MediWales LifeStories Magazine 2021

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ISSUE 6

THE SHOWCASE MAGAZINE FOR WELSH LIFE SCIENCE 2021

The Welsh health technology sector celebrating new ideas and innovation NHS Wales innovation and successful collaborations

Welsh Government - Health Technology, Digital and Transformation

Advances and achievements in the Welsh life science industry


SHOWCASING ADVANCES IN WELSH LIFESCIENCE

150 years protecting ideas

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SHOWCASING ADVANCES IN WELSH LIFESCIENCE

Contents 5-21

Innovation and collaboration in NHS Wales 6 Velindre Cancer Centre in fluorouracil based chemotherapy genetic screening first

13 Video consulting in NHS Wales rated highly by patients and clinicians

18 Respiratory Innovation Wales

7 TriTech Institute supports the development of new healthcare solutions

14 Digital Health and Care Wales: Technology at the heart of NHS Wales’ response to the pandemic

20 Talking Type 1: Books to support psychological needs of people living with diabetes

8 Innovative digital bike to encourage exercise 9 Introducing a locally designed electronic ureteric stent register 10 Helping people with mental health problems to find and remain in work 12 Journey to joint QMS accreditation for manufacture of medical devices in two NHS Wales services

25-60

21 Swansea University Academies driving global healthcare transformation

16 Innovation that matters: Working with the NHS to improve pregnancy care 17 Award winning SBRI Centre of Excellence goes from strength to strength

Success stories from the life science industry 26 Celtic connections turn brilliant ideas into practical reality 27 Abel + Imray: 150 years protecting ideas 28 Cytiva: the life sciences company opening a new factory in Cardiff 31 SolasCure announces £15m Series A raise 32 Safe endoscopy starts with the SNAP, Endoscope Guide 34 Scale-up for medical device contract manufacturing in Cardiff 36 Investment in sustainable manufacturing initiatives 37 Developing breath analysis into a rapid diagnostic 38 Bringing multimodal AI to healthcare 39 PCI Pharma’s game-changing digital platform 40 Facilitating advanced therapies by streamlining the value chain

61-72

15 Why digital technology is now more important than ever for healthcare in Wales

19 Health Technology Wales

41 Keeping patients safe int he community using a portable 6 lead ECG device 42 High quality PPE masks: Made in the UK, for the UK 43 Blue Stream Academy - Supporting the health and care sector throughout the pandemic and beyond 44 Bollé forms partnership with Welsh manufacturer 46 Redefining the field of flexible endoscopy 47 Business growth for Cryo Storage Solutions 48 Evolve Raybotix UV-C Disinfection Robots at Techniquest 49 Pandemic musings from Greaves Brewster 50 NHS and industry collaborate to improve compression garments 51 Why should companies undertake patent searching?

52 Audit by a data protection authority: How does it work? 53 The world’s first ingestible supplement to help manage eczema and dry skin 54 RedKnight helps secure grant for med-tech start-up’s rapid COVID-19 diagnostic 55 Consult Smartly: reducing the outpatient waiting list backlog 56 Harnessing technology to clear the surgical backlog 57 Space2B at The Maltings 58 Taking science to Westminster Welsh biotech firm secures further investment for next-generation cancer therapies 59 I am now Ataxia aware 59 Fulcrum grows its team! 60 Design Studio Services help Cortigenix commercialise a new test providing early warning of potential health and fertilify issues

Forward thinking health research 62 Customised knee implant pioneered by TOKA®, Accelerate and Cardiff University Biomechanics Research Facility

66 How HCEC collaborates to innovate and translate valuable research into practice for patient and public benefit

63 New investment in the Life Sciences Research Network Wales

67 €1.5 million project aims to work with 3,000 women to study impact of sex hormone changes on mental health

64 Achieving the remarkable: supporting and delivering COVID-19 research in Wales

LifeStories is produced and published by Teamworks for MediWales. www.teamworksdesign.com

68 Projects developing the next generation of cancer therapeutics

The Maltings, East Tyndall Street, Cardiff CF24 5EA Tel: +44 (0)29 2035 1453 Web: www.mediwales.com

69 Study into antibiotic use wins research paper of the year prize 70 Researchers venture into Covid hotspots to recruit patients for unique study 72 Supporting the research response to COVID-19: The COPE Cymru study

Gwyn Tudor, CEO: gwyn.tudor@mediwales.com

Polly Carr, Events and Engagement Manager: polly.carr@mediwales.com

Debbie Laubach, Operations Manager: debbie.laubach@mediwales.com

Katie Maxwell, Membership Manager: katherine.maxwell@mediwales.com

Thank you to our Corporate Sponsors and University Partners

SUPPORTED BY WELSH GOVERNMENT


Welcome to the 2021 edition of MediWales Life Stories – the publication dedicated to sharing success stories from the Welsh health technology sector. This edition of Life Stories has been published to coincide with the MediWales Innovation Awards 2021. The Awards Dinner is an excellent opportunity to celebrate the life science and health technology sector in Wales, especially all the incredible achievements from the past 18 months. This being the sixteenth year the awards have taken place, we had over 100 applications for the awards this year across 11 different award categories, demonstrating how many companies and NHS teams have been doing incredible projects. This edition of MediWales Life Stories is divided into three sections:

Innovation and collaboration in NHS Wales, highlights all the

successful projects completed by the NHS Wales Health Boards and Trusts. The Welsh NHS has strong connections with industry, resulting in many collaborative projects throughout the year. Stories in this edition include collaboration with Roche on how to improve pregnancy care in the NHS and the work by Velindre Cancer Centre on fluorouracil-based chemotherapy genetics screening. An increase in digital projects has seen an increase in the last 18th months, this edition includes articles on why digital technology is important now more than ever for healthcare in Wales and how DHCW have used technology at the heart of the pandemic. Successful projects have also been completed between Welsh Government and the NHS including how to help people with mental health issues to find and remain in work. This issue of Life Stories has a range of inspiring projects and success stories throughout the NHS, showing the importance of the work done every day.

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Success stories from the life science industry

demonstrate the success our members have had over the last year and beyond. We are always looking for ways to support our members and to showcase their successes. Projects include Jiva. ai bringing AI into healthcare, Creo redefining the field of flexible endoscopy and the work by Imspex to develop developing breath analysis into a rapid diagnostic. Other notable projects include the work by GX, GS Verde, The Maltings and Abel + Imray, our corporate partners. Cytiva are expanding their facility by opening a new factory in Cardiff and Hiring over 250 people and Trakcel are working to facilitate advanced therapies by streamlining the value chain. There are so many exciting projects in the sector at the moment and many more to come.

Forward thinking health research puts a

spotlight on the research and projects taking place within the Welsh academic community, showcasing how universities work together with organisations to undertake important projects which change the landscape of our sector. Projects in this edition include the work between Health and Care Research Wales and Cardiff University looking into antibiotic use and working with women to study the impact of sex hormone changes on mental health, as well as a variety of other unique and fascinating projects.


Innovation and collaboration in NHS Wales Innovation has been an important part of our response to the Covid-19 pandemic. For example, we have seen a rapid shift to new digital ways of working, close partnership working between the NHS and suppliers to provide essential PPE and to develop new apps, and excellent contact tracing and vaccine delivery services, all set up across Wales in record time. This was an outstanding effort from the NHS, local authorities, and key partners. It was also enabled by our investment in innovation over recent years, as set out in ‘A Healthier Wales’, our strategy for health and social care, published in 2018. During this most challenging of times we have seen just how strong innovation in Wales is. I am determined that we continue to build on those achievements, recognise excellence and good practice, and hold on to the learning from the last 18 months. I want to maintain the pace and scale of change, as part of our recovery from Covid-19, and to ensure that we deliver the best possible outcomes for patients and the public in Wales. I have asked officials to consolidate existing health and social care innovation activities into a single programme, and to engage with key partners and stakeholders on the new programme and future opportunities, including how the new programme will form part of the future Innovation Strategy for Wales. This Innovation Programme for Health and Social Care will bring a tighter focus to existing activities, will strengthen national direction, and will lock in changes we have seen in response to the pandemic, helping to maintain the pace and scale of change in health and social care. In June I joined Ministers from all four nations to discuss the Life Sciences Vision, recently published by UK Government. The Vision is an ambitious statement of intent. The Innovation Programme for Health and Social Care will help to ensure that Wales is fully engaged in the work to translate that vision to delivery, across every part of the UK.

Eluned Morgan,

Minister for Health and Social Services

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Cwm Taf Morgannwg Innovation and collaboration in NHS Wales University Health Board

Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Bwrdd Iechyd Addysgu Powys Powys Teaching Health Board

Velindre Cancer Centre in fluorouracil based chemotherapy genetic screening first Iechyd Cyhoeddus Cymru Public Health Wales

Ymddiriedolaeth GIG Ymddiriedolaeth Gwasanaethau Ambiwlans Cymru to ensure this screening was launched Velindre Cancer Centre are delighted GIG Prifysgol Felindre Welsh Ambulance Services Velindre University NHS Trust to become the first in the UK to NHS Trust during the pandemic as unidentified DPD-

routinely provide all cancer patients being treated with fluorouracil based chemotherapy genetic screening to identify their risk of severe side-effects and help prevent this occurring. This has been done through implementing a new way of DPYD gene testing which launched in May 2020. DPYD gene testing is used to determine whether a patient has one of five known genetic variants which result in either an absence of or reduced levels of DPD. It is performed using a blood test which is processed at the All Wales Genomics Laboratory. If a variant is identified, clinical guidance is to dose reduce or avoid fluorouracil based drugs to minimise the risk of severe sideeffects thus improving patient safety.

deficient patients may develop significant side-effects requiring hospital admission at either VCC or neighbouring Health Boards during the COVID-19 outbreak which may increase their risk of exposure to the virus. Unidentified DPD-deficient patients with severe toxicity may also require hospital admission at a time when bed capacity at VCC and neighbouring Health Boards is likely to be reduced during the COVID-19 outbreak. Establishing a project board with multidisciplinary clinical input and experienced project support was key to the success of this project, especially during the challenges of the COVID pandemic. This is a model that should be available for future genomics service developments.’’

“What an achievement! Our collaboration to pilot DPYD gene testing, which commenced early in 2020, led to all Health Boards across Wales routinely offering the test by autumn 2020. It is motivating to see Wales once again leading the way to improve patient care.’’ Sian M Morgan

FRCPath, Consultant Clinical Scientist Head of Laboratory All Wales Medical Genetics Service All Wales Genomics Laboratory

Working closely with the AWMGS, VCC has developed processes and systems to ensure that DPYD genetic test results are available prior to the patient’s treatment start to ensure safe treatment doses right from cycle 1. Since the launch, the team have now identified its 100th patient who has tested positive for DPD variants, and so whom have had their chemotherapy dosages safely amended accordingly. Speaking of the DPD Testing, Sian M Morgan FRCPath, Consultant Clinical Scientist / Head of Laboratory, All Wales Medical Genetics Service, All Wales Genomics Laboratory said “What an achievement! Our collaboration to pilot DPYD gene testing, which commenced early in 2020, led to all Health Boards across Wales routinely offering the test by autumn 2020. It is motivating to see Wales once again leading the way to improve patient care.’’ Samantha Jane Cox, Consultant Clinical Oncologist at Velindre Cancer Centre told us “It was more important than ever

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www.velindre.nhs.wales/velindrecc


Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Bwrdd Iechyd Addysgu Powys Powys Teaching Health Board

TriTech Institute supports the development of new healthcare solutions

Ymddiriedolaeth GIG Prifysgol Felindre Velindre University NHS Trust

Iechyd Cyhoeddus Cymru Public Health Wales

Ymddiriedolaeth GIG Gwasanaethau Ambiwlans Cymru Welsh Ambulance Services NHS Trust

TriTech Institute is a collaborative initiative across Hywel Dda University Health Board, involving Clinical Engineering, Research/Innovation departments, the Assistive Technology and Innovation Centre in UWTSD, and the Healthcare Technology Centre in Swansea University focused on healthcare technology. During the onset of the pandemic, Clinical Engineering and Research came together to look at addressing the shortage of equipment and medical technologies, and this relationship has continued to develop. Professor Chris Hopkins, Head of TriTech, explains “This is an exciting opportunity to bring clinical teams, academia, industry and patients together. Tritech Institute adopts a Value-Based approach to novel technologies in healthcare, and offers an opportunity to improve the health and wellbeing of our patients in Wales and beyond.” TriTech has a team of engineers, scientists and clinicians moving innovative medical technologies into trials and direct patient care. It provides a single point of access to clinical services for designers and manufacturers. Clinical and research design skills are combined with technical engineering experience to manage the whole innovation pathway – from early unmet need, concept design, prototyping, regulatory approvals and clinical testing to established service evaluations. Translating more established products and innovative medical technologies into a real-world clinical ecosystem.

The team has been working with local, national and global companies to design, research and evaluate technologies, in addition to offering a consultancy service on regulatory approvals and licensing guidelines. It can support local manufacturers through the regulatory framework to CE marking.

TriTech is committed to leading world class research and innovation. Chris added: “We aim to lead technology development and integration within the NHS and undertake robust, real-world testing.”

Research Case Study TriTech, in collaboration with NHS, academia and industry partners, is carrying out research on a new digital e-learning programme for people suffering with chronic pain. The platform includes an innovative design to implement novel learning techniques; educating, preparing and providing resources to enable people to better manage their own pain. This research will allow application of prudent healthcare principles in the delivery of care within the Hywel Dda region and beyond.

Consultancy Case Study TriTech undertakes regulatory consultancy. For example, it was recently commissioned to prepare a step-by-step guide report on

‘Medical Device Development Prototype to Clinical Testing’ for a local company. The report provides information and template documents that are designed to help develop the evidence case before submission to the MHRA prior to carrying out a first clinical investigation. The recommendations in the tools and guidance documents were used and followed in agreement with TriTech’s risk classification analysis of the device. The report also had flowcharts giving correct pathways from the device’s classification to market with hyperlinks to both the relevant medical device standard and regulations. The guidance and recommendations in the report were based on the latest regulations provided under the EU MDR 2017/745, UK MDR 2002 and MHRA guidance documents.

Evaluation Case Study Tritech is currently evaluating the use of technology enabled care (TEC) in the remote monitoring of patients with chronic conditions, such as COPD. This mixed-methods evaluation aims to determine the perceived and actual benefits, and disbenefits, of remote patient monitoring in a realworld environment. Remote patient monitoring could help to provide quality care in situations where face to face contact is inappropriate.

www.tritech.nhs.wales

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Bwrdd Iechyd Prifysgol Innovation and collaboration in NHS Wales Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Innovative digital bike to encourage exercise Bwrdd Iechyd Addysgu Powys

Iechyd Cyhoeddus Cymru

Powys Teaching Health Board

Public Health Wales

Ymddiriedolaeth GIG

Gwasanaethau Ambiwlans Cymru About half of the physical decline Ymddiriedolaeth GIG Prifysgol Felindre Welsh Ambulance Services associated with ageing can be attributed Velindre UniversityThe NHS bike: Trust NHS Trust to a lack of physical activity. Without l is easy to set up for the use, to store and to manoeuvre. regular exercise, people over the age l is a cost-effective modification. of 50 can experience a range of health problems including: reduced muscle mass, l can be adapted to the individual patient for the best clinical outcome. strength and physical endurance; reduced coordination and balance; reduced joint flexibility and mobility; and reduced encourage older patients to do physical smart phone to move the view of Google cardiovascular and respiratory function. exercise, thereby helping them to improve Street View, or the recorded video, which These problems increase blood pressure, their muscle strength and their balance. encourages the user to push more in order to which in turn can increase the risk of older see more. This self-encouraging equipment The self-encouraging digital bike allows a adults developing cardiovascular disease, motivates the user to push more and thus do user to pedal with both their hands and feet, stroke and other medical problems. However, more physical exercise. and is linked to a visual screen powered by it can be a significant challenge to motivate Google Maps. The user can travel around The same technology could also be applied older adults to improve their physical any destinations they choose, from their to a treadmill. wellbeing through exercise. own familiar area to a city they’ve always Rakesh Kumar has secured a grant to take Rakesh Kumar, Clinical Specialist wanted to visit. this project to the next level with support Physiotherapist at Ysbyty Gwynedd, Bangor, Each cycle of the pedalling activates the from AgorIP. came up with an idea for a device that ‘enter’ button of the computer/laptop/ uses digital technology to incentivise and

www.bcuhb.nhs.wales

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Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Introducing a locally designed electronic ureteric stent register Bwrdd Iechyd Addysgu Powys

Iechyd Cyhoeddus Cymru

Powys Teaching Health Board

Public Health Wales

Ymddiriedolaeth GIG

Ureteric stents are inserted in every Ymddiriedolaeth to guide the wider urological At Wrexham Maelor Hospital (Betsi Cadwaladr Gwasanaethau information Ambiwlans Cymru GIG Prifysgol Felindre Welsh Ambulance Services on how to adopt this into their own urology unit around the UK on an almost community University Health Board), a simple solution has Velindre University NHS Trust NHS Trust daily basis. National datasets on the exact departments. been designed and implemented to overcome numbers inserted across the UK are not all of the aforementioned issues – an electronic Here is an insight into Wrexham Maelor Hospital’s available, but a figure of several thousand ureteric stent register. Alarmingly, to date, there electronic ureteric stent register/database and annually would not be an unreasonable are only a few departments in the UK that utilise their experience of using it for the past 24 an electronic database. These have usually been estimate. These stents are inserted for a multitude of conditions: re-establishing urine flow from the kidney due to obstruction by a ureteric stone; relief of obstruction of the ureter from malignant pathologies; and occasionally prophylactic temporary post-operative urine drainage after successful endoscopic removal of a stone. By far the most commonly used stent is made of a polymer (polyurethane). All manufacturers of this type of stent advise maximal patient indwelling stent time of six months. Depending on patients’ individual circumstances, the urologist may advise removal of the stent in a time period spanning anything from a few days up to the maximum allowed six months. Currently, individual departments rely on their own methods of identifying when stent removal dates are approaching. The standard practice is maintenance of paper-based reminder systems. The British Association of Urological Surgeons (BAUS) recommends the use of a ‘ureteric stent database’ in all hospitals that carry out ureteric stent insertions, but no standardised system exists that can be adopted by all hospitals. Paper records are cumbersome at best. They are prone to getting lost in a vast hospital infrastructure, can degrade over time, may not be accessible in all hospital areas that require stent data recording, rely on dedicated personnel to review and update them regularly, and so on. The ultimate consequence is dire: ‘the forgotten stent’. Any stent that is not removed in the recommended time frame can lead to continued morbidity for the patient (symptoms related to having a ureteric stent), ‘financial morbidity’ for hospitals from recurrent hospital admissions due to stent symptoms, and stents becoming encrusted. The latter can convert a routine outpatient stent removal into a complex urological procedure requiring hospital admission, a general anaesthetic, and specialist endourologists experienced in dealing with the removal of encrusted or ‘stuck’ ureteric stents.

developed in-house, with no available published

months…

Methods: Concept and database structure

Governance and monitoring

The software used was Microsoft Excel. The database was designed with the central concept of a traffic-light-colour based system. Stent episodes needing removal in >3 months automatically appear green, <3 appear amber, and those past the removal date appear red. Formulas are embedded into the database that automatically calculate this date based on the user’s input of the removal time period required. The described colour code (green/amber/red) then immediately highlights the stent removal data cell, alerting the user of the urgency with which stent removal must be arranged. Once the stent has been removed, the entire field (row) turns ‘blue’ to highlight no further action is required. To comply with audit and clinical governance policies, the database has been amended to prevent accidental deletion of patient episodes and to include other safety measures.

At the monthly departmental governance meeting, ‘Ureteric Stent Database Review’ is a compulsory agenda item where the previous month’s stent insertions are discussed and all that are close to requiring removal are reviewed. This highlights which patients require urgent dates, if any, and also highlights if any stents are overdue. Two ‘stent officers’ (one consultant and one SpR) are responsible for the maintenance of the database and prepare the monthly presentation for the governance meeting.

Accessibility The database is available as a password protected document within a dedicated internal hospital network folder. Password access is only available to urologists who are directly involved in stent insertions. The database can be accessed from any hospital location (e.g. theatre, ward, administrative offices) on a hospitalissued laptop. Through appropriate encryption and hospital IT approved access protocols, the database can also be accessed remotely on hospital laptops if required by urologists. Following approval in a governance meeting, the database was shared with all acute urology sites in the health board and is currently in use across the whole health board.

Results: The database was designed and launched in September 2019. Over the past 24 months, over 300 stent insertion episodes have been logged into the database by 10 Urology doctors (consultants and SpRs). In this electronic stent database era, there have been no overdue stents. This has meant that all patients in the last two years have had their stents removed at the expected time, without delay. Subsequently, there have been no serious complications associated with prolonged stent indwelling time, such as heavily encrusted stents.

