and effective remote care management, and working with WMAHSN allows us to ensure that it reflects the ‘best in class’ not just in technology, but also in methodology and content.”

NHS Dudley Clinical Commissioning Group is also planning to expand the solution to care homes across the area.

The technology is able to monitor other conditions such as diabetes, asthma, high blood pressure and general health of all care home residents.

www. dignio.com/en/

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Issue 20

People and Places

Bristol company brings medical innovations to market P3 Medical Limited specialises in the design, manufacture and marketing of innovative, high-quality medical devices for the global healthcare market.

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ne example of the company’s success in bringing new innovations to market is Tracheseal, which was designed by three clinicians, along with the help of Health Enterprise East, who identified a need for a specific post-decannulation dressing.

Temporary tracheostomies are used in many areas of surgery and anaesthesia.

Following decannulation (or removal of the tube), it is important that the tracheostomy wound heals as quickly as possible, preventing any delay which can be problematic for the patient.

Tracheseal is a dedicated dressing to be used after removal of the tracheotomy tube. It allows the patient to communicate better by easily finding their stoma site using the “centre button plate.” This also promotes faster healing of the stoma.

P3 Medical’s team of engineers worked closely with the clinicians to help design the button and source an absorbent dressing material. The dressing is now used in several NHS trusts and sold across Europe and the Middle East.

P3 Medical’s headquarters and international distribution centre are based in Bristol. This is also the location of their manufacturing site, fully equipped with four modern cleanrooms. They have a further production and cleanroom facility in Preston in the North West of England.

products of high quality and value to the NHS and private hospitals. They also export their devices to over 60 countries worldwide and have recently joined the ABHI US Accelerator programme based in Austin, Texas.

The firm works closely with clinicians to develop cost-effective solutions which enhance hospital efficiency, patient care and overall safety in operating theatres. They specialise in anaesthesia and airway management, general surgical & equipment drapes (including robotics drapes), gynae & colorectal, wound care & haemostats, and a range of veterinary products.

In addition to marketing their own range, P3 Medical acts as UK distributor to a number of leading medical device manufacturers, bringing innovative

www.p3-medical.com

For daily lifescience news visit www.lifescienceindustrynews.com 37

Money

Business booms for Welsh healthcare firm during pandemic Revenue for Welsh healthcare firm Forth has doubled during 2020, despite the many challenges faced due to the COVID-19 pandemic.

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hrough an innovative at-home blood test kit, Forth enables customers to stay healthy and active by unlocking valuable insights into their health. As the world searches for ways to maintain good health and strengthen the natural immune system, Forth has come out on top as a much needed solution.

Not only was Forth the first UK company to market with COVID-19 antibody testing kits, but it also achieved a record number of sales in 2020, with the topline growing month on month and January 2021 being the biggest sales month to date. Additionally, Forth has secured a grant from SMART Cymru to develop a ground-breaking female health product, agreed a partnership with Superdrug, and achieved ISO accreditation.

Forth’s total revenue for 2020 increased by 100 per cent on the previous year. This additional revenue, coupled with the increased demand, has allowed Forth to create a third more jobs at their Chepstow HQ than there were at the beginning of 2020. It is apparent that people are investing more energy and money into their health as Forth’s average order spend increased by 30 per cent in 2020 on the previous year.

The grant awarded by SMART Cymru to Forth is an innovation grant to enable and support the development of a unique female health product.

Forth hopes that this new female health product will reduce healthcare inequality for women.

Forth’s partnership with Superdrug comes after demand for home nurse appointments soared amidst resource pressure from the pandemic. The result was a new partnership allowing customers to book blood test draws

at 60+ in store clinics throughout the UK. The Superdrug clinic appointments, costing £30 per appointment, allow customers to continue using Forth’s healthcare service at a time when they need it most, in a convenient and quick way. Home nurse appointments remain available, costing £55 per appointment.

taking control of their health. Female health is a very underinvested area, with many women going undiagnosed or misdiagnosed for years due to the inequality within healthcare provision and research. As a female led business, I’m proud to be supporting women’s health with our new product.”

