Lifescience Industry Magazine Issue 19

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Issue 19 2020


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

Future Watch

Clinical Need

Going Global

People & Places


New technology and innovations

Meeting unmet clinical needs

Cracking international markets

Influential people and places in the industry

Updates and expert 1 advice


InterSystems makes your data healthy so it’s accessible, useable, and ready for action.

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




Hospital Direct signs exclusive distributor agreement for infection control solution

T cell immunity test developed for COVID-19

Producing next-generation material for PPE

An observation of COVID-19 through a regulatory lens



Lifescience Industry is now online – visit for the latest news

A message from the editor Welcome to Lifescience Industry magazine This edition focuses on how companies across the UK have responded to COVID-19, from development and adoption of new technologies to a look ahead at the sector’s future.

working on diagnostic tests, advanced PPE, digital tools and infection control solutions to tackle COVID-19. It also features companies which have adapted their businesses, formed new partnerships and supported the global mission to fight the pandemic.

Reflecting the current landscape, this edition of Lifescience Industry puts a spotlight on companies which have been

Aside from COVID-19 stories, this edition includes new innovations for mental health treatment,

peritonitis detection and epilepsy management. Meanwhile, regulatory experts offer guidance on topics such as the UKCA mark, patient data collection and clinical evidence.

Sophie Davies Editor

Future Watch

Clinical Need

People & Places

Going Global

9 T cell immunity test

18 New approach to diagnosis

26 How the Midlands has

34 Nottingham company lands investment to

10 TranQuality wins Innovate

19 Collaboration delivers

27 Discovery and development of

35 Providing technology to fight COVID-19 in

developed for COVID-19 UK grant to develop AI for mental health treatment

11 Breath test for COVID-19 undergoes clinical trial

12 Consortium to develop

new system for peritonitis detection

13 Producing next-

generation material for PPE

14 Recruitment begins

for innovative patient monitoring study

and management of epilepsy COVID-19 test kit in record time

20 Bringing to life NHS

responded to COVID-19 Issue 5

new therapeutics during the pandemic

28 Launch of personal handheld

expand its share of neonatal health tech market 2012 ISSUE 4


36 Delivering molecules for COVID-19 research in

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distributor agreement for infection control solution

veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea Medicines Manufacturing commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur orem ipsum dolor Innovation Centre 47 Online Events Calendar sit amet, consectetur adipisicing elit, sed do eiusmod tempor incididunt ut labore et dolore magna aliqua. Ut enim ad minim veniam, quis nostrud exercitation ullamco laboris nisi ut aliquip ex ea commodo consequat. Duis aute irure dolor in reprehenderit in voluptate velit esse cillum dolore eu fugiat nulla pariatur. Excepteur sint occaecat cupidatat non proident, sunt in

Published by Teamworks. Editor: Sophie Davies, Executive Editor: Gwyn Tudor, Advertising Sales: Art direction: Lee Gillum. Produced by MediWales for Medilink UK 7 Schooner Way, Atlantic Wharf, Cardiff CF10 4DZ Designed by Teamworks Design & Marketing Tel: 029 2047 3456 Web: Contact: The views expressed in this publication do not necessarily represent the Editor: Jess Fisher opinions of individual partners unless explicitly © Teamworks. 2020

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


Advertising: Charlotte Tyson

The future of the UK’s life science industry post COVID-19 As 2020 comes to an end, most of us will be glad to see the back of a totally unprecedented year. At the start of 2020, global markets were growing and the investment market in life sciences was in good health. Investors were backing advanced therapeutics (ATMP), precision medicine and diagnostics, digital healthcare and AI. But even at that time, there were warning signs that COVID-19 was approaching. Health technology companies were needed to respond to the COVID-19 challenge. Manufacturers of products as diverse as masks and gowns, hand sanitiser, in-vitro and point of care diagnostics, ventilators and respiratory products, and digital tracking and monitoring faced unprecedented demand. The urgent need for supplies encouraged numerous companies new to the sector to pivot their production facilities in an attempt to support the NHS. They also had to meet this challenge while keeping their own workforce safe. Not all health technology companies experienced unprecedented demand. Many PPE, digital, diagnostics and respiratory products were selling stock as fast as they could manufacture, but other companies (those

involved in scheduled procedures that were being cancelled and postponed across the country) had to meet a very different challenge, to ensure their businesses would be in good health when the NHS restores normal services. In September, Lifescience Industry held its first Spotlight event – showcasing how the life science and health technology sector has worked, collaborated and persevered to meet the challenges presented by COVID-19. The national and regional trade associates and networks who make up the partners behind Lifescience Industry led the event. During the early days of the pandemic, these organisations provided vital contact with UK manufacturers through daily liaison with the NHS, UK and devolved governments, in some cases through

full-time secondment of key staff. Between them, they coordinated thousands of offers of critical PPE, testing and medical technology supplies, and brought together businesses from across the UK to collaborate on the development of new essential products, new supply chains and support for companies who were new to the health technology sector. They provided business support, guidance and grant support, and also delivered events and publications to showcase the remarkable efforts made by UK manufacturers during the pandemic. The Spotlight event focused on some of the numerous examples of companies which have delivered critical solutions at the pace required. Sensyne Health presented their successful

Expert opinion: Kevin Kiely, CEO of Medilink UK

Nick Rodgers, Chair of SEHTA

Andrew Davies, Digital Health Lead at ABHI

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

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

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

As many countries were chasing the same suppliers, the UK needed to exploit its existing manufacturing capabilities to increase its level of self-sufficiency in the production of strategically important products e.g. PPE, ventilators, diagnostic test kits and vaccines. In certain instances, this required manufacturing companies in other sectors to repurpose their production almost overnight. Put simply, the UK was too reliant on a globalised supply chain, which hampered our response. To learn from this experience, we need to better understand our manufacturing and supply chain capabilities, identify potential risks and vulnerabilities, and use these insights to inform decision making and optimise future investment in UK manufacturing.


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

The use of technology in monitoring patients with long-term conditions has also improved. We have seen the creation and adoption of platforms that support remote video consultations, with multi-disciplinary teams if required, and virtual tools, all linked through to the patient’s record and data. Increasingly sophisticated, these platforms can integrate vital sign monitoring devices and highlight any decline in a patient’s status, enabling clinicians to intervene early and remotely, before a need for admission. This use of virtual platforms is certainly one that will endure beyond COVID-19. By providing access to care outside of the hospital, and empowering patients to better self-care through access to their own results, the move will lead to fewer unnecessary A&E visits, an improved patient experience and a reduction in the overall cost to the health system.

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

Looking ahead to the post COVID-19 landscape, our partner networks and their members, who make up the UK’s medical technology, diagnostics, pharmaceutical and digital health sectors, have stressed the need to retain and build on the accelerated development and adoption of products and digital solutions seen during the crisis. They see a need to reshore the lost manufacturing capability of critical supplies back to the UK, in order to ensure the continuity of supplies, as well as a need to build in resilience throughout the supply chain of critical supplies and specialist expertise. They are unanimous in believing that the contribution UK manufacturers can make to the continued health of our NHS supply chain needs to be properly recognised as part of the procurement process. Our sector is at a crossroads. The

choice: return to pre COVID-19 practices, or grasp the opportunities that now appear far more achievable to accelerate product development, trials and adoption, and to support and nurture a strong, robust, indigenous manufacturing base.

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

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

Cari-Anne Quinn, CEO of Life Sciences Hub Wales The life sciences sector can take pride in its response to tackling the COVID-19 pandemic. The widespread collaboration, innovative thinking and agility has highlighted the best of what our industry can offer. While the outbreak has delivered unprecedented challenges, the truth is that our health and social care system faced pressures long before its arrival,

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T cell immunity test developed for COVID-19 Cardiff-based Indoor Biotechnologies Ltd has been awarded funding from Innovate UK to develop a new type of test for COVID-19.


dentifying people who have already been infected with the virus and become immune could have huge benefits for enabling society to safely return to normality. However, since the symptoms of COVID-19 can vary from person to person, and some people display no symptoms at all, reliable testing methods for prior infection and subsequent immunity are vital. One way of determining whether someone has been infected with the virus is by looking for specific antibodies in blood samples. Numerous antibody tests exist, but doubts remain about their reliability in determining whether a person has gained immunity, as well as more recent concerns about their longevity post infection.

Long-term protection against viruses comes not only from antibodies, but also from cells of the immune system including T cells, which play a critical role in controlling and eradicating viral infections. The new test developed by Indoor Biotechnologies Ltd is a different type of immunity test, focusing on T cells rather than antibodies. The simple cellular immunity test can identify the presence of T cells that respond to the virus which causes COVID-19 from a single tube of blood, within 24 hours.

In addition to assessing immunity status, the test may also be valuable during vaccine development to help identify whether an adequate immune response has been generated to protect people from COVID-19, and for testing how long that immune response remains.

The test is designed so that it can be easily used by labs across the world, enabling mass testing of COVID-19 T cell immunity to be performed. It also has the potential to be more sensitive and more reliable at determining immunity than antibody testing.

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Future watch

TranQuality wins Innovate UK grant to develop AI for mental health treatment TranQuality has been awarded an Innovate UK grant to develop AI capable of identifying depression and anxiety in brain activity. Currently, the company uses cognitive neuroscientists to analyse brain activity captured by an Electro Encephalogram (EEG), but they believe that AI could take on a significant amount of that work in the future.


oor mental health is the single largest cause of disability in the UK and one in six people experience a mental health problem each year. The total economic costs of mental illness through lost productivity has been estimated at £105.2 billion each year and treatment accounts for more than 10 per cent of the annual NHS spend. TranQuality provides mental health assessment and treatment programmes for the NHS and private patients with clinical depression and anxiety as well as companies. For patients, it uses EEG to identify specific areas for treatment using Transcranial Magnetic Stimulation (TMS). TMS stimulates neurons in the brain through an electromagnetic field that reduces or reverses an individual’s symptoms.

“This Innovate UK funding will allow us to explore and implement AI technology, which has seen a significant interest in healthcare. This could be a step towards a more personalised treatment of mental health conditions, addressing the mental wellness of each patient individually, which is important as everyone deals with it so differently. Our mission is to support clinician analysis and treatment to reduce its cost to below £1,000 per patient. AI development has started well, and a successful solution would help an EEG targeted TMS become more affordable and accessible across the UK and globally.” Bernard McMahon Chairman TranQuality Solutions Ltd

TMS is often used when conventional drug and talking therapies are not working effectively or have stopped working completely. The treatment is approved by the National Institute for Health and Care Excellence (NICE) and is non-invasive, painfree and has no known side effects.

The standard TMS approach requires around 20 to 30 sessions, and costs between £4,000-£8,000 per patient, which is limiting its adoption as a mainstream treatment. TranQuality has reduced the cost and number of sessions by targeting the TMS using a patient’s EEG. An AI support tool could further reduce treatment length and cost. TranQuality is a key partner of the Beingwell Group, a family of wellness companies providing solutions across mental health, cognitive fitness and sleep. It opened its newest clinic in the North of England in January 2020. The company has wider clinics in Humberside and has an online platform that enables individuals to check and monitor their mental health at regular intervals to maintain good mental wellbeing and to better understand their mental health.


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Future watch

Breath test for COVID-19 undergoes clinical trial Exhalation Technology has announced the start of a large clinical study with its novel CoronaCheck diagnostic test for COVID-19 in exhaled breath condensate.


he company, based in Cambridge, has used its expertise in exhaled breath diagnostics to develop CoronaCheck. This is a rapid antigen test (aiming for a result in under five minutes) of high specificity and sensitivity for COVID-19, meeting the need for efficient and accurate testing in a wide range of environments including hospitals, airports, retail outlets, schools and similar spaces. Before the initiation of clinical trials in the UK, the test has shown promising results on the laboratory bench. Exhalation Technology has now opened its human clinical trial programme for CoronaCheck at the Clinic for Respiratory Medicine, based in The Queen Alexandra Hospital, Portsmouth. This will enable a cohort of 300 patients to be tested in a blinded, ethics-approved clinical trial on infected and normal patients. The company is also seeking one or more global strategic partners with which it can collaborate to exploit its new COVID-19 test.