Conclusion: To the health board’s knowledge, this is the first electronic stent register to be introduced in Wales. Review of practice has shown significant patient benefit through timely stent removal. The hospital has benefitted from a reduction of unnecessary patient admissions which would have arisen from complications of forgotten stents. The team would encourage a Waleswide adoption of an electronic ureteric stent register, in order to improve patient care across the country.

www.bcuhb.nhs.wales

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Bwrdd Iechyd Prifysgol Innovation and collaboration in NHS Wales Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Helping people with mental health problems to find and remain in work Bwrdd Iechyd Addysgu Powys

Iechyd Cyhoeddus Cymru

Powys Teaching Health Board

Public Health Wales

Ymddiriedolaeth GIG

evidence indicates that good work is I CAN Work is the first large-scale Ymddiriedolaeth Working to these same overarching principles, GwasanaethauThe Ambiwlans Cymru GIG Prifysgol Felindre Welsh Ambulance Services to health and wellbeing, and lack of pilot in Wales to test the integration of beneficial the I CAN Work pilot looked to adapt and test Velindre University NHS Trust NHS Trust employment support with health support work is detrimental to health and wellbeing. the IPS model in a locally relevant context in order to help people into employment. Unemployed people consult their GPs more and in line with the approach set out in the The service is led by Betsi Cadwaladr often than the general population, and those Together for Mental Health national strategy. University Health Board and delivered unemployed for more than 12 weeks show across North Wales by voluntary sector The service was quickly and successfully between four and ten times the prevalence of partners RCS and Adferiad Recovery, in integrated under the Health Board’s ‘I CAN’ depression and anxiety. For many with mental partnership with Welsh Government and brand, which describes and promotes a health needs, a job is an important part of DWP. person-centred approach to mental health recovery, but few receive tailored support provision across health and community to seek paid work. The I CAN Work project The pilot ran from June 2019 to June 2021, settings in the locality cluster. The service ensures that patients with mental health during which time it engaged and supported eligibility was also broadened to include over 800 people, with nearly a third of these people living with mild-to-moderate mental securing employment, despite the challenges health challenges, which meant that people presented by COVID-19. The service is now were able to access the service from a range Daniel, a 27 year old trained chef from moving into its second phase following of community settings. This embedding of I Prestatyn, experienced anxiety and low confirmation of continuation funding. CAN Work within a whole-system-approach mood from spending five months out to mental health support across community, I CAN Work is based on the principles of of work, after bullying in a previous job affected his mental health. His life took primary care and specialist services created the internationally recognised Individual a new turn when the jobcentre referred a framework for effective joint working and Placement and Support (IPS) employment him to support through RCS, where a provided a highly receptive environment for programme. The model has been shown dedicated I CAN Work employment the pilot. The positioning of I CAN Work as to help people find work more quickly than specialist helped him to find work a clinical routeway has been pivotal for its traditional employment support, with those with the catering team at Glan Clwyd success and has led to proactive engagement involved in the programme enjoying better Hospital. from BCUHB staff. health, staying in work for longer, and earning more per hour.

The key elements of IPS are: l Competitive employment is the primary goal

l Integration of employment and health support l Zero exclusion – eligibility is based on patient choice l Employment is promoted as a core part of recovery and wellbeing l Job search is rapid and not determined by work-readiness or illness l Job search is guided by individual preferences l There is systematic job development l Personalised planning/counselling l Support provided is time-unlimited including in work support

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Daniel said:

“My confidence and anxiety were shot after receiving a number of knock backs and I felt like giving up. But my I CAN Work employment specialist was amazing and helped to boost my self-esteem by sending me on a confidence boosting course. She was very proactive and understood what type of work would suit me, rather than pushing me towards any old job.”


needs can access quality, work-focussed support as part of their care plan, thereby reducing pressure on primary care services. The service evaluation conducted by Bangor University concluded that the I CAN Work programme was successful in integrating mental health support with employability support, providing personalised and tailored support at the interface between the areas of wellbeing and employability.

Participants have given consistently positive feedback about the benefits of receiving continued, tailored, focussed support, which many viewed as distinct from the more traditional employment support programmes that they had experienced. In particular, they highlight the vital role of the ‘Employment Specialists’, who provide person-centred support and use a range of skills to support, encourage and empower clients to address areas of difficulty in their mental health and wellbeing in order to build opportunities for employment.

Participants also report the importance of I CAN Work in terms of alleviating their mental health issues. Many present to the service with issues of anxiety, depression or low confidence, which can act as barriers to gaining work. The programme was seen as providing valuable support to help them move forward, with some participants identifying the need for less visits to GPs as a result.

www.bcuhb.nhs.wales

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Innovation and collaboration in NHS Wales

Bwrdd Iechyd Prifysgol Bae Abertawe Swansea Bay University Health Board

Bwrdd Iechyd Prifysgol Caerdydd a’r Fro Cardiff and Vale University Health Board

Journey to joint QMS accreditation for manufacture of medical devices in two NHS Wales services Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Bwrdd Iechyd Prifysgol

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Cadwaladr Designing and providing bespoke Betsi University Health Board medical device solutions to patients comes with specific risks and quality implications. Two specialist services in Swansea Bay University Health Board Bwrdd Iechyd Addysgu Powys (SBUHB) have successfully worked Powys Teaching together to implement a certified Health Board Quality Management System (QMS), an approach that would ensure they were compliant to Article 5.5 (in-house Ymddiriedolaeth GIG Prifysgol Felindre manufacture and use of medical devices Velindre University NHS Trust within the same health institution) of the EU Medical Device Regulations (EU MDR).

Both the Maxillofacial Laboratory (MFL) and the Rehabilitation Engineering Unit (REU) provide a supra regional tertiary service and are considered to manufacture medical devices, which they provide to patients under the care of SBUHB.

The MFL provides a service to construct custom-made devices and appliances including facial and body prostheses, surgical /surgical support devices, fixed and removable intra-oral prosthetics, and orthodontic appliances. The REU provides services to meet the complex needs of patients requiring engineering solutions for their wheelchair seating, mobility and pressure ulcer care across South West Wales. An external review by Justin McCarthy, Consultant Clinical Engineer, recommended establishing a joint QMS could satisfy Article 5.5 of the EU MDR. The teams recognised their limited experience and the requirement for support from either an external consultancy or the creation of a fixed term NHS post to lead implementation. The

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Iechyd Cyhoeddus Cymru Public Health Wales

Ymddiriedolaeth GIG Gwasanaethau Ambiwlans Cymru Welsh Ambulance Services NHS Trust

latter option was chosen and a business case was developed, with funding successfully secured for a specialist to project manage implementation of an ISO 13485 compliant QMS. ISO 13485 is an international standard written as a framework for organisations involved in the design, production, installation and servicing of medical devices, and is considered best practice. The specialist commenced in post in September 2019, after which followed eighteen months of planning, writing documentation, implementation of new working practices and cultural change. In February 2021, both services successfully completed their Stage 1 external assessment and, two months later, passed their Stage 2 external assessment with no nonconformities (one recommendation), subsequently receiving formal certification of their Joint QMS as compliant with ISO 13485. The certificated Joint QMS is a significant team achievement, and will be maintained

via annual surveillance visits by the external certification body, and cyclic re-certification assessments, following the approach of continuous improvement. There are significant positives for Services and Health Boards achieving such certification, including with regards to patient safety and compliance toward evolving medical device legislation. The implications of EU MDR and the evolving UK legislation affects all services providing any medical device. This level of quality assurance and the practices therein provide substantial confidence to teams and patients alike. A formalised QMS also provides a reliable platform for service improvement and device innovation, which will continue to promote MFL and REU as exemplars of high standards in medical device provision within NHS Wales, wider healthcare and industry.

www.sbuhb.nhs.wales


Bwrdd Iechyd Prifysgol Bae Abertawe Swansea Bay University Health Board

Bwrdd Iechyd Prifysgol Caerdydd a’r Fro Cardiff and Vale University Health Board

Video consulting in NHS Wales rated highly by patients and clinicians Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Bwrdd Iechyd Prifysgol

Bwrdd Iechyd Prifysgol

Cadwaladr Hywel Dda There has been significant increaseBetsi To paint a realistic picture of how VC NHS Wales, and the sustainable use of VC University Health Board University Health Board in the uptake of video consulting in was being used and received in Wales, moving forward. This wouldn’t have been health and care services across Wales the team was keen to capture qualitative possible without such a detailed evidence as a result of COVID-19. However this and quantitative data, enabling them to base of real life data. widespread transformation has created identify ways to continually improve the Bwrdd Iechyd Iechyd Cyhoeddus Addysgu Powys Cymru the need for consistent and objective service. Powys Teaching Public Health evaluation of the use, benefits and Health Board Key results from the latest Wales Gemma Johns, TEC Cymru’s Research challenges of digital innovations in evaluation report show that & Evaluation Lead said: “In our latest healthcare across Wales. the most reported benefits by report, we have been able to deep-dive Ymddiriedolaeth GIG patients were ‘lowered infection As part of the nationwide rollout of the Ymddiriedolaeth into patient and clinician experiences, Gwasanaethau Ambiwlans Cymru GIG Prifysgol Felindre rate’ (94.2%) and ‘saved travel Welsh Ambulance Services NHS Wales Video Consulting (VC) Service, identifying how the benefits clearly Velindre University NHS Trust NHS Trust and parking’ (92%). Clinicians the TEC Cymru team embedded evaluation outweigh the challenges. We have agreed with these benefits, but right from the start to understand how been able to demonstrate how well also noted other benefits such as it was being used, as well as challenges, VC is working for our Welsh patients benefits, user satisfaction and frustrations. and clinicians, and have also had ‘reduced waiting times’ (68.6%) This was delivered by a programme of and ‘more efficient use of their the opportunity to challenge many end-of-call surveys for both patients clinical time/space’ (74.8%). assumptions on digital exclusion in and clinicians, as well as conducting 1:1 Wales.” interviews. The team has had an incredible Insight from this wealth of data meant 50,000+ user responses from an the team could go back to policy makers increasingly wide range of health and care “This useful evaluation shows settings, including dental practices, prisons to help inform future decisions on how promising results on the use of VC was impacting ways of working in and care homes. video consultation in healthcare settings. It’s encouraging to see that this service has been highly rated by both patients and clinicians and I hope that it will continue to be used and developed beyond the pandemic to allow wider access to healthcare services.”

Eluned Morgan Welsh Government Minister Health & Social Services

With over 250,000 video consultations having taken place so far and the consistently high satisfaction rates among clinicians and patients, Welsh Government are looking at the longer term options for the sustainable use of video appointments as one of the ways health and care services will be delivered in Wales.

www.digitalhealth.wales/tec-cymru

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Innovation and collaboration in NHS Wales Iechydd a Gofal Digidol Cymru Digital Health and Care Wales

Digital Health and Care Wales: Technology at the heart of NHS Wales’ response to the pandemic iOS and Android devices. It offers patient information on the go and at the bedside, including notifications, the ability to view/ sign off test results and add/edit notes and tasks for patients, and removing the need for paper-based handovers. As an early priority, the COVID-19 testing process was digitised so test results were streamlined and results recorded in the patient’s medical record, regardless of where the test was taken. As part of Wales’ Test, Trace and Protect service, DHCW worked with industry partners to develop the all-Wales digital contact tracing system within six weeks.

As the COVID-19 pandemic hit, health and care in Wales was placed under tremendous pressure. The adoption of digital services accelerated overnight, and Digital Health and Care Wales (DHCW) worked with health staff to deliver the technology needed. Before the pandemic, Wales had already taken big steps to transform patient care using technology and data, making it easier to introduce new capabilities and data flows. There is a digital health record for each of the 3.1 million people in Wales, and a digital service supporting every step of the patient’s journey. Yet as we have all seen, the COVID-19 pandemic put digital health and care in the spotlight like never before. This digital innovation and adoption of new ways of working made a significant difference to the NHS Wales response to COVID, making it possible to restrict virus spread. Take the benefits delivered by contact tracing, video conferencing, online health records, and access to real-time data to monitor demand. All services delivered by DHCW.

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At the outset, GPs were given remote access to the clinical desktop so they could work anywhere, from home or the surgery, and this enabled an email at home service – allowing practice staff access to their NHS email from any location. DHCW also put the Welsh Clinical Portal (WCP) on the desktop, so family doctors can view patients’ hospital information such as discharge summaries and clinical letters. This is aiding diagnosis and dramatically reducing the time spent chasing patient information. Patients are now able to use video and phone for remote non-contact consultations with their GP, community nurses and mental health teams. Support, implementation and training to accelerate uptake is provided by the DHCW Primary Care Services Team. New systems that not only provided social distancing benefits but also contributed to the longer-term transformation of care. Video conferencing for outpatient clinics was also adopted alongside accelerated implementation of the Fuji Mobility image viewing software, which allows secondary care clinicians to view images across health board boundaries. DHCW also launched the Welsh Clinical Portal mobile app to use on

Then with the arrival of COVID-19 vaccines, their technical solutions were needed to manage vaccination of the Welsh population. The in-house developed Welsh Immunisation System has made a major contribution to the success of the vaccine programme in Wales. It is used to identify people eligible for vaccination, schedule and send out appointment letters, and record details about each vaccination. DHCW also collaborated with NHS England to deliver the COVID-19 digital passport for Welsh people travelling outside the UK. Information is a key weapon, so working collaboratively with health boards, DHCW fast-tracked development of a new Data Hub, giving decision makers a real-time view of the NHS Wales response to the pandemic. It can be used to identify hotspots and trends in access to healthcare, and to manage capacity based on demand and availability. Technology doesn’t stand still and neither does DHCW. Their products and services are constantly evolving to meet user needs as health and care in Wales resets and recovers.

www.dhcw.nhs.wales


Iechydd a Gofal Digidol Cymru Digital Health and Care Wales

Why digital technology is now more important than ever for healthcare in Wales Helen Thomas is CEO of Digital Health and Care Wales, the special health authority leading the digital transformation of NHS Wales. As we navigate our way through the next stages of the global pandemic, Helen discusses the increasingly important role digital will play in health and care. Technology has been absolutely critical to support the NHS response to COVID-19, and over the last year has highlighted the wider role digital can play in improving our health and care services. While it’s not always been smooth sailing, it is impressive to consider how the health services we depend on have changed. Technology in healthcare has come to the fore – it’s no longer seen as a background IT system keeping day-to-day operations running, but recognised as central to a modern healthcare approach, and to shaping and leading innovation as we move forward. With tech and data playing a big role in healthcare, we now have the opportunity to consider how much has changed, and what the future looks like. In April, as we began to ease our way out of the second wave of the COVID-19 pandemic, the former NHS Wales Informatics Service became Digital Health and Care Wales – a move reflecting the importance of digital and data in modern health. And it makes sense. We depend on technology for so many aspects of our lives; we shop online, we bank online, increasingly over the last year we work and even socialise online. A digital-first approach is already aligned with our lifestyles – why should it be different for health and care? These are examples of how we use digital technology in ways that, hopefully, make our lives easier. Whereas in health, digital technology is mainly used behind the scenes to streamline processes and improve care, leading to a better, integrated service for patients. For example, the recently introduced Welsh Nursing Care Record has replaced the time-consuming paper forms

across Wales to access the single digital health record – bringing together medical information for a patient from many sources and health boards. It can be accessed via the desktop or on the go through a mobile app. More than 28,000 healthcare professionals use the platform which hosts patient records, including test results, images and scans. Meaning wherever you are in Wales, your clinician has the information they need to care for you at their fingertips.

The Choose Pharmacy platform enables community pharmacists to keep a record for each patient, allowing them to help people with minor ailments, treat sore throats or dispense emergency medications, freeing up GPs’ time. This service has been crucial throughout the pandemic, as pharmacies have kept their doors open to patients and have been providing ever more front-line, drop-in support and advice.

As with every move towards a more digital way of life for all of us, there is always concern for how personal data is being collected and shared by the organisations that use it. Privacy is a major priority for DHCW, and all patient information is handled in the strictest confidence wherever it is used, protected using the highest international standards of data, internet and cyber security. Digital literacy still needs improvement to ensure that health technology can benefit all. People without access to the internet

or digital tools will still be supported and empowered with alternative options. Digital services are not replacing existing NHS procedures – there will always be a need for offline, face-to-face services. The past year has further highlighted the incredible compassion, resilience, and determination of our NHS Wales staff at all levels. If used well, digital healthcare can better enable staff to focus on the personal, human elements of care – while streamlining and automating processes like administration and information sharing, creating time and capacity for staff to focus on what matters. There are many things next on the agenda for Digital Health and Care Wales, including the on-boarding of cancer services to the Single Patient Record (Wales Clinical Portal). We’re also looking at eye-care, accelerating referrals into secondary care, and e-prescribing, using digital to enhance and improve the prescribing process. All of this requires lots of hard work and knowledge from the people who work at DHCW, and the increasing demand on digital technology means we are continuing to expand our workforce and recruit more. Last year we were named the ‘best place to work in IT’ at the UK IT Awards, so it’s fair to say digital healthcare is an exciting place to be at the moment if you’re looking for a rewarding career. That said, there are still huge challenges ahead and digital healthcare will be crucial to the future smooth running of our NHS, to support patients, doctors, nurses and healthcare professionals and to provide the best possible healthcare for the people of Wales.

www.dhcw.nhs.wales

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Innovation and collaboration in NHS Wales

Innovation that matters: Working with the NHS to improve pregnancy care By Daniele Gaudiosi Women’s Health Market Manager, Roche Diagnostics UK and Ireland Pre-eclampsia is a serious complication that occurs in 3-5 % of pregnancies and is one of the leading causes of maternal and perinatal mortality worldwide.1 Whilst it can be a life-threatening condition, with a clear diagnosis both mother and baby can receive the care they need. Placental Growth Factor (PlGF)-based testing, a blood test which can confirm or exclude pre-eclampsia in pregnant women within the same day, received NICE approval in 2016.2 It took some time for the test to become available consistently across England, but by February 2021 more than 100 maternity services had adopted one of the NICE recommended tests and more than 40,000 women had benefited from them. What’s more, projected annual savings in England are estimated at £4m per year due to a reduced hospital bed occupancy3 and this summer NHS England announced that it would make testing for pre-eclampsia available across the country.4 In Wales, we are at the start of a similar journey, with health boards and clinicians looking together at how the test could be used to help prioritise treatment and care for those pregnant women at highest risk and, at a time when the NHS is facing such enormous challenges, alleviate pressure on much-needed inpatient beds and save clinical time. Routine antenatal appointments involve the assessment of clinical signs and symptoms. Women with suspected pre-eclampsia are usually referred to hospital for further assessment, which includes multiple checks of blood pressure and urine protein, as well as a suite of blood tests.5 But preeclampsia diagnosis can still be challenging, as these tests are non-specific so healthcare professionals must rely on their own clinical

judgement.6 This is why swift prediction or rule-out of pre-eclampsia can be vital, both for patient safety and for managing cases efficiently.7 Not only does the test help those that have the condition, it’s also important in helping women to return home from hospital if preeclampsia can be ruled out, freeing up muchneeded beds. One study demonstrated that PlGF-based testing enabled clinicians to exclude pre-eclampsia for one week with very high confidence, reassuring women suspected of having the disease that it is safe to go home.8 Healthcare professionals are discovering this firsthand. Trusts in Greater Manchester have been using the PlGF-based testing for some time in all their maternity units thanks to support from Health Innovation Manchester.

“The PlGF test enables us to make the right decisions for the women in our maternity care. We can ensure that those with pre-eclampsia or who are at the highest risk of developing pre-eclampsia are getting the care they need, when they need it.”

Professor Jenny Myers Consultant Obstetrician and Professor of Obstetrics and Maternal Medicine The University of Manchester

We at Roche Diagnostics are proud that our PlGF-based test for the assessment of pre-eclampsia are becoming more widely available across the UK and to support the positive discussions going on in Wales to help improve the pre-eclampsia pathway, including the introduction of PlGF-based testing to help ensure pregnant women get the specialised treatment they need or avoiding unnecessary hospital admission.

www.roche.com

Verlohren, S., et al. (2012). Am J Obstet Gynecol 206(1), e1-8; Verlohren, S., et al. (2010). Am J Obstet Gynecol 202(161), e1-11; Verlohren, S., et al. (2014). Hypertension 63(2), 346-352 www.nice.org.uk/guidance/dg23 (Accessed Sept 2021) www.ahsnnetwork.com/more-than-40000-pregnant-women-have-benefited-from-pre-eclampsia-test-following-national-ahsn-rollout (Accessed Sept 2021) 4 www.england.nhs.uk/2021/08/life-saving-world-first-nhs-test-for-pregnant-women/ (Accessed Sept 2021) 5 Overview | Hypertension in pregnancy: diagnosis and management | Guidance | NICE. www.nice.org.uk/guidance/ng133 (Accessed Sept 2021) 6 Herraiz, I., Llurba, E., Verlohren, S. & Galindo, A. Update on the Diagnosis and Prognosis of Preeclampsia with the Aid of the sFlt-1/ PlGF Ratio in Singleton Pregnancies. Fetal Diagn. Ther. 43, 81–89 (2018) 7 www.oxfordahsn.org/our-work/strategic-and-industry-partnerships/the-innovation-exchange/spread-and-adoption-of-supported-innovations/pre-eclampsia/ (Accessed Sept 2021) 8 Hund, M., et al. (2014). BMC Pregnancy and Childbirth 14, 324; Zeisler, H., et al. (2016). N Engl J Med 374(1), 13-22 1

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Bwrdd Iechyd Prifysgol Aneurin Bevan University Health Board

Bwrdd Iechyd Prifysgol Cwm Taf Morgannwg University Health Board

Bwrdd Iechyd Prifysgol Betsi Cadwaladr University Health Board

Bwrdd Iechyd Prifysgol Hywel Dda University Health Board

Award winning SBRI Centre of Excellence goes from strength to strength Despite their first year as a team being under the cloud of a global pandemic, they have managed to come together and deliver projects to develop solutions that have helped in the fight against COVID-19 and have been recognised for their success.

