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uk centre for medical research and innovation

MRC Impact Showcase

How the people and projects we invest in at the Medical Research Council (MRC) are making an impact on our lives and the world we live in.

uk centre for medical research and innovation

Our mission at the Medical Research Council (MRC), part of UK Research and Innovation, is to improve human health through world-class medical research. To achieve this, we invest public money into some of the best medical rese arch in the world across every area of health. Our work has led to some of medicine’s biggest breakthroughs – from deciphering DNA’s structure to inventing the MRI scanner and developing the first COVID-19 vaccine. Our scientists have transformed modern medicine, and in turn have been recognised by 32 Nobel Prizes.

The impacts of our work are broad and diverse – benefiting the economy, society, culture, public policy and services, health, the environment, and quality of life for people in the UK and around the world. They are made possible not just through funding science, but also through targeted investment supporting entrepreneurial activity and supporting enterprise. MRC has built up emerging areas and funded world-class ideas, working with stakeholders across all sectors and partners across the world, guided by our vision to accelerate improvements in human health and economic prosperity.

The case studies below showcase just some of the non-academic impacts arising from MRC funding, with examples from higher education institutes (HEIs) and MRC-supported institutes and major investments.

A confocal microscopy image of the urinary filtration apparatus of the developing kidney

Credit: Dr Daniyal Jafree and Professor David Long, Kidney Development and Disease Group, UCL Great Ormond Street Institute of Child Health

MRC supporting jobs and boosting the UK economy

uk centre for medical research and innovation

First gene therapies for haemophilia, and creation of spin-out Freeline Therapeutics

  • UCL developed single-dose gene therapy that restores blood-clotting and can be delivered at 1% of the cost of conventional treatment – changing the lives of thousands with haemophilia
  • The inherited disorder causes internal bleeding and significantly affects 800,000 affected men and boys worldwide
  • Therapies have treated over 300 patients in clinical trials to date, and a spin-out company, Freeline Therapeutics, was launched in 2015 to develop the approach
  • MRC funding has supported the underpinning haemophilia research for over 60 years

New cancer therapies insight leads to spin-out companies worth £54m and 326 new jobs

  • Research into how cancer cells interact with the immune system has led to new avenues for developing treatments
  • Researchers at the Francis Crick Institute – a partnership between MRC, Cancer Research UK and Wellcome – have identified several unique cellular processes involved in driving cancer growth, providing opportunities to develop targeted therapies aimed at disrupting them
  • The research has led to several spin-out companies, collectively valued at £54.4m and employing 326 people, with several therapeutic candidates in phase I/II trials for melanoma, solid cancers and leukaemia

Creating the world’s largest retinal gene therapy company

  • Gene-therapy research into inherited diseases that cause blindness led to new treatments and the formation of a successful spin-out company
  • MRC-funded research at Imperial College London and the University of Oxford pioneered the first clinical trials of gene therapy for the diseases choroideremia and X-linked retinal pigmentosa, which demonstrated significant improvement in vision for some of the patients treated
  • Spin-out company Nightstar was created with the novel treatment as its lead programme. Licensing of subsequent research extended the approach to other kinds of retinal pigmentosa, and created the world’s largest retinal gene therapy company

Abstract image showing red blood cells

MRC tackling the impact of COVID-19

uk centre for medical research and innovation

Global adoption of effective COVID-19 treatments saves lives

  • RECOVERY trial (Randomised Evaluation of COVID-19 Therapy) – world’s largest clinical trial into treatments for COVID-19, more than 48,000 participants across 185 sites
  • Results found dexamethasone, a cheap, readily available steroid, reduces death rates among seriously unwell patients
  • Findings immediately transformed global clinical guidelines and practice
  • MRC funding directly supported RECOVERY trial through the COVID-19 Rapid Response Initiative in 2020 with the National Institute of Health Research
  • The initiative saved an estimated 650,000 lives by the end of 2020
  •   Find out more about the RECOVERY trial