The latest of Forth’s achievements is the ISO13485 accreditation. This certification demonstrates the company’s quality in the delivery of its service and its commitment to safety, as the accreditation is only awarded to businesses that provide consistent design, development, production, installation, delivery and disposal of medical devices that are safe for the intended purpose.

Sarah, who won Health and Wellbeing Entrepreneur of the Year for Wales at this year’s Great British Entrepreneur Awards, continued: “The past year has been tough on all of us, but through the tenacity of the team here at Forth, we’ve managed to finish the year in a better position than where we started. It’s only upwards and onwards for 2021.”

Sarah Bolt, Forth CEO and Founder, commented: “Although we are not quite free of the challenges of COVID-19, I’m really excited for the year ahead and hope it will bring even more success than the past year has. We’ve got a great new, innovative female health product in the pipeline which will really help to empower women when it comes to

Forth’s at-home blood test service is proven to support people become healthier and be their personal best. Over the past year, 58 per cent of customers improved their Vitamin D levels, 45 per cent lowered their risk of Cardiovascular disease and 52 per cent lowered their risk of type 2 Diabetes. Forth predicts enormous growth in the industry as digital health is predicted to grow by 28.5 per cent for the next 5 years. www.forthwithlife.co.uk

38

Issue 20

Money

Cresco celebrates funding wins to start 2021

Expert bid writing consultants at Cresco Innovation have had some cause for celebration, starting 2021 by winning more than £6 million in funding for three projects.

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he company explained: “This is an incredible achievement, especially considering the challenges we, like so many other companies and business, continue to face during the ongoing coronavirus pandemic. And it is testament to the hard work and dedication every member of the team has shown.

We are very proud indeed, and we’re delighted to share this with you because it shows there can be light at the end of the tunnel.”

Cresco’s funding successes

Cresco successfully supported two projects: l

l

Project 1: 36-month collaborative project between a UK SME, a university and a hospital. The project size is £1.5 million and it will develop a medical device for treatment of cancer.

Project 2: 36-month project by a UK SME. The project size is £3.9 million and it is a drug development project.

The recent Biomedical Catalyst competition had £30 million to support innovative healthcare products, technology and processes. Funding was available between £250k and £4million for projects lasting between 12 and 36 months. Innovate UK received 373 applications and they were able to fund 18 projects.

The company also won just under £1 million for the Foundation Industries call. This win was a collaborative SME-led project to the IETF deployment of energy efficiency technologies in industry competition. This project is supporting the drive to a net zero economy.

Ultimately that’s more than £6 million in total for innovative, exciting and, in some cases, life-saving projects.

Jo Derbyshire, Cresco CEO, said: “We’re just a little company in Loughborough that happens to work all across the UK and Europe. That we’ve managed to win more than £6 million in funding for these three projects is fantastic news, and it’s a real shot in the arm for all of us. We don’t normally talk about our wins but, this year more than ever, we need good news. In fact, good news is essential at the moment! Innovate UK are working really hard to reinvigorate the economy by investing in long-term innovative technology, so to play our part in that is very rewarding.

“As a company, Cresco emerged from the Loughborough University enterprise community. We have chosen to remain in Loughborough, with our office based in the centre of the town, because this area is a real hotbed of innovation. That we’re celebrating these three wins so far this year demonstrates that, even though we’re a small company based in a small market town in Leicestershire, our reach is international, and that success can be just around the corner. That is good news worth celebrating, and hopefully offers inspiration to other small companies during these difficult times.”

www.crescoinnovation.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 39

Money

Funding to support growth at high-achieving healthcare manufacturer Healthcare manufacturer CellPath has secured a seven-figure funding package to develop an extension of its premises and support its growth plans in both the UK and international markets.