The SBRI Centre of Excellence is hosted by Betsi Cadwaladr University Health Board and funded by Welsh Government. Its focus is to work with public sector bodies to ‘challenge’ industry and academia to develop innovative solutions to challenges that we face, improving the health and well-being of those living in Wales. The past 18 months has been very busy and a short update of each innovative project taken forward during this period is detailed below:

Rapid Sanitisation of Ambulances: This rapid project was an integrated collaboration throughout with WAST, SBRI Centre and the Welsh Government and other UK departments including the Defence and Security Accelerator (DASA) and the Defence and Security Technology Laboratories (DSTL). The solutions developed were able to reduce the time taken to clean an ambulance by 86% giving staff the time to undertake other duties whilst the cleaning process is underway. The cost of cleaning an ambulance was also reduced by 82%. The SBRI Centre of Excellence and Welsh Ambulance Service were presented with a St David Award by the First Minister of Wales for their work on this project.

Bwrdd Iechyd Addysgu Powys

Iechyd Cyhoeddus Cymru

Powys Teaching Health Board

Public Health Wales

Ymddiriedolaeth GIG Ymddiriedolaeth ideas in three key areas inGwasanaethau the response to Ambiwlans Cymru GIG Prifysgol Felindre Welsh Ambulance Services the significant backlog caused by COVID. University NHS Trust onVelindre the issues NHS Trust

Face Mask Challenge:

This challenge focussed faced with finding suitable fitted FFP3 level masks with various shaped and sized faces of Health Board staff became apparent during the height of the Covid-19 pandemic alongside the need for transparency to aid communication with vulnerable patients. This project brought about a collaboration between the SBRI Centre, Welsh Government, NHS Wales, experts from the Surgical Materials Testing Laboratory, NHS Wales Shared Services Partnership. Six suppliers were successful in gaining contracts for this rapid project and are expecting approvals from notified bodies imminently.

Better Lives Closer to Home: Following the success of the Better Lives, Closer to Home Challenge Phase 1, where we asked businesses and academia for their ideas to help communities, businesses and public sector manage the impact of COVID. Three contracts have now been awarded for very different and exciting solutions to progress and develop to become commercially available products.

Outpatient Transformation: In April this year the SBRI Centre launched its Outpatient Transformation Challenge in collaboration with Welsh Government and colleagues from across NHS Wales. We asked applicants for their

The competition closed in May with some exciting applications, four contracts have been awarded and work is well underway developing some exciting innovations.

Simulation Training in Healthcare: The Simulation Technology Training project is an exciting collaboration bringing together the SBRI Centre of Excellence, Welsh Government, CardiffCapitol Region, Cardiff and Vale University Health Board and experts from the wider NHS Wales with the aim to improve the way clinical training is provided. Contracts were awarded to four suppliers for the initial Phase 1, two of which have since gone on to Phase 2 and work is going full speed with support from our clinical leads.

If you require any further information on these projects please contact the team at SBRI.COE@wales.nhs.uk

www.sbriwales.co.uk

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Innovation and collaboration in NHS Wales

Respiratory Innovation Wales Respiratory Innovation Wales (RIW) Ltd was established in 2018 as a not for profit, subsidiary of Welsh Government limited by guarantee. Like so many small organisations, the global pandemic had a significant impact on business - but it also created an opportunity to re-purpose, re-brand and and refresh the management structure of the organisation, it’s drive and invigorate it’s ambition to be a world leading gateway for lung and respiratory innovation to improve the health, wellness and wealth of Wales. Positioned within Health and Social Care and Economy, Skills and Natural Resources, RIW is both privileged and uniquely placed to innovate – whether that’s ‘outside the box’ thinking on prevention and impacting on the wider determinants of health or new ways of managing, and treating conditions more effectively. This future facing approach is expected to bring about substantial benefits to health outcomes, reduce economic and environmental burden and create opportunities for the creation of wealth for the people of Wales.

RIW has made great progress over the last few months in establishing a network of clinical affiliates across Wales and, through it’s investment in people, skills and expertise, now has a future facing, specialist team of professionals expert in research, and advanced physical and digital engineering to support our partners. Coupled with RIW’s ethical approach to citizen’s science and user centric design, this ensures any product is developed from insights directly from service users. This new approach has led to some immediate success but we are always seeking to do more through collaboration to: l Enhance and develop respiratory products, services, or treatments; l Seeking real world insights advanced data science and digital engineering; l Expand our research and innovation activities The best way of illustrating our impact is by example. Recent projects include: l Long COVID virtual assistant – Cwm Taf University Health Board were pioneers in developing and introducing one of the first virtual assistants (CERi) using IBM Watson artificial intelligence trained specifically for COVID-19. RIW is working to develop and enhance this product for patients suffering from long COVID symptoms in collaboration with Scienapp following on from success at the TriTech challenge in September 2021. This will be the first virtual assistant using AI specifically for long COVID (insert hyperlink) l Dedicated Portal for 3D printing - A collaborative project between University College London IXN programme, Respiratory Innovation Wales and Cwm Taf Morgannwg University Health Board in developing an online repository for 3D printable designs and product risk files to enable NHS and public sector to rapidly and safely 3D print anything from medical device parts to anatomical models. This physical engineering is linked to the state-of-the-art HoloRepository 2020, which allows any scan to be rendered as a 3D view using the latest techniques for organ segmentation (insert hyperlink); l Project Aria – Voice pattern recognition and analysis to support care in chronic disease - Chronic disease can often alter breathing and speech patterns and voice represent a new paradigm in data science. Subtle changes in patients with raised physiological stress, exercise or speech might not at first be apparent. ARIA uses the power of artificial intelligence to aid detection of clinically relevant information that might previously have been undetected (insert hyperlink); l Characterising Immune Response to COVID-19 - RIW submitted, won and managed an Innovate UK grant application to enable a collaborative research study with the Defence Science and Technology Laboratory and Hywel Dda University Health Board, with support from Accelerate at Swansea University. We believe in RIW we have the opportunity to translate good ideas into products and approaches that will improve the respiratory and lung health, wellness and wealth agenda in Wales and beyond. Interested in finding out more? Get in touch with us and ask how we can help you.

www.riwales.com

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Health Technology Wales Health Technology Wales (HTW) is a national body working to improve the quality of care in Wales. They have collaborated with partners across health, social care and the technology sectors to ensure an allWelsh approach. Funded by Welsh Government and hosted within the Welsh NHS, HTW is an independent organisation. They have recently been working on a variety of exciting projects, including their Strategic Plan for 2021-2025. The plan outlines HTW’s goals to drive improvements in population health and social care by applying the best available evidence to inform decisions on the appropriate use of health and social care technology innovations in Wales. HTW have recently been working with Social Care Wales, to explore whether their methods and processes are appropriate for social care and to raise awareness of their remit. In May, they facilitated a roundtable for experts and high-level decision makers within Wales to discuss how health technology assessment and social care sit together. Furthermore, in June they helped to run a workshop for people accessing and working in social care to provide feedback on the appropriateness of HTW’s processes. They also played an important role in the Wales COVID-19 Evidence Centre by engaging in the development of the evaluation methods of the centre which are being used to better inform Wales on COVID-19 topics. HTW has led reviews on a range of COVID-19 related topics, including face coverings, surveillance,

and Oximetry. This research has directly influenced the COVID-19 strategy within Wales. A final project to touch upon, is the pilot of the HTW adoption audit process. They have consulted widely with stakeholders across Wales, including those involved in the assessment of medicine and non-medicine technologies, commissioning and procurement and international partners with experience in this area. HTW have met with named contacts from each local health board and commissioning bodies, ensuring their efforts are aligned with and fit existing processes. They have developed a draft

adoption audit process as a result and are now preparing to pilot their audit with eight pieces of guidance, already having been published.

Lastly, HTW will be a sponsor of one of the forthcoming MediWales Awards, they have always been a strong supporter of MediWales and this has remained throughout COVID-19.

www.healthtechnology.wales

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Innovation and collaboration in NHS Wales

Talking Type 1: Books to support psychological needs of people living with diabetes Dr Rose Stewart, a Clinical Psychologist who works for the All-Wales Diabetes Implementation Group, has published a selection of books to help people living with diabetes, specifically concentrating on the psychological side of having diabetes. Back in 2016, Dr Rose was running a pilot in a Young Adult Diabetes service in North Wales when she quickly became aware of the lack of psychological support for people who have diabetes. From this, Dr Rose began to write her first book.

The ‘Talking Type 1’ book range has a selection of books to support children, adults and families living with diabetes. There are currently four books in the range – Diabetes Burnout, Not OK with Needles?, Diabetes Distress & Burnout for Parents & Carers, and a children’s book, How to Manage a Mammoth.

“AgorIP helped us to take the next step with our project and navigate the confusing world of contracts and publishing agreements. The team were really friendly and took the time to understand exactly what we needed.” Dr Rose Stewart Clinical Psychologist All-Wales Diabetes Implementation Group

AgorIP stepped in and supported Dr Rose Stewart and her team in taking the next step to getting the books published, negotiating a contract with Cambridge University Press. Yvonne Jones, a Technology Transfer Manager who is assisting Talking Type 1, said: “It has been a pleasure to help Rose negotiate a publishing contract for her books. These materials will soon be distributed worldwide, helping many more children and their families to cope with diabetes.”

With all of this in place, a large order of 300,000+ books has been requested from NHS England. With the success of the books and the publishing deal, profits from the books will go back into the All Wales Diabetes Implementation Group. This will help to fund and continue the project and support more people in Wales who are living with diabetes.

There are another two booklets in the pipeline – Adjusting to Life with Diabetes, for people who have recently been diagnosed with type 1 diabetes, and another book for children, How to Handle a Hedgehog. Dr Rose Stewart said: “It’s been really exciting to see Talking Type 1 develop from a passion project to an international book range. We hope that these books can help people with diabetes to access some of the psychological support that they need, and realise that they are not alone.”

The books were an immediate hit with the NHS, have been distributed in all diabetes clinics in Wales, and are free for anyone in Wales. If you would like to access a book, please contact your Diabetes Specialist Nurse to arrange this for you. With the books being released across Wales, it wasn’t long until NHS staff in other areas of the UK were asking how they could get copies for their services, and people were getting in touch internationally too. Dr Rose Stewart approached AgorIP after receiving a recommendation. AgorIP brings clinicians, academics and businesses together to pioneer research into cuttingedge technologies and drive commercial success with the support of Swansea University. It has been part-funded by the European Regional Development Fund through the Welsh Government.

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www.agorip.com


Swansea University Academies driving global healthcare transformation Wales is leading the way by launching the first wave of specialised Intensive Learning Academies (ILAs) which will help create the next generation of global innovative leaders in health and social care. The academies, part-funded by Welsh Government, focus on critical policy areas for sustainable healthcare systems, including Value-Based Health and Care, Innovation and Preventative Health. Led by Swansea University and Bangor University, working with partners across Wales and globally, the Academies each offer a range of flexible courses designed for working professionals. These include intensive Executive Education programmes, Masters and Doctorate-level opportunities. Targeting learners from Wales, the UK and internationally from Health, Social Care and the Third Sector, as well as the Life Science Industries, the Academies offer great opportunities for professional development. Alongside education, the Academies are delivering a range of cutting-edge research and tailor-made consultancy services. This will support individual organisations to identify, develop and embed innovative

practices that will help to meet the challenges facing health and social care. Swansea University’s Academies are hosted by its School of Management, and each specialises in a key future growth area for local and global health and social care markets: l The ‘Value-Based Health and

Care Academy’ offers educational courses, research opportunities and consultancy services for Value-Based Health and Care. For more information, visit: www. swansea.ac.uk/som/vbhcacademy

l The ‘All-Wales Academy for

Innovation in Health & Social Care’ – a collaboration between Swansea University, Cardiff and Vale University Health Board, Cardiff University and the Bevan Commission – is focusing on innovation and transformation within health, social care and the third sector. For more information, visit: www.swansea.ac.uk/som/ innovation-academy/

The goal of the ILAs is to empower workforces around the globe with the expertise, skills and confidence to drive the redesign of health and care systems for the better, improving patient outcomes and experiences, while boosting the efficiency and sustainability of services. Educating learners from industry, health, and social care together is encouraging crosssector innovation and collaboration. This will allow the co-development of valuable skills and partnerships to support transformative health and social care. Cari-Anne Quinn, CEO at Life Sciences Hub Wales, said: “Ongoing innovation is essential to ensuring a pipeline of groundbreaking discoveries and developments. By uniting health and industry professionals and encouraging them to learn and work together, these academies will establish a foundation for sustainable and collaborative innovation for years to come.” Professor Hamish Laing, Director, ValueBased Health and Care Academy, said: “Wales is at the forefront of the global movement for Value-Based Health and Care, which is reflected in its recent designation by the World Economic Forum as a Global innovator Hub. The VBHC Academy builds on that excellence and international links to educate, conduct research and provide consultancy support to health and care organisations and industry partners around the world wanting to become value-based.” Professor Gareth Davies, Swansea Lead at the All-Wales Intensive Learning Academy for Innovation in Health and Social Care, commented: “The Academy offers a range of learning opportunities to develop leaders and managers, drawing excellence from across Wales and international networks. These include the Intensive Learning Week with the Bevan Commission, C&VUHB Climb Programme and MSc/Doctoral schemes. We look forward to welcoming the first cohorts from Health, Social Care and third sector, and supporting them in their development to benefit of the communities and citizens we serve.”

www.swansea.ac.uk/som/ila

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Digital solutions paving the way for transformation There is remarkable potential for digital healthcare technologies to improve diagnosis and treatment accuracy, care efficiencies and healthcare professionals’ workflows. The convergence of such technologies such as mobile phones, sensors, machine learning, artificial intelligence and imaging, together with standard medical practices, promises exciting advances and creates huge new market opportunities.

The Digital Solutions Fund (DSF), launched in May 2020 by Welsh Government and coordinated by Digital Health Ecosystem Wales (DHEW), a collaboration between Life Sciences Hub Wales and Digital Health and Care Wales (DHCW), set out to identify and pilot innovative technology that could help accelerate the response to the pandemic and benefit patients for years to come.

Supporting those who answered the call NHS assessors selected five digital health initiatives, with Welsh Government providing a £150,000 grant for the rapid piloting and evaluation of new digital platforms, applications and technologies - determining their long-term use and potential.

from patients in advance and maximising staff capacity. And, by allowing patients to better support their own health, it aligned with the aims of Welsh Government’s ‘A Healthier Wales’ policy. Unbound by typical service referral routes or opening hours, patients can self-refer for quick direction to the appropriate care pathway. Be it contacting 111, accessing urgent physio, or routine physio.

PhysioNow: Providing remote physiotherapy support A clinically led, chat-bot support tool, PhysioNow – provided by Connect Health – provides a remote triage solution for Musculoskeletal (MSK) conditions such as arthritis and back pain. These are the most reported illnesses in Wales, affecting 887,000 people and placing a significant

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challenge on healthcare systems: covering 20% of GP appointments and 7.9% of hospital admissions. The pandemic increased difficulties in receiving system care, with routine referral pausing delaying MSK service access. The DSF’s first project aimed to reduce health service strain by limiting unnecessary contact points, gathering more information

The Cwm Taf Morgannwg and Hywel Dda University Health Boards physiotherapy teams worked closely with Connect Health to agree appropriate information governance (IG) processes, adapt current referral and triage processes and communicate the pilot to GP clusters. Over 16 weeks, the pilot enabled 1,029 patients to complete the remote physio triage, with 22% providing anonymous feedback. This was overwhelmingly positive: 81% stated they would recommend using PhysioNow to friends and family.


MedTRiM: Digitally supporting healthcare trauma management The last year has shown how vital managing wellbeing is for healthcare employers. What’s more, according to a recent Deloitte report, an average of £1 spent on supporting mental health sees employers get £5 back from reduced absences and staff turnover. Health and care staff of all specialisms often find themselves in demanding and emotionally charged environments, with potential long-term physical and mental health consequences. This impacts staff welfare and long-term clinical services quality. MedTRiM is a medical trauma and resilience management programme to support those exposed to such pressures. Originally developed for military personnel, Trauma Risk Management (TRiM) was repurposed in 2011 by DNA Definitive. Working in collaboration with Dr Mark Stacey, Associate Dean of New Initiatives at Health Education Improvement Wales and Consultant Anaesthetist at Cardiff and Vale University

Lessons learned The Digital Solution Fund’s value is already beyond the individual successes of its first two projects. While those achievements must be applauded, learning from these pilots is being applied as new programmes come online. For example, ensuring developers understand the IG standards in Wales, which ensure appropriate handling and processing of patient data. A key challenge to delivering change is creating mechanisms and support for rapid and scaled adoption of pilots. This must be planned from the outset, with sufficient time and a robust evaluation approach.

Health Board, they adapted and deployed TRiM in healthcare settings. The result was a well-established resource for face-to-face learning, creating an atmosphere where healthcare staff can openly learn to support colleagues following traumatic experiences. However, Covid-19 interrupted the programme’s classroom delivery, although the pandemic’s pressures on healthcare staff meant MedTRiM’s need was greater than ever. The DSF piloted the adaption of training into a digital delivery format to make MedTRiM courses accessible during the pandemic, while also exploring the potential of a long-term blended learning approach. Open to anyone working across NHS Wales, the course provides access to a digital framework and credible training for managing adverse psychological consequences of potentially traumatic events. This ongoing project saw 322 digital learners from across Wales accessing the course online between October 2020 and May 2021, almost four times the delegates who could access the face-to-face programme in a similar period. Delegates represented a wide snapshot of healthcare

The remaining three projects in the DSF’s pipeline are already applying such learning. These projects include Huma (formerly known as Medopad), a real-time remote patient monitoring system that allows clinical teams to assess, support and manage cardiac patients at home through a smartphone app. This builds on policies that are already allowing earlier discharge. CliniTouch Vie by Spirit Digital will explore remote monitoring of

professionals, including nurses, general practitioners, staff working in intensive care and anaesthetists. As a result, Cardiff and Vale University Health Board is embedding digital MedTRiM as training for all theatre staff and support is being given to allow uptake in Betsi Cadwaladr University Health Board. There has also been UK-wide and international interest in the programme. The digital MedTRiM course will remain available to NHS staff in Wales. DNA Definitive can now provide the training in three ways for healthcare professionals: online, face-to-face and blended.

patients in care homes, and SPOT by Healthy. IO will deploy a wound assessment app that scans wounds, digitalises record keeping and shares images with relevant healthcare staff for further assessment. What began as a chance for businesses to support the Welsh Covid-19 response continues highlighting how we can transform lives through new ways of working, technologies and digital innovations.

A digital future Life Sciences Hub Wales and the DHEW programme is built on experience of how industry can support with health and social care’s evolving needs. The Digital Solutions Fund applies that understanding to demonstrate how cross-sector partnerships can help drive innovation.

If you have an innovative idea or solution for improving an aspect of health or social care, please get in touch: hello@lshubwales.com 23


Innovation and collaboration in NHS Wales

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Success stories from the life science industry

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Success stories from the life science industry

Celtic connections turn brilliant ideas into practical reality Medical product design engineering company GX is living proof that collaboration within the Welsh life science and health technology community, facilitated by MediWales, works. GX worked in collaboration with the University of South Wales and Llusern Scientific with support from the Welsh Government. GX works with a wide range of clients, from medical and healthcare professionals to scientists and companies, developing new cutting edge medical products.

“Our design team has helped to develop some truly groundbreaking products, from an online water toxicity monitor to our most recent collaboration – an assay processor and reader. Several projects like these started as conversations during events hosted by MediWales. Then, to bring the product to life, we frequently rely on our local supply chain, and many of these organisations are fellow

A multidisciplinary approach One of GX’s key strengths is their ability to retain control of the entire project, since they have a range of skills within their multidisciplinary team. When developing a product, as Mark recounts, the team draw on their vast experience from one sector to help solve a problem in another. “We have both the agility and the ability to switch direction occasionally when developing products, because we are a small team,” notes Mark. “Being adaptable was crucial to the successful development of the recent assay reader, since it started as an idea to develop a reader for urinary tract infections. As the pandemic gripped the world, the scientists behind the programme switched their focus, sorted funding, and enlisted GX to help them develop a rapid assay reader.”

Benefits of a local network To ensure quick completion of the projects they are designing, GX frequently taps into their local supply network – many of whom are also members of MediWales.

Mark commented: “The assay reader we helped to design and develop is just one example of how local collaboration can turn brilliant ideas into commercial reality. We are so fortunate to have a ready-made network through MediWales who we can call upon to support the work that we do as a medical product design company.” To assess the feasibility of their design for the assay reader, the first and second versions were modelled by Drumlord. Test kits used were sourced from Biomonde’s Bridgend manufacturing facility. At a time in the midst of the lockdown when raw materials were scarce, GX managed to obtain the key electric components from Axiom. In order to pass the many medical and product tests necessary, several products were manufactured locally by JC Mouldings, an expert in custom injection mouldings. “Without doubt being a member of MediWales is invaluable to us,” concludes Mark. “It is a great forum to meet, share and help each other to develop and advance medical and life science products.”

members.”

Mark Helmich Managing director GX

www.gxgroup.com

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Abel + Imray: 150 years protecting ideas

This year is our 150th anniversary at Abel + Imray of helping businesses to protect their brands and ideas. Intellectual property is increasingly recognised as an asset worth developing and investing in, and throughout our history we have been fortunate enough to work with a range of businesses in Wales, the rest of the UK and beyond. To celebrate this milestone, we have showcased 50 inventions and brands that we feel have made a positive impact to our world, and demonstrate the diversity of intellectual property and what can and has been protected. Below are some examples that we hope will be of interest to other members of the MediWales community and we invite you to take a more in-depth look at abelimray150.com Originally developed with glass in the 1880s, the contact lens has evolved to make use of thin plastics and more recently silicon hydrogels to enable the user to wear them for longer periods. Around the same time digestible pills were being developed, and William Upjohn, a great physician, inventor and as it transpires marketing whiz, helped to bring this innovation into mainstream use. Upjohn achieved a patent for the process he invented, and ultimately his company, through a previous merger, became part of Pfizer. It will be no surprise that we have included the discovery of penicillin by Alexander Fleming, or indeed Jonas Salik’s polio vaccine, which was history’s biggest global public health effort prior to the current coronavirus pandemic, in the list. However, perhaps lesser known is the use of an in vitro test developed by Murex Diagnostics that Abel + Imray helped to protect. The test helps to detect the presence of hepatitis B and is a critical tool in the World Health Organisation mission to reduce liver disease and reduce deaths by 2030.