Abstract image showing coronavirus

Oxford-AstraZeneca Covid-19 vaccine contributed to 6.3m lives saved

  • Oxford-AstraZeneca COVID-19 vaccine contributed to saving 6.3 million lives around the world in the first year of rollout
  • More than 11,000 trial participants showed 70% reduced risk of COVID-19 and 100% reduction in risk of hospitalisation or death
  • MRC funding supported vaccine’s development – success underpinned by decades of MRC funded research that supported the development of ChAdOx1 platform – an adenoviral vector for vaccines to induce and boost cellular immunity
  •   Find out more about our role in developing the vaccine

COVID-19 vaccine bottles

Coronavirus samples inform national COVID-treatment guidelines

  • Sotrovimab was one of the first anti-viral therapies licensed for the treatment of COVID-19 and an essential defence for people who have a poorer response to vaccination. However, by 2022 there was concern sotrovimab may not respond to newer variants circulating
  • Led by researchers at the MRC-funded Francis Crick Institute, the Legacy Study utilised a unique bank of more than 400,000 coronavirus samples that had been collected since 2020 to test a variety of therapies
  • They were able to show sotrovimab offered protection against newer strains. As a result, NICE issued guidelines for its continued use

Medical research laboratory sampling equipment

UK Biobank provides evidence of COVID-19 brain changes

  • Brain scans from UK Biobank – a database established by MRC with genetic and health information from 500,000 UK participants – revealed how even mild COVID-19 infection can cause physical changes to the brain
  • The UK Biobank COVID-19 Repeat Imaging study enabled researchers to access brain scans of individuals around three years apart, making it the only study in the world to demonstrate ‘before and after’ changes in the brain associated with SARS-CoV02 infection
  • The results showed participants who contracted COVID-19 had a greater reduction in brain size compared to uninfected participants. UK Biobank will be a vital resource in understanding whether these changes are reversible over time

UK Biobank participant undergoing a brain scan as part of the UK Biobank COVID-19 Repeat Imaging study

UK Biobank participant undergoing a brain scan as part of the UK Biobank COVID-19 Repeat Imaging study. Credit: UK Biobank

MRC improving UK health and wellbeing

uk centre for medical research and innovation

Lifesaving treatments for neuromuscular diseases in children

  • More than two million children worldwide are affected by neuromuscular diseases
  • Work funded by MRC and medical research charities, in collaboration with biotechnology companies, led to approval of the first effective treatments for the genetic diseases Duchene Muscular Dystrophy (DMD) and Spinal Muscular Atrophy (SMA)
  • Researchers from UCL, Royal Holloway and Bedford New College developed Spinraza – the only approved drug for the treatment of SMA in the UK and most of the world – available via the NHS since June 2019, with 300 patients already gaining access
  • Two medicines developed for DMD – Exondys 51 and Vyondys 53 – which improve quality of life and life expectancy for at least 20% of patients, approved in the US and benefitting over 1,500 people so far
  • These medicines have also generated sales of more than $5.5 billion

Medical professional providing muscle therapy to patient

Cell discovery offers potential new asthma treatment

  • The discovery of a type of immune cell could provide a valuable new tool for treating asthma
  • Researchers at the MRC-funded Laboratory of Molecular Biology discovered cells that secrete an inflammatory molecule, interleukin-13 (IL-13), which can trigger a reaction in asthma patients. The release of IL-13 is activated by interleukin-25 (IL-25)
  • Scientists developed a therapy to block the action of IL-25, preventing it from activating IL-13 and triggering an asthma reaction. A clinical trial is underway to establish its use in treating asthma. The therapy also has potential in the treatment of colorectal cancer

Microscope images of a mouse intestine showing smaller cancers and a more active immune response when ILC2 immune cells are blocked or removed

Microscope images of a mouse intestine showing smaller cancers and a more active immune response when ILC2 immune cells are blocked or removed. Credit: MRC Laboratory of Molecular Biology

Repairing damaged cartilage in knee joints

  • Left untreated, defects in cartilage can progress to osteoarthritis. A team of researchers at the University of Keele has developed a cell therapy that helps repair cartilage in knee joints
  • An MRC-funded trial provided the evidence and cost-benefit data that led to the therapy, known as autologous chondrocyte implantation, which received NICE approval in 2017. The team also developed a tool to help identify patients who would most benefit from the treatment
  • The team are currently investigating a new ‘off the shelf’ cell therapy that uses donor cells, which would reduce cost and improve patient outcomes