CoronaCheck is an IP-protected test for rapid detection of Severe Acute Respiratory Syndrome CoronaVirus 2 (SARS-CoV-2 also known as COVID-19), using a novel biosensor housed in a safe breath analysis device which is suitable for rapid point-of-care coronavirus testing. The test measures directly the presence of virus in breath, as opposed to antibodies in the blood.

The test is aimed to be available at under £8 or $10 per test. It has safety features to prevent cross-infection and contamination, and it does not require any laboratory equipment or special handling or training. The biosensor is mounted in a test cartridge which is inserted into the device. The subject breathes into this, with results obtained in minutes, after which the test cartridge is safely discarded and the device is then ready for a new test cartridge and subject.

“Initial results from patients recruited into our clinical study are very promising. Our CoronaCheck test is set to provide novel technology for high volume screening of individuals in a range of environments. The technology is entirely innovative and our initial test is based on rapid testing in exhaled breath, a simple and convenient means of sample collection. Our collaboration with Imperial College in London and clinical centres in the UK is providing rapid proving and validation of this novel approach to COVD-19 testing.” Helle Funch Nielsen CEO, Exhalation Technology

Stig Lytke Brejl, Director of Exhalation Technology, commented that “building on an existing CE marked IVD medical device platform is expected to enable a short time to market while at the same time de-risking the project significantly.”

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Future watch

Consortium to develop new system for peritonitis detection Medilink East Midlands patron Datalink Electronics has joined forces with MicroBioSensor and Smallfry for a £1.7m grant funded project. The project will be focused on the development of an electronic test system that can rapidly detect peritonitis in vulnerable patients with kidney or liver failure and identify the effective antibiotic for its treatment.


atients with advanced kidney disease, who are reliant on peritoneal dialysis (PD), as well as advanced liver disease patients with liver cirrhosis, are both at risk of life-threatening infection in the abdomen, referred to as ‘peritonitis’. This develops quickly and typically requires hospital admission.

The choice of antibiotic therapy has to be made by doctors ‘blind’, based on an educated guess. After around four days, antibiotic susceptibility information arrives from the hospital’s centralised microbiology laboratories. Frequently the choice of antibiotics needs to be modified, but by then the infection may have progressed appreciably, in many cases fatally, and most patients are extremely ill. Managing these patients is very expensive for healthcare providers, with this exacerbated as PD patients must permanently switch to more expensive haemodialysis. MicroBioSensor, the lead partner, develops products to miniaturise and speed up conventional high-quality hospital

microbiology tests. These are made available in a simple and inexpensive form for use at the bedside with vulnerable patient groups. They have previously developed a device (QuickCheck) to screen for peritonitis in the homes of PD patients, where the therapy is normally carried out.

There is an urgent need for doctors managing these critically ill patients to rapidly and reliably obtain antibiotic sensitivity information. The consortium has a significant track record in the area and has been awarded the Smart Grant by Innovate UK to develop the system.

Datalink Electronics is an award-winning, ISO13485 accredited, contract electronic product design and manufacturing company, with an extensive track record in

a variety of industries including medical devices, rail, oil and gas, and scientific instrumentation. They work closely with leading-edge companies, universities and start-ups in order to turn state-ofthe-art technology and research into commercial products. They provide a flexible and comprehensive service offering, including feasibility study, design, development, prototyping, certification support and full-scale production. Smallfry is an industrial design and engineering consultancy. Their scope of work covers the complete concept-tocommercialisation process. Operating globally, they offer research, innovation strategy, marketing, industrial design, engineering, prototyping, production ramp-up and 50 years of experience to deliver market-leading products and services across the consumer, industrial, FMCG and medical sectors.


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Producing next-generation material for PPE Hybrisan is using advanced nanotechnology to produce a new material, impregnated with liquid sanitiser, for use in personal protective equipment (PPE).


ybrisan Surface + Hands is an aqueous solution for the disinfection and sanitisation of surfaces and hands. The novel composite biocide is the result of extensive collaboration between industry and research experts. The product offers several advantages in comparison to conventional biocides and alcohols, including its non-hazardous nature, its resistance to organic foulants, and its non-corrosive properties. Having conducted research in collaboration with Swansea University, the Welsh company has tested and proven that the product can not only control planktonic bacterial loads, but also prevent the colonisation of surface infrastructure. As a result, it is capable of preventing and re-mediating fouling of the system, without compromising vulnerable infrastructure components. Another unique attribute of Hybrisan Surface + Hands is its disruption of biofilm, which enables the product to give ongoing protection

between applications, where traditional biocides do not. It has been proven effective against all enveloped viruses, including SARS-CoV2.

The sanitiser liquid is highly effective in killing coronavirus without alcohol, even on surfaces. It can also be used with advanced nanotechnology to produce advanced material for use in high quality PPE. The company’s nextgeneration facemasks offer significant benefit to the NHS in terms of cost, safety, comfort and environment, as there is less waste to landfill.

Hybrisan is a team of antimicrobial specialists, engaging in cutting-edge research and development to bring products to the

market for a range of industrial and medical requirements. One area of focus is the wound care market, which they aim to revolutionise with a novel antimicrobial dressing for chronic wounds. During the pandemic, the company diverted its efforts to increase the production of its Hybrisan Surface + Hands product and its reusable facemasks, working in partnership with Gwalia Healthcare. This involved developing a new range of products, including scents, and adding a gel to the range. Having developed an electrospinning recipe, which allows the sanitiser liquid to be spun by a cutting edge machine into ultrafine fibres (nanofibres), Hybrisan is working closely with Welsh Government and other PPE manufacturers to further scale up production of electrospun filters for use in facemasks. The company has also used venture capital to purchase a new electrospinning machine, enabling them to scale up manufacturing of facemask filters.

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Recruitment begins for innovative patient monitoring study Aptus Clinical Ltd has started recruitment for the COSMIC-19 study, which they believe will help transform and shape clinical trial monitoring in the future.


he COSMIC-19 study (COntinuous Signs Monitoring in Covid-19 patients), sponsored by The Christie NHS Foundation Trust in collaboration with Manchester University Foundation NHS Trust, utilises advanced AI capabilities provided by Zenzium. Aptus Clinical is providing specialist Data Management and Clinical Operations support, enabling compliant data handling and aggregation infrastructure.

The COSMIC-19 pilot study aims to recruit 60 inpatients who are suspected or confirmed as having COVID-19. Each patient will have vital signs and observations monitored using advanced wireless wearable sensors, with Zenzium’s proprietary AI technology used to retrospectively look for predictive patterns in the patients’ vital signs which could be used

to alert the medical team if the patient is deteriorating. If the prediction indicates that the patient needs critical care, the medical team could then potentially intervene earlier, giving patients the best chance of recovery. Steve McConchie, CEO of Aptus Clinical, said: “We are delighted to have provided clinical operations support for this important and transformative clinical trial. Working with the NHS and AI partners, we have developed a novel data sharing system that compliantly integrates biosensor data from patients with their clinical data and transfers it seamlessly to Zenzium for analysis. We are confident that the infrastructure we have built in Manchester can be easily applied to ensure future clinical trials benefit from these AI driven insights, and ultimately lead to better therapies for patients.”

“Unfortunately some patients who are suffering from COVID-19 on our hospital wards can become seriously unwell. By using this system, we hope to be able to identify these patients early and this may mean we can optimise their management without the need for them to go to intensive care.” Professor Fiona Thistlethwaite COSMIC-19 Principal Investigator Medical Oncologist The Christie

“This technology is a glimpse of how we will monitor hospital patients in the future and it’s fantastic that MFT and The Christie are frontrunners in such innovation.” Dr Anthony Wilson Intensive Care Consultant Trial Coordinator, MFT


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How can Wales futureproof its healthcare system? Cari-Anne Quinn, CEO of Life Sciences Hub Wales, discusses the challenges that healthcare and social services in Wales will face over the next decade, exploring what needs to be done to address them and ensure people continue to live longer, happy and healthier lives. Prior to the arrival of Covid-19, it was all too easy to overlook how fortunate we are here in the UK. We have a dedicated healthcare service, staffed by top clinicians, caregivers and researchers who are striving to keep us living as healthily and as long as possible. What was even easier to overlook is the fact that, as well as frontline staff working daily to protect our health, we also benefit from an entire industry dedicated to developing the next generation of healthcare solutions. While Covid-19 has brought unprecedented challenges, the truth is that the challenges our healthcare system faced before its arrival have not gone away. Wales is home to an array of innovative companies working hard to develop new technologies and practices that will not only address the problems of today, but ensure that our healthcare system is prepared to meet our future needs as well. It is a massive undertaking, but if this year has shown us anything, it is that the Welsh life sciences sector’s ability to innovate can match that of the global leaders. Life Sciences Hub Wales exists to accelerate the development and adoption of innovative solutions for better health and wellbeing. This will prepare our health and social care system for rising patient numbers, fiscal pressures, the complexities brought by an ageing population and the need to tackle social isolation. One thing is for sure – we need to rethink how we approach healthcare delivery. At Life Sciences Hub Wales, we believe that futureproofing Wales’ health and social care system requires a concentrated effort to develop and roll out innovative solutions targeted around five key areas – digital and artificial intelligence, advanced therapies, precision medicine, healthy ageing and value based healthcare.


Digital, Artificial Intelligence (AI) and Robotics Embracing artificial intelligence (AI) and machine learning (ML) is starting to unlock enormous resources of real-world data that will transform how our healthcare is planned and delivered. Today, data is potentially our most valuable asset when working to improve patient centred outcomes, with applications in fields such as medical imaging analysis, patient medical records and genetics. Take radiology for example – AI systems can interpret X-ray images much quicker than humans, immediately identifying abnormalities that need further human investigation. Such technology will not replace clinicians; instead it will allow them to focus on more complex cases, speeding up diagnosis and treatment. As a result, forging such a partnership between clinicians and AI systems could help address the current shortages of radiologists. Going forward, AI in healthcare will become the norm. However, we are not quite there yet. While we are starting to see AI used within clinical settings, we are not at the stage of seeing it used daily across the country. With so many new AI innovations vying for support against the context of limited resources, deciding which products to scale up will be a key challenge in speeding up AI’s development and adoption. It’s also crucial to remember that data used by AI and connected systems will be the personal data of patients, so safeguards must be in place to ensure it is used both confidentially and ethically.

Advanced Therapeutic Medicinal Products Advanced Therapeutic Medicinal Products (ATMP), which include treatments like cell and gene therapies, are set to transform care pathways for a range of conditions, by providing the ability to repair, replace, regenerate and re-engineer genes, cells and tissues to restore normal function. We are seeing impressive developments in 3D printing of tissue made from human cells, which could have huge implications for facial reconstructive surgery, as well as in the battle against cancer. Two lymphoma patients in Cardiff were recently treated by genetically modifying their immune cells to recognise and destroy cancer cells, offering hope for a one-size-fits-all treatment.

As it stands, Wales isn’t set up to adopt advanced therapies on a large scale as we do not have the resources, infrastructure or sufficiently skilled workforce in place to support them. Bridging the gap between research and treatment will enable cuttingedge transformative therapy development and use in our health services.

This approach – known as ‘precision medicine’ – will enable clinicians to develop personalised treatment plans that are the best fit for individual patients, as opposed to testing numerous options. This will not only improve patient experiences and recovery rates but will bring economic benefits by eliminating the use of unnecessary treatments.

In Wales, over 1000 companies are working in this area, with over 1,100 ATMP products currently used in clinical trials. Estimates suggest we will see 20-40 new therapies licensed by 2025. By 2030, we will be able to design, develop and administer ATMPs much faster and cheaper, with ‘off the shelf’ therapies immediately to hand. Therapies will be more widely available in Welsh hospitals and used as ‘first line’ treatments rather than a ‘last resort’.