Our showcase of innovations also includes devices that have made our lives simpler, more convenient and in some cases safer. Take the hairdryer: while early models had some issues with being bulky and overheating, they were an advancement on using the reverse flow of the vacuum cleaner. And the microwave, which now adorns many a household and workplace kitchen. Its inventor Percy Spencer went on to have 300 patents granted during his career. We also take a look at the PC and World Wide Web, and how they have shaped our working and personal lives by enabling us to access information and communicating in a way unseen by generations 40 years ago, and the impact the likes of Sinclair and Amstrad had on driving up PC ownership in the UK.

We excel in the biotech, medical devices and healthcare sectors, and many developing and leading names in these sectors trust Abel + Imray to help them protect their intellectual property by offering practical and tailored advice, coupled with technical and commercial experience and expertise. A complimentary consultation session is offered to new enquirers, so if you have an idea you’d like to discuss or you’ve been inspired by our 150th website (abelimray150.com), please get in touch with our Cardiff team.

www.abelimray.com

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Success stories from the life science industry

Cytiva: the life sciences company opening a new factory in Cardiff Cytiva is the life sciences leading company whose name might not be familiar to you. They are a global provider of technologies and services on a mission to advance and accelerate the development and manufacture of therapeutics. While only having been known as Cytiva since 2020, the company has a rich heritage tracing back hundreds of years. Cytiva has been in Cardiff for over 40 years and now they are expanding. Cytiva’s existing and additional site which will become operational later this year. Work is underway to fit out a new factory next to their existing site. Over 250 new jobs are being filled to staff the new facility, which will make equipment used to manufacture biologic medicines including COVID-19 vaccines and cancer therapies.

Cytiva’s existing and additional site which will become operational later this year.

40 years in Cardiff with deep expertise in genomics For decades, those working in genomics have helped to uncover the genetic basis of disease, which in turn has helped to develop more effective and targeted medicines. Cytiva supports both established and emerging genomics companies. Their customers work on projects from proof-of-concept to scale-up and commercialisation, as well as research and diagnostic labs. Their in-house R&D teams advance the science in novel fields such as liquid biopsies and single-cell analysis. The pandemic has shown the criticality of the industry on a whole new level. In 2020, Cytiva’s magnetic bead products made in Cardiff enabled more than 120 million COVID-19 PCR tests worldwide. The company doubled manufacturing capacity of these products to meet ongoing needs. Cytiva is investing in their diagnostic operations in Cardiff by hiring more staff and building out infrastructure to meet future anticipated growth.

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Genomics products manufactured at Cytiva’s Cardiff site. The site in Cardiff was established back in 1981, when it made hundreds of products per year. Since then, the site has grown both by square feet and by number of associates. Over 6,000 products each year are shipped internationally from the site. Originally, the laboratories focussed on synthesising radiolabelled drugs or advanced

intermediates containing carbon-14 and tritium (H-3). The site became the company’s principal life sciences manufacturing site when it began operations under the direction of Dr John Maynard in 1980. When Sir William Castell became Chief Executive of the company in 1989, a new course was set to expand the product


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next two years to expand its operations to meet these needs. 36 million GBP of that is being invested in the Cardiff site, with the majority being used to fit out a new 11 000 m² facility. At the new factory, the team will make single-use bioprocessing equipment including jumper tubing assemblies, cell bags, and ÄKTA flow kits. These products are used across the bioprocessing workflow to make biologic medicines, such as vaccines. The first product is expected to come off the assembly line this year. Since the announcement in July, the team has already made progress both in building cleanrooms in the new facility as well as hiring staff.

Cytiva’s Cardiff site under construction in 1980

“It’s exciting to see our campus expand and to welcome 250 new associates to Cytiva. The fact that the business has chosen to open a new facility here as well as invest in our existing operations shows the level of confidence in the South Wales team. What we do has a critical role in Cytiva’s mission to advance and accelerate therapeutics and this is the next chapter of the site, building on our 40-year heritage.”

Dr Mike Cooper Plant Manager Cytiva Cardiff Cytiva’s Cardiff site today. portfolio. The focus of nuclear medicine would gradually move towards branded, innovative diagnostic and therapy products. A benefit of the company’s long heritage in Cardiff is the links with local academic centres, a key source of scientific talent, as well as connections with industry associations such as MediWales.

New factory for 2021 to make bioprocessing equipment There is a growing global demand for biotechnology solutions – a trend accelerated by the COVID-19 pandemic. Along with sister operating company within Danaher (Cytiva’s parent company), Pall Corporation, Cytiva is investing 1.5 billion USD globally over the

www. www.cytivalifesciences.com

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Success stories from the life science industry

The Medical, Life Science & STEM Specialists who Advise, Support and Protect Growing Businesses Mergers and Acquisitions - Business Sales - Investment Raising

We are a corporate finance led deal-making group, proudly supporting businesses in the medical, life sciences and STEM industries from early stage and throughout their growth.

Legal Services | Corporate Finance | Investment Network | Business Sales | PR & Comms | Financial Management

Industry Experience Multi-million sale of Brecon Pharma to Ameriscource Bergen

Eight figure sale of Biotec Worldwide to PCI

Multi-million sale of Markes International to Schauenberg GmbH

Companies we’ve worked with

Call: 029 2009 5500 Email: hello@gsverde.group Bristol | Cardiff | Milford Haven | Dublin London | Oxford

www.gsverde.group 30

Multi-million series A–D fundraising for Trakcel from Telegraph Hill


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GS Verde Group

SolasCure announces £15m Series A raise

Biotech start-up SolasCure has announced completion of its Series A investment round, in a deal advised on by MediWales corporate sponsor GS Verde Group. The investment will support the development of their wound cleaning product, Aurase. The Cambridge based biotech company has successfully completed its Series A raise of £15m, with funding from industry veterans, institutional venture and strategic investors. SolasCure is developing proprietary technology leveraging biomimicry and evidence-based medicine to empower health care professionals to treat patients with chronic wounds. Their first investigational product, Aurase, is a hydrogel containing an enzyme cloned from medical maggots, which can be used to support healthcare professionals treating patients with chronic wounds.

The raise began with investment from BRAIN Biotech AG, who are SolasCure’s largest shareholder. Adriaan Moelker, CEO of BRAIN Biotech AG, said: “It has been an encouraging sign for all partners that SolasCure has been able to successfully close another financing round with rising pre-money valuation during the pandemic. We continue to be committed to support SolasCure on its way to market for the innovative wound debridement enzyme, Aurase.” The round was completed following investment by Seneca Partners, an investment management business based in the UK. Matt Currie, Investment Director at Seneca said: “We are delighted to support SolasCure as part of this latest funding round. The team they have brought together are truly world-class, producing ground-breaking work in the

wound care sector. Practitioners are crying out for a high-quality solution that can be transported, stored and administered in an efficient and effective way, which is something severely lacking in the treatments available at present. We believe SolasCure’s Aurase product has the potential to become the go-to solution in this space”. In addition to the investments from BRAIN Biotech AG and Seneca Partners, other notable investors to date include Bionova Capital, experienced entrepreneur and life sciences angel investor Jonathan Milner (founder of Abcam), strategic investor EVA Pharma, the Development Bank of Wales, and François Fournier (former lead of Smith & Nephew’s Advanced Wound Care division). The GS Verde Group acted as advisors to the fundraise.

“We are delighted to have completed our Series A round, which will help us to move onto the clinical trial stages of product development. We are excited to be working with such knowledgeable and specialist investors, as they join us on our mission to support healthcare professionals with wound care products that significantly improve the health and wellbeing of patients with chronic wounds.”

Dr Sam Bakri Founder and CEO SolasCure

www.gsverde.group

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Success stories from the life science industry

Safe endoscopy starts with the SNAP, Endoscope Guide By Dr Dafydd Loughran, Concentric Health CEO

The MediWales award-winning SNAP, Endoscope Guide was designed in response to COVID-19. With the pandemic meaning only 8% of nasendoscopies were able to be carried out, there was a clear demand for a device that enabled safe endoscopy. Alongside endoscope-i, DTR Medical developed a UKmanufactured device that ensures nasendoscopies can be conducted, providing critical diagnosis of Head and Neck Cancer.

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Why use the SNAP, Endoscope Guide? A risk to both ENT Clinicians and Speech & Language Therapists is that whilst carrying out nasendoscopy procedures, the healthcare professional is at significantly


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higher levels of contracting airborne risks and diseases. The SNAP, Endoscope Guide aims to provide better safety for both the patient and clinician.

“COVID-19 has disrupted many aspects of our home and professional lives. ENT services across the world have been placed into disarray whilst clinicians debated the true meaning of an Aerosol Generating Procedure (AGPs). Like many clinicians, we were concerned to see the huge negative impact that reducing nasendoscopic examinations had on the early diagnosis of cancer, not to mention many of the other commonly presenting ENT conditions. Being both clinicians and innovators, we were able to pool the skill sets within our company, endoscope-i, to conceive, prototype, design, test and manufacture a safe method of performing nasendoscopy through a surgical mask. Safe endoscopy starts with a ‘SNAP’.”

Ajith George, FRCS Chris Coulson, PhD, FRCS Consultant ENT Surgeons

The device ensures a safe passage through a surgical mask, facilitating movement of a scope up to 4mm in diameter, creating an aperture for the endoscope to pass through into the nasal cavity. This means any coughs, splutters or sneezes throughout the procedures are caught in the mask, which is easily doffed after use.

MediWales award-winning DTR Medical won the ‘Partnership with the NHS’ Award at the 2020 MediWales Innovation Awards. This recognised the company’s collaboration and partnership with Consultant ENT Surgeons Chris Coulson, PhD, FRCS, and Ajith George, FRCS, in the development of this essential product and helping to bring it to market. DTR also ensured a free box was offered to every UK ENT Clinic in the UK, with the opportunity for those who have not yet received one to do so.

the importance of continuing nasendoscopy procedures during the coronavirus pandemic.

ENT UK Guidelines ENT UK recently released their latest guidelines for potential Aerosol-Generated Procedures (AGPs) within the ENT Clinic, with a focus on advice for ENT Surgeons conducting upper-airway endoscopy. The guidelines suggest that patients are advised to wear a mask during nasendoscopy procedures, which is a problem solved using the SNAP. Our device maintains the Medical Device Regulation of the mask and is currently the only regulated and standardised method to do so, recently receiving UK Patent Application Number 2105626.2.

Want to try the SNAP in your Clinic? The device has been implemented throughout the UK and Ireland from which we are seeing huge success stories where the device is becoming standard practice. If you are interested in the SNAP and would like to find out more, please contact dtrmarketing@innoviamedical.com

In addition to the award, DTR also hosted a webinar alongside MediWales, focused on

www.dtrmedical.com

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Success stories from the life science industry

Scale-up for medical device contract manufacturing in Cardiff Following the unprecedented success of its medical device contract manufacturing business, EKF Diagnostics has expanded its Cardiffbased facilities twice within six months. In early 2021, EKF opened new, larger manufacturing facilities at Llandough Trading Estate to increase production of PrimeStore® MTM viral transport media, a key component for the COVID-19 testing regime. Just six months on from

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this opening, EKF has further developed its production area, warehousing and work force with the opening of two more adjacent units. The additional units, which include cleanroom facilities, triple EKF’s existing manufacturing area at Llandough to nearly 2000m2. This latest manufacturing area expansion, which can accommodate a further 100% increase in workforce, will now enable EKF to fill up to 100,000 PrimesStore MTM tubes daily. This will

ensure they can meet the ever-increasing UK and EU demand for this novel, patented sample collection device successfully evaluated for effective SARS-CoV-2 inactivation by Public Health England. An established device for safe and easy transportation of pathogenic samples, millions of PrimeStore MTM tubes have now been sold globally during the SARSCoV-2 pandemic, and EKF has continued to receive escalating numbers of orders from healthcare, education and industry for


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COVID-19 testing programmes. As well as the additional manufacturing capacity in Wales, EKF has also increased production at its facilities in Barleben, Germany, and the USA in Boerne, Texas, and South Bend, Indiana. In addition to the increased floor space, EKF has quadrupled its Cardiff-based workforce at a time when many companies have been forced to make redundancies. The new facilities, fitted out using only local contractors, can now accommodate up to 80 staff operating six tube filling pump lines and eight production lines for sample kit assembly. Since September 2020, EKF has already created 54 new jobs, including production line operatives, and in quality assurance, customer services, purchasing, operations and logistics to meet the demand for PrimeStore MTM. EKF expects to employ even more staff as it expands into the new facilities. The success of PrimeStore which has necessitated the increased production capacity is due to high-volume customers, such as PHE and the NHS, as well as MyHealthChecked plc, the supplier of Boots’ COVD-19 home testing kits. Orders from other customers, including global industry partners, have also escalated as they realise PrimeStore is helping them to significantly streamline their sample collection and testing processes. Leicester University has established an asymptomatic SARS-CoV-2 screening programme to support and reassure staff and students on campus, and to reduce viral transmission. “By choosing PrimeStore MTM with its viral inactivation properties, we are ensuring the safe transportation and processing of participants’ samples and ensuring protection for our staff,” said Dr Rebecca Allsopp, Research Associate at Leicester Cancer Research Centre,

“We are proud to be bucking the current employment trend in Wales by taking this strategic decision to further increase the size of our manufacturing facilities in Cardiff. Our new facilities provide EKF with a unique positioning for companies looking for contract manufacturing facilities and allow us to ensure our increasing staff numbers can operate in a safe and secure environment.”

Julian Baines EKF’s CEO

University of Leicester. “We have the reassurance of RNA stabilisation, protecting sample integrity at room temperature without the need for additional storage requirements. EKF has also provided excellent customer service.” With the continued and significant growth in its manufacturing capabilities, including the addition of two cleanroom facilities and extra warehousing, EKF can also now offer a range of contract production services to other medical device companies.

These include full capability for labelling, commercialisation, regulatory support, GTIN barcode encoding and usability testing, amongst other services. The new Cardiff facility has also become a distribution hub for EKF’s latest portfolio addition related to the COVID pandemic, the Kantaro COVID-SeroKlir SARS-CoV-2 IgG antibody test kit. It is one of first tests in the world to detect both the presence and precise levels of COVID-19 neutralising antibodies.

www.ekfdiagnostics.com

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Success stories from the life science industry

Investment in sustainable manufacturing initiatives Gwalia Healthcare has seen dramatic changes in the last two years and diversified to address the latest environmental challenges as they strive to achieve their sustainable manufacturing goals. Significant investment in new machinery has seen Gwalia Healthcare take delivery of 11 new machines across their site, all of which are electric instead of hydraulic and use less energy. It is estimated that a single electric injection moulding machine uses 1.4kW of energy every hour, which is less than half of what is needed to boil a household kettle once. The investment was vital in enabling the company to meet increased demands across all divisions, whilst also reducing the carbon footprint associated with the manufacturing process.

Gwalia Healthcare’s pharmaceutical and nutraceutical customers are expected to take advantage of, particularly with the NHS setting out their Net Zero Policy. Gwalia Healthcare is confident that customers will be able to support the NHS’s goals following their latest manufacturing initiatives. The company has continued to develop its facilities on the Treforest Industrial Estate, Pontypridd, South Wales. The latest installation is the addition of a new, larger cleanroom to accommodate an exciting new project. This new contract work sits well with their ‘granule to product’ approach all available on one site, reducing road

“We are at a very exciting point in the company’s development, and by investing in sustainable initiatives, I hope we will be well placed in the future to meet the new challenges.”

Rod Parker Managing Director Gwalia Healthcare

miles and carbon footprint before arriving with the end customer. The company has a passion for using local UK supply chains wherever possible which provide a sustainable benefit and wider social value.

Gwalia Healthcare has also been working closely with British waste management companies on the supply of commercially available food-grade recycled HDPE, enabling them to integrate recycled granules back into the manufacturing process. This has led to a programme of in-house production trials to evaluate different compositions. The company has observed promising results with 30%, 50% and 97% recycled content.

Gwalia Healthcare has received its first purchase order for bottles integrating 50% recycled content. The order came from a public sector organisation which aims to procure as much as possible from within Wales and to promote the model of sustainable manufacturing. The use of recycled HDPE is something that all of

www.gwaliahealthcare.com

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Developing breath analysis into a rapid diagnostic

A lot can happen in a year and a half. In the world of healthcare analytics, disease screening and medical diagnostics, familiarity with test details and interpretation of the results of these tests, which was previously the realm of medical professionals, has become part of everyday household terminology amongst the general public. The pandemic has underlined the need for accurate, easily accessible and rapid diagnostic tests to generate maximum protection for patients and society more broadly. This is precisely where breath analysis, using a combination of gas chromatography and ion mobility spectrometry (GC-IMS) technology, comes into its own. We reported last year on how Imspex Diagnostics’ GC-IMS BreathSpec technology was being trialled for its ability to detect coronavirus. The findings of this multicentre feasibility study were published in the Lancet eClinicalMedicine in October last year. BreathSpec distinguished between patients with COVID-19 and those with other respiratory conditions, and results continue to be validated at multiple sites. A large Horizon2020 study, completed in the last year, similarly showed that BreathSpec could also differentiate between patients with acute respiratory infections caused by bacteria as opposed to those caused by

viruses. This offers a promising platform which could be used to guide prescription of appropriate treatments for people with respiratory infections, and Imspex is continuing to add to the breath profile database for this application.

An urgent need for rapid diagnostics to fight antimicrobial resistance Antimicrobial resistance (AMR) has been described as both the “next pandemic” and the “silent pandemic”. In 2016, the O’Neill Review on Antimicrobial Resistance recommended that rapid diagnostics should be developed and used as a matter of urgency to identify infectious disease agents and to guide prescription of the most appropriate treatment for each specific causal agent. Five years later, this recommendation has yet to be broadly taken up.

Doctors are in a difficult position A large proportion of patients that come to GP surgeries present with a respiratory infection. Doctors currently have no reliable on-the-spot way of being able to determine whether this infection is caused by a bacteria or a virus. This puts them in the position of having to consider prescribing antibiotics, where they would otherwise not do so if they could verify that the causal agent was a virus. This is a gap that breath analysis and more specifically BreathSpec would be perfectly suited to fill.

Breath as a non-invasive, rapid diagnostic Breath has long been viewed as a desirable source of information on which to judge a body’s state of health. As far back as Hippocrates’ time, people noted that unique odours were linked to certain diseases. Until now, however, neither state-of-the-art technology nor the knowledge base around metabolomics of volatile organic compounds has been sufficiently well developed to detect and recognise breath profiles accurately and reliably. This is now changing with technology combinations, data science advances and growing breath profile databases. The momentum that breath analysis continues to gain makes it a strong contender for use to detect and/or contribute to earlier diagnoses of both infectious diseases, including respiratory tract infections, and non-communicable diseases.

Taking breath analysis to patients Imspex Diagnostics has recognised this opportunity and has taken several steps to meet this need. We are continuing to collect data with multiple global partners to build up breath profile databases. Over the past year, Imspex Diagnostics has also set up Imspex Medical as a specific internal division of the company to take breath analysis to patients at their point-of-care. This will definitely be a space to watch.

www.imspex.com

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Success stories from the life science industry

JIVA

Bringing multimodal AI to healthcare

The importance of AI across all industry sectors is now universally accepted. Organisations will apply AI technologies to transform business in ways not seen since the Industrial Revolution, fundamentally reinventing how they are run, compete and thrive. Implemented responsibly, AI will amplify human existence and improve how we live and work. The AI market in totality is predicted to be worth $15.7 trillion by 2030. The opportunity is so great that the UK has created an AI Council to purposefully position the UK as a world leader in AI. However, AI has failed to address complex problems at scale and will not reach its full potential until it is more widely accessible to all levels of business. Real-world applications are multifaceted and data is siloed, which leads to fragmented AI models. To truly achieve scale, we need a way to consolidate the existing fragmentation. The solution is ‘Multimodal AI’ – the future of deep learning.

Jiva has developed next-generation machine learning in AI, helping users to create, modify, enrich, store and deploy scalable multimodal systems. At the core of the company is a team with over a century of experience in creation and commercialisation of AI, data, life sciences, healthcare and software products.

The company’s flagship project, JivaRDX, revolutionises the diagnosis of prostate cancer, which is one of the most prevalent cancers on the planet with an estimated 1.3 million new cases globally every year. Whilst early treatment of the disease yields good outcomes, diagnosis remains problematic.