Man clutching his knee

MRC improving outcomes for cancer patients

uk centre for medical research and innovation

Anti-cancer treatments across the world

  • University of Southampton developed anti-cancer monoclonal antibodies. The most advanced are two used to treat leukaemias such as Chronic Lymphocytic Leukemia (CLL) and Follicular Lymphoma (FL) called Ofatumumab and Obinutuzumab
  • The patented research was collaboratively developed and licensed to a Swedish biotech firm, resulting in a clinical trial programme that led to a £73 million commercial agreement
  • MRC funding has supported this field of research since the 1970s when scientists at the MRC LMB discovered monoclonal antibodies and later developed humanised monoclonal antibodies in the 1990s for which they won Nobel prizes

Two female adults sitting on a sofa holding hands. younger is wearing a headscarf due to loss of hair

Trial improves prostate cancer patient health and care

  • Research led by the Universities of Oxford and Bristol has changed the way that men with early-stage prostate cancer are diagnosed and treated
  • The ProtecT trial compared active monitoring with more invasive treatments, radiotherapy and surgery, finding that patients who did not undergo invasive treatment had the same high survival rates
  • The trial also found that the negative impacts of radiotherapy and surgery on urinary and sexual function persist much longer than previously thought – for up to 12 years
  • Evidence has changed health policy and clinical practice through updated guidelines and optimised treatment
  • MRC funding has supported the underpinning work carried out at the University of Bristol through the MRC ConDuCT-II Hub since 2014

An older man wearing a blue hospital gown sits in front of an MRI scanning machine

MRC supporting healthy ageing

uk centre for medical research and innovation

Preventing falls in older people

  • Falls are a significant concern for older people and come at a cost of more than £2.3 billion per year to the NHS
  • Home adaptation services – such as stairlifts, grab-rails and ramps – are available for those who want to continue living in their home. However, until now, there has been no evidence to demonstrate their effectiveness
  • Researchers from the MRC-funded Health Data Research UK have created a dataset that shows these adaptations can help prevent falls and also identifies those most at risk of falling. The research could help inform policy for proactive interventions

A younger woman helps an older lady with a walking frame through the front door of a house

Identifying genetic risk of Alzheimer’s disease

  • An international study has identified 75 genes associated with an increased risk of developing Alzheimer’s disease, including 42 new genes that had not previously been implicated
  • Researchers at the MRC-funded UK Dementia Research Institute analysed the genomes of 111,326 people diagnosed with Alzheimer’s disease and 677,633 genomes from healthy people, making it the largest genetic study of Alzheimer’s disease to date
  • The development of a new genetic risk score could be used when recruiting patients for clinical trials aimed at treating the early stages of the disease, when damage to the brain is minimal

A medical image showing brain inflammation with microglia that fail to clear debris, causing astrocytes to react

Brain inflammation with microglia that fail to clear debris, causing astrocytes to react. Credit: National Institute on Aging, National Institutes of Health

MRC informing health policy

uk centre for medical research and innovation

Big data to improve care and outcomes for millions of people with cardiovascular disease

  • UCL researchers used large-scale patient data to shape national and international clinical guidelines for the prevention, diagnosis, and treatment of a range of cardiovascular diseases. This has benefitted care and improved outcomes for millions of patients worldwide
  • Evidence from the research informed a major change in guidelines, to lower the blood pressure threshold which defines hypertension, making diagnosis more accurate
  • MRC funding has contributed to this research since 2012

A man in his 60s sat on a bed clutching his chest

Understanding the transmission and control of COVID-19

  • Research from Imperial College London and Oxford University provided key data which underpinned recommendations and policies during the COVID-19 pandemic. This included school closure policy, social gatherings and contributed to the recommendation of interventions to protect those living in large households
  • The evidence transformed our understanding of the epidemiology of COVID-19 and the measures required to protect public health
  • MRC Centre for Global Infectious Disease Analysis (GIDA) scientists have tailored their research focus to COVID-19 to provide rapid, open access, real-time modelling and assessment analysis targeted at the needs of policymakers
  • Since its establishment in 2008, MRC GIDA scientists provided insight into previous outbreaks of Ebola and Zika and worked with public health agencies and policy makers to improve preparedness and responses to disease outbreaks