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he Welsh company, based in Newtown, is a manufacturer and supplier of consumables, equipment and services to the global cellular pathology sector. The familyrun business has received funding from HSBC UK to develop a 12,000 sq ft extension of its premises, creating a fourth warehouse at its headquarters.

Alongside additional warehouse space, the extension of premises will involve the opening of a new staff welfare facility including a canteen, modern cafeteria area, recreation room plus additional meeting room facilities for the business’ 100 plus employees. In 2016, HSBC UK funded the development of a 10,000 sq ft extension at CellPath’s current site.

BresMed’s new global HQ at Steel City House in Sheffield is the heart of the company’s worldwide operation. Commenting on the move, CEO Nic Brereton said: “I am so proud to be expanding BresMed to these premium “With more space, we will be able to premises in the city. The building very much service more clients across the UK and fits with our brand – it’s iconic with a quirky overseas, ultimately meaning that more feel and, like us, it dares to be different.” patients will be receiving better and care.”

The quicker company has come a long way since Nic

moved a one-person office in the city Paulinto Webber many years ago, adding: “Actually, it was more Joint Managing Director a cupboard!

However, it helped me launch the CellPath business.”

“We have great confidence in CellPath’s growth plans and know this will help the team to successfully increase capacity of the CellNass service and supply products to both the domestic and international markets in 2021 and beyond.”

Jon Higginson Corporate Relationship Director HSBC UK

The extension will give CellPath additional capacity for its tissue archiving service, CellNass, which provides remote archive management services for specimens and biopsy material for analysis, helping hospitals with limited resources to manage their specimen archives.

In 2020, CellPath quietly celebrated its 50th anniversary of supplying the cellular pathology industry. With biomedical scientists and NHS hospitals making up a large proportion of the company’s customer base, when the COVID-19 pandemic began, CellPath was keen to continue with an uninterrupted supply of essential goods to laboratories, whilst also protecting valued staff. Office staff quickly transitioned to remote working, allowing for more space so that onsite workers could

socially distance. CellPath distributed PPE, followed strict hygiene practices, and has been able to continue with both manufacture and distribution throughout the pandemic.

Having ensured that the core operation could continue, the company began to see where it could help with other local efforts. Upon realising there was a local shortage of hand sanitising products and face visors, chemical manufacturing and 3D printing facilities were redeployed to produce essential supplies which were donated to local facilities like care homes, schools and funeral parlours. Building upon this offering, CellPath released hand sanitising products (CelliTizer) and a face shield (CelliVizor) to the market, and also developed a nose clip which allows glasses-wearers to use a face mask without their glasses steaming up. www.cellpath.com

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Issue 20

Money

Cancer diagnostics firm completes £3.5 million funding round ClinSpec Diagnostics Limited (ClinSpec Dx), the Glasgow-based developer of liquid biopsies for early detection of cancer, has reached its round two funding target of £3.5 million by securing an additional investment of £1.1 million.

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he company, which is a spinout from the Department of Pure and Applied Chemistry at the University of Strathclyde, has recently secured the £1.1m investment from Norcliffe Capital Limited, the University of Strathclyde, Eos Advisory and the founders. The first tranche of the investment (£2.4m) was secured in 2020 and led by Mercia’s EIS Funds with Scottish Enterprise, profit with purpose investor SIS Ventures, Eos Advisory and the University of Strathclyde.

Fast, inexpensive and easy to undertake, the ClinSpec Dx liquid biopsy is a blood test using revolutionary technology based on the world-leading research of Dr Matthew Baker. Through a combination of infra-red light and artificial intelligence, its ‘drop, dry, detect’ technology provides results in minutes.

“Our two clinical studies on detection of brain cancer have been successful and papers are in draft for publication over the next 6 months.

This, plus the development of our multi-cancer platform covering the most common cancers, will form the bedrock for Series A investment in 2022, with the target of commercial launch in 2024.

“We are also delighted to have further strengthened our leadership team by the appointment of Prof David Onions of Norcliffe Capital to the Board of Directors.”

then moving to clinical application of the technology after the Series A funding round next year.”