Far too many patients are having unnecessary, invasive biopsies after their initial scans, which causes massive health

economic impacts. As many as 50% of patients suffer complications due to biopsy, whether or not they actually have cancer, and many of them fall into life-threatening illness – a situation that is largely avoidable if diagnosis is more accurate and less subjective at the scanning stage. Combining access to unique data from prominent partners with its AI fusion technology, Jiva has developed a solution that can outperform a human radiologist. The prostate cancer diagnostic product is on track to complete regulatory alignment towards the end of 2021 and commercialise in 2022. In another project, IDLiver, Jiva is is creating multiple diagnostics for liver disease, taking into account patient record data, socioeconomic statistics, imaging, genetics, biomarkers and more. This is a truly multimodal analytics project, and counts Roche Diagnostics, GE Healthcare, Manchester and Nottingham universities and NHS trusts as partners.

www.jiva.ai

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PCI Pharma’s game-changing digital platform

The pharmaceutical industry has historically been risk averse and slow to adopt technology. PCI Pharma Services is blazing a trail in digitalisation. “PCI Pharma Services is recognised in the industry as a leader when it comes to providing world-class customer service,” said Wayne Hull, Global Chief Digital and Technology Officer, PCI. “In order to retain that leadership position going forward, digital experiences and capabilities are essential.”

PCI is now two years into a three-year corporate digital transformation strategy that is already differentiating the company, and providing real and measurable returns – the pci | bridge platform is a prime example of this. pci | bridge gives customers real-time visibility into their clinical and commercial supply chain to enable closer collaboration with PCI’s teams and provide instantaneous data and insights to inform decision-making. “We wanted to build a very customercentric, user experience (UX) platform with information that is relevant to customers’ projects and their relationship with PCI,” said Morgan Brandt, Director, Digital Products, PCI. “We also want to provide as much transparency as possible, saving time and resources to ultimately help bring lifechanging therapies to patients faster.”

Addressing clinical trial management needs Clinical trial services is the fastest-growing and most logistics-heavy division at PCI. Clinical trial activity intensified further during the coronavirus pandemic, with a greater demand for new COVID-19 tests and therapies. While pci | bridge was not developed specifically in response to COVID-19, PCI had to scale up to meet the moment. “COVID-19 highlighted a need we were already focused on” said Tim Roberts, Vice President for Global Sales for Clinical Services, PCI. “The level of detail in the platform is a big differentiator. Users can easily navigate among clinical trials and drill down into deep layers of data to maximise transparency.” The platform helps customers to better manage the clinical trials process from start to finish, from shipments to temperature control, with seamless functionality. A key feature of pci | bridge is its ability to pull in real-time data across inventory, production and distribution.

Built from the outside in PCI wanted to go beyond data to create a consistent yet technologically leading platform built around the entire customer experience. PCI worked with customers to illuminate their desires for a better way to work together, such as more supply chain visibility and less time spent on manual activity to manage the PCI relationship. “The benefits of using pci | bridge is that is that it eliminates the need for clients to constantly reach out to the project teams for

updates,” said Kevin Gregorczyk, Director, Development Operations at eFFECTOR Therapeutics, which participated in the development process. “Now, we will have that information at our fingertips and can instead focus on the bigger picture with PCI, such as what’s coming next.”

The digital journey continues While clinical trials are often the entry point for PCI customers, pci | bridge can be used throughout the product lifecycle. The company is continuing to invest and enhance the platform with more integrations and other expanded functionality. For example, PCI plans to integrate pci | bridge into systems customers already use, such as interactive response technology (IRT) systems – an essential component of clinical trial management.

“We are always looking to the future and can see the potential that digitisation holds for the pharma and biopharma supply chain,” said Wayne. “pci | bridge is a leading-edge client experience that will continue to evolve as the business requires. Ultimately, if you work in 10 systems, we want to eliminate nine so you only have to use one resource for a seamless experience.”

www.pci.com

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Success stories from the life science industry

Facilitating advanced therapies by streamlining the value chain Launched in 2012 and headquartered in Cardiff, UK and with offices in the USA, TrakCel provides software solutions and professional services that facilitate the orchestration of advanced cell therapies from early-stage clinical trials to commercialisation and beyond by simplifying the complex value chain associated with these treatments. Working with clients across a broad range of therapy classes including autologous, allogeneic and personalised cancer vaccines, the second-generation platform OCELLOS by TrakCel allows therapy developers to manage and monitor the supply chain, from patient enrolment, through temperature-controlled logistics, to manufacturing and delivery of the final drug product to the patient. These lifesaving treatments are subject to multiple, complex processes and legislations to ensure that they are safe and effective for patients. Combined with the nature of the materials being worked with and the health of the patient, all of this needs to be accomplished as quickly, efficiently and safely as possible with a full record of every stage of the supply chain journey. OCELLOS puts shipping information, Chain of Identity, Chain of Custody and audit information at the fingertips of the relevant platform users,

integrating with systems such as shipping and labelling to highlight if conditions go out of range and to help prevent errors that might lead to the product being unusable or, at worst, incorrectly delivered, potentially causing harm to the patient. In medicine’s most complex value chain, the successful delivery of advanced therapies presents a unique set of challenges and relies upon a connected, compliant and scalable value chain. With multiple stakeholders involved in the delivery of successful

OCELLOS is a new generation SAAS platform built on Salesforce.com which was launched to give customers the flexibility of a highly scalable and modular solution. The platform can be quickly and easily configured using ‘clicks not code’ methodology, and deployed to meet process and therapy requirements as well as exception management in a cost-effective and timely manner in a highly regulated environment.

treatment, issues can arise from many areas, including manufacturing challenges and constraints or the incorrect delivery of samples or treatments, and the need to see the journey in its entirety has never been as pressing. TrakCel use the phrase ‘cellular orchestration’ for this very reason and are dedicated to coordinating the services, experience and knowledge of the various stakeholders across the partner ecosystem that work together to deliver these life-changing therapies. So, what is next for TrakCel? There is always a patient at the end of everything we do, so we continue to recruit talented people to further develop and deliver OCELLOS, ensuring we meet and exceed the needs of an ever-changing and developing industry. We also continue to broaden our partner network, where integrations simplify the process of connecting these vital treatments to the patients who need them.

www.trakcel.com

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Keeping patients safe in the community using a portable 6 lead ECG device Tees, Esk and Wear Valleys NHS Foundation Trust (TEWV) have introduced the use of KardiaMobile 6L by AliveCor – the world’s only six-lead personal ECG device that health care professionals use to support patients in the community. This ensures that patients can be remotely monitored without going to a hospital setting, therefore reducing the risk of COVID-19 transmission for both parties. The team at TEWV (Dr M Santhana Krishnan, Consultant in Old Age Psychiatry & Senior Clinical Director, and Lauren Bennett, Innovations Coordinator) identified that the six-lead AliveCor device could be used to monitor patients in the community during the COVID-19 pandemic. Their patients include those who are on, or are to

be started on, psychiatric medication and need to be carefully monitored for detection of potentially dangerous QT prolongation. A prolonged QTc can lead to a potentially fatal effect, called drug-induced sudden cardiac death (DI-SCD). Previously, monitoring was ordinarily done by a 12-lead ECG connected to the patient who is required to partially undress, have their skin prepared, and have ten separate leads attached. Staff and patients have found the six-lead device less intrusive, as no clothing needs to be removed and patients can use the device themselves. The whole process lasts five minutes and the ECG can be sent instantly and electronically from the Kardia app to a clinician’s secure NHS email address to measure and report on the QTc immediately.

The team has produced a user guidance document, ‘The Tees Remote ECG Pathway’, and a resource page which can be found at ahsn-nenc.org.uk. Dr Krishnan ran webinars for staff and recorded a step-by-step video guide on how to operate, record and transmit the ECG safely following all the Trust guidelines. With support from NHSX, there are now 100 KardiaMobile 6L devices in use across community teams at TEWV NHS Foundation Trust and 40 in use across inpatient wards at Cumbria, Northumberland, Tyne and Wear NHS Foundation Trust. The AHSN NENC assisted throughout the project, offering advice and funding to test, roll out and scale up the pathway.

“The AHSN NENC was instrumental in the procurement and roll-out of the AliveCor KardiaMobile 6L device within our Trust. This is an excellent digital solution which has been rapidly deployed at pace and scale, providing our community teams with a device which reduces the risk of COVID-19 transmission. It is promising to see this has been extended to further Trusts in our region, so that NHS staff and patients can benefit from this unique technology and also the innovative pathway which was developed at TEWV.”

Dr M Santhana Krishnan Consultant in Old Age Psychiatry & Senior Clinical Director

www.alivecor.co.uk

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Success stories from the life science industry

High quality PPE masks: Made in the UK, for the UK Hardshell, a British manufacturer of safety products such as body armour and armoured vehicles, is now one of the UK’s first medical-grade PPE mask manufacturing companies. The company stepped up to the country’s challenge and established manufacturing lines in Wales to provide the UK healthcare industry with the resilient supplies it needs in the fight against COVID-19 and any future pandemic.

Hardshell UK produce a full range, including FFP3 masks that protect healthcare workers from COVID-19 MediWales member Hardshell UK worked diligently, with the support of the Welsh Government, to establish a 1500sqm facility in Cardiff, which is now manufacturing a comprehensive spectrum of PPE, ranging from single-use Type IIR, FFP2 and most importantly FFP3 masks that provide protection to the wearer. The company also has reusable face masks for personal social use.

Short supply chain with base fabrics produced onsite in Cardiff The primary objective of Hardshell UK was to create a resilient supply of PPE that is sustainable in the event of another crisis, such as a pandemic. The venture is unique in that the company produces the raw materials for the masks in its facility in Cardiff. The production team works on its own line of machinery to complete the full manufacturing process on the same site. This shortens supply chains and offers a sustainable and reduced carbon footprint.

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Quality assured thanks to in-house testing

Future Focus on Customer Net Zero Plans

While the ambition of Hardshell UK to become an agile PPE manufacturer was boosted by the production of melt-blown fabric at the same facility, the company has gone a step further towards selfsufficiency by establishing an advanced in-house testing facility. In this stringent laboratory setting, a series of tests for filtration efficiency, breathability, splash resistance and face-fit are performed. This valuable capability contributes to the rapid completion of these comprehensive tests on the Type IIR, FFP2 and FFP3 masks, assuring the highest quality standards throughout the production process.

Keeping environmental concerns in mind, and the stated needs of customers like the NHS for net zero in future, the company has been working closely with recycling firms to investigate, evaluate and reduce the impact of its products to the environment. By manufacturing masks locally, including raw materials, Hardshell UK eliminates the need for large scale overseas imports. Through these significant steps towards sustainability, Hardshell UK reduces the end user’s contribution towards their carbon footprint. Hardshell UK, being a vertically integrated company, is capable of manufacturing and delivering masks in very short lead times, reducing the UK’s dependence on foreign suppliers. The company also works in close collaboration with other UK-based manufacturers to provide other raw materials in the long run, allowing it to speed up mask production and supporting other British companies.

www.hardshell.co.uk


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Blue Stream Academy – Supporting the health and care sector throughout the pandemic and beyond As the leading provider of eLearning to UK health and care professionals, Blue Stream Academy is committed to supporting a userbase of over a quarter of a million trainees – throughout the COVID-19 pandemic and beyond. In February 2020, Blue Stream Academy released one of the market’s first COVID-19 eLearning modules, specifically designed for health and care professionals who were adapting to changes in the workplace and patient care. Shortly after, on 11th March 2020, the World Health Organization confirmed that the COVID-19 outbreak was in fact a worldwide pandemic. With the true magnitude of the pandemic becoming apparent, the Blue Stream team reacted quickly and this time the objective was clear – to develop a COVID-19 Staff Support Toolkit, free-to-all health and care workers, covering relevant topics via an easy-to-use and accessible digital platform. The COVID-19 Staff Support Toolkit covered everything from infection prevention and control measures to a range of organisational guidance, all available free-of-charge to any health and care professional in the UK. Following its launch, the Toolkit was updated regularly, reflecting daily COVID figures and changes in relevant recommendations, guidance and legislation. Since launching on 1st April 2020, the Blue Stream Academy COVID-19 Staff Support Toolkit has had over 33,000 trainee completions on the GP eLearning suite alone.

The rise in cases and hospitalisations quickly escalated, and with that came the sector’s second unprecedented challenge – the shortfall in trained staff to care for the increasing number of COVID-19 inpatients. The General Medical Council contacted over 15,000 doctors, the Nursing and Midwifery Council wrote to over 50,000 nurses, and Social Work England contacted 8,200 social workers, all of whom had given up their registration over the last few years, and offered them temporary registration to help manage the COVID-19 pandemic.

To support the potential return of over 70,000 health and care professionals, Blue Stream Academy developed a tailored set of Essential Refresher Training modules, covering 14 mandatory topics, designed to refresh each returning staff member on the essential training required to safely deliver patient-centred care.

Since launching, Blue Stream Academy’s COVID-19 training resources have had over 55,000 completions. That’s an average of over 110 completions per day! Blue Stream’s support for health and care has continued with the launch of Vaccination Training in December 2020. This training was subsequently expanded to create the Blue Stream Vaccinator Passport, which covers the subjects and training required to become a COVID-19 vaccinator. The Vaccinator Passport is continually updated in line with vaccination recommendations and provides a central information resource for our trainees. Amid the pandemic’s immense challenges and demands, Blue Stream has witnessed the resilience and courage demonstrated by its community of trainees and, for that, they would like to say a massive thank you to every health and care worker who continues to provide dedicated, compassionate and high-quality patient-centred care.

www.bluestreamacademy.com

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Success stories from the life science industry

Bollé forms partnership with Welsh manufacturer Bollé Safety, world leader in the design and manufacture of protective eyewear, has announced a partnership with Welsh firm, RotoMedical, part of the Rototherm Group, as their exclusive UK manufacturer of PPE eyewear for the healthcare industry.

More than 3 million PPE items are set to be produced monthly at RotoMedical’s manufacturing base in Port Talbot, South Wales, following the production’s launch. The partnership, which has been praised by Life Sciences Hub Wales, will see products distributed across the UK and Ireland as well as exported to healthcare markets globally, with key regions including Europe, Australia, and North America. Ian Walbeoff, Vice President of Sales at Bollé Safety said: “At Bollé Safety, our mission has always been to protect the eyesight of healthcare professionals across the world, even in the most challenging environments, ensuring they are able to safely work on the frontline. At the heart of our brand is a genuine desire to continually innovate and use the best available technology to create the highest quality products, and our partnership with RotoMedical will play a key role in achieving this. Combining the long-standing legacies and expertise of both our companies will enable us to collaboratively design, manufacture and assemble products that put innovation at the fore and set a new global industry standard when it comes to performance, excellence and sustainability.” Rototherm Group, a company dating back to the 1880s, specialises in the production of industrial measuring instruments. During the pandemic, the firm pivoted to also produce medical masks and protective face shields for health and care workers under the brand RotoMedical. Since the pandemic’s arrival in the UK, the Port Talbot manufacturer has increased

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production capacity of plastic face visors from a 1,000 per day to 250,000 every week. That rapid success has catalysed further expansion into the life sciences sector, as RotoMedical has progressed to produce BSI certified Type IIR face masks, which are surgical grade and designed for use by healthcare professionals. Tarkan Conger, Business Development Director at Rototherm Group, commented: “Our ambition has always been to continue to expand and develop the business, and in turn to create more jobs for the local economy. The partnership with Bollé Safety will enable us to build on our industrial expertise and innovation as we embed ourselves in the life sciences sector, expanding into new manufacturing capabilities and markets.” Following the supply contract with Bollé Safety, the company added safety goggles to its remit, for which it has created a dedicated automated production line. The Bollé Safety face shields will be manufactured by RotoMedical, Rototherm’s medical and protective equipment division, using locally sourced raw materials.

“We’re proud to be an SME in Wales, and the drive is to continue securing partnerships with other companies in Wales and internationally. With the help of Life Sciences Hub Wales, we have been able to establish links throughout Welsh industry, and we’re committed to further growing our global presence. We’ve invested everything we’ve got into the local economy and into the business, which will continue as we expand internationally.”

Oliver Conger Managing Director, Rototherm Group

Ian Walbeoff, Vice President of Sales at Bollé Safety added: “This partnership marks the beginning of an exciting new chapter for Bollé Safety in Wales and the UK as we continue to grow our presence in the country and invest in local communities. It will help us to further our capabilities developing products with sustainability at their core as we will


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work with locally sourced materials, proudly boasting the ‘Made in Britain’ stamp of excellence. The capabilities at Rototherm are testament to the highly skilled manufacturing workforce available here in Wales, and we look forward to playing a part in further driving manufacturing excellence from the region.” It is Bollé Safety’s shared commitment to provide the highest quality protection for all healthcare professionals. Ultra-innovative, materials, lenses and accessories of the complete Bollé Safety range have a simple goal: to prevent eye injuries, and provide all healthcare professionals with the highest levels of protection, clarity, and vision.

www.bolle-safety.com

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Success stories from the life science industry

Redefining the field of flexible endoscopy

Founded in 2003, Creo Medical focuses on the development and commercialisation of minimally invasive devices by bringing Advanced Energy to therapeutic endoscopy. Creo’s first device, Speedboat Inject, is now in use worldwide, providing physicians with new treatment approaches and patients with life-changing outcomes. Innovative technology to revolutionise surgical endoscopy Creo’s first device, Speedboat Inject, is part of a suite of miniature endoscopic devices, with a further five receiving regulatory clearance over the past year. Each device is underpinned by groundbreaking research and development, with more than 247 patents granted and a further 763 pending. Speedboat Inject is a non-invasive device for treatment of tumours in the lower GI tract. With Speedboat, patients are treated under mild sedation rather than requiring invasive surgery with a general anaesthetic. This offers a better patient experience, allows more patients to be treated and can reduce hospital costs. Unlike other devices on the market, Speedboat Inject uses Advanced Bipolar Energy for dissection and Microwave Energy for coagulation, which means physicians can perform endoscopic surgery with a single device. The difference that Speedboat Inject is making in terms of time, cost and patient outcomes has been recently recognised in a Health Economics study that shows savings of up to £4,294 per treatment under the NHS. Microwave Energy holds exciting possibilities for minimally invasive tumour ablation 2020 saw the regulatory clearance and first in-patient use of a brand new device for microwave ablation. MicroBlate Fine utilises very high frequency microwave energy, allowing physicians to precisely ablate diseased tissue in multiple organ types and many different clinical access methods.

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MicroBlate Fine has the same dimensions as a standard biopsy needle, which enables improved access to a wide range of organs (such as pancreas, liver, kidney, lung and muscle) for treatment. The first treatment performed using MicroBlate Fine took place successfully in Ecuador in December 2020. The patient, who had an unresectable pancreatic neuroendocrine tumour, remains well and is enjoying life. Dr Carlos-Robles-Medranda from Instituto Ecuatoriano de Enferemdades Digestives, Ecuador, said: “I am excited about the potential of this technology for use in EUS guided therapy. The microwave energy allows me to precisely target and ablate difficult lesions. I believe this technology will have a positive impact on my patients, and I will continue to offer this treatment option.” Partnerships and collaboration provide opportunities to widen impact and treat more patients Creo Medical has now achieved an international customer base. They sell their technology directly via offices in the UK, the USA and the APAC region and also have routes to market through a channel of certified Distributors globally. The addition

of European medical companies Albyn and Boucart to the Creo family over the past year has also opened up new possibilities for partnership and exploring new clinical spaces. The CROMA Advanced Energy platform, powered by Kamaptive technology, remains the heart of Creo’s technology and has allowed them to develop a range of devices to treat lesions throughout the body.

There’s no reason we can’t use this technology in many applications, whether we’re talking about general surgery, colorectal surgery, urology, OBGYN, you name it. We have the ability to shape the technology based on the unmet clinical needs we’re trying to address. That’s why we call it Kamaptive technology.”

David Woods CCO of Creo Medical

www.creomedical.com


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Business growth for Cryo Storage Solutions

Four years ago, Wales’ own cryogenic storage facility was founded down on Cardiff Docks. Edwin Dyson, founder and MD of Cryo Storage Solutions, says this time has passed incredibly quickly. The business has grown rapidly, doubling turnover in Year 2 and again in Year 3. It has also gained an additional two members of staff. Cryo Storage Solutions won design and build contracts for their German-made SiVL pipework with prestigious scientific research organisations such as Diamond Light Source, The United Kingdom Atomic Energy Authority, and new biotechnology research building The Rosalind Franklin Institute at Harwell. There is now significant cryogenic expertise and support for companies both in Wales and over the border.

“This cryogenic pipework business is all very well and good, and most definitely not to be sneezed at, but we have some biobanks to fill with stem cells, tissue samples, and other such tiny things”. He is happy to report that several companies and organisations have now entrusted him with their special babies (for that’s how they get treated at Cryo Storage Solutions), and that there is still plenty of room for more.

Edwin Dyson Founder and Managing Director Cryo Storage Solutions

This leads us nicely to Edwin’s other news. Namely, that the company has outgrown its starter unit on the Docks as previously mentioned and will soon be on the move to Rogerstone. They are signing a lease on a unit five times the size than what is currently occupied, and this will allow them to offer Disaster Recovery services and biobank hosting to more clients than before. Edwin added: “We’re also currently working on signing a deal with a Cambridge biotech company which will enable us to thoroughly audit their samples, associated barcodes and their database. This will give them confidence that they know where each and every sample is in their inventory.” When the move to Rogerstone is complete, Edwin intends to throw his doors wide open to interested parties from the MediWales network and will personally give you a tour. And then shut them again for security reasons, obviously.

www.cryostoragesolutions.com

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Success stories from the life science industry

Evolve Raybotix UV-C Disinfection Robots at Techniquest Techniquest, the educational charity and science attraction based in Cardiff Bay, has announced its commitment to the fight against Covid-19 with the use of Evolve Raybotix state-of-the-art robotic disinfection units to keep staff and customers safe as the attraction re-opens to the public.

These robots use UV-C light supported by an ozone generating function for maximum disinfection, giving peace of mind to the public. They map their surroundings and kill 99.9% of microorganisms on all surfaces by destroying their DNA structures.