Precision medicine is set to grow enormously but its wider roll out will be dependent on clinicians having access to full patient medical data, both on an individual and population level, to inform their decisions on diagnosis and treatment. Harnessing AI and digital technology will be necessary to make this happen.

Precision Medicine Clinicians have access to a huge array of treatment options for conditions, but certain treatments aren’t guaranteed to work for all patients. As well as potentially being detrimental to a patient, ineffective treatments can waste valuable resources. What people may not realise is that a person’s genetic makeup can have a huge impact on whether a treatment is successful, with some drugs only effective in people with certain specific gene mutations. The good news is that advances in genetic testing are providing clinicians with a clearer indication of the success rates of treatments for certain patients

Healthy Ageing By 2030, one in four people in Wales will be over 65 – that’s an estimated 700,000 of us. Our ageing population is perhaps the most pressing issue facing our NHS. We must adopt new technology and processes that will help people stay healthy, happy and active for as long as possible. The goal is to delay the need for additional care as we age, but as well as helping individuals maintain physical health, Wales’ health and social care services need to guard against the very real risk of loneliness and social isolation, which is all too common in later life. Across Wales, businesses, social enterprises and researchers are developing approaches and products to support healthy ageing and combat cases of loneliness and social isolation. These factors are often associated with higher rates of emergency admissions, rehospitalisation and earlier entry into care homes.

Encouraging continued collaborations between technology developers and health and social care providers will be key to ensuring cuttingedge solutions are not only developed but implemented.

Value Based Healthcare A value based healthcare system will transform how we plan, deliver and pay for treatment across health and care in Wales. Unlike the current fee-for-services and products, where care providers pay for treatments regardless of their effectiveness, a value-based system sees developers and pharmaceutical companies paid if their product successfully improves patient’s health outcomes and experience. This transition will require a major shift in how the NHS and wider industry operates, which takes time and investment. It also raises issues of data sharing, so building trust and collaborative partnerships will be crucial to transitioning to a value-based system. However, it’s vital that we focus on what such a system will deliver. It will allow patients to make better informed decisions and access information on likely treatment outcomes, based on data that comes directly from patient feedback. This will lead to a better understanding of costs and outcomes in health and social care, as well as improved knowledge on how best to allocate resources. Our organisation will continue to support industry to understand and develop approaches that enable value-based innovation development to effectively meet the needs and approaches of patients, and health and care in Wales.

Life Sciences Hub Wales is committed to continuing to support the acceleration and adoption of innovation across health and social care. To find out more, visit: 17

Clinical Need

Beyond observation towards prediction: New approach to diagnosis and management of epilepsy John Terry (co-founder and managing director) and Chrissie Walker (operations director) from Neuronostics explain why there is a need for new ways of diagnosing and managing epilepsy.


ver 600,000 people in the UK have epilepsy, a neurological condition characterised by recurrent seizures. Seizures are abnormal discharges of electrical activity within the brain, which typically occur infrequently and seemingly at random. Epilepsy is difficult to diagnose and hard to treat – on average it takes over a year to diagnose, misdiagnosis rates are more than 30 per cent, and over half of people still have seizures a year after beginning treatment. Epilepsy also results in significant economic, social and personal cost. Having uncontrolled epilepsy reduces educational outcomes, employment opportunities and productivity, with salaries of people with epilepsy being on average 10 per cent lower than the median. It is estimated that epilepsy costs the NHS around £2bn per year. Currently, the gold-standard for epilepsy diagnosis is for a clinician to observe seizures, or other abnormal brain activity, using an EEG: a clinical device that measures electrical activity of the brain. Approaching 70 per cent of the first EEG recordings taken when assessing people for suspected epilepsy show no abnormal activity. This means, for the majority of people, repeated visits to hospital for progressively longer term monitoring. These delays increase the length of time before people with epilepsy are appropriately treated, create stress and uncertainty, and result in higher costs for the healthcare system. At Neuronostics, we are developing a full stack platform to provide decision support to healthcare professionals – improving speed, accuracy and objectivity of diagnosis and treatment of epilepsy. Our technology uses patented algorithms to interrogate EEG recordings generating the first digital biomarker of epilepsy, which we term #BioEP.

#BioEP works as follows: 1. Routine clinical data recordings (such as EEG) are uploaded directly to the BioEP clinical platform. 2. Algorithms use these recordings to create an in silico model of the brain. 3. The model is used to understand under what conditions seizures can emerge. 4. These inform a risk score of epilepsy that provides decision support for diagnosis.

Critically #BioEP is not reliant on observing seizures. Instead our technology utilises segments of seizure-free data. Key to this are algorithms that can extract these seizure-free segments of data automatically. This minimises the burden on the healthcare professional and enhances the objectivity of the risk score provided. By revealing the risk of seizures from the very first EEG, #BioEP improves the diagnostic yield of EEG and can reduce the time taken to make an accurate diagnosis.

At present there are no prognostic markers for epilepsy. Treatment outcome is essentially a case of “watchful waiting”. The #BioEP seizure risk score offers the potential for change. From EEG recordings collected prior to, and post administration of, drug treatment, variation in the #BioEP score provides a quantitative measure of response to medication. This can rapidly reveal successful treatment or highlight cases where medication is ineffective. The #BioEP seizure risk score is based upon clearly defined equations, informed by clinical data. This means that, unlike many other AI approaches in healthcare, our risk score is transparent, providing reassurance and certainty to both healthcare professionals and people with suspected epilepsy alike. We passionately believe in a future where epilepsy can be diagnosed quickly, and successful treatment identified, without the need to observe seizures.


Issue 19

Clinical Need

Collaboration delivers COVID-19 test kit in record time The Binding Site has launched a new test to detect COVID-19 antibodies in people with recent exposure who are asymptomatic or have mild symptoms. the test in a non-hospitalised population that had mild symptoms, which is the largest target population for COVID-19 testing. We designed the testing kit so it can be used by any laboratory in the world.” The test was developed using over 800 blood samples taken from people who had mild to moderate disease, including over 100 samples from healthcare workers in Birmingham. The test is already being used in many of the clinical studies conducted at Birmingham hospitals, and is expected to be rapidly adopted by surveillance teams seeking to understand the distribution of infection in the population, as well as vaccine researchers who need to assess antibody responses in clinical trials.


ith the focus on mild non-hospitalised patient blood samples, the SARSCoV-2 Antibody ELISA assay was developed in partnership with the University of Birmingham’s Clinical Immunology Service, with the initial antigen being provided by the University of Southampton. This latest development is a natural progression for The Binding Site, utilising its knowledge of 35 years in developing highly precise, accurate blood tests that affect the immune system. The Birminghambased company already produces over 35 million IVD tests per year for sale globally and expects this UK manufactured product to be in high demand.

The new test specifically detects antibodies (IgG, IgA, and IgM) to the SARS-CoV-2 trimeric spike protein, which is an important protein for the virus infectivity. Targeting IgG, IgA and IgM, the assay will cover all the immunoglobulins which are vital in the body’s fight against the virus. These three antibodies appear at different times after infection. The test was

designed to detect all three, to increase detection at the earliest possible stage after exposure to the virus.

Charles de Rohan, CEO of The Binding Site, commented: “The long-standing partnership with the University of Birmingham has brought together unrivalled academic, clinical and commercial expertise, and the combined team worked together seamlessly and quickly to deliver this unique and forward thinking test in record time.”

“Humans make three types of antibodies – Anti-IgM, IgG and IgA. IgM tends to appear first, and IgG and lgA tend to appear later. By combining all three, The Binding Site test is able to detect COVID-19 infection in people who have only recently been exposed, or who have mild symptoms.”

Professor Alex Richter, Professor of Clinical Immunology at the University of Birmingham, who led the team that identified the antibodies to the spike protein, added: “There are two things to get right in an antibody test – which antibodies are we looking for, and what are they recognising? Testing for IgM, IgG and IgA antibodies to the spike protein should give an advantage in terms of early and accurate detection of people with recent exposure who are not showing symptoms.”

Professor Adam Cunningham University of Birmingham

The CE-marked ELISA test is simple to use and provides up to 93 test results in 60-90 minutes. Dr Stephen Harding, Chief Scientific Officer at The Binding Site, said: “We set out to develop a test with the University of Birmingham that would detect COVID-19 early, and validated

The Binding Site has provided free kits to support work in developing countries where the disease continues to spread quickly and is impacting on children through Paediatric Multisystem Inflammatory Syndrome (PIMS). The test has been submitted for rapid FDA approval and is expected to be available in quantities of over 2 million tests per month.

For daily lifescience news visit 19

Clinical Need

Bringing to life NHS breakthrough innovations for anaesthesia, airway and critical care In the complex world of anaesthesia, airway and critical care, where people may be fighting life-threatening conditions, preventing harm and cross-infection remains important for both patient and clinician. This is particularly poignant at a time where the world is battling a highly infectious respiratory disease.


nnovation is becoming increasingly important as the healthcare industry faces unprecedented challenges, with efficient and successful outcomes forming the cornerstone of quality care.

Furthermore, the European Society for Regional Anaesthesia (ESRA) and the American Society of Regional Anesthesia and Pain Medicine (ASRA ) have recently released joint COVID-19 recommendations stating that regional anaesthesia – which avoids aerolisation – should be preferred if appropriate over general anaesthesia whenever surgery is planned for COVID-19 patients.

UK-based innovation development company Medovate is helping to bring to life pioneering medical devices – designed to improve care in anaesthesia, airway and critical care for patients across the world.

In enabling regional anaesthesia to be carried out as a one-person procedure, Medovate’s innovative system further helps to reduce the risk of viral infection amongst healthcare staff than the current two-person practice, as one less person is required for the procedure to be carried out.

Chris Rogers, Sales & Marketing Director, explains: “Medovate was established to provide the NHS with a structured pathway that is dedicated to developing and supporting clinicians’ innovations to market. We specialise in bringing together all of the aspects that are required for successful product development such as finance, expertise, proven experience, a robust quality system, and partnerships and networks.” “As a company, our vision is to improve patient care on a global scale. We do this by working with clinicians to develop pioneering technologies, with the potential to create real value and impact by addressing unmet clinical needs. Our goal is to identify and support high-value innovations at every step of the development pathway.” Medovate was spun out of the NHS in 2017 and was created to identify and develop high potential innovations within the NHS, providing vital expertise and funding to support these through clinical trials, regulatory approval and market launch. The company operates on a unique business model. With the NHS as a key partner, they offer direct benefits to the UK’s health system, supporting NHS innovation at the same time as delivering direct commercial benefits and reinvestment to the NHS. Today the company has established itself as a key player in the medtech industry for medical devices.

Based in Cambridge, Medovate recently brought to market their first medical device, SAFIRA (SAFer Injection for Regional Anaesthesia), developed in collaboration with NHS clinicians and designed to help make regional anaesthesia safer for patients across the world.

In current procedures, anaesthetic solutions can be inadvertently injected at high pressure, which can cause transient or even serious nerve damage. SAFIRA improves patient safety by preventing anaesthetic from being injected at high pressures, thus helping to reduce the risks of nerve damage.

With both European CE Mark approval and FDA clearance, SAFIRA can be readily integrated into markets across Europe and the US and other CE Mark territories across the globe. The class IIb medical device has been successfully launched in the United States. A major distribution partner for Europe, Vygon, has been secured, as well as distributors for Israel, Australia and New Zealand, with additional distributor discussion in progress. Chris adds: “Medovate has shown we can take an NHS idea from concept through to commercialisation, and there are many other innovations that we are looking at. While we continue to focus our efforts on the anaesthesia and care critical space, we have also recently taken on our first surgical device and are looking to build complementary products in the coming years and expand our global footprint.”


Issue 19

Clinical Need

Enhancing a COVID-19 test with digital capabilities Bond Digital Health explains how COVID-19 quickly demonstrated the need for connected diagnostics and accelerated the company’s development plans.


n January this year, before it had even been declared a global emergency by the World Health Organisation, we wrote about how the emerging coronavirus outbreak demonstrated the need for digitised rapid diagnostic tests. Within a month we were putting our words into practice, having joined a global consortium led by our Canadian partners Sona Nanotech to digitise their new rapid test for the virus and make it better with data. By this point we had been developing our white label platform, called Transform, for two years, and were due to launch it officially at an international trade show towards the end of 2020. But the coronavirus outbreak changed everything. We quickly realised that we would have to bring forward our development timeline if we were to add this invaluable functionality to Sona’s muchneeded test.