A graphic depiction of multiple coronavirus cells

Genome sequencing to inform outbreak response

  • Researchers at the University of Birmingham developed rapid whole genomic sequencing methods to transform the management of infectious disease around the world
  • The research has improved identification of transmission pathways, evolution of pathogens and sites of persistence. MRC funding supported the team to apply rapid genome sequencing to pathogens such as Ebola, Zika and SARS-COV-2
  • In addition, MRC-funded research at the University of Oxford was crucial in the development of the MinION sequence platform – a ‘pocket sequencer’ that enables rapid analysis of data in the field – and the creation of spin-out company Oxford Nanopore Technologies

A series of colourful rectangles arranged in circles to represent genomic sequencing

MRC improving health globally

Protecting human health from infectious disease in low-resource settings.

  • Research from the University of Brighton has contributed to reducing human health risk from diseases including cholera, ebola, typhoid, and childhood diarrhoea in regions of Africa, Asia, and South America
  • The Brighton team helped the National Institute of Cholera and Enteric Diseases to prioritise effective public health interventions in urban slum districts in India (home to 100,000 people) and the Kenyan Medical Research Institute to protect 1,170 rural inhabitants
  • This research was supported by MRC in 2017 in a project which quantified routes of microbial contamination between livestock and drinking water

A woman wearing a white lab coat looks into a microscope

Improving treatment of meningitis in developing countries

  • Cryptococcal Meningitis is a major cause of HIV-related deaths in developing countries, accounting for more than 180,000 deaths per year. Previous treatments involved costly medications and regular monitoring in hospitals
  • Researchers at the University of Oxford, Liverpool School of Tropical Medicine, London School of Hygiene and Tropical Medicine and St. Georges, University of London demonstrated the efficacy of low-cost antifungal drug flucytosine. The WHO implemented the findings into their guidelines, which reduced costs, improved access, and led to reductions in mortality
  • MRC-funded research supported key clinical trials to determine the optimum combinations of flucytosine, providing the evidence needed for implementing these guidelines
  • The findings also led to a $20 million investment from global health organisation UNITAID, benefiting seven African countries

A close up of white tablets in packaging on a production line in a factory

Our mission is to improve human health through world-class medical research. To achieve this, we support research across the biomedical spectrum, from fundamental lab-based science to clinical trials, and in all major disease areas. We work closely with the NHS and the UK health departments to deliver our mission, and give a high priority to research that is likely to make a real difference to clinical practice and the health of the population. Together, we:

  • encourage and support research to improve human health
  • produce skilled researchers
  • advance and disseminate knowledge and technology to improve the quality of life and economic competitiveness of the UK
  • promote dialogue with the public about medical research

Further information

Explore more impacts arising from MRC-funded research

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NIHR awards £42m to new centres to develop innovative technology solutions to improve healthcare

uk centre for medical research and innovation

Published: 13 November 2023

The NIHR has awarded almost £42 million (£41,790,690) to establish 14 new centres across England that will drive life-changing research into health technologies.

From 1 April 2024, the 14 new NIHR HealthTech Research Centres (HRCs) will work with businesses to support the development of medical devices, diagnostics and digital technologies.

These technologies will enable people to:

  • better monitor their health
  • diagnose ill health sooner
  • improve management of conditions including cancer, dementia, cardiovascular and respiratory disease

The HRCs will also work with companies to develop and test products to support rehabilitation and help those with social care needs to maintain their independence. They will work closely with carers, patients and users at all stages.

Each HRC will be hosted by an NHS organisation in England, bringing industry, academia and the health and care system together. The HRCs will:

  • drive innovation and efficiency
  • bring new technologies to those who need them most
  • support the health and care workforce to reduce workload
  • help alleviate pressures on the health and care system

The HRCs will keep the UK at the forefront of research and the place companies want to come to in order to invest in the development of health technologies.

Health and Social Care Secretary Steve Barclay said:

“These centres will help bring the latest advances in medical technology into patients’ lives sooner improving care, treatment and diagnosis including for those with cancer, dementia and brain injuries.

“We are already seeing the benefits of previous investment in health technologies - such as using artificial intelligence to predict how different patients respond to medication for inflammatory bowel disease meaning the right treatment is provided to patients sooner.