These robots use UV-C light supported by an ozone generating function for maximum disinfection, giving peace of mind to the public. They map their surroundings and kill 99.9% of microorganisms on all surfaces by destroying their DNA structures. It’s an environmentally friendly and chemical-free way to quickly and safely eliminate harmful bacteria and viruses. Disinfection takes place in a matter of minutes, making it an incredibly versatile and efficient device for the centre to use in between visitor sessions. In July, Techniquest became home to the largest robot in the Evolve Raybotix portfolio called SOL. This model is fully autonomous and can operate independently when areas are closed. The SOL detects obstacles to manoeuvre safely around spaces, and can even be programmed to operate lifts where cleaning multiple floors is required. The robot will also be displayed onsite during sessions, with a short video running alongside so that Techniquest visitors can learn about the technology and its impact.

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“We know that Techniquest is one of Wales’ best loved science centres, and it’s a delight to work with a team who highlight the vital role technology and innovation play in taking action against Covid. The disinfection units have been classified as a Medical Device by the Ministry of Health in Italy where they are designed and manufactured. Closer to home, the robots are purchased or leased from Evolve Raybotix which is based in the Institute of Life Science (ILS), Swansea University, who have the unique distribution rights to these innovative machines in the UK.”

Amin Farah Director Evolve Raybotix

Commenting on this partnership, Lesley Kirkpatrick, CEO at Techniquest, said: “We’re delighted to team up with Evolve Raybotix. It highlights our commitment to innovation and technology, as well as driving high standards for our visitors so

that they can rest assured that their visit will be as safe as we can make it. Science has driven conversations around Covid to date, and Techniquest plays a big part in supporting people to realise the potential of Science, Technology, Engineering, Art and Mathematics (STEAM) for education and career paths as well as more generally in our lives.”

www.evolveraybotix.com


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Pandemic musings from Greaves Brewster

Like many of you, as we’ve settled into the clichéd ‘new normal’, we’ve had to find new ways to stay connected with our clients, suppliers and, of course, each other. Whilst nothing beats a faceto-face catch up with a friend, client or colleague, we have learned over the past year or so that the technology at our disposal does allow us to maintain strong relationships and build new connections. Further, in using that technology we’ve been able to make some significant strides towards our social and environmental targets. To help us help our clients obtain their crucial patents, trade marks and designs, it’s vital that we understand each client’s business, goals and needs. Before 2020, we made regular visits to all of our clients to get to know them really well. In pandemic times, those meetings have been replaced primarily by video calls. We’ve found, surprisingly, that this can lead to even better contact, with clients being more inclined to set up a call than they might have been to have a meeting. Impromptu catch ups have allowed client work to progress more quickly than it might have otherwise, and have generated very close working relationships due to regular and less formal contact. We have also provided clients with updates via webinars, videos and articles, including guidance on how to meet the requirements of the patent process when you can’t be in the lab. If you are interested in any of these updates, visit our website or contact us. To allow easy discussion of potential new matters, in the absence of real-life meetings, we have offered virtual IP clinics which have helped both existing and prospective new clients to navigate any intellectual property issues they may be facing. We are continuing to offer these free to our fellow MediWales members. If you are interested,

then please feel free to book a slot at www. calendly.com/ip-clinic Securing IP protection, especially overseas, takes a whole team. We rely on the expertise of carefully selected attorneys in all of the jurisdictions in which our clients need coverage. We choose those attorneys on the basis of their technical and legal expertise, as well as their values and how they work. We rarely work with attorneys we haven’t met, usually either by connecting at conferences like BIO and INTA, or by visiting their offices. So as not to miss out, we organised a Greaves Brewster virtual world tour. Free from airport queues, missing luggage, jetlag and carbon emissions, our travels took us to New Zealand, Australia, Hong Kong, China, Canada, the length and breadth of the US, as well as destinations much closer to home. We shared meals and drinks, updated each other on new law and practice and met new team members.

There have also been changes in day-to-day work. Videoconferencing now plays an important part in IP prosecution, with virtually all hearings before the European Patent Office (EPO) moving online. This has enabled cases to progress despite the travel ban. Whilst we look forward to the resumption of in-person hearings for particularly complex, multiparty cases, the wider use of ViCo will reduce costs, both financial and environmental, for many hearings, which benefits us all.

Two of our most important questions in relation to remote work were whether we could maintain our connection with our colleagues, and how staff wellbeing might be affected. Having a happy, satisfied team is very important to us. We’ve missed

putting the world of IP to rights over a morning coffee in the Greaves Brewster kitchen and hearing about the latest antics of our colleagues’ pets and children. Video calls have successfully replaced much of this, but we are still working on how to create the serendipitous conversations that arise when one bumps into a colleague in the office. To maximise wellbeing, we’ve had a series of online get-togethers, fuelled by snack boxes of local produce, and we’ve had regular surprise deliveries including letterbox brownies, houseplants and recently pens in our GB blue colourway. Seeing a far away colleague use the same stationery created an unexpected sense of togetherness. Most recently, we’ve been taking part in The Wildlife Trusts’ 30 Days Wild Challenge as a way to boost team happiness. During the first week, we were challenged to take our breakfast outside, to enjoy the fresh air and to see what wildlife we could spot. It was a great way to start each day and our inner David Attenboroughs were soon spotting all manner of insects, plants, fungi, and even some larger creatures. Although we all no doubt wish we could wake up and be told the pandemic was just a bad dream, there have been some silver linings to the lockdown clouds. Our coming together through this shared gargantuan, world-changing event has strengthened our team. The way we’ve had to work recently has improved our carbon footprint tremendously, made our business more accessible to a diverse workforce, and made us focus even more closely on communication and wellbeing. And, whether we’re thinking about the technology that we’ve relied upon, or the rapid vaccine development, we all have a renewed appreciation for the innovation that surrounds us and the wonderful scientists that make it happen.

www.greavesbrewster.co.uk

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Success stories from the life science industry

NHS and industry collaborate to improve compression garments Flat knit compression hosiery is effective at managing vascular conditions and chronic oedema, but it can be difficult to apply and remove. Dr Robert Lister, a Wrexham based Dermatology Consultant, was well aware of the struggles that his patients faced with their compression stockings, so he turned his thoughts to finding a solution. He initially had the idea of a two-piece garment six years ago, and the finished product is now ready to launch into the NHS. Legs are the part of the body that Dr Lister is referred to most for dermatology consultations, and he is passionate about people not developing a leg ulcer. Chronic oedema and varicose eczema can lead to an ulcer, so it is essential that patients use their compression as directed. Compression hosiery prevents leg ulcers from developing and can heal them when they do. Using medi UK’s duomed soft® for his initial trials, he cut the below knee stocking in two and the principle was established – a compressive anklet that could be applied first, then a calf sleeve that slides over the top. He approached medi UK, a leading manufacturer of compression hosiery, with his idea in 2016. Sharing Dr Lister’s enthusiasm for the product idea, medi UK began the process of collaborative product development. A key aspect of the product design was to ensure that there was no increase in the pressure applied where the two pieces overlapped. To assist with the correct application of the two parts, a small mark was added to the anklet. When this is correctly aligned, the overlap is in the right place. Further prototypes were developed to test the garments on volunteers and the feedback was universally positive. The two parts were easy to apply and remove and

stayed in place all day, as Dr Lister proved by wearing his whilst playing tennis. The brand name was born, duomed soft® 2easy– two parts and easy to apply and remove. Andy Holman, Business Development Manager, medi UK Ltd, said: “Dr Lister came to us with a simple but brilliant idea, and I’m now being asked by clinicians being introduced to the two-piece concept ‘why did no-one think of this before?’ This has been a true clinician and industry collaboration, and we’re delighted to bring this innovative and unique product to the UK where we know that it will be a great help to those who have struggled with their compression therapy.”

“This has been one of the hardest things I’ve ever done – harder than medical school, harder than my first consultant post. The design, development and patenting processes were exhausting and I was very pleased when medi UK agreed to work alongside me to make my dream a reality. Working with industry has been a whole new world to me, and as a clinician you have to find a commercial partner who believes in a concept as much as you do. This has been a real passion project for me and hearing from patients who have benefited makes it all worthwhile.”

Dr Robert Lister Dermatology Consultant Wrexham Maelor

Now available to order into the NHS, Dr Lister and medi UK anticipate being able to offer duomed soft® 2easy via the prescription route later in the year.

www.mediuk.co.uk

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Why should companies undertake patent searching? Companies within the Life Science sector are constantly innovating, whether undertaking new research or creating new products. The pandemic has shown no sign of this slowing down and the World Intellectual Property Organisation recently stated that in 2020 Scientific output, expenditures in research and development (R&D), intellectual property filings and venture capital (VC) deals continued to grow. As part of the innovation process, many companies will undertake a patent search.

Patent searching is the mining of patent data to identify what products are currently, or previously, covered by a patent. A patent in simple terms provides the inventor/owner with the right to stop other people making, using, selling or importing without your consent.

Research Stage

● Landscape Mapping Search ● State of the Art Search

Patent Stage

● Patentability Search

Product Launch Stage

● Infringement Search (FTO)

Defence Stage

● Invalidity Search ● Patent Strength Analysis

Patent stage

There are various types of searches depending on which stage in the innovation process you are.

A patentability search aims to uncover documents in patent and non-patent literature that are similar or identical to the proposed invention, and may prevent your patent application from being granted. A granted patent can be beneficial if you are looking for additional funding to help you launch your product.

Research stage

Product launch stage

At the research stage, an important search known as patent mapping or landscaping helps you to see the high concentration areas of patents and possible gaps in patented technologies. Another important search at this stage is a state-of-the-art search. This can help to focus Research and Development (R&D) and provide inventors with background technical information to help generate ideas for a product or invention. These searches can be a powerful tool to aid research, support funding opportunities, identify competitors and collaborators etc.

Prior to launching a product to market, to try to avoid infringing other patents you will need to consider having an infringement search, also known as a freedom-to-operate (FTO) search, carried out on patents in the countries in which you wish to operate. Otherwise, you may be attacked by a patent owner and may be deemed to have wilfully infringed their patent rights.

Defence stage At the defence stage, to defend against a patent that is being used against you, an invalidity search (also known as patent

busting search) can be used to see if the patent can be broken. A similar type of search, but for a different purpose, is a Patent Strength Analysis search. This can be used to compile an assessment of the vulnerability of a patent or design against an attack from a third party who may supply evidence against its validity. This is an important tool when looking to purchase or licence a third-party patent, or if you are looking to increase the saleability and value of your own patent. Understanding what patent search type is required for the various stages of a product’s life cycle can be a challenging and often confusing task. Furthermore, choosing the wrong search may have significant consequences. Patent Seekers are expert patent searchers, for over 15 years our patent research teams have provided the knowledge and expertise for patent, design and trade mark attorneys, corporate IP departments, entrepreneurs, and inventors.

www.patentseekers.com

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Success stories from the life science industry

Audit by a data protection authority: How does it work? It has been more than two years since Data Protection Authorities of EU Member States (DPAs) started to perform data protection audits. As part of their general task of monitoring compliance with the principles laid down by the General Data Protection Regulation (GDPR), each competent DPA may carry out inspections and impose sanctions. Whether you are a data controller or processor, you may therefore be subject to an audit at any time. This is why all organisations need to be ready now.

How does an audit work? A DPA audit may occur generally as a result of a complaint or request from a data subject, following a breach notification, or if the competent authority finds or suspects a noncompliance with the GDPR.

In practice, there are two types of audits: survey inspection (the audit is carried out on the basis of documents, at a hearing or online) or field inspection (the audit is carried out on site on the basis of information with physical inspection at the controller’s facilities). Consequently, an audit does not necessarily imply a visit of the DPA’s agents to the company premises.

The scope of the DPA’s audit is particularly wide. Xavier GOBERT, CEO of MyDataTRUST, says: ”DPA’s agents can come at any time and without even giving you prior notice of their arrival. It is therefore essential to have your GDPR file ready to be made available to them at their first request. In the context of an audit by the CNIL, the French DPA, particular attention was paid to the DPO, his skills and qualifications, as well as his effective role within the company. The CNIL then checked all contracts with customers and service providers, procedures, records of data processing activities, security measures and training records. They even interviewed staff members on the concrete implementation of GDPR procedures.” In this context of onsite visits, DPAs have a number of means to control data controllers and processors. In particular, they are authorised to consult and request copies of documents, to interview staff members, and to examine and print electronic documents. They can also carry out checks on tools, data supports or information systems used for data processing, and they can also request written or oral clarifications.

After DPAs have assessed the extent to which you comply with the relevant data protection requirements, they will provide you a risk-focused report with recommendations. “We received a report three weeks after the CNIL audit and a report of the visit three months later”, highlighted Xavier GOBERT. Following the German DPA, the main objective of an audit is not to issue fines but to determine where organisations still have compliance gaps and requirements. However, if the DPA audit is conducted subsequently to a violation, the DPA can impose a fine up to €20 million or up to 4% of the total annual worldwide turnover, taking into account the severity, the nature and the duration of the violation. It will also consider if the violation has been caused by intention or negligence. In addition to the financial risk, such an audit can affect your reputation and your brand image. The continuity of your business may even be jeopardised. In conclusion, what should you keep in mind? Don’t wait any longer – get ready today for a potential DPA audit! MyData-TRUST can help you.

www.mydata-trust.com

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The world’s first ingestible supplement to help manage eczema and dry skin

According to the ‘Global Burden of Disease’ study, eczema is the leading contributor of all skinrelated disabilities, affecting up to 2-4% of the global population. The recent encouragement of frequent handwashing, wearing of masks and prolonged use of personal protective equipment has further increased the frequency and severity of eczema across the general population. A recent study showed that hand eczema tripled in young children during Spring 2020, when mandatory hand hygiene regimens were in force. Dr Neil Gibbs FRSB, renowned skin biologist, has worked in the dermatology sector for over 40 years. He is the inventor and entrepreneur behind pellamex, the world’s first skincare supplement formulated for sensitive and eczemaprone skin, designed to feed the skin barrier protein, filaggrin. The journey to develop pellamex began after a landmark paper was published that identified filaggrin as a significant factor in causes of eczema. Dr Gibbs then researched and clinically validated the ‘filaggrin feeding’ technology at the University of Manchester Dermatology Centre and launched pellamex.

The first of its kind in the global market, pellamex offers an alternative way for patients to take back control of their skin. With a unique patented formula, combining a high purity amino acid with other key EFSA-approved skin nutrients such as zinc, biotin, vitamins B2, B3 and E. It works with the skin’s biology to strengthen and restore the skin barrier. The active ingredient, l-histidine, is a natural amino acid that acts as a key building block for filaggrin, which eventually gets broken down into natural moisturising factor (NMF) in the epidermis, ultimately hydrating the skin from the inside.

Filaggrin is important in maintaining a normal healthy skin barrier, which we all need in an increasingly polluted world, but especially those with dry, sensitive and eczema prone skin. When filaggrin fails, the skin barrier is disrupted and this can lead to dry skin, irritation and atopic dermatitis. Research has shown that the pellamex active ingredient helps skin cells to make filaggrin and, unlike creams and lotions,

reaches the entire skin area, helping to block the entry of irritants and allergens and retain essential hydration. Pellamex’s technology has been assessed in a randomised, double blind placebocontrolled study in both adults and children with atopic dermatitis, who saw a 40% and 49% improvement in their skin respectively over the study period. “This is the largest effect of any treatment affecting the skin barrier in atopic dermatitis that I have seen in a clinical trial. Seriously impressive effects.”

A commenting on the adult study by: Professor Mike Cork Professor of Dermatology University of Sheffield

The daily 25ml dose comes in a portable sachet and can be consumed straight away or dissolved into water for a refreshing drink. A one-month supply (30 sachets) costs £49.99 and is available from www. pellamex.com or through subscription saving 15% per box (minimum six months).

www.pellamex.com

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Success stories from the life science industry

RedKnight helps secure grant for med-tech start-up’s rapid COVID-19 diagnostic RedKnight Consultancy Ltd has supported GeneFirst Ltd with its successful application to Horizon 2020, securing the med-tech start-up and its four collaborating partners (two SMEs and two hospitals) over €2.8m in Horizon 2020 grant funding to optimise and clinically validate GeneFirst’s innovative Multiplex Probe Amplification Technology (MPA). In response to the need for faster and better detection of multiple respiratory pathogens, GeneFirst has developed the proprietary technology to simultaneously detect and differentiate SARS-CoV-2 and 30 other common respiratory bacteria and viruses, allowing for accurate, cost-effective and comprehensive diagnoses. As of July 2021, COVID-19 has caused over 191 million infections globally, claiming more than 4 million lives. With case numbers increasing each day, rapid and definitive diagnosis of SARS-Cov-2 is essential. However, research has shown that single target testing is not optimal; one study found that 5.8% of SARS-CoV-2 infected and 18.4% of non-SARS-CoV-2-infected patients had other concurrent pathogen infections. Concerningly, failure to distinguish between different pathogens can have adverse effects, including unnecessary antimicrobial use, cross-infection of mis-grouped patients, and further spreading of the infection. Through the RAPID-COVID project, the consortium aims to analytically and clinically validate GeneFirst’s assay on both high throughput and point of care platforms. This strategy provides maximum flexibility for screening and triage, allows better and faster care, alleviates pressures on healthcare systems, and improves patient recovery rates. Dr Winnie Wu, COO at GeneFirst, said: “We are ecstatic with this outcome and all consortium partners are very excited to be involved in the project. For an SME, securing this funding allows GeneFirst to further its R&D and to deliver these crucial diagnostics

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at scale and pace in time for the winter season. We have pulled together a great project team for the delivery. “We credit our bid success to the RedKnight team. Without their support, we would not have been able to achieve what we did in the short time needed to submit the application. We found RedKnight to be professional and diligent, and it has been a real pleasure working with them. This is our first collaborative opportunity, and I am confident that our partnership will continue into the future.” Mr Dayne Hodgson, Company Director at RedKnight, commented: “Securing this funding was a phenomenal achievement, given we only had four weeks to develop and finalise the 70-page proposal. In total, 144 applications were submitted to the Innovative Medicines Initiative competition, of which just eight projects were selected for funding (6% success rate). The successful projects are among the most promising advances in therapeutics and diagnostics to combat the COVID-19 pandemic. We are delighted for GeneFirst to be considered amongst the leading players in the area, and we look forward to seeing the results of the

clinical studies which, if successful, will pave the way for future commercialisation of the novel diagnostic.”

GeneFirst is a molecular diagnostics company working in the fields of infectious disease, cancer diagnostics and personalised medicine. Their solutions enable accurate diagnosis and delivery of safe and effective medicines. RedKnight supports techbased start-ups and SMEs with innovation funding applications. Since 2015, RedKnight has secured over £10 million of grant funding for its clients to develop innovative products, processes and services.

www.redknightconsultancy.co.uk


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Consult Smartly: reducing the outpatient waiting list backlog An innovative Welsh Health Hack 2020 winning project from Cwm Taf Morgannwg Health Board is addressing the severe outpatient waiting list backlog created by the impact of the COVID-19 pandemic. Consult Smartly is enabling secure patient-clinician remote communication and patient-clinician initiated flexible appointments.

assignment to capture patient responses from the comfort of their own homes and triggering auto-reminders. Patient initiated follow-ups (PIFU) empower patients whilst encouraging self-management to develop a deeper understanding of their health conditions, which is a much-aspired feature portrayed in this system design. Specialist web design is being produced for the radical interactive communication element, for waiting patients once they click the secured video consultation link. A virtual waiting room with relevant and supportive information display is added to ensure patient support.

The Need As NHS staff continued their unyielding efforts in the fight to manage the Coronavirus pandemic, the national picture of the unforeseen crisis data emerged. Nationwide the NHS experienced significant backlogs in secondary care referrals review.

Welsh NHS figures revealed waiting times of over 36 weeks towards the end of 2020, an increase of 1,600% in some areas. The logistics involved in holding traditional face-to-face consultations were considerably more complicated due to the contagious nature of the virus. Existing manual procedures result in high percentage of non-attendance (DNA), consequently causing delays and valuable time and cost wastages.

A widely recognised positive change, ushered in by the pandemic, is the accelerated adoption of innovative digital technology, replacing manual processes to meet the demands required to protect, treat and monitor the population. Video consultation calls is one such technology that addressed the need of face-to-face consultations, virtually. Nevertheless, the waiting backlog is far from being addressed.

Consult Smartly Consult Smartly is a Welsh Health Hack 2020 winning project by Cwm Taf ENT Consultant Mr Mouli Doddi, partnering with SymlConnect, to design an automated seamless, digital virtual consultation platform for a more self-directed model of patient care, facilitating improved communication between patients and clinical teams. Consult Smartly takes this video conferencing concept to an advanced level, allowing clinicians to create appointment time slots according to their availability, at the touch of a button. Patients experience enhanced flexibility, ‘choosing’ slots according to personal suitability. Thus, the appointment offering could be out of office hours as no clinic room preparation needs to be manned. The advanced system incorporates patient consent, auto communication and auto reminders, consequently reducing the risks of non-attendance. The system integrates an online hearing test facility to assist effective clinical decision making during the video consultation. Email or SMS messages would be used for ‘patient information giving’ communications, utilising questionnaire

The aspiration is to reduce the estimated cost and time of delivery for the current waiting list by one third, whilst delivering more than double the number of consultations than the existing appointment allocation manual process. The intention is to ease the process flow without demanding any extra resources or extended learning curves. SymlConnect proposes a modular system founded on their existing standards based multi-tiered modular software framework, for patient-clinician engagement permitting future interoperability with clinical/ administrative systems, enhancing clinical time usage whilst reducing administrative time requirements. Role-based user authentication, interactive reporting and respective clinical pathway logics are built in according to protocols. The flexible framework could be adapted to develop an asynchronous, seamless solution featuring user-friendly frontends and bespoke processes. Assistive communication technology opens up the visibility of patient flow and caregiving, based on informed decision making. Such use of technology aids in eliminating the possibility of human error whilst reducing financial detriment, delivering patient care in a prudent value-based way ensuring a sustainable health-care model for the future.

www.symlconnect.com

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Success stories from the life science industry

Harnessing technology to clear the surgical backlog to reduce the backlog, as this evaluates if patients are fit and ready for elective surgery. A robust digital POA solution allows clinical teams to reevaluate and re-prioritise patients according to their medical needs. A conventional pre-operative assessment that is paper based can often be difficult to streamline and coordinate if the patient has a complex medical history and needs further tests and investigations which may be requested by anaesthetic teams. With a digital pre-operative assessment solution, these complexities can be minimised, and a greater level of collaboration is created supporting perioperative teams to manage the waiting list backlog.