The new test is based on lateral flow technology, which is used in a wide range of human diagnostics, including for infectious diseases such as cholera, malaria and HIV. It can be administered at the point of use without the need for skilled technicians or additional laboratory equipment.

Sona’s test is a direct antigen test that looks for a specific coronavirus protein. Using a nasal swab sample, it produces results in 15 minutes. The test is currently under review for emergency use authorisation with Health Canada and the Sona Connect app, powered by Transform, was launched on the Google Play Store in September.

This is the test that governments and health authorities across the world want. It will have no competition in situations where quick and accurate information is needed – for example at airports, in the health service, going into work, etc. Testing is only one piece of the puzzle when it comes to COVID-19. We need to go beyond just testing and capture the data at the point of testing, manage it in the cloud and then geo-map the results visually. Only then will we stand a chance of controlling the spread of the virus in real time and deploying resources fast and effectively. That’s what Transform does. It’s a secure and compliant platform with end-to-end connectivity, which transforms traditional lateral flow devices into web connected diagnostics with accessible, shareable data. Adding this to diagnostic tests will allow valuable test data to be securely captured, stored, analysed and shared in real time. This could ultimately allow authorities to monitor the spread of this and future disease outbreaks. In April we received a huge boost to our efforts when we received £700,000 in equity funding that would allow us to hire additional technical and admin staff to help speed up

development of the technology. At the time of writing we’re currently in the middle of a follow-up investment round. 2020 has been a challenging year, but for Bond there has also been much to celebrate. At the start of the year we moved into our new offices at The Maltings in Cardiff – a new base for our growing team. During lockdown we recruited six new members of staff remotely, essentially building a new development team from the ground up. Our growth and innovation has led to a series of award nominations. In November we won the Innovation in Technology Award at the inaugural Wales STEM Awards, and we have been shortlisted for the Digital Engineering / Technology Award at the Insider Made in Wales Awards. We were also listed in BusinessCloud’s Wales Tech 50 2020, a ranking of the country’s most innovative technology companies. We knew that 2020 was going to be an important year for Bond Digital Health and our technology. But we could never have imagined that a global pandemic would be the thing to prove the urgent need for that technology. Alongside our partners, we’re proud to be playing our part in the global fight against this devastating virus.

For daily lifescience news visit 21

Clinical Need

Transforming data into actionable insights to tackle COVID-19 Paul Johnson, CEO of Radar Healthcare, explains how digital technology can help clinicians and carers to save lives in the context of COVID-19. Data is transformational Using technology more effectively can help save lives. From using data to analyse the efficacy of particular treatments, to prompting clinicians and carers to take a particular action at a key moment, utilising information in creative ways can be transformational for healthcare. We have seen these successes in our sector, from Google’s pioneering work to help doctors speed up the detection of Acute Kidney Injury through their ‘Streams’ app, to Babylon’s remote GP consultation software. Personal protective equipment (PPE) is no doubt a vital component for keeping doctors and patients safe. But focusing solely on PPE and ventilators as weapons for fighting infections is not enough to win the battle. Organised, real-time data is crucial in helping healthcare professionals to reduce the spread of infections and should be considered an essential frontline tool.

Pandemics are different Pandemics are unusual because there are so many complex data points: the rate of infection in the population and how that differs between settings; how the virus is being transmitted; which interventions are being made and how effective they are;

the list goes on. This information is often disparate and there are knowledge gaps at an organisational level. Resolving this would enable us to gain a full understanding of what’s happening regionally and nationally.

Information is our weapon At Radar, we transform data into actionable insights. We know safe environments exist where decision making is supported by real-time data. Clinicians and carers are more effective when outbreak workflows are automated, symptom information is communicated effectively and hazards are digitally audited. At regional and national levels, a range of infection control methods are used such as syndromic surveillance, which is useful but usually suffers from a time delay that can hamper the response. Decision support tools, like we provide, can significantly impact outcome likelihoods by putting patient management strategies in place. This is effective and based on organising information and identifying trends which may have otherwise been hidden. The role played by AI in COVID-19 to complement human intelligence has been significant, demonstrating the vital role of data

collection. Used correctly, the ability to collect and analyse data and use the results to initiate interventions is extremely powerful. Imagine a situation where an outbreak occurs in a nearby care home. Custom protocols can identify this event and trigger automatic interventions, like flagging to staff a requirement to suspend visiting and increase resident monitoring, helping carers to react in time to save lives.

Thoughts on the future The battle against a virus isn’t fought in Whitehall. It is fought in the hospitals, surgeries and care homes across the country. It is fought by nurses, practice managers, doctors and carers. The battlefields are the handles, hugs and hands, and we’ll need more than soap to win. We need information – it’s there, we just need to start collecting and using it. Global collaboration is needed for AI to make an impact on a higher level. We can be better prepared for future pandemics, respond better and contain outbreaks more effectively with the help of an innovationled approach that embraces data sharing. The key is to be brave and embrace the transformative potential of information.


Issue 19

Clinical Need

Restart for Cardiopulmonary Rehabilitation services Spirit Digital has announced that CCGs across the UK whose Cardiopulmonary Rehabilitation services were suspended during COVID-19 will be able to restart these services supported by its digital, remote monitoring platform, CliniTouch Vie.


s the government aims to substantially increase referral rates, CliniTouch Vie will enable clinical teams to remotely monitor patients’ progress with minimal impact on clinical caseloads and offer patients essential education and guidance within a home care setting. Patients with heart failure and certain lung conditions, such as COPD, asthma and bronchiectasis, or lung problems due to other conditions, may be referred to undergo Cardiopulmonary Rehabilitation, which is a supervised programme that includes breathing techniques, health education and exercise training. With respiratory disease in the spotlight, NHS England and NHS Improvement aim to increase the number of patients who would benefit from this treatment, by increasing referral rates to Cardiopulmonary Rehabilitation from 13 to 60 per cent by 2023. To support this expansion, the updated GP Contract includes a new Quality Outcome Framework incentive to encourage

these referrals, as well as the availability of targeted funding to support expansion of services. The CliniTouch Vie Cardiopulmonary Rehabilitation programme aims to help patients breathe easier, educate them on their condition, monitor their exercise and improve overall quality of life. Evidence has revealed that Cardiopulmonary Rehabilitation can support better patient self-management, with 90 per cent of patients who complete the programme having higher activity and exercise levels, and reporting an improved quality of life. Additionally, clinical studies have found that the treatment helps to reduce the number of exacerbations, acute and emergency admissions and primary care appointments.

“With cardio and respiratory disease identified as a national clinical priority within the NHS Long Term Plan, it’s more important than ever to ensure that patients with these conditions can continue to access their treatment programmes, while also facilitating increased capacity without adversely impacting clinical teams’ workloads. As a digital platform, CliniTouch Vie enables remote access to Cardiopulmonary Rehabilitation and collaboration between clinicians and patients, meaning more people can benefit from the treatment from the safety of their home, while still being monitored by their healthcare practitioner.” Simon Applebaum Managing Director Spirit Digital

For daily lifescience news visit 23

Clinical Need

Hospital Direct signs exclusive distributor agreement for infection control solution Hospital Direct (Marketing) has signed an exclusive distributor agreement with CopperTree Forensics for their innovative infection control solution, the CiFi Torch.


he CiFi Torch is one of the most powerful high-quality LED forensic light sources currently available on the global market. Standing for ‘Cleaning Inspection Forensic Investigation Torch’, the product can locate traces not visible to the naked eye, even in bright light ambient conditions. Developed by CopperTree Forensics, this new technology has changed the landscape of crime scene investigation, with clients including the NYPD and MET Police. Supported by research conducted by Professor Cassella and presented to the Chartered Society of Forensic Sciences, the time was right to introduce the unique CiFi Torch to the healthcare market. Hospital Direct was the clear partner of choice to introduce this product throughout the NHS, private healthcare organisations, community and care home establishments. At the height of COVID-19, the need for the CiFi Torch became apparent within these sectors. Holding both a national and global presence in the healthcare market and being a 2019 Shropshire Chamber of Commerce award winner, they were also chosen to be the supplier of specialty equipment for the nationwide Nightingale Hospitals. Hospital Direct is a trusted supplier across the healthcare market. The company has been manufacturing and supplying the NHS and associated healthcare establishments with UK-made patient handling aids for over 25 years.


Issue 19

help healthcare organisations and their staff manage cleaning effectively during and post the COVID-19 pandemic.” The COVID pandemic heightened the need for effective ways of identifying poor cleaning. The CiFi torch can see what the naked eye cannot, as its powerful LEDs can locate and detect traces of latent fingerprints, sweat, urine, saliva, blood, and other biological traces which can encourage the spread of infection and viruses. The torch uses specific colour wavelengths of light to highlight unclean and potentially infectious surfaces during forensic examination.

Hospital Direct has been developing and enhancing their services for the healthcare sector to tackle and solve problems created by COVID-19, such as developing new PPE products. This opportunity came at just the right time, as they embarked on providing deep cleaning technology and services to the care home and healthcare sector. The CiFi Torch highlights the problematical areas and shows where they have been treated and eradicated post cleaning, thus serving as part of a 360-degree solution.. The link between CopperTree and Hospital Direct was made by Medilink West Midlands. Helen Gutteridge, Technical Director at Hospital Direct (Marketing) Ltd, commented: “Medilink West Midlands has been instrumental in introducing our two companies, previously unknown to each other, but linked by a common desire to

The two companies are excited about opening up the healthcare market to the CiFi Torch and its ability to manage their cleaning protocols effectively and efficiently to the benefits of all – organisations, staff and patients. Chris Dyke at Medilink West Midlands was delighted that two ‘look ahead’ companies struck a deal via the B2B Opportunities service: “It has been great to help another two companies that have been supporting the health and care sector during the COVID-19 crisis with this newly launched service. It also goes to show that working together with our colleagues at the WMAHSN, NHS and other business support organisations, such as the West Midlands Combined Authority and the Department of International Trade, we can pool our support and services to make a difference not only for people using health and care services, but for the region’s economic prosperity. This new service is gaining a lot of attention and is allowing us to help companies engage with one another and develop new business arrangements and relationships, whilst enabling them to see new business opportunities and growth in these difficult times.”

Clinical Need

Examples showing a microwave and kettle which had been deep cleaned, but the CiFi Torch showed a different reality...

For daily lifescience news visit 25

People and Places

How the Midlands has responded to COVID-19 Darren Clark, Director of Medilink Midlands, provides an insight into how the Midlands life science industry has responded to the pandemic.


s I sit at home writing this, expecting a Teams call in the next half hour, having reviewed the company risk register to allow staff back to the office at working distances no less than two metres apart and ensuring we’ll have enough hand sanitiser and disinfectant wipes, I’m struck by how ludicrous such an arrangement would have sounded less than a year ago, but now is as normal a consideration as which shirt to wear. The reason for such a change is of course, COVID-19. This is a crisis which has been incredibly disruptive for us all and has forced us to adapt to different ways of working. Whilst I would never say that it has been plain sailing, the Midlands has ably met the challenges faced over the past six months and adapted accordingly. Fluidity and dynamism are characteristics of Midlands businesses as a whole, and during the COVID-19 crisis, these attributes have shone. Connecting businesses has been more important than ever. As a focal point of life science industry in the Midlands, Medilink Midlands has played a pivotal role from the onset; supporting the business community by connecting them with suppliers, distributors, key NHS contacts and other like-minded businesses pursuing similar COVID-related goals. This led us to set up ‘The Big Ask’ alongside the East and West Midlands’ academic health science networks (AHSNs). The Big Ask started as a central repository of all current needs and wants of life science businesses in the Midlands,

and to date we’ve had 111 offers of products and services from 105 different companies. This has included the manufacture of gowns, gloves, masks and face shields, COVID-19 testing, remote consultation, mental health services and medical textiles. Alongside this repository, it has grown into a sourcing service, helping our companies find the materials and components needed to meet the unprecedented demand as their traditional supply chains failed. We plan to continue operating The Big Ask for the foreseeable future and will continue to bring companies, clinicians and academics together as part of our mission to help the Midlands life science community to grow and prosper. As well as continuing our support of business, there have also been some exciting developments within Medilink itself, with the ongoing creation of a Medilink Midlands group structure. Prior to COVID-19, Medilink East and West Midlands had been working together under the Medilink Midlands brand when delivering region wide initiatives such as CoDex4SMEs – an Interreg NW Europe project helping to develop companion diagnostics and personalised medicine, our work with the Department for International Trade showcasing the Midlands Life Sciences capabilities, and our MOU with the City of Mentor, USA. This ever-growing relationship saw Medilink Midlands and the City of Mentor come together again for the third year running (albeit virtually in the current circumstances) in October, helping Midlands life science businesses to trade in the American market.