“I look forward to seeing what our world leading scientists, clinicians and inventors bring forward next.”

The HRC scheme replaces the successful NIHR Medtech and In Vitro Diagnostic Co-operative (MIC) scheme, which comes to an end in March 2024.

The previous scheme delivered significant impact, including the development of:

  • Virtual reality rehabilitation physiotherapy for children. This enabled them to undergo treatment from the comfort of their own home, reducing pressures on hospital services;
  • The “HeadUp Collar”. This drastically improves the quality of life for people with motor neurone disease. It addresses problems with communication, swallowing, breathing, mobility and pain;
  • A breath test for multiple gastrointestinal cancers. This enables detection at an earlier stage, when treatments are more effective;
  • QbTest, a computerised assessment of attention deficit hyperactivity disorder (ADHD). This is now used in NHS ADHD Clinics in England to support clinical decision making and more efficiently diagnose ADHD. QbTest enables people to have fewer consultations and receive support much earlier.

The new scheme will continue to support innovative projects like these. It will also build capacity and expertise to support the development of health and care technologies to meet growing demand. The HRCs will develop technology for hospitals and in general practice as well as for use within community and social care settings. This will enable patients to benefit from these innovations wherever they come into contact with the health and care system.

Professor Lucy Chappell, Chief Scientific Adviser to the Department of Health and Social Care and CEO of the NIHR, said:

“Research into health technology is recognised as being of vital importance for patients, carers and users, our workforce, and the wider health and care system.

“The establishment of the NIHR Healthtech Research Centres shows our firm commitment to driving innovation in healthtech research from conception through to adoption.

“Our existing research centres in MedTech have delivered new technologies that have helped prevent, diagnose and treat ill health for many individuals, as well as ensuring increased efficiencies in the health and care system.

“The increased funding for the HealthTech Research Centres will build capacity and  expertise in health technologies, bring new innovations to market and enable people to live healthier, better-quality lives.”

The funding will support government priorities including:

  • Levelling up across the country. Nine of the 14 HRCs will be based at NHS organisations outside the Greater South East. They will receive the majority of the funding (64%).
  • The HRCs will support the development of innovations that address the most pressing healthcare challenges, including cancer, mental health, neurodegeneration and dementia, ageing, respiratory disease, and cardiovascular conditions.
  • The HRCs will support industry, including small and medium sized enterprises and local innovation clusters, to develop new medical technologies and diagnostics, and increase the chance of adoption in the NHS and other health and care settings. This will further cement the United Kingdom as a leading global hub for Life Sciences.
  • The HRCs will support delivery of the Government's medical technology (“medtech”) strategy. Medtech is of vital importance to the UK health and care system, helping people live more independent, healthier lives for longer.

Here is a full list of the new HRCs:

Cambridge University Hospitals NHS Foundation Trust

Brain and spine injury

£2,999,532

Guy's and St Thomas' NHS Foundation Trust

Cardiovascular and respiratory disease

£2,999,210

Imperial College Healthcare NHS Trust

Diagnostics for cancer, infectious and respiratory diseases, critical care, primary and social care

£2,993,768

Leeds Teaching Hospitals NHS Trust

Surgical technologies and rehabilitation

£2,999,204

Manchester University NHS Foundation Trust

Urgent and emergency care

£2,998,433

Nottinghamshire Healthcare NHS Foundation Trust

Mental health

£2,999,840

Nottingham University Hospitals NHS Trust

Rehabilitation and assistive technologies

£2,873,791

Oxford Health NHS Foundation Trust

Community healthcare (cancer, infectious diseases, mental health and technology for care homes)

£2,999,912

Royal Devon University Healthcare NHS Foundation Trust

Diagnostics, rehabilitation and frailty

£2,999,014

Sheffield Children's NHS Foundation Trust

Children and young people’s health

£2,998,577

Sheffield Teaching Hospitals NHS Foundation Trust

Long-term neurological conditions, diabetes, kidney care, women’s health, rehabilitation, mental health

£2,999,738

South London and Maudsley NHS Foundation Trust

Dementia and brain health

£2,938,217

The Newcastle Upon Tyne Hospitals NHS Foundation Trust

Diagnostics for infectious diseases, ageing and multiple long-term conditions and rare diseases