Statistics published by the Royal College of Surgeons (RCS) in May 2021 describe the longest ever waiting list in Wales since records began in 2011. In excess of 600,000 patients have been waiting for planned treatment since March 2021, including for surgeries such as hip and knee replacements, post-mastectomy breast reconstructions and ear, nose and throat operations, described as ‘high volume, low complexity’ cases. As indicated in the Paving the Road to Recovery Report by the RCS there are 620,000 patients waiting for orthopaedic surgery. Closely behind is ophthalmology with 511,000 people waiting, general surgery with 406,000, otolaryngology with 385,000 and gynaecology with 374,000

It is estimated that over 216,000 patients have waited more than nine months for their treatment, highlighting the devastating impact of the COVID-19 pandemic. Comparing these figures to the same time last year for March 2020 showed 28,294 people in Wales waiting more than nine months for treatment.

There is light at the end of the tunnel as the lockdown measures have now eased and restrictions have been lifted. This has allowed health boards to resume elective surgeries and start the process of working through the backlog.

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The adoption of digital solutions could be the saving grace to help effectively manage the backlog, enabling elective surgery to return to pre COVID capacity. Many Health Boards in Wales have fully embraced digital solutions since the start of the pandemic to facilitate normal working for members of staff. By efficiently harnessing the full capabilities of a digital data-driven solution to manage waiting lists, maximise operating theatre capacity and conduct digital pre-operative assessments in a COVID safe environment. There is a huge opportunity for healthcare providers to achieve digital transformation by embracing technology and implementing solutions to help manage the waiting list backlog. Digital Pre-Operative Assessments (POA) are a critical part of the entire perioperative process and an important aspect in helping

Digital POA ensures that at each stage of the assessment and follow-up any number of clinical tests may be administered, medications prescribed or stopped, and exercises recommended. Such interventions typically require coordination between a range of healthcare professionals, from doctors and nurses, to pharmacists and physiotherapists. A digital POA solution places the patient-clinician relationship at the centre of a smart, accessible software platform ensuring that all the information needed to carry out each step successfully is always available making the patient fit for surgery, resulting in numbers decreasing with waiting lists. To tackle the waiting list backlog and for elective surgery to return back to pre COVID levels, health boards must embrace technology and take advantage of digital solutions. For more information on how the team at Open Medical can help your health boards tackle the surgical backlog through our digital pre-operative assessment software please email info@openmedical.co.uk or book a demo

www.openmedical.co.uk


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Space2B at The Maltings

Space2B at The Maltings is the ultimate divergent business hub in Cardiff city centre; offering state-ofthe-art serviced offices, steeped in heritage. If you’re looking to downsize, or a flexible office space to grow your company with adaptable monthly agreements, we are the place for your business to call home! Rooted in one of Cardiff’s most reassured historical landmarks – a Grade II listed Victorian Malthouse – Space2B is a fine example of where heritage meets innovative engineering and design.

Taking public transportation? Our office space to rent in Cardiff is at a convenient central location that benefits both employees and visitors. Tenants of Space2B enjoy a free on-site gym and a dedicated on-site café. With hand sanitiser dispensers and sensor activated doors, taps, soap dispensers and flushes, along with CCTV coverage and a dedicated security team, we provide a safe and hygienic environment for people to work in.

Our modern office work space provide state-of-the-art facilities and our on-site management and customer care team are on-hand to help our tenants be as efficient as they can be in doing what matters most – nurturing their business. Seeing our tenants and their businesses thrive is what brings a smile to our faces. It’s why we do what we do.

www.space2b.wales

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Success stories from the life science industry

Taking science to Westminster One thing shared by the spectres of the COVID-19 pandemic and climate change is that science is broadly accepted as being important to understand how they work and to guide strategies that manage their impacts.

At Biophys, this is exactly what we found ourselves doing in recent months. It was a real thrill to be asked to contribute to the Spring 2021 and Summer 2021 editions of the Science in Parliament journal – providing a piece about groundbreaking research into an emerging alternative explanation for Alzheimer’s disease progression and offering a view on commercialisation of late-stage science innovations.

Both phenomena have placed science fairly, squarely and centre stage on the public’s radar and have got people talking. For those of us who are inspired and excited by science, this has been a good thing. There is a caveat, though. If science is to be useful as a beacon to navigate through the perils of pandemics and epidemics, we need to make sure that our leaders have access to and understand the facts that they need to help them carry out their public duties.

We look forward to continuing to share science stories with and fly the flag of Welsh life sciences in the Parliamentary & Scientific Committee - All Party Parliamentary Group.

www.biophys.co.uk

Welsh biotech firm secures further investment for nextgeneration cancer therapies BiVictriX Therapeutics is working to deliver a broad pipeline of first-inclass therapeutics (named Bi-Cygni) which would enable potentially higher dosing and more aggressive tumour eradication in patients, without causing harmful side effects. Its lead programme is focused on treating Acute Myeloid Leukaemia – one of the most aggressive forms of blood cancer. The company has announced that it is listing on the AIM market of the London Stock Exchange. The Development Bank of Wales, the existing lead investor in BiVictriX Therapeutics, will make an additional £500,000 share purchase and will remain the largest shareholder of the company following the listing. BiVictriX is

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BiVictriX is a high-growth company and a future leader in cancer therapeutics. This transaction provides an exciting path ahead for both the firm and its investors. Angelina Drljaca-Chandler and Catherine Golledge from Capital Law’s corporate team advised the Development Bank of Wales on the transaction.

proposing to raise £7.5m by way of placing a subscription of new ordinary shares as part of its IPO.

Capital Law is a commercial law firm which works nationally and internationally with businesses of all sizes. It regularly provides corporate, commercial, employment and intellectual property legal advice to businesses in the life sciences sector.

www.capital-law.co.uk


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I am now Ataxia aware MediWales charity member Ataxia and Me has launched its new website (www.ataxia-and-me.org). The content for this website was compiled by volunteer Kirsty, who has written a few words about becoming Ataxia aware… Up until a few months ago, I had never heard of Ataxia. As a third year English Literature and Creative Writing student, unless it was Shakespeare, I was oblivious. Out of chance, I saw an advertisement on my university job board for a volunteer content writer at a charity called Ataxia & Me. I thought I would take a chance and maybe get some real-life experience outside of the classroom, so I applied. Here I am a couple of months later, and I can now proudly say that my name is Kirsty and I am Ataxia aware! From working with Alan, the founder of the charity, I have been so privileged to read about everyone’s journeys and to help create a platform that raises awareness not only of Ataxia but also other rare diseases.

significant lesson I have learnt from my experience is that raising the profile of the disease, and the subsequent charity, is the key factor. Misdiagnosis is common. Only by raising awareness can we help to mitigate misdiagnosis, ensuring that more people are aware of the symptoms.

When joining the rare disease community, I wanted to make sure that I educated myself as much as possible, from hearing stories, attending webinars, and talking to other rare disease charities. Perhaps the most

One question you might be asking yourself is: what can I possibly do to help? Since joining the rare disease community, I have started using my social media to share information about events I have attended,

supported other people’s posts about rare diseases and followed charities. Therefore, I can stay informed about any new research and keep an eye out for webinars or events that interest me. By doing this, not only will you learn more information (as I did), but you will also be able to meet people who are affected by rare diseases, helping you to feel less alone.

www.ataxia-and-me.org

Fulcrum grows its team! Fulcrum has taken on new team members Tom Burden and Charlotte Mayho in order to provide more market research and marketing services to life sciences and technology businesses

business development services to start-up companies. Tom has worked on several projects for Fulcrum including multiple market assessments for clients in both industry and academia.

Tom recently joined Fulcrum in the role of Senior Researcher. He has gained experience in the biotechnology and healthcare fields after receiving a first in biochemistry from Cardiff University. With Tom joining the team, Fulcrum is able to offer comprehensive market research and

Charlotte has been recruited as Marketing and Sales Executive for Fulcrum. Spending her early 20’s exploring the world as a travel journalist for a Cardiff based magazine, Charlotte then worked in retail, gaining a senior management role in sales for The Walt Disney Company. Through

her experience in both traditional and digital marketing, Fulcrum is able to provide marketing communications services for clients by using Charlotte’s knowledge of email campaigns, social media and content creation to enhance reach and audience engagement across multiple platforms.

www.fulcrumdirect.co.uk

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Success stories from the life science industry

Design Studio Services help Cortigenix commercialise a new test providing early warning of potential health and fertility issues

In this example we share how Design Studio Services supported Cortigenix to go from scientific cortisol understanding and how it is tested into full commercial product launch.

200 blood or saliva cortisol tests. The sample for the test can be done easily from home, without clinical supervision, and the result provides an indication of one’s general health over that 3month period.

Scientists have hailed a breakthrough new test that can provide an early warning of overall general health as well as fertility issues by detecting levels of the hormone cortisol accrued over several months using a tiny sample of hair.

Working with Dr Adam Massey (CEO of Cortigenix, and researcher at the University of Nottingham’s Centre for Academic Primary Care, School of Medicine.) we recognised that this product is an important opportunity for individuals to monitor their own health markers, as part of the global drive for preventative medicine.

Cortisol is a glucocorticoid steroid hormone that is crucial for maintaining overall health including regulating the immune system, brain health, controlling blood pressure and reproductive function. Cortisol levels fluctuate throughout the day so it can be difficult to assess levels of the hormone over longer durations. Existing blood, saliva and urine tests only provide a short-term indication of cortisol levels and involve taking many samples over the course of a day, but even with many samples taken over time these tests are limited for understanding long-term health. Cortigenix’s new Cortisol Over Time (COT) test detects levels of circulating cortisol built up in the body and brain over 3 months; With just a few strands of hair, we can now track cortisol levels that have accumulated in hair strands over the previous 3 months – which is the equivalent of needing over

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“We don’t know we are at risk of a health problem until a condition is manifest or we begin experiencing symptoms. And at that stage it can be more difficult to reverse declining health when starting from the inception of disease. We believe that fundamental to preventative health is to be able to detect health problems as early as possible. This way, we are shifting from treating ill health to preventing it in the first place. Working with design studio services has helped create a brand and product that will help us to deliver a breakthrough in preventative healthcare and start to realise the potential of our Cortisol test and the cortigenix brand.”

Dr Adam Massey Cortigenix CEO

So we looked to create a brand and language that reflected knowledge and support; Understanding that the product use is a proactive one, looking to maintain and optimise inner health. This empowerment of the general public to take control of their health via an early indication – before symptoms may present - of how cortisol and lifestyle factors may be affecting long-term health such as stress related health conditions, impaired immune function, cognitive decline, increased risk of cardiovascular disease and fertility problems. To ensure the test could be successfully executed we created easy opening packaging that gave a premium feel. With easily accessible contents and instructions. This was complemented with website design / simple result delivery mechanisms

and communicating complex mechanisms and insights into how the body is effected by cortisol and support in relation to the outcome of the result, in a simple and engaging way. Design Studio Services is now working with cortigenix to get the message out about this breakthrough test – helping as many people as possible to get the benefit of proactive healthcare!

www.designstudiosevices.co.uk


Forward thinking health research

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Forward thinking health research

Customised knee implant pioneered by TOKA®, Accelerate and Cardiff University Biomechanics Research Facility Osteoarthritis is a highly prevalent disease affecting nearly nine million people in the UK causing pain and mobility issues. Bath based med tech company 3DMP and its subsidiary based at Cardiff Medicentre specialise in developing surgical planning software and digital healthcare applications.

3DMP have pioneered a revolutionary customised surgical implant technique to deliver a novel solution for knee osteoarthritis. The TOKA® device combines 3D printing and data-imaging technologies to create a customised knee implant device. TOKA® is a precision engineered, patient specific device for High Tibial Osteotomy (HTO) surgery. HTO is a common ‘knee preserving’ surgery particularly indicated for younger (40 to 65 years) patients as alternative to partial or total knee replacement.

A new Accelerate funded project is enabling Cardiff University Musculoskeletal Biomechanics Research facility to apply its unique research equipment and expertise to better understand the individual requirements of each patient and create a more personalised implant. Currently TOKA® offers device personalisation based on individual patient anatomy, matching their geometry (shape). Patient outcomes are still dependent on the accuracy of the procedure, and the current solution is a onesize-fits-all approach. HTO surgery is successful if it can preserve the knee joint by re-aligning the tibia bone and redistributing the painful high-pressure regions within the knee. The precision of each device can be improved by also meeting the individual biomechanical loading requirements of each patient.

The Accelerate funded research collaboration with Cardiff University is addressing this problem by providing new biomechanical data to inform TOKA®’s bespoke surgical planning tool. The research team are collaborating to collect biomechanical and knee joint imaging data both pre- and post-surgery from patient volunteers scheduled for HTO surgery at Cardiff and Vale Orthopaedic Centre (Cardiff & Vale University Health Board). The resulting data will be used to alter existing surgical planning software, create custom-made devices and improve 3D planning tools for surgeons. Ultimately the collaboration will support the surgeon and offer the patient a much better surgical outcome and a faster recovery time. The Musculoskeletal Biomechanics and Bioengineering facility (MSKBRF) based in Cardiff University School of Engineering is a world class, integrated, state of the art human movement research centre focussed on biomechanics and musculoskeletal disease. The facility is one of only a few locations globally with bi-plane fluoroscopy equipment able to create highspeed 2D video X-ray images. These images in combination with 3D models created

from 3D imaging (CT or MRI) can directly measure the position and orientation of bones during different activities. This information is invaluable to be able to understand the effects of disease and determine the efficacy of surgical interventions. The Accelerate support programme was established to facilitate and speed up the translational pipeline from the identification of healthcare needs, through to the delivery of evidence-based innovation. Accelerate is part funded by the European Regional Development Fund through the Welsh Government and focuses on the delivery of innovative healthcare solutions driven by expert collaborations between clinicians, industry, academia and the third sector. The Cardiff University Innovation Accelerator is one of four key partners, the others being the Life Sciences Hub, the Assistive Technology Innovation Centre ATiC (University of Wales, Trinity St David) and the Healthcare Technology Centre (Swansea University). The resources at the MSKBRF are available to clinicians, sports teams and businesses requiring biomechanical, clinical or physiological data. Please get in touch to view or book the facility.

www.cardiff.ac.uk/engineering/research/facilities/musculoskeletal-biomechanics-research-facility

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New investment in the Life Sciences Research Network Wales The Life Sciences Research Network Wales (LSRNW) has received new funding from the European Regional Development Fund via the Welsh Government’s Sêr Cymru II scheme. The new investment of £173,789 has supported the appointment of a new Network Manager, Dr Angharad Watson, and will sustain LSRNW activities until March 2023 The LSRNW is led by its Directors, Prof Andrea Brancale (Cardiff University), Prof Cathy Thornton (Swansea University), Prof Karl Hoffmann (Aberystwyth University) and Dr Edgar Hartsuiker (Bangor University). As well as the Network Manager, who is based in Cardiff University’s School of Pharmacy, the LSRNW will shortly be appointing additional administrative support, also based at Cardiff University. Between 2013 and 2018, the LSRNW was a prominent feature of the Welsh life sciences landscape. With more than 300

collaborative projects were still actively working with partners they met through the Network. Furthermore, Network PIs had secured a further £23.3m of grant funding based on their LSRNW-funded research.

Dr Angharad Watson

university researchers based across Cardiff, Swansea, Aberystwyth and Bangor, the Network held extremely popular annual Congress events, and members leveraged more than £35m of external funding as a result of the Network’s investment in them. In 2018, its original Welsh Government Sêr Cymru I and HEFCW funding came to a close, but while the Network may have officially been on hiatus, its members continued to produce world-leading research. When asked about their activities since 2018, 82% of Principal Investigators who received LSRNW funding for

The Network is currently focusing on capacity building, and is holding a range of events to support this. These range from informal networking events and virtual writing retreats to larger events, including the Welsh Life Science Showcase in October 2021. This joint event with MediWales brings together research leaders from the fields of neurobiology, oncology, and infection and immunity, with roundtable sessions about working with companies, investors and handling IP. All of the Network’s events are free, and details including registration can be found at www.lsrnw.ac.uk. For the rest of 2021, the Network plans to continue delivering virtual events to keep members safe. However, they hope that 2022 will see a return to in-person meetings.

CASE STUDY Dr Salvatore Ferla, Lecturer at Swansea University I was initially involved with the LSRNW as a research associate at Cardiff University working on the WCADD platform. This had an enormous impact on my career for two different aspects: l I was involved in more than 40 drug discovery research projects, ranging from anticancer to antivirals, broadening my scientific knowledge and strengthening my expertise in the drug discovery field. Several of these projects produced different outputs, including scientific publications and grant applications, helping to consolidate my reputation as a scientist and in building an important network of collaborators.

l The great results obtained from one of these projects set the basis for my Sêr Cymru Personal Fellowship, which was a fundamental step towards my current position as Lecturer in Pharmaceutical Chemistry at Swansea University. l The LSRNW has been a “jump start” for my career both as an academic and as a scientist, therefore I will always be grateful to have had the opportunity to be part of such a great scientific network.

www.cardiff.ac.uk/centre-for-trials-research

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Forward thinking health research

Achieving the remarkable: supporting and delivering COVID-19 research in Wales On 28 February 2020, the first person in Wales tested positive for COVID-19, and within weeks the first COVID-19 urgent public health study in Wales was opened. Since then, the Welsh research community has worked tirelessly to support and deliver research into the development of new tests, treatments and vaccines for COVID-19. Through the collaboration of people working in research at all levels across the NHS and in academia, a staggering 37 urgent public health studies have been delivered under the leadership of Health and Care Research Wales since March 2020. Jayne Goodwin, research nurse and Head of Research Delivery at Health and Care Research Wales, continues to oversee COVID-19 studies in Wales. Jayne said: “Our clinical research staff have worked together to deliver so much over the past 16 months. What we have achieved in Wales is remarkable and the results will continue to save lives.” In May 2021, research carried out by YouGov on behalf of Health and Care Research Wales revealed that 91% of people in Wales think health research has been important during this pandemic. Jayne continued: “The support of the public, particularly patients and their families has been crucial. More than 46,000 people in Wales have participated in 102 COVID-19 research studies. As we move forward, we need to build on this interest in research and continue to show the general public that all research matters.” Health and Care Research Wales supported the study setup and recruitment of participants to multiple vaccine trials, including Oxford/AstraZeneca, Janssen, Novavax and Medicago. Recently, studies into combining COVID-19 and seasonal flu vaccines (ComFluCOV), and into

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COVID-19 booster vaccinations (COVBoost), launched in Cardiff and Wrexham respectively. Vaccine development is only one element of the huge research effort, and studies have been established to look into the best care and treatments. For example, RECOVERY, a UK-wide study, has recruited just over 1,250 Welsh participants so far and has already discovered various treatments to save the lives of seriously ill COVID-19 patients. Ongoing studies include REMAP-CAP, identifying new treatments for COVID-19 patients who are admitted into intensive care units across Wales, and PRINCIPLE, investigating which treatments are best for reducing the recovery time for patients at home. With so many studies underway in Wales, Health and Care Research Wales established the £3 million Wales COVID-19 Evidence Centre, on behalf of the Welsh Government, to use this body of evidence to help answer the key questions around the pandemic and support decision making for the NHS and social care in Wales.

“Looking to the future, there’s so much we’ve learned from the pandemic that we can build on. Wales has proven it can play a key role in delivering worldleading research and this will only grow with deeper collaboration across sectors and the four nations of the UK. Wales will work collaboratively with all stakeholders to improve the health and well-being of the population. The UK recovery vision and plan are aligned to ‘A Healthier Wales’ strategy, whereby individuals are at the heart of transformation and modernisation of health and care services, and where research is embedded in high quality care.” Professor Kieran Walshe Director Health and Care Research Wales


About Health and Care Research Wales Health and Care Research Wales is supported by Welsh Government and exists to ensure that today’s research makes a difference to tomorrow’s care. This involves working strategically and practically across multiple sectors in health, social care, the third sector and industry to deliver worldclass research. Health and Care Research Wales is a networked organisation which brings together a range of partners across the NHS in Wales, universities, research institutions, local authorities and others. It funds a community of over 20 leading research centres in Wales to support and increase capacity in research and development. Health and Care Research Wales works to improve the speed and efficiency of study set-up and oversight as part of realising a One Wales seamless service. Involving patients, carers and the public is key to ensuring the work of Health and Care Research Wales is relevant and effective.