ClinSpec Dx has raised £5.1million to date, including a first round of seed funding in 2019 led by Eos Advisory alongside Mercia’s EIS Funds and Scottish Enterprise, as well as grant funding from the Higgs EDGE Special Award, and from Innovate UK through the precision medicine accelerator fund.

Professor David Onions, Adviser to Norcliffe Capital, commented: “The team at Norcliffe Capital are delighted to be supporting the next phase of development of Clinspec Dx. Early diagnosis of cancer is critical for effective treatment but can require complex and expensive procedures. Clinspec Dx has developed a revolutionary, rapid, diagnostic system for cancer that only requires a drop of blood. We were very impressed by the results from the clinical studies on brain cancer and the clear strategy of the company; first in widening the range of cancers being examined and

Worldwide, 26,000 people die from cancer each day. Earlier diagnosis of cancer results in significantly higher survival rates compared to late-stage diagnosis, increasing the availability of treatment options and improving chances of recovery and a better quality of life. The liquid biopsy also has the potential to indicate the type and severity of the tumour, allowing doctors and clinicians to prioritise and fasttrack the most appropriate and effective treatments.

Mark Hegarty, CEO of ClinSpec Dx, said: “Achieving the £3.5m target enables us to accelerate our plans. We will shortly complete our move into new lab and office facilities and increase staffing to 15, bringing forward key operational and commercial appointments. www.clinspecdx.com

For daily lifescience news visit www.lifescienceindustrynews.com 41

Regulatory

Data: supporting health and wealth

By Andrew Davies, Digital Health Lead, ABHI

L

essons from the pandemic have already been well rehearsed; the shift to remote GP access, the increased use of telehealth to keep people safe in their own homes and the reduction in bureaucracy to enable streamlined sharing of patient data. We must now look at how we can integrate these lessons post-pandemic.

Changes in access to healthcare were enabled by a common purpose, use of derogations in regulations and clarity of risk versus benefit. Not all of these circumstances will remain post-pandemic and new ways of working will need to be established to ensure we maintain these benefits. These may be legislative, cultural and some will inevitably require funding.

It is of particular interest how the pandemic will shape attitudes to sharing data, and in turn, influence legislation. It is widely accepted that data sharing is vital to aid efficient service delivery, support improved

outcomes and provide insights for innovation. There are of course legitimate concerns over privacy.

Ensuring legislation works with innovation On 1st January 2021, the UK entered a six-month interim arrangement with the EU on data sharing, with a full decision on adequacy due within that period. This agreement, and (presumably) largely unchanged UK Data Protection rules, will set the overall legislative context for UK data handling.

However, there are many calling for flexibilities derived from COPI notices to be enshrined in new information governance rules. Sarah Wilkinson, CEO of NHS Digital, has been quoted as saying: “The current legislation is very labyrinthine and that makes it difficult to have a clear dialogue with a broad cross-section of people, even within the health and care system.”

Any changes to legislation that enable a more streamline flow of data across the

NHS and helps build critical datasets would be welcome.

Ensuring faster access to care through data The ‘data economy’ in health is hugely prized and the UK has an opportunity to develop an open-data resource that could attract clinicians, academics and industry to help develop next generation solutions to critical health problems, stimulating economic growth and enabling UK health services to reduce the “bench to bedside’ timeline.

Some baulk at the idea of profit from health data but ‘health and wealth’ are two sides of the same coin. Healthcare performance is strongly dependent on the economy. Wealthier countries have healthier populations and it is a basic truth that poverty adversely affects life expectancy. The UK needs to leverage its health assets to the widest possible benefit for its patients, citizens and economy.

www.abhi.org.uk

42

Issue 20 www.abhi.org.uk

Regulatory

What does the expiry of the Brexit transition period mean for your IP rights?