The reason we decided to formalise the Medilink Midlands group structure now, of all times, was because we felt that in times of uncertainty and unknown, what businesses need more than anything is reliability and steadfastness. We saw the opportunity to give this to the Midlands life science community by providing a united, Midlandswide front, in the form of Medilink Midlands. This operating model will ensure there is a truly region wide life science network operating under a single governance structure, whilst the delivery of our sub-regional contracts continue.

For us here at Medilink Midlands, lockdown and COVID-19 has been an invaluable time to revise and reflect on our current internal processes and capabilities, take stock and adjust our approach to allow us to continue to serve the Midlands life science community, unburdened of current circumstances. I can’t predict everything that the the time ahead will hold for us, but we all approach it a little wiser and more experienced. Throughout the entire COVID-19 situation, I have maintained that the Midlands has the skill, ingenuity and know-how to push through, and by working together we’ll face down any new challenges that stand in our way.


Issue 19

People and Places

Expert CROs join forces to support discovery and development of new therapeutics during the pandemic Nottingham-based contract research organisations (CROs) have strengthened their existing links to work together and support the discovery and development of new therapeutics during the pandemic.


any businesses have been impacted by the restrictions on the movement of people and supplies, which has created barriers and slowed down drug discovery and development. However, four specialist CROs – Charnwood Molecular, Reach Separations, Aurelia Bioscience and XenoGesis – benefit from being colocated at BioCity Nottingham. Following the implementation of safe working environments to adhere to social distancing rules, the CROs have been able to remain open and provide specialist services to ensure seamless continuity for drug discovery programmes. This collaboration brings together specialist expertise in synthetic and medicinal chemistry, analytical and purification support, bioassays, pharmacology screening, DMPK, bioanalysis, PK modelling, and dose prediction. It also means that clients are able to access niche CROs with specialist expertise, which are already experienced at working together, allowing drug discovery programmes to continue seamlessly with minimal disruption.

“In these unprecedented times, the need for new therapeutics is higher than ever. Being colocated at BioCity Nottingham has huge advantages and enables us to navigate some of the barriers that are affecting other businesses, ensuring our clients’ projects can continue.” Robin Wilkes Director of Business Development Charnwood Molecular

“Clients can feel confident that they are still able to access the best specialised CRO in its respective discipline, and also dip into the services that they need at different stages of their project. In the past few weeks, we have seen a marked increase in new work and projects with clients coming to us for our specialist DMPK expertise. There is a genuine appetite for access to niche CROs that are leaders in their field.” Dr Richard Weaver CEO and Founder XenoGesis

“We already have a proven track record of working together to provide services for clients across the globe. By coming together and offering a collaborative approach, we are able to build on this, and help clients expedite their drug discovery projects in spite of the lockdown.” Victoria Coulthard Head of Business Development Reach Separations

“In the current climate, the co-localisation of subject experts has come to the fore. Together at BioCity, Aurelia Bioscience, Charnwood Molecular, Reach Separations and XenoGesis have been able to provide seamless business continuity for drug discovery programmes, combatting the disruption that is being experienced elsewhere in the sector.” Gary Allenby Chief Scientific Officer Aurelia Bioscience

For daily lifescience news visit 27

People and Places

Launch of personal handheld device to help limit the spread of COVID-19 With the world in the midst of a global pandemic, a team of engineers at Sylatech stepped away from their usual projects and focused on a new challenge, creating a personal handheld device that limits your contact with potentially contaminated surfaces when out and about.


ylatech has launched the KeepSafe, which enables users to avoid touching handles and buttons or grabbing items unnecessarily. Whether you are in a hospital, in a shop or using a cash machine, the device can be used as a simple hooking or pushing mechanism so that the user does not need to touch potentially contaminated surfaces with their hands or fingers. As it fits on a key ring, it can always be with you when you’re out and about. Crucially, the KeepSafe is manufactured from a copper-based alloy, which is antimicrobial, and it is known from laboratory tests that copper is highly effective in killing a broad range of bacteria, fungi and viruses. The MB1 copper alloy has been scientifically proven by the University of Southampton to

kill the coronavirus within 10 minutes, providing an extra level of confidence. Charlie Breese, Sylatech’s Managing Director, commented: “Our aim for the KeepSafe is simple – to help limit the spread of Covid-19 and to reduce potential exposure to the virus. It has good application use with door handles, light switches, toilet levers, taps and more.” He added that “the KeepSafe is not a substitute for regular and thorough handwashing, but an extra weapon in the fight against this invisible enemy.” Having known of the antimicrobial properties of copper for some time, Sylatech developed this product very quickly with support from the York & North Yorkshire Growth Hub. Andrew Raby, the Growth Hub Manager, said:

“We’re keen to support this project because the product helps to protect frontline staff against the coronavirus threat, as well as potentially securing manufacturing jobs and enabling good growth for the business.” Medilink West Midlands was introduced to Sylatech when the company answered a call from West Midlands Combined Authority’s (WMCA), who joined forces with local councils and business groups to support the supply demand for PPE during the initial height of the COVID-19 pandemic. Sylatech took advantage of Medilink WM’s B2B Opportunities Service and posted an opportunity for a distributor of their KeepSafe device. Worcestershirebased Safe Options Ltd responded and has now added the KeepSafe to complement their existing product range.

The benefits of using antimicrobial alloys are clear in reducing disease-causing bacteria, so Sylatech is pushing for their increased use within healthcare facilities and wider applications such as cash machines, ticket machines and much more.


Issue 19

People and Places

Working at the forefront of COVID-19 research Since the beginning of the pandemic, thousands of researchers, individuals, groups and organisations have been working tirelessly to find ways to treat COVID-19 and stop its spread.


mong the leaders in this field of research have been the Barts Life Sciences (BLS) teams from Barts Health NHS Trust and Queen Mary University of London. The BLS motto of ‘discovery, diversity, delivery’ has been applied to finding new ways of treating COVID-19. Barts serves a large, diverse population which includes many Black, Asian and ethnic minority (BAME) communities. It is important to have these groups front of mind in any COVID-19 research because there is known to be a clear link between deprivation, ethnicity and the chances of dying from COVID-19. There is a big difference in COVID-19 deaths among different ethnic groups, with BAME groups being more likely to die from the virus than the White British population. Recognising a need in its population and an opportunity to help them and others, BLS sprung into action. It rapidly mobilised a new research team made up of 120 trained clinical

research volunteers, who enrolled 1,600 patients and 550 healthcare workers across five hospitals in COVID-19 related studies. BLS have also been heavily involved in studies looking at diagnosing COVID-19. One study, run in partnership with Abbott, looked at using antibodies to diagnose the disease, with a linked, sub-study looking at how the body’s immune system responds to the virus. Another study, looking at Barts staff, assessed how the immune system makes antibodies after being infected with COVID-19 and how long they last.

BLS also created the Vaccine Trials Platform which is leading phase 3 clinical trials for potential COVID-19 vaccines.

To support further research, the Barts Bioresource co-ordinates the storage of biological samples and data from patients who have consented to participate in research. This will help with monitoring and tracking any long-term effects COVID-19 might have on people. In light of their rapid and robust response to COVID-19, you’d be forgiven for thinking BLS don’t do other research. However, while the wider work of BLS was put on hold when the pandemic struck, many areas of work have now adapted to the new normal. This includes a lot of research into how big data and artificial intelligence (AI) can be used to improve health services and outcomes, as well as developing targeted interventions (socalled precision medicine) to find new, better ways to treat diseases. BLS is clearly making good on their motto of ‘discovery, diversity, delivery’, something which particularly shone through during the COVID-19 pandemic. They have been heavily involved in research into the virus, ensuring the diverse population they serve, who are disproportionately affected by it, are considered.

For daily lifescience news visit 29

People and Places

Celebrating the best of UK life sciences at the Medilink UK Healthcare Business Awards Over 190 individuals from across the healthcare and life sciences sector came together online to celebrate success at the Medilink UK Awards.


he awards recognised a multitude of achievements and outstanding contributions to the life sciences industry, and five companies from across the country were crowned as national winners. Winning companies from the regional Medilink awards, which were held throughout 2019 and early 2020, were automatically shortlisted for the national titles. The award winners and runners-up were:

Start Up Award For newly established companies (trading for up to three years) that show a promising future, sponsored by HORIBA.


Neuronostics (Exeter) which provides

novel diagnostic decision-support tools for neurologists. Their first commercially available clinical indication is a novel and potentially revolutionary seizure susceptibility technology called BioEP, enabling fast and accurate diagnosis of epilepsy. Highly commended:


Export Achievement Award For outstanding performance in international trade, sponsored by Morningside Pharmaceuticals.


Cellpath (Powys), a long-established family business specialising in the manufacture and worldwide supply of products, consumables and services for the Cellular Pathology Cancer Diagnostic market. Highly commended: TissueMed (Leeds), a company specialising in the development, manufacture and worldwide sales of a unique surgical sealant technology. Bailey Instruments (Manchester) which specialises in the manufacture of medical devices (diagnostics for diabetes and neuropathy) and surgical instruments for Podiatry, General surgery and ENT.

Collaboration with the NHS Award

Cansense (Swansea), a start up developing an accurate, fast, non-invasive diagnostic for early detection of cancer using Spectroscopy and AI technology on a simple blood sample.

For a collaboration with the NHS that has had, or will have, a major impact or benefit to both business performance and patient care, sponsored by The AHSN Network.

LightOx (Newcastle) which is developing light activated drugs for the treatment of oral cancers. The aim is to provide clinicians and patients alternative options to surgery in precancerous and early stage cancer.


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Spirit Health Group (Leicester) which has been a trusted partner of the NHS since 2009. Their growing range of innovative products and services empower people to take control of their health, make best use of NHS resources, and utilise new technology to improve patient outcomes and add value for clinicians.

Highly commended: Cievert (Newcastle) which for years has been providing the NHS with innovative software to better manage cancer patients from diagnosis to recovery, cutting the waiting times of over 100,000 NHS oncology patients. Docobo (Leatherhead) which has developed digital health solutions to support seamless care for patients with multiple long-term conditions.

Innovation Award For the development of an innovative technology, design or process that has produced a major improvement in business performance or end-user benefit, sponsored by Kallik.


Magstim (Whitland), a Wales-based medical device manufacturer and leading supplier of Transcranial Magnetic Stimulation (TMS) equipment, coils and complete packages used for both Magstim TMS therapy and neuromodulation research. Highly commended: SurePulse Medical (Nottingham), a medical vital signs monitoring company committed to delivering innovations that improve monitoring when needed most. SurePulse VS is a wireless heart rate (HR) monitor for newborn babies. PEDAAT, developed by the South Tyneside and Sunderland NHS Foundation Trust’s Paediatric Emergency Department, which identifies asthma patients with inadequate routine care or treatment adherence to provide an appropriate and timely intervention.

People and Places

Outstanding Achievement Award For an achievement that has had a significant or vital impact on the company, sponsored by Mills and Reeve LLP.