£2,992,173

University Hospitals Birmingham NHS Foundation Trust

Trauma and emergency care

£2,999,281

Latest news

New findings on the use of molnupiravir to treat COVID-19

New funding opportunities for novel brain tumour research launched

ADHD digital test approved for use by the NHS

NIHR welcomes £300m investment into clinical trials infrastructure bringing new medicines to patients across the UK

First UK lung cancer patient receives novel immune therapy at NIHR Clinical Research Facility

Plans approved for UK Centre for Medical Research and Innovation

Plans to build a world-leading medical research institute at St Pancras in London have been approved by councillors at Camden Town Hall. The UK Centre for Medical Research and Innovation (UKCMRI), designed by the architects HOK with PLP Architecture, will have 1500 staff, including 1250 scientists.

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UKCMRI is founded by the Medical Research Council, Cancer Research UK, the Wellcome Trust and UCL (University College London).

The members of the Development Control Committee voted in favour of the £500 million project at a meeting at the Town Hall on 16 December.

Chief Executive of Cancer Research UK, Harpal Kumar, welcomed the decision: "The councillors have brought this institute significantly closer to reality. It will help to tackle some of the most difficult scientific and medical questions - bringing benefits to health and helping us to treat and beat diseases that affect us all, including cancers, heart disease and stroke, infections and diseases of the immune and nervous systems. It will bring benefits to health and be a national resource for the training and development of scientists. It will engage the public in its work and will provide educational benefits to schools locally and nationally."

Sir David Cooksey, Chairman of UKCMRI, added: "UKCMRI will harness the talent and potential of doctors, nurses, biologists, mathematicians, physicists, chemists, computer scientists and engineers to understand the underlying causes of disease. This will accelerate our ability to treat disease - bringing benefits to patients through the NHS and to the economy by developing a sector in which the UK already excels."

In October, the Government gave its commitment to UKCMRI by confirming its investment in the project through the Medical Research Council. Prime Minister David Cameron announced that UKCMRI would have a central role in the Government's National Infrastructure Plan to ensure the UK remains a world leader in science and research. Over half the funds are being contributed by Cancer Research UK, the Wellcome Trust and UCL.

The construction of UKCMRI is expected to begin in the spring with completion in 2015.

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Centre for Cardiovascular Medicine and Devices

The Centre for Cardiovascular Medicine and Devices  has been created to bridge the gap between academics and clinicians in their endeavour to innovate in translational medicine.

The Centre houses a productive transatlantic relationship with Yale University which focuses on research and innovation. Our projects include next-generation stent technology and big data consolidation. Our Yale colleagues include Prof. Alexandra Lansky, one of the Centre’s research leads, alongside Prof. Carlos Mena-Hurtado, Prof. John Forrest and Prof. Eric Velasquez. The Centre also has a strong working relationship with Prof. Bernard Gersh, based at the Mayo Clinic.

The Cardiovascular Devices Hub (CVDHub) sits within this Centre. The CVDHub, partly funded by the ERDF, supports collaborations between academic, clinical, engineering and industrial innovators to develop clinically and commercially viable cardiovascular devices. This novel, cross-speciality unit helps small to medium enterprises (SMEs) over the hurdles involved in taking new innovations to human trials. We are currently building a new space for collaborative interaction which will include flexible meeting and conference facilities.

The overall research objectives of this internationally acknowledged group are:

  • Mathur : Role of biologics (stem cells, gene therapy) in the treatment of CV disease. Use of advanced cardiac imaging to examine mechanistic aspects of translational research. Novel devices, first in man trials, device innovation, digital technologies (e.g. Avatars), artificial intelligence, megakaryocyte biology, and the role of platelets in cardiovascular disease.
  • Ahluwalia : Effects of nitrite and nitrate on the cardiovascular system, sex differences in cardiovascular function and disease, the role of TRPV1 in vascular reactivity.
  • Baumbach : Clinical evaluations of device-based embolic protection to reduce stroke during cardiovascular interventions, definitions of endpoints for neurological injury in cardiovascular trials, new stent technology, first in man use of novel device concepts.
  • Lansky : The clinical impact of silent embolic events and consequences on neurocognitive function following TAVR procedures.