Find out more: w: healthandcareresearchwales.org e: healthandcareresearch@wales.nhs.uk

t: @ResearchWales / @YmchwilCymru

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Forward thinking health research

How HCEC collaborates to innovate and translate valuable research into practice for patient and public benefit Health and Care Economics Cymru (HCEC) is an all-Wales collaborative research infrastructure group funded by Welsh Government via Health and Care Research Wales. Its mission is to provide world-class health economics expertise (through an agile, integrated all-Wales approach) to enable excellent health and social care research and development in Wales to the benefit of patients, the public and the economy. Health and care resources are limited, and every choice we make on how to allocate our scarce resources has an opportunity cost. This means we need to sacrifice one thing in order to provide another, and every decision will have unintended negative health and care consequences, with some groups within society disproportionally affected. We therefore must know the value for money, or cost-effectiveness, of the health technologies, interventions and services we provide. So, we can reduce inequalities, promote a fair prioritisation of resources, and ensure sustainability of our health and care system. HCEC makes a strong contribution to that evidence base and endeavours to translate research into practice. Here are two case studies that demonstrate how HCEC collaborates on big research projects and real-world evaluations to make a change for the people of Wales.

Empowering oesophageal cancer patients at the end of life Patients with advanced oesophageal cancer have a median survival of three to five months. Most will require intervention for dysphagia (difficulty in swallowing), which usually comprises of oesophageal self-expanding metal stent insertion. However, recurrent dysphagia and re-insertion is common. The ROCS multi-centre, open-label, randomised controlled trial was funded by the National Institute for Health Research (NIHR) Health Technology Assessment (HTA) Programme and led by the Centre for Trials Research at Cardiff University in collaboration with Tayside Cancer Centre, Birmingham University, University of Southampton, and Marie Curie and Velindre Cancer Centres. The trial examined the clinical and cost-effectiveness of external beam radiotherapy (EBRT) following stenting compared to usual care

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(no EBRT after stent) in maintaining swallow and quality of life in palliative patients.

needed a programme that was affordable and implementable with a strong evidence base.

Berni Sewell, Mari Jones, Katherine Cullen and Deb Fitzsimmons designed and conducted a comprehensive health economic analysis alongside the ROCS trial, including a de-novo economic model to assess the cost-effectiveness of the ROCS intervention. A detailed chapter was submitted in the NIHR report which, on peer review, received excellent feedback on the quality of analysis.

An effective, brief lifestyle intervention pioneered by the Afan Valley cluster was identified as suitable for implementation in Wales, together with a supporting pathway designed by the All Wales Diabetes Implementation Group (AWDIG). Establishing the value of the AWDIG pathway, compared with ‘usual care’, in a primary care setting for people with pre-diabetes was a vital step in planning for implementing such an intervention in Wales. AWDIG had very limited budget to invest in any research to estimate the value of rolling out the pre-diabetes intervention, so this placed constraint on the scope of the evaluation. Timing was also crucial in order to be able to present evidence at key Welsh Government and NHS Wales meetings.

The ROCS trial, named a ‘landmark’ trial in the field of palliation, concluded that radiotherapy alongside stenting was not a clinically or cost-effective option in the palliative management of dysphagia. This evidence will inform clinical management in this group, empowering practitioners and oesophageal cancer patients who had self-expanding metal stents to make informed end-of-life health and care choices. These results are expected to inform national guidelines on the use of this palliative treatment across the UK in line with the ‘Palliative and End of Life Care Delivery Plan’ (2017) on how the NHS and its partners can provide care and support for people at the end of their life, as well as their families. For more information, please see the full study publication: Palliative radiotherapy after oesophageal cancer stenting (ROCS): a multicentre, open-label, phase 3 randomised controlled trial. The Lancet Gastroenterology & Hepatology.

Value Assessment of a Lifestyle Intervention for People with Pre-diabetes across Wales Wales currently has no national diabetes prevention programme. Whilst English and Scottish Diabetes Prevention Programmes (DPPs) are in place, it was judged that the costs were too high for implementation in Wales. Additionally, the evidence around the DPP showed that it was ineffective in areas of socio-economic deprivation. Wales

Pippa Anderson and Shaun Harris collaborated with AWDIG and the Diabetes Research Unit Cymru and undertook a model-based economic evaluation, as well as an implementation and roll-out costs analysis for all Wales. The results of the health economic evaluation showed that the pre-diabetes pathway proposed by AWDIG is less costly and more effective than current care of people with pre-diabetes. Using Cwm Taf Morgannwg and Cardiff and Vale University Health Boards as examples to represent the best and worst levels of pre-diabetes in Wales, investing in the AWDIG pathway will cost £44 per recipient of the programme and will save NHS Wales resources in the order of £6 million in each Health Board over a ten-year period. These savings result from avoiding the healthcare costs of managing people with diabetes. Furthermore, the personal and quality of life impacts of having type 2 diabetes are also avoided. The findings of the evaluation were received well by a variety of audiences, with the case study being an Award Winner at the Quality in Care Awards at the end of 2019. In March 2021, Welsh Government announced that, based on this collaborative research, it will invest £1million in the first diabetes prevention programme for Wales as an initial step of a National roll out. This decision, based on our evaluation, has the potential to save and improve countless lives and to help make NHS

Wales more sustainable for the future.

www.healthandcareeconomics.cymru


€1.5 million project aims to work with 3,000 women to study impact of sex hormone changes on mental health Researcher and clinical psychiatrist Dr Arianna di Florio, from Cardiff University’s Division of Psychological Medicine and Clinical Neuroscience, has been awarded a grant to launch the first molecular genetic study of psychiatric sensitivity to sex-hormone changes. Dr di Florio will be studying the Genetic Architecture of Sex Steroid-related Psychiatric Disorders and was awarded €1.5 million as part of the 2020 European Research Council (ERC) competition.

“It is the first molecular genetic study of the psychiatric sensitivity to sex hormone changes. We’re aiming to recruit more than 3,000 women living with psychiatric disorders which are temporally related with changes in sex hormones. This will be the largest cohort of women experiencing these conditions to date. It will help us to identify and reach people living with these conditions, making it easier for them to participate in research. It will enable us to conduct sophisticated analyses, integrating detailed longitudinal clinical and psychosocial information with aggregated genome-wide data and functional

As part of the study, Dr di Florio will be working alongside the National Centre for Mental Health (NCMH), funded by Health and Care Research Wales, to build a collaboration with women who are living with these disorders. Professor Ian Jones, Director of NCMH, said: “We are delighted at NCMH that one of our key collaborators, Dr di Florio, has won this prestigious grant from the ERC. These conditions can be devastating for women and are clearly under researched and poorly managed. We are delighted to be able to work with women to make a difference for them in the years to come.”

Clinical and Research Programme, set up by Dr di Florio to study how genetic and environmental markers can help identify women at risk of psychiatric disorders in relation to changes in sex hormones and improve the current approach to diagnosis, prevention and treatment. Dr di Florio said: “I hope this work will contribute to the de-stigmatisation of mental health disorders related to female reproduction by providing evidence-based, easy-to-understand information to the public, and addressing the gender gap in psychiatry highlighted by the European Commission and the World Health Organization.”

The study will become a project of the Reproductive Neuroscience

annotations.” Dr Arianna di Florio Division of Psychological Medicine and Clinical Neuroscience

www.ncmh.info

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Forward thinking health research

Projects developing the next generation of cancer therapeutics Swansea University’s Reproductive Biology and Gynaecological Oncology (RBGO) group, together with a leading group of life science industry partners, are delivering a programme of work to develop the next generation of cancer therapeutics. Supported by the European Regional Development Fund through the Welsh Government, the two integrated projects are enabling businesses to deliver advances through accessing translational research excellence and capabilities in Swansea’s Medical School. RBGO are leading two major SmartExpertise projects: The Cluster for Epigenomic and ADC Therapeutics (CEAT) valued at £4.9M and ReNeuron, IgInnovations and Swansea University development of Exosomes (RISE) valued at £2.5M. Through the CEAT project, RBGO and multinational players Glaxo Smith Kline (GSK), Cytiva and Bruker, with UK-based partners Porvair Sciences Ltd, Axis Bio and recently BiVictriX, have worked collectively to advance epigenetic and ADC-based ovarian cancer therapeutics. To date, partners have developed screening platforms for new drug candidates and identified multiple epigenetic compounds effective against this disease. With recent additional investment from industrial partners and the Welsh European Funding Office, the project will now carry out further developments in both areas including the preclinical testing of novel ADCs. The opportunity offered by CEAT has led to growth within the cluster, with Welsh SME Bivictrix Therapeutics having recently joined the project. Tiffany Thorn, CEO of Bivictrix, said: “CEAT presented a clear opportunity for Bivictrix, providing mutual benefit to ourselves and the partners. The project has given us access to the depth of expertise and highly specialised equipment required to assess our portfolio of precision drugs for further development. At the same time we are able to bring our own capabilities to the cluster, which has opened up opportunities

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Swansea University’s Reproductive Biology and Gynaecological Oncology (RBGO) group

for CEAT partners to test and validate their ADC development pipeline.” The RISE project has also grown in profile in recent months. RISE is a collaboration between RBGO and two innovative Welsh businesses – Bridgend-based company ReNeuron and IgG innovations (part of the Abbott group) in Ceredigion. Through the RISE project, partners have access to a specialised range of facilities and expertise available through the University and via reciprocal technology transfer between the two businesses. This is delivering increased productivity, R&D capacity, and the ability to translate discoveries into high-value products and services. Since project initiation, RISE partners have developed novel methods to analyse the therapeutic efficacy of proprietary exosomes. Having received additional investment, researchers on the project will carry out further preclinical exosome validation and streamline the development process. Dr. Paul Hole, Principal Investigator at ReNeuron, said: “The durable and cooperative approach of the RISE project is helping us undertake the fundamental research needed to transform our library of therapeutic exosomes to clinically viable products. This type of innovation and discovery is only possible through projects such as RISE,

which enable us to build relationships with trained researchers and specialists to support our innovative efforts.”

“Research plays a crucial role in advancing our knowledge about disease, improving healthcare and ultimately improving outcomes for people in Wales. By focusing on prevention and helping to combat ovarian cancer, these projects will help us deliver effective, high-quality and sustainable healthcare, which will help improve people’s lives.” Vaughan Gething Economy Minister Welsh Government

To find out more about how CEAT and RISE industrial partners are benefitting from these collaborations, join us on the 29th September 2021 for industry showcase. Keep an eye on our Twitter feed (@RBGO_SwanseaUni) for more information and announcements.

www.swansea.ac.uk


Study into antibiotic use wins research paper of the year prize A study into antibiotic use led by Cardiff University, in collaboration with the University of Oxford and King’s College London, has won research paper of the year. The study, by researchers from Cardiff University’s School of Medicine and Centre for Trials Research, found that a simple finger-prick blood test could help to prevent unnecessary prescription of antibiotics in patients with chronic obstructive pulmonary disease (COPD). ‘C-reactive Protein guided antibiotic prescribing for COPD exacerbations’ was published in the New England Journal of Medicine and has now won the overall prize for clinical research in 2019 from the Royal College of General Practitioners (RCGP). Professor Nick Francis, formerly of Cardiff University’s School of Medicine and now at Southampton University, said: “Governments, commissioners, clinicians and patients living with COPD around the world are urgently seeking tools to help them know when it is safe to withhold antibiotics and focus on treating flare-ups with other treatments. This is a patient population that is often considered to be at high risk from not receiving antibiotics, but we were able to achieve a reduction in antibiotic use that is about twice the magnitude of that achieved by most other antimicrobial stewardship interventions, and demonstrate that this approach was safe.” Professor Chris Butler, former professor of primary care medicine at Cardiff University, said: “This rigorous clinical trial speaks directly to the pressing issues of preserving the usefulness of our existing antibiotics, the potential of stratified, personalised care, and the importance of contextually-appropriate evidence about point-of-care testing in reducing unnecessary antibiotic use and enhancing the quality of care for people with COPD.” The academics who led the study have asked the RCGP to donate the £1,000 prize money to the British Lung Foundation in memory of Margaret Barnard, a patient representative in the study who sadly died of lung cancer

before the research concluded. The researchers said they wanted to recognise the valuable contribution she and other public contributors make, as well as her passion for this study. The study found that use of a finger-prick blood test resulted in 20% fewer people using antibiotics for COPD. More than a million people in the UK have COPD, a lung condition associated with smoking and other environmental pollutants. People living with the condition often experience flareups, which leads to three out of four being prescribed antibiotics. However, two-thirds of these are not caused by bacterial infections, so antibiotics have little benefit.

The study found that use of a finger-prick blood test resulted in 20% fewer people using antibiotics for COPD. More than a million people in the UK have COPD, a lung condition associated with smoking and other environmental pollutants. People living with the condition often experience flare-ups, which leads to three out of four being prescribed antibiotics. However, two-thirds of these are not caused by bacterial infections, so antibiotics have little benefit.

Professor Butler said: “Most antibiotics are prescribed in primary medical care, and many of these prescriptions do not benefit patients. Point-of-care testing is being vigorously promoted as a critical solution for better targeted antibiotic prescribing. “However, there have been virtually no trials of point-of-care tests that measure impact on clinician behaviour, patient behaviour and patient outcomes. Acute exacerbations of COPD account for a considerable proportion of unnecessary antibiotic use, but a good solution to the problem in ambulatory care (where most of the antibiotics are prescribed) has not been identified until now. Ours is the first trial of biomarker guided management of AECOPD in ambulatory care and has found an effect that should be practice-changing. “We are obviously delighted on behalf of the universities involved (Cardiff, Kings and Oxford), the National Institute of Health Research Health Technology Assessment Program who funded the study, and the NIHR Clinical Research Network and Health and Care Research Wales. “We would like to thank the GP practices who implemented the trial, and the some 600 patients who gave their time and data to implement the study and generate the findings, as well as the public contributors who helped with design and dissemination. We are deeply grateful for this wonderful recognition by the RCGP for a superb team effort by UK primary care research.”

www.cardiff.ac.uk/centre-for-trials-research

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Forward thinking health research

Researchers venture into Covid hotspots to recruit patients for unique study Experts involved in a unique COVID-19 study at Morriston Hospital had to go to extreme measures while recruiting patients to the cause. They went way beyond the clichéd image of researchers as people in white coats peering down microscopes in laboratories. Instead, two of the team from the hospital’s Welsh Centre for Emergency Medicine Research donned PPE gear to go into Covid hotspots, including the emergency department and intensive care. There they screened patients to check whether they were suitable and willing to take part, and took blood samples if they were. They then set up a kind of human chain to ensure the blood was taken to the lab for processing without a second’s delay. Around 1,000 patients were screened between October 2020 and the end of January 2021, with the target of 155 patients achieved months early. They provided hundreds of blood samples for the Welsh Government-funded investigation – the only one of its kind in the UK – into one of the most devastating effects of the virus on the body. COVID-19 is known to trigger the formation of abnormal blood clots that may damage organs such as the brain and lungs and could cause life-threatening complications such as stroke. The centre is looking into why this happens, using new biomarkers that the team previously developed with Swansea University to screen patients at risk of thromboembolic disease such as stroke and sepsis. In addition to gaining a better understanding of why the virus causes these abnormal clots, the study will focus on how drugs such as dexamethasone and anticoagulants like heparin affect the disease process and outcome. The study involved screening patients with suspected Covid when they arrived in Morriston Hospital’s Emergency Department. Blood samples were taken from those who agreed to take part, and carried straight to the centre’s laboratory just outside the main ED area.

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Research assistant Jan Whitley and research nurse Jun Cezar Zaldua, who joined the team on secondment last autumn specifically for this study, were at the forefront of the screening and blood sample collection. Jun, wearing full PPE, went into the ‘red’ areas where the Covidsuspected patients had been taken. He explained the research study to them and, if they consented to become involved, took samples of their blood.

“I had to explain to the patients what the research was about and its importance. I really had to communicate to them in a very clear and concise manner. That was the most challenging part. They were struggling to breathe and they didn’t really feel well. Some felt so unwell that they didn’t want to take part. But most of them really wanted to help. They didn’t want others to be in that situation, because they were struggling.” Jun Cezar Zaldua Research Nurse Morriston Hospital

Time was of the essence, as the blood samples had to be taken to the lab before they could clot. Jan waited in ED but outside the red areas for Jun to hand over the samples, which she then took to the lab. Jan explained: “PPE throws up its own difficulties. We always needed a team of three people, someone taking the blood and someone outside of the red area who was still protected but not in full PPE, who could leave and bring the blood samples straight back to the laboratory.” The third person in the chain was the scientist in the laboratory who immediately loaded the samples into a rheometer, a device used to analyse the blood using the centre’s bespoke biomarker. This would

have been either Dr Matthew Lawrence or Professor Karl Hawkins, who undertook specific testing. Not all patients who went through the initial screening could participate in the study even if they wanted to, because certain criteria had to be met. Some who were suspected Covid cases on arrival were subsequently found negative. Others were already on anticoagulants and could not be included as this would have affected the blood test results. Of the 155 patients recruited, 120 came from ED. All follow-up samples were carried out on the wards or in the intensive care unit, depending on where the patients had been moved to. The samples were taken after 24 hours, three to five days and one week, which made it a seven-day operation for the team.

“We collected samples during the evenings and at weekends. Once you have recruited a patient, you need to do the follow-up samples to make sure you’re getting them at the appropriate time. If that meant coming in on a Saturday or Sunday, that’s what we did, along with other members of the team.” Jan Whitley Research assistant Morriston Hospital

Jun said all the staff in ED, intensive care and the wards had been fully cooperative and supportive. That was vital as, without their support, it would have been impossible to complete the study. “They were really accommodating. They wanted us to do the research because they were seeing firsthand the consequences of the disease and how it was affecting patients,” he explained. “It was a sharp learning curve for me and a fantastic experience. I learnt a lot about the methodology of carrying out research in acute illness.”


Research assistant Jan Whitley and research nurse Jun Cezar Zaldua

For Jan, it was a very different experience to what she was used to. “As a research assistant, I’m usually in an environment where I would be handling and analysing data,” she said. “I have recruited patients before on other acute studies, but the Covid situation was a completely different environment. Initially you are a bit wary. You are very aware of the situation you’re walking into. But we have been particularly careful and strictly followed all recommended guidelines and protocols. I was given confidence by all the staff and had total admiration for their professionalism and the dedicated care they gave to these very sick patients.” The study, which also involves the collection and recording of large volumes of clinical and scientific data at the bedside,

is led by Professor Adrian Evans and his consultant colleague Dr Suresh Pillai. Professor Evans, the research centre’s Director, said the volume of data to be analysed meant the results of the study would not be published until later in the year. He added: “The patient recruitment target was met within four months of an eight-month grant period. This is a tribute to the entire team effort and to Jan and Jun’s highly effective partnership. The reason we recruited so quickly was because of their professional and sensitive approach, as well as the huge efforts of the whole team and all those involved in the health board such as laboratory medicine.”

“It was particularly remarkable because of the intensity of the disease and the hazardous environment that Jun and Jan had to work in. Undertaking research in acute settings is the most difficult because of the sensitivities involved for patients, relatives and staff.” Dr SureshPillai

www.sbuhb.nhs.wales

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Forward thinking health research

Supporting the research response to COVID-19: The COPE Cymru study Understanding the impact of the COVID-19 pandemic and related policies on physical health and psychological wellbeing is a high priority for government and public health agencies. How people respond to, and are affected by, the pandemic is influenced by an array of psychological and socio-demographic factors. These need to be understood when designing and implementing public health interventions to minimise harm across the population. In doing so, PRIME Centre Wales will contribute to Welsh Government’s strategic aims of preventing ill health, with a focus on person-centred approaches to improving health and wellbeing in line with the Wellbeing and Future Generations Act and Welsh Government’s ‘A Healthier Wales: Our Plan for Health and Social Care 2019’. The project also aligns with the Chief Medical Officer for Wales’ statements relating to the importance of research in order to learn from past events to prevent future pandemics, and understanding wider effects of COVID-19 on health and society in Wales, including effects on health inequalities (Protecting our Health, CMO Report, 2021).

The COPE Cymru study is a longitudinal cohort study, using a combination of research methods to understand attitudes, beliefs and behaviours of a large cohort of the Welsh public in response to the coronavirus pandemic.

In March/April 2020, an inter-disciplinary team carried out an online survey of 8,942 people recruited through HealthWise Wales, an online public recruitment platform for health research. Follow-up surveys and interviews were conducted. The COPE Cymru team received a grant from Sêr Cymru to support research on this project between August 2020 and March 2021.

The COPE Cymru team represents a multidisciplinary collaboration between Cardiff University and Cardiff Metropolitan University, as well as lay partners as recommended by the UK Standards of Public Involvement. PRIME colleagues involved are Dr Natalie JosephWilliams, Dr Anna Torrens-Burton and Prof Fiona Wood. Since setting the cohort up in Spring 2020, the team has completed data collection for baseline, 3-month follow up and 12- month follow up, with analysis ongoing. They have published a study protocol paper as an open access article on Figshare. There are also a number of other papers in draft format or submitted for publication. Papers led by PRIME colleagues include vaccine hesitancy and patient safety in primary care and

experiences of using NHS services during lockdown. PRIME staff members have also been invited to give presentations at the Society of Academic Primary Care meeting on patient reported safety concerns during the pandemic and public attitudes towards the COVID-19 vaccine. The COPE Cymru team has provided Welsh Government and Public Heath Wales with study updates and briefings. These will be extended as analysis progresses. For example, the team’s work on vaccination hesitancy is identifying key reasons for vaccine refusal and could help to improve communication around the vaccine in order to improve uptake. Further information on the study is available at: www.copestudy.yolasite.com

www.copestudy.yolasite.com

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