Sygnature Discovery (Nottingham), a world-leading independent integrated drug discovery and pre-clinical services company. Since 2011, Sygnature has delivered 30 compounds into pre-clinical development, 15 of which have subsequently entered the clinic (Phases I, II and III) in areas including cancer, spinal injury, severe asthma and COPD. Highly commended: Kapitex (Wetherby, Yorkshire), a specialist in airway intelligence and a manufacturer and distributor of medical devices for tracheostomy, laryngectomy and dysphagia management. YourGene Health (Manchester), an international molecular diagnostics group which develops and commercialises genetic products and services, enabling scientific advances to positively impact human health.

For daily lifescience news visit 31

People and Places

Medilink West Midlands helps forge new partnerships in response to the COVID crisis The West Midlands Academic Health Science Network (WMAHSN) and the West Midlands Combined Authority (WMCA) have joined forces to support the region’s Personal Protective Equipment (PPE) supply during the COVID-19 pandemic.


fter issuing a call to arms for businesses to help supply or manufacture PPE, the WMCA teamed up with Medilink West Midlands, the WMAHSN’s link to the wider industry, who have been supporting the recruitment of suitable companies. Two of many businesses that came forward were Autins Group, specialists in providing materials and products for acoustic and thermal management solutions, and Contechs Holdings, a T1 automotive design, development & trimming consultancy. Both companies were exploring how their manufacturing capabilities, facilities and skills could be used to address the issue of supplying PPE products. Thanks to the WMAHSN’s industrial gateway team, they are now working collaboratively. Initially, Autins was manufacturing face masks utilising its skills and knowledge of specialist acoustic and insulation materials, while Contechs was supporting specialist workwear companies by preparing material to produce scrubs, using its large cutting platform. Without this work, both companies

would have needed to furlough all, or the majority, of their staff and their manufacturing technology would have been dormant due to the shutdown of the automotive sector. Chris Dyke, Connectivity Manager at Medilink West Midlands, said: “The COVID-19 pandemic has meant that a lot of organisations have had to explore new ways of working, and that WMAHSN had to call upon the region’s businesses to help keep our healthcare workforce safe. Not only have we been successful in finding organisations via the WMCA Challenge that can help with this, but we have also managed to link two businesses together that will benefit from each other’s knowledge and expertise in the long term. Andy Street, the Mayor of the West Midlands and chair of the WMCA, added: “It is great to see two local companies with no prior experience of PPE manufacturing coming together to help support the West Midlands during this difficult time. I know these are just two of many businesses across the region who answered our call to arms, and the response from organisations looking to help has been brilliant to see.”

Since being linked together, the two companies have now been working together on manufacturing face masks. Autins is continuing to produce the face masks, while Contechs has been subcontracted and is using sewing and trimming expertise to finalise and attach ear loops to the masks. Joshua Kimberling, Autins Group’s Sales Director, commented: “In a time of significant downturn in our largest sector, Automotive, our response has been to look for opportunities to make a positive contribution during the current crisis. Using our expertise in materials and manufacturing, Autins is bringing face mask manufacturing back to the UK. It has been great to be supported by other UK companies also wanting to do the right thing.” Following the two automotive companies being introduced, Autins and Contechs are in talks to collaborate on other areas of work within the automotive sector after COVID-19. The two companies are located just 20 miles apart and are exploring ways to combine industry knowledge, skills and expertise.


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People and Places

Construction starts on the Medicines Manufacturing Innovation Centre CPI has announced the start of construction at the Medicines Manufacturing Innovation Centre in Renfrewshire, Scotland.


he new technology and innovation centre is set to become a unique and world-leading facility offering transformative solutions in small molecule and pharmaceutical manufacturing. It will accelerate the development and industrialisation of next-generation medicines, manufacturing innovations and maximise technology opportunities within the medicines supply chain. Industry, academia, healthcare providers and regulators will work collaboratively within a GMP environment to address industry challenges and de-risk new technologies, providing a clear pathway for their widespread adoption within the pharmaceutical industry. The Medicines Manufacturing Innovation Centre is a collaboration between CPI, the University of Strathclyde and founding industry partners GSK and AstraZeneca, with funding provided by Scottish Enterprise and UK Research and Innovation. The Centre has recently agreed partnerships with four leading technology companies to further strengthen the range of expertise in the collaboration.

The facility will translate, at industrial and commercial scale, novel techniques for producing patient-centric medicines, including real-time release of drugs and integrated process analytics to drive the transformation of medicines manufacturing. These technologies will enable a reduction in quantities of the materials currently required in process development; accelerate timelines to achieve just-in-time, right-first-time and real-timerelease manufacturing principles; and ultimately accelerate access of affordable medicines for healthcare providers and patients.

Companies of all sizes will be able to use the facility to evaluate, test and prototype processes using an array of advanced Industry 4.0 manufacturing technologies, including continuous, digital and autonomous manufacturing. The utilisation of nextgeneration technology will enable more efficient drug production to protect future generations by bringing new medicines to market safely and quickly. The facility is due for completion in late 2021 and will be operational in early 2022. It is expected to eventually house over 80 staff in both technical and non-technical roles. Professor Sir Jim McDonald, Principal and Vice-Chancellor of the University of Strathclyde, said: “As strategic partners in the Medicines Manufacturing Innovation Centre, the University of Strathclyde is utilising its research, innovation and internationallyleading experience and expertise in advanced medicines manufacturing to meet the biggest health challenges facing our world. We are delighted to be working in collaboration with our partners across industry, academia, government and healthcare to accelerate and transform the medicines manufacturing process. We are excited to see construction begin on what will be a distinctive and important asset to the Glasgow City region and to Scotland.” Jon-Paul Sherlock, Technology Strategy Lead at AstraZeneca, commented: “Manufacturing innovation is critical to future pharmaceutical supply chains. Molecules are more complex, development times shorter and the expectations of patients and healthcare

systems higher than ever before. However, for a highly regulated industry, innovation is risky and potentially expensive. This facility will enable close collaboration between industry, government and academia and will be a gamechanger, resulting in faster industrialisation and implementation of exciting new opportunities.” Dave Tudor, Managing Director of the Medicines Manufacturing Innovation Centre, Quality and Biologics at CPI, said: “We are thrilled to be starting the construction of this new, collaborative centre. The consortium is already working together on several ambitious projects with the aim to de-risk disruptive technology that can lower the cost of drug development. Live projects include a digitally-twinned continuous direct compression platform to increase the productivity of drug product manufacture, and an automated platform to enable just-in-time supply for clinical trials which will drastically cut lead times. We look forward to bringing that technology and cross-sector expertise to these new facilities.” Frank Millar, CEO at CPI, added: “Ageing populations, the increasing cost of drug development, and resource constraints impeding the adoption of emergent technologies are just some of the challenges facing the pharmaceutical industry today. The increasing financial burden on the healthcare system as a whole has led to a pressing need for more cost-effective medication. By connecting the dots between academia, government, industry and healthcare providers within this state-of-the-art centre, we can address these issues and transform the pharmaceutical supply chain for the future.”

For daily lifescience news visit 33

Going Global

Nottingham company lands investment to expand its share of neonatal health tech market The company behind a revolutionary newborn baby heartbeat monitoring device is set to explore foreign markets and grow its product portfolio thanks to £1m investment. 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 “Despite the uncertainty surrounding premises in the city. The building very much the coronavirus pandemic, investors fits with our brand – it’s iconic with a quirky continue to be upbeat about the feel and, like us, it dares to be different.” long-term commercial potential of the business, have reinforced The company hasand come a long way since Nic thisinto through the newoffice investment. moved a one-person in the city “The need innovative medical many years ago,for adding: “Actually, it was more devices isHowever, more important a cupboard! it helpedthan me launch the ever as our healthcare systems business.” experience unprecedented pressure. This investment will help SurePulse to drive market-share gains and continue its exciting product development plans.” James Carpenter CEO, SurePulse


urePulse Medical Ltd was established in 2014 as a joint venture between the University of Nottingham and Derby-based Tioga Ltd – combining academic strength with the expertise of one of the UK’s top electronics manufacturers. The company’s first product, the awardwinning SurePulse VS, is the world’s only wireless heartrate monitor specifically designed for newborn babies. One in 10 babies need resuscitation or stabilisation at delivery. This means that doctors often need to check vital signs continuously to guide optimal care in those critical first few minutes of life, in a bid to reduce the risks of long-term neonatal health complications such as brain damage. With the SurePulse VS, a baby’s heartrate is measured by a forehead sensor that sits inside a specially designed, disposable cap, which transmits pulse information back to a

wireless display. The device provides simple, hands-free, accurate and uninterrupted monitoring, enabling clinical staff to make fast, confident decisions and focus on performing procedures in time-critical situations.

SurePulse VS was awarded its CE mark in 2019 and has been trialled in NHS hospitals on over 300 newborns. Adoption of the device across the NHS (and other medical providers) presents far-reaching gains in neonatal healthcare, potentially saving the lives of new babies, heartache for their families and costs for the health service.

The optical sensor technology underpinning the hands-free heart monitor was developed in the Faculties of Engineering and Medicine at the University of Nottingham. The research teams were led by Professor Barrie Hayes-Gill and Dr Don Sharkey – both academic co-founders at SurePulse Medical. Professor Hayes-Gill, Research Director at SurePulse, commented: “It is a great achievement to see a medical device that was designed and trialled by our collaborative research groups reach clinics around Europe. SurePulse is another spinout success story and one that aligns with the UK Government’s Industrial Strategy to commercialise research and deliver skills and jobs in STEM fields.”


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Going Global

Providing technology to fight COVID-19 in Wuhan Technology designed by Vaisala is supporting the global mission to fight COVID-19.


ealth and well-being are now on the table more than ever. People are increasingly interested in their health, and authorities are tightening requirements on the safety of medicines and pharmaceutical supply chains. Good Health and WellBeing is one of the United Nations Sustainable Development Goals (SDG 3) and this is tied to Vaisala’s business – even more critically during the COVID-19 pandemic. The company’s industrial measurement solutions are being used to help fight the pandemic by monitoring process conditions in medicine and biotechnology manufacturing.

Vaisala’s viewLinc Continuous Monitoring System has been designed to ensure the research, manufacturing and storage conditions of essential supplies in highly regulated life science applications, such as pharmaceutical warehouses, laboratories, cold rooms and cleanrooms. Spaces that require such continuous monitoring include blood and tissue banks that handle, store and distribute human tissues. By monitoring the critical parameters in these spaces, valuable materials are preserved and safeguarded for human use. The company’s instruments are used to monitor medicine manufacturing and development, in order to ensure the safety of the medicines we use. The most recent example of this is vaccine development for COVID-19.

Research and development to find a treatment for the novel Coronavirus (SARS-CoV-2) is happening all over the world. In March, Vaisala received an express order from Wuhan, China, and quickly delivered several GMP231 Carbon Dioxide Transmitters, which monitor and control CO2 incubators. These incubators are chambers that can be used to cultivate microorganisms, e.g. a virus, and the cultured virus is then used to help develop a vaccine. The GMP231 probe ensures that CO2 levels inside the incubators maintain the optimal pH level in cultivation. The carbon dioxide probe is not the only Vaisala instrument being used for vaccine development. The K-PATENTS Pharma refractometer is utilised in vaccine

manufacturing, where it ensures safety and efficacy. It can be used in the development of virus-based vaccines, such as for influenza, swine flu, and potentially also for COVID-19. The refractometer was specially designed for the pharmaceutical industry. It measures the dissolved components in liquids and, more specifically in vaccine production, the sucrose densities in purification of viruses. After centrifugation, the viruses band to a certain known sucrose density gradient. By measuring this density with the refractometer, the viruses can be safely and efficiently collected. With the reliable measurements, vaccines can be developed as quickly and as safely as possible without compromising quality. In addition to supporting vaccine development work, Vaisala’s measurement technology is also in use in frontline bio-decontamination work to kill viruses on surfaces. Cleamix Oy performed hydrogen peroxide vapour bio-decontaminations in South Korea during the coronavirus outbreak in early 2020. The Cleamix portable H202 vapour generators use Vaisala’s HPP270 series probes to monitor and control vapour output during biodecontamination. Hydrogen peroxide vapour is capable of killing even the most resistant microorganisms, which is why it is efficient in disinfecting critical spaces. Vaisala’s vapourised hydrogen peroxide probes provide multiple measurements, including relative humidity, relative saturation, temperature and H2O2 parts per million. This information guides the process, helping to ensure a successful bio-decontamination. By monitoring and measuring critical environments and conditions in healthcare, pharmaceutical and biotechnology industries, Vaisala solutions help to ensure patient and personnel safety in hospitals, as well as the safety and efficacy of medicines and vaccines.