Principal Investigators

  • Professor Anthony Mathur , Centre Lead
  • Professor Amrita Ahluwalia , Deputy Centre Lead (WHRI)
  • Professor Andreas Baumbach , Deputy Centre Lead (Barts Heart Centre)
  • Professor Alexandra Lanksy , External Scientific Advisor
  • Dr Vikas Kapil , Senior Lecturer and Centre Education Lead
  • Dr Dan Jones , Senior Lecturer
  • Dr Vahitha Abdul Salam , Lecturer
  • Dr Claudio Raimondi , Lecturer
  • Dr Krishnaraj Rathod , Senior Clinical Lecturer
  • Dr Christos Bourantas, Honorary Senior Lecturer
  • Professor Charles Knight , Honorary Chair 
  • Professor Richard Schilling , Honorary Chair 
  • Professor Peter Groves, Honorary chair

Overseas Faculty

  • Professor Eric Velasquez (Yale)
  • Professor Carlos Mena-Hurtado (Yale)
  • Professor Bernard Gersh (Mayo Clinic)
  • Dr Didier Locca, Honorary Reader, QMUL ( EPFL, Swiss Institute of Technology)

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  • v.114(1); 2021 Jan

Advancing UK regulatory science and innovation in healthcare

Melanie j calvert.

1 Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, University of Birmingham, Birmingham B15 2TT, UK

2 National Institute for Health Research (NIHR) Applied Research Centre West Midlands, Birmingham B15 2TT, UK

3 NIHR Birmingham Biomedical Research Centre, NIHR Surgical Reconstruction and Microbiology Research Centre, University of Birmingham, Birmingham B15 2TT, UK

4 Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham B15 2TT, UK

5 Health Data Research UK, London NW1 2BE, UK

Eliot Marston

Mark samuels.

6 Lifesci Ltd, London WC2H 9JQ, UK

Samantha Cruz Rivera

Barbara torlinska, kathy oliver.

7 International Brain Tumour Alliance (IBTA), Tadworth KT20 5WQ, UK

Alastair K Denniston

8 University Hospitals Birmingham NHSFT, Birmingham B15 2GW, UK

9 Regulatory Horizons Council London SW1H 0ET, UK

Steve Hoare

10 The Association of the British Pharmaceutical Industry, London SW1E 6QT, UK

As the UK exits the European Union, there is a pressing need for the UK to invest in regulatory science and innovation if it is to be globally competitive and internationally collaborative. Innovation in life sciences, including digital tools, robotics, artificial intelligence and new therapeutic approaches, such as cell and gene therapy, will play a crucial role in continued improvement in health outcomes and life expectancy. The UK is powerfully positioned to lead in the discovery, development and evaluation of these new approaches, enabling accelerated routes to market, increasing benefits to public and individual health, improving patient safety, influencing international practice and promoting investment in the UK. 1 , 2

Advances in regulatory science, or ‘the application of the biological, medical and sociological sciences to enhance the development and regulation of medicines and devices in order to meet the appropriate standards of quality, safety and efficacy’, 3 matter more than ever to inform and evaluate new approaches to regulating these innovative technologies. In this commentary piece, we argue that the UK has a unique opportunity to advance regulatory science and innovation and drive global advances in this area and make a series of recommendations to this end based on key findings from Birmingham Health Partners Advancing Regulatory Science and Innovation in Healthcare Report (Box 1). 4 , 5 The UK should take a coordinated approach to foster and prioritise advances in regulatory science and innovation and build a workforce to ensure its sustainability and continuing evolution. We should actively support the emergence of both existing and new clusters in regulatory science. Support for these clusters should draw on world-leading academic expertise, leverage increasingly integrated regional ecosystems, connecting industry, policy and the NHS and – crucially – the voices of our patients and citizens (Box 2).

Recommendations. a

• A specific national healthcare/life sciences strategic advisory committee should be established to provide dynamic oversight to complement the UK’s new Regulatory Horizon Council, enabling multidisciplinary and cross-sector input to advance UK healthcare regulation and promote innovation informed by regulatory science. Dynamic oversight should be provided in accordance with principles specified by the Wellcome Trust blueprint (inclusive, anticipatory, innovative and proportionate).