By David Gwilliam, Chartered UK and European Patent Attorney, Adamson Jones IP Ltd

T

he United Kingdom left the European Union on 31 January 2020, although many of the effects of this were suspended during the transition period of the withdrawal agreement, which expired on 31 December 2020. So, what does the expiry of the transition period mean for your intellectual property (IP) rights? In summary:

European patents The European Patent Office (EPO) is not an EU institution and hence European patents will be unaffected by Brexit. European patent applications will continue to designate the UK, and we will remain European Patent Attorneys able to represent clients at the EPO.

EU trade mark and design registrations EU trade mark and design registrations, as well as EU designations of International trade mark and design registrations, will cease to cover the UK and separate UK registrations will automatically be created that will provide equivalent protection in the UK. EU trade mark and design applications will have to be re-filed in the UK within nine months of the end of the transition period in order to retain filing and priority dates of the EU application.

The European Union Intellectual Property Office (EUIPO) will no longer accept representation by UK representatives, although we will still be able to handle EU trade mark and design matters via our international network of associates.

National IP protection in the UK The United Kingdom Intellectual Property Office (UKIPO) will require a UK address for service for the filing of UK patent, trade mark and design applications and for challenging or defending UK IP rights.

What happens to your existing UK and European IP rights? Who can represent your interests in the UK and Europe?

Patent protection will be unaffected by Brexit, because the EPO is not an EU institution and there is currently no EU system for protecting patents as there is with trade marks and designs.

The UK will continue to be a member of the European patent system, European patent applications will continue to designate the UK, and we will remain European Patent Attorneys able to represent clients at the EPO. In respect of trade marks and designs, the UK is currently covered by separate UK and EU systems of protection. The UK system will of course be unaffected by Brexit. However, the EU system will cease to cover the UK from the end of the transition period and the UK will automatically issue equivalent new rights under the UK system.

The holders of any registered trade marks and designs under the EU system will automatically be issued with an equivalent registration under the UK system that will provide equivalent protection.

The holder of any pending EU trade mark or design applications will not automatically be issued with an equivalent application under the UK system, and instead will have to apply for equivalent protection under the UK system within nine months of the expiry of the transition period, in order to benefit from the same filing date and priority date as the EU application.

The unregistered design rights that are granted under the UK and EU systems have several significant differences, which include that surface decoration is protected under the EU system but not the UK system, and hence the protection provided under the EU system cannot be replicated by simply granting a right under the existing UK system. Accordingly, any unregistered design protection that exists under the EU system will be automatically replaced by a new UK “continuing unregistered design” that will provide equivalent protection for the remaining term of the EU right. The UK is also creating a new unregistered design right called “supplementary unregistered design” that will provide protection equivalent to the EU system and therefore will ensure that all forms of unregistered design protection that are currently available will continue to be available in the UK following the end of the transition period.

In addition to the above, the EUIPO, which administers EU trade mark and design rights, will no longer accept representation by UK representatives following the expiry of the transition period. However, we will of course still be able to handle EU trade mark and design matters via our international network of associates.

Because of this, from 1 January 2021 the UKIPO will require a correspondence address (i.e., an “address for service”) in the UK (which for these purposes includes the Isle of Man), Gibraltar or the Channel Islands. Accordingly, parties not based in the UK will require a representative with a UK address in order to file UK patent, trade mark and design applications or challenge or defend a UK IP right in proceedings before the UKIPO, such as opposition, invalidation, or revocation proceedings.

If you have any questions about intellectual property protection in the UK or Europe, please call us on +44 (0)115 947 7977 or email contact@adamson-jones.co.uk

www.adamsonjones.co.uk

For daily lifescience news visit www.lifescienceindustrynews.com 43

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VA L U E E N G I N E E R I N G

Following the success of the first 6 conferences, the 7th International Conference on Bio-Sensing Technology will be back in Europe and will continue to bring together leaders from industry and academia to exchange and share their experiences, present research results, explore collaborations and to spark new ideas, with the aim of developing new projects and exploiting new technology for bio-sensing applications.