For daily lifescience news visit 35

Going Global

Delivering molecules for COVID-19 research in New York Sygnature is supporting Professor Sachin Gupte, a pharmacologist at New York Medical College, in his endeavours to find a drug treatment for the lung damage that can result from COVID-19 infection. The company has synthesised two important compounds which Prof Gupte will test in a model of coronavirusinduced lung injury.


ung damage is a common symptom for some of the most badly affected COVID-19 patients, and especially those who end up on ventilators. Prof Gupte has been working for some time on the drug discovery target G6PD, initially in pulmonary arterial hypertension. His thinking is that drugs acting at this target might also be beneficial for COVID-19 lung injury, resulting in a need for experiments to test his hypothesis. However, he had no remaining supplies of the lead molecules. So he contacted Dr Allan Jordan, Sygnature’s Director of Oncology Drug Discovery, with whom he had collaborated on an earlier research project, to determine if the Nottinghambased company could help him secure molecules to use in his screens. “We were delighted to be able to help out an old friend and collaborator,” Allan said. “In these unprecedented times, it is important to move fast, and our experienced medicinal chemists were well placed to assist.”

The Sygnature team was able to spring into action immediately, as their labs remained fully operational throughout the UK’s pandemic lockdown, with scientists working according to strict social distancing protocols. Dr Emma Blackham, Senior Scientist, set about synthesising the molecules which are derivatives of the steroid androsterone. “When the starting materials arrived, the synthesis was relatively straightforward and I was able to make the molecules rapidly,” she said. “I’m really proud that I was able to use my chemistry skills to help in this way.”

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 “Lung damage is a serious sidepremises in the city. The building very much effect of COVID-19. It’s early days, fits with our brand – it’s iconic with a quirky but I am hopeful that drugs acting feel and, like us, it dares to be different.” at G6PD might prove beneficial to patients. I am extremely grateful Thethese company has come a long way since Nic to Sygnature Discoveryoffice for their moved into a one-person in the city assistance in providing the molecules, many years ago, adding: “Actually, it was more without which we could notme have a cupboard! However, it helped launch the tested the idea in my lab.” business.” Professor Gupte New York Medical College

The molecules will enable Prof Gupte’s lab in New York to start the experiments, in order to assess their potential in treating COVID-19 lung problems.


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We innovate healthcare At Roche our aim is to improve the health, quality of life and well-being of people around the world by providing an innovative range of diagnostic solutions and medicines. Roche is a global, research-focused healthcare company with Group Headquarters in Basel, Switzerland. Our strategy is clear - the patient lies at the heart of everything we do and our focus is fitting the treatment to the patient through prescription pharmaceuticals and in-vitro diagnostics. What makes Roche distinctive is our pursuit of excellence in science as we deliver the best solutions for healthcare professionals and improve patient outcomes; this is achieved through our unique combination of Pharmaceuticals and Diagnostics. Everyday, our products help patients and the healthcare professionals who care for them by detecting, preventing, diagnosing, treating and monitoring diseases. We are proud to have played a pioneering role in UK healthcare since 1908. Today, we are the leading in-vitro diagnostics company in the UK and the leading provider of pharmaceutical treatments for cancer and viral diseases. We are also a major supplier of medicines for the treatment of transplantation, virology, bone and rheumatology and renal anaemia. In total, our UK pharmaceutical and diagnostics businesses employ nearly 2,000 people.

Personalised Healthcare We combine our strengths in pharmaceuticals and diagnostics to better fit treatments to patients. When genetic differences can be identified, the efficacy and safety of medicines can be improved enormously. To this end we have a companion diagnostic strategy for every molecule we develop.

Diagnostics As the UK leader in diagnostics solutions, we offer a uniquely broad and innovative portfolio of products to patients, physicians, researchers, hospitals, laboratories and universities. Our UK Diagnostics business, headquartered in Burgess Hill, West Sussex, employs approximately 500 highly skilled individuals. Diagnostics is set to play an increasingly important role in the future of healthcare as genetic knowledge presents new and exciting opportunities. Our desire is to provide clinicians and patients with Actionable Health Information - information that reduces the uncertainty in the medical decision making process, enabling them to choose between available alternatives to prevent or treat disease.

Tel: +44 (0)1444 256000 At Roche we focus on developing medicines and diagnostics that will help patients live longer, better lives

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The UKCA Mark: Prepare for 1st January 2021 Phil Brown, Director, Technical and Regulatory, ABHI, advises how manufacturers can prepare themselves for 2021.


he ‘Standstill Document’ published by the UK Government on 1st September has provided a topline vision for a future sovereign regulation of medical technologies here in the UK, starting from 1st January 2021. Whilst providing this clarity however, it still leaves some operational questions.

What We Do Know Any manufacturer wishing to place product onto the UK market from 1st January 2021 should be aware of the following fundamentals; n The UK Competent Authority (the MHRA), will ‘unilaterally recognise’ the affixing of the European CE Mark on medical technology products, as a route to placing on the UK market, until 30th June 2023.

n The UKCA Mark can be affixed to product being placed on the UK market from 1st January, 2021. There is however, no mutual recognition of the UKCA Mark in Europe, where the EU CE Mark is the legal route to product compliance. n The UKCA Mark must be supported by certification issued by UK-based Conformity Assessment Bodies (CABs). These UK CABs will be designated by the MHRA from 1st January 2021. n At present, there will be no mutual recognition of certification issued by UK CABs as a basis of compliance to the European CE Mark process. n If the manufacturer of the medical technology is based outside of the UK, they must identify and contract a UK ‘Responsible Person’, to act on their behalf. n Likewise, if the manufacturer is UK-based and they intend to market in Europe, they have to identify and contract a European based ‘Authorised Representative’.

n The new UKCA Mark must be affixed to product placed in the UK market from 1st July 2023, implying medium-term labelling changes. n The MHRA will be increasing the scope of its current ‘Registration scheme’, to ensure that all products placed on the UK market and any respective Responsible Persons, are registered during 2021. n This registration process will be staggered according to product risk demanding that Class III, Class IIb implantable medical devices and List A IVDs are captured by May 2021, other Class IIb and Class IIa medical devices and List B and self-test IVDs by September 2021 and all other devices by January 2022. n Timescales for the registration of the Responsible Person will also be dictated by the risk of products they cover. n There will be specific requirements in Northern Ireland, as the European CE Mark will still be mandated as the applicable regulation.

What We Do Not Know These fundamentals are yet to be supported by firm operational requirements issued by the MHRA. For example, whilst the UKCA Mark has to be supported by certification issued by a UK CAB, the designation process and the identity of these bodies has yet to be announced. Likewise, with the UKCA Mark available from 1st January 2021, the technical requirements that have to be satisfied to ensure regulatory compliance are unsure, although compliance against the current UK transposition of the European Medical Device Directive and In-Vitro Diagnostics Directive (the Statutory Instrument for medical devices from 2002) can be assumed.


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The importance of a patient data ‘trust model’ during 2020 and beyond Dr Roberto Liddi, Senior Vice President Quality Regulatory and Information Governance at Sensyne Health, discusses issues around public trust of patient data collection.


OVID-19 has created turmoil globally, placing healthcare as a unifying priority and forcing technology to rapidly be integrated into health systems. The need to quickly respond to the coronavirus pandemic initiated a gradual evolution of digitising healthcare, putting digital health technology in the public spotlight – from creating apps that help prevent and monitor disease spread, to remote patient monitoring and the use of machine learning to help interpret COVID-19 patient data and provide meaningful insight to drive medical research. This revolution creates the ability to analyse large sets of real-world patient data and provide actionable clinical insights and better disease understanding, in order to aid treatment and ultimately lead to improved patient care and lower costs. Many refer to patient data as being the ‘Holy Grail’ for the future of healthcare. The fact of the matter is that using patient data effectively presents science and society with the opportunity to deliver a healthier future, but also raises important questions around ethics, transparency, privacy and existential risk. Sharing patient data has always been controversial – especially with moves from the UK Government to centralise patient data, in partnership with global technology platforms such as Google and Palantir, creating nervousness around how that data will be analysed and used by third parties who are often motivated by profit over privacy. Therefore, robust information governance and regulatory processes are key for the healthcare industry to gain the public trust necessary as an ethical license to operate. Looking at the pharmaceutical industry, there is a public acceptance that prescribed drugs

and products are safe to use, having been through a strict regulatory process before being made available. It’s a good model for creating public trust, appreciation and acceptance in using patient data and proves that a robust Information Governance (IG) framework, which provides the necessary rules to ensure that all processes involved are actioned in a controlled and compliant way, will ultimately help benefit patients and clinicians.

We use a principle and model at Sensyne Health that we hope will be universally copied to drive public trust. As a company we highly value patient privacy, transparency and trust, and as such we have created an IG framework that not only complies with existing GDPR regulations, Caldicott principles and UK Government Codes of Conduct, but also aims to exceed regulatory and legal requirements.

This approach unquestionably adds complexity and many self-imposed hoops to jump through in managing our research projects, but it is the right thing to do. We have invested in resource to do this, creating a dedicated team within Sensyne including a DPO (Data Protection Officer), a CG (Caldicott Guardian), a SIRO (Senior Information Risk Officer) and an IAO (Information Asset Owner) to oversee all activities that require data transfer, movement and/or control prior to the data being released for research analysis and to monitor the journey of the data through this process. In particular, the Data Request and Processing procedure explains in detail the data flow and governance control steps and establishes that the partner Trust is always acting as Data Controller, therefore keeping control of the shared data even in an anonymised form. We hope that by doing this we can create a mark of trust and an industry benchmark, demonstrating that there are ways to maximise the opportunities that technology brings for new models of scientific collaboration, improved disease prediction and patient care, all while balancing transparency, privacy and public assurance that patient data is being used to improve patient outcomes.

For daily lifescience news visit 39


Clinical evidence: Seven tips to satisfy the needs of clinicians, payers and regulators Dr Patrick Trotter, Head of Innovation, Commercialisation and Regulation at Medilink North of England, looks at generating the right clinical data for Clinical and Performance Evaluation Reports.


he new Medical Device Regulations (MDR) (Regulation EU2017/745) and the new In vitro Diagnostic Regulations (IVDR) (Regulation EU2017/746), due to come into effect on 26th May 2021 and 26th May 2022 respectively, are causing an immense level of concern and anxiety for medical device and in vitro diagnostic companies who have traditionally launched products with little or no clinical evidence. This is often seen as a barrier to innovation. However, the changing regulatory environment provides an opportunity for companies to collect the right clinical evidence to drive sales, growth and profitability.

This article will explore how the product development process and clinical strategy can be tailored to maximise the probability of success in securing market adoption.

1. Optimise your product development process In order to reduce uncertainty, the product development process should be optimised to consider the business case for adoption and ensure that the needs of users, both patients and clinicians, are considered during the initiation of the project. This standardisation at the front end of the innovation process ensures that the company has a clear understanding of all the needs from all the stakeholders, which will require clinical evidence for both adoption and regulatory purposes. The status of whether the concept aligns with both users’ and payers’ needs should be used as an early Go/No Go decision point, and should be used to de-risk the project and ensure only projects with a high probability of success are progressed.