Deadlines Abstract submission deadline: 17 December 2021 Author notification deadline: 23 February 2022 Author registration deadline: 25 March 2022

www.elsevier.com/events/conferences/international-conference-on-bio-sensing-technology

Develop and grow your business with the help of Medilink Midlands www.medilinkmidlands.co.uk

Business Development

Market Research

Accessing The NHS

Funding & Finance

Medilink Midlands is part of the Medilink UK Network 46

Issue 18

Events and Training

Events Calendar 2021 May

July

October

10 - 14

5-6

5

11 - 14

6-7

6-9

Making Pharmaceuticals Coventry

Rehacare Düsseldorf, Germany

15

8

ChinaBio Partnering Form Shanghai, China and Digital

Sensor100 Cancer Diagnostic Technology Summit Digital

20

ABHI Spring Regulatory Seminar Digital

20

WEBINAR: IP: Four things you should be doing right now Digital

25

SEHTA Finding Funding Webinar Digital

25 - 26

17th Annual Anglonordic Life Science Conference Digital

June 10 - 11 & 14 - 18 BIO Digital Digital

21 - 24

Arab Health Dubai, UAE

21 - 25

BioTrinity Digital and London, UK

28

ABHI Access Conference Digital

ON Helix Digital

ABHI Digital Health Conference Digital

ABHI IVD Regulatory Seminar Digital

13 - 15

BioJapan Pacifico Yokohama, Japan

September 1-3

25 - 27

FIME Miami, USA

BIO-Europe Stockholm, Sweden or Digital

6 - 17

LSX Nordic Congress Digital Medical Fair Thailand Bangkok, Thailand

14 - 15

Africa Health Johannesburg, South Africa

November 15 - 18

MedFIT Grenoble, France

Medica 2021 Düsseldorf, Germany

16

ABHI Procurement Conference Digital

20 - 23

22

ABHI Regulatory Conference Digital

BioPharm America Digital

20 - 24

Life Sciences Baltics Digital Forum Digital

27 - 29

The Med-Tech Conference Digital

28 - 29

30

27 September - 1 October

Medilink Midlands Business Awards Digital

26 - 28

8 - 10

29

Medilink Midlands Innovation Day Digital

SEHTA International MedTech Expo & Conference London, UK

Med-Tech Innovation Expo Birmingham, UK BioSpain Pamplona, Spain

For daily lifescience news visit www.lifescienceindustrynews.com 47

DISCOVERING HEALTH TECHNOLOGY

Partnerships achieve more Written by the sector, for the sector. In print and online, Lifescience Industry magazine is supported by some of the UK’s most respected medical organisations.

Partner organisations National & Regional Partners

Medilink UK Partners Medilink Midlands BioCity Nottingham Pennyfoot Street Nottingham NG1 1GF Tel: +44 (0)115 822 3154 www.medilinkem.com 4 Greenfield Crescent Edgbaston Birmingham B15 3BE Tel: +44 (0)121 452 5630 www.medilinkwm.co.uk Medilink South West c/o Institute of Bio-Sensing Technology University of the West of England Coldharbour Lane Bristol BS16 1QY www.medilinksw.co.uk

48

Medilink North of England Hydra House Hydra Business Park Nether Lane Sheffield S35 9ZX Tel: +44 (0)114 232 9292 www.medilink.co.uk Workplace Churchgate House 56 Oxford Street Manchester M16EU Tel: +44 (0)7734 383 407

MediWales The Maltings East Tyndall Street Cardiff CF24 5EA Tel: +44 (0)29 2047 3456 www.mediwales.com South East Health Technologies Alliance Lancaster’s West End Lane Henfield West Sussex BN5 9RB Tel: +44 (0)7905 201857 www.sehta.co.uk

BioPartner UK 16 Old Queen Street London SW1H 9HP Tel: +44 (0)20 7193 7815 www.biopartner.co.uk ABHI Suite 2, 4th Floor 1 Duchess St London W1W 6AN Tel: +44 (0)20 7960 4360 www.abhi.org.uk