2. Utilise methodologies that identify and prioritise clinical needs A range of methodologies can be used to identify end user needs. Techniques such as ‘ethnography’ and ‘lead users’ can be used to identify opportunities that are potentially radical or transformational and that might lead to the launch of highly differentiated or novel products. Other techniques such


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as traditional market research (e.g. focus groups), customer complaint analysis and competitor benchmarking are effective means of identifying, dissecting and prioritising individual needs which can be translated to design inputs. These are likely to form the basis of product claims that will need to be supported by clinical evidence.

3. Align your technology with the needs of the payer For adoption in the NHS, it is essential that the new device is aligned with the quality indicators that govern cash flows and have a major influence on commissioning decisions. The quality indicators are prescribed by the NHS Outcomes Framework, Commission for Quality and Innovation (CQUINS), the Quality Premium. A consideration of whether the technology aligns with these indicators will influence intended use and product claims, and will also provide insightful information on the type of clinical evidence that is needed for adoption. Conducting a thorough value proposition will also help drive clinical trial design and importantly will identify the specific type of evidence/ data that should be gathered in both premarket and post market clinical studies, which should improve the probability of adoption and commercial success.

4. Make sure your CER/ PER contains sufficient evidence to support the claimed benefits For a company to make formal claims from a regulatory perspective, there must be sufficient evidence to support these claims, and these should be documented in the Clinical Evaluation Report (CER) for medical devices and the Performance Evaluation Report (PER) for in vitro diagnostics. These documents are key parts of the technical documentation that assess all the clinical evidence, both negative and positive, and they are needed to support the intended use and clinically related product claims. The CER and PER are used to determine the benefit-risk ratio and to demonstrate that the benefits of the technology outweigh any risks (and to compare this to what is considered “state of the art”). State of the art is not the most technically advanced solution, but the solution that is readily used and adopted in clinical environments. As part of post market surveillance, it is important to proactively perform competitor analysis, using the clinical literature and other relevant sources, to identify benchmark performance and risks with respect to what is considered “state of the art” and similar.

5. Understand if you can use an ‘equivalent’ product To reduce the costs involved in generating clinical data, there are a number of ways in which you can reduce the amount of new clinical data that might be needed. For example, using other products as equivalent devices is one option. The rules on equivalence have tightened up under the MDR, and gone are the days when you could use a competitor product as an equivalent device to support the benefits and safety of your


product (particularly for implants and class III devices), unless you and your competitor have a contract in place that allows access to their technical files and documentation. A manufacturer can use products from their own portfolio as equivalent devices, although they have to demonstrate that they are equivalent in terms of clinical, technical and biological characteristics. In essence, using an equivalent device allows you to use clinical data from the equivalent device to support the newer device, which might reduce the amount of new clinical data required and, in some cases, eliminate the need to generate new clinical data. Although it should be remembered that new clinical data might help drive sales, extend the list of indications and claims and increase profitability.

6. Is your technology a “Well -Established Technology (WET)�? For legacy devices that were originally marketed under the medical device directives (MDD) there is new guidance (MDCG 2020-6) which shows that if a rational can be formulated that the device is a WET then there is likely to be a requirement for

less clinical data. For a device to be considered as a WET, it must fulfil the following criteria: i. Relatively simple, common and stable designs with little evolution ii. The generic device group has well-known safety and has not been associated with safety issues in the past

clinical evidence (Post Market Clinical Follow Up (PMCF)) is required, it is worth reappraising both the clinical needs and those of the payer, as this might provide a chance to gather additional data that might allow an extension of claims and, in doing so, help differentiate your device from competitors and enhance market penetration, sales and profitability.

iii. A long history on the market iv. Well-known clinical performance characteristics, and the generic device group is standard of care devices where there is little evolution in indications and the state of the art The demonstration that a device fulfils the criteria of a well-established technology does not necessarily mean that no clinical data is required. It is recommended that the reader considers whether additional clinical data might enhance the probability further market penetration.

7. Use the CER/ PER to identify gaps During the CER/PER process, clinical evidence gaps might be identified that if addressed can help maintain existing claims. If additional

Summary Despite the challenges the regulatory system imposes on us, we should embrace it as an opportunity to understand the real value of our devices and to ensure that we gather evidence not only to get our devices through the regulatory system, but to enhance future sales and profitability. Medilink North of England offer a range of consultancy services covering innovation strategy, product development, market reports/ competitor analysis, and our new Medilink Regulatory service is designed to be a one stop access point for your regulatory and quality needs. If you have any questions or would like advice or assistance with any of the activities or issues raised please do not hesitate to get in touch

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An observation of COVID-19 through a regulatory lens Janet Worrell, Head of Regulatory at Jenson R+ Ltd, provides an insight into the COVID-19 pandemic from a regulatory perspective.


pandemic or crisis is often the catalyst for innovation, as collective minds and thought power look to necessity as the mother of invention. Companies and entrepreneurs will always look to push the boundaries of regulatory custom and practice to drive commercial success. Meaning that if a boundary between adjacent categories can be blurred, then opportunity could knock. My personal observation of COVID-19 to date is that it is easy for a regulatory professional to default to an enforcement perspective, rather than the art of the possible. Let me explain further‌


Issue 19

biocides and medicines, depending on the claim on pack.

n Products primarily used to clean and/

or moisturise skin while providing a secondary antimicrobial effect, such as a liquid soap or solid soap bars, are classed as a cosmetic.

Hand Sanitisers The explosion of hand sanitisers, and enquiries for companies to market fast, was exponential in spring 2020. All hand cleaning and sanitising products (such as liquids, gels and soaps) are regulated in the UK. Hand sanitiser gels can sit within three regulatory frameworks: cosmetics,

n Products primarily claiming to kill germs, disinfect or sanitise using an active antimicrobial ingredient, such as hand sanitisers, are classed as a biocide. General hand sanitiser products are not permitted to name specific pathogens (such as COVID-19).


n Products which make claims to treat/prevent

infections associated with specifically named pathogens (such as COVID-19) are classed as medicines, as are products specifically used as surgical scrubs for use in operating theatres.

The associated claims between these categories are such that manufacturers of non-medicinal products may like to blur the boundary, in the hope that stronger claims influence a purchase decision. In this instance, my regulatory colleagues have had to enforce the existing rules as the Medicines and Healthcare products Regulatory Agency (MHRA) are now taking a harder line on the naming of any pathogen, on either a label or a website. They are asserting the right of the medicines claim position against both biocidal and cosmetic products, where this practice may have been used. The usual suspect trigger words – ’controls’, ‘prevents’ and ‘protects’ – cannot be used on non-medicinal products. The definition of these words are reproduced here for reference:

n Controls - In context, a claim to treat disease or adverse condition and prevent further problems.

n Prevents - In context, a claim to stop

development of and prevent disease or an adverse condition.

n Protects against - In context, a claim to

prevent a specific disease or an adverse condition.

The MHRA issue and work within the ‘Guide to what is a medicinal product’. At 70 pages it’s a chunky document, but it does give examples and insight for borderline products. It’s a useful reference source.

Vitamin D Vitamin D continues to generate media interest. There are many papers and much research conducted or ongoing for Vitamin D and its role in COVID-19. Evidence suggests that it can support participants with respiratory disease, reduce the effect of COVID-19, or generally support immunity and well-being.

Vitamin D sits within two categories in the UK regulatory framework – food supplements and medicines. In the UK, approximately 1 in 5 people have low Vitamin D levels (defined as serum levels below 25 nmol/L). Low levels are associated with a higher risk of poor musculoskeletal health such as rickets, falls and poor muscle strength. The UK Scientific Advisory Committee on Nutrition (SACN) now recommends Vitamin D as a food supplement in the following ways:

fair to say that any product wanting to link COVID-19 to Vitamin D would be a medicine and not a food supplement. The regulatory professional here needs to tread carefully and not cross the borderline from health to treatment.

n a reference nutrient intake (RNI) of 10

micrograms (400IU) of vitamin D per day, throughout the year, for everyone in the general population aged 4 years and older

n an RNI of 10 micrograms of vitamin D per

day for pregnant and lactating women and population groups at increased risk of vitamin D deficiency

n a ‘safe intake’ of 8.5 to 10 micrograms

per day for all infants from birth to 1 year of age

n a ‘safe intake’ of 10 micrograms per day for children aged 1 to 4 years

The RNI and safe intakes were developed to ensure that the majority of the UK population has enough vitamin D to protect musculoskeletal health, all year round. The SACN advice is about nutritional deficiency and ensuring that 97.5 per cent of the population have levels above deficiency. This however is only part of the picture, as not being deficient answers only part of the story. Much of the population even with 10µg daily would remain in the insufficient classification. So for an individual to move from insufficiency to sufficiency, they may need to resort to higher levels of Vitamin D as a nutrient supplement or take a medicine, with an approved indication for ‘The treatment and prevention of Vitamin D deficiency’. Consumers can be forgiven for being confused, as doses for both products overlap. A food supplement containing Vitamin D can carry a ‘contributes to the maintenance of normal bones’, with a nutrient intake level at 10-25µg. Whilst a medicine can be seen to prevent deficiency, with a daily dose from 10µg to 1.25mg. To a consumer, both are for maintenance of musculoskeletal health, but the claims and enforcement are considerably different. It is

Medicines Showing that it is possible to justify an alternative regulatory strategy, I read in September about a new assessment ongoing by the European Medicines Agency (EMA). The centralised procedure within the European Union is intended for biotech medicinal products: biosimilar, new chemical entity molecules and orphan drugs. So it was pleasing to see that the EMA have acknowledged receipt for a marketing authorisation application (MAA) for Dexamethasone for a COVID-19 indication. Dexamethasone is a very old molecule indeed, having been authorised for several decades for treating various conditions based on its anti-inflammatory properties. Such molecules would not normally be permitted to be assessed via the EMA. Earlier in the summer, results from the Recovery trial found that in patients receiving hospital treatment for severe respiratory complications of COVID-19, there were fewer deaths in those treated with dexamethasone. EMA has started evaluating an application for the authorisation of Dexamethasone Taw for treating hospitalised adult patients with COVID-19. The application will be evaluated by EMA’s human medicines committee (CHMP) according to an accelerated assessment timetable. This will enable the CHMP to issue an opinion on the benefits and risks of Dexamethasone Taw within the shortest possible timeframe. Demonstrating that good regulatory affairs professionals can show flair and imagination when under pressure.

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Our services include but are not limited to t Innovation strategy – Portfolio planning, new project creation and multigenerational product plans t Market reports – Market opportunity, competitor analysis, and regulatory and reimbursement support t Value proposition – Market research, business case for adoption, evidence generation plans and development of product claims t Regulatory support - Gap analysis, clinical and performance evaluation reports, and competitor benchmarking as part of post market surveillance t Our one stop Medilink Regulatory service provides a solution for all your regulatory needs





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Issue 18

Online Events Calendar 2020 2021 December











MediWales Innovation Awards

Medilink Midlands Webinar: How to plan and deliver a successful marketing campaign - for life sciences companies


MedFIT 2020


BioFIT 2020


Medilink East Midlands Webinar: Medtech Regulatory Special Interest Group (SIG) - Keeping up with the ever changing regulations

Biotech Showcase Digital

Medilink Midlands Webinar: Mental Health in the Workplace

SEHTA Webinar: CE & UKCA Marking

LSX World Congress 2021

SEHTA Webinar: Software UKCA Marking

Medilink Midlands Webinar: Reimagining healthcare post COVID-19


Medilink Midlands Webinar: The UKCA Mark - implications on medical devices and product import/export


SEHTA Webinar: Clinical Evidence


ABHI Annual Reception




SEHTA Webinar: Brexit/UKCA Marking

Medilink Midlands Webinar: The Impact of Brexit - How has your business been affected?

2nd European HealthTech CEO Forum



14th Annual European Life Sciences CEO Forum


Genesis Digital 2020


Medilink Midlands Webinar: Planning & executing a post COVID-19 business recovery plan

MediWales Webinar: Working with the Welsh NHS market access and procurement




BIO-Europe Spring Digital

BioSeed 2021

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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.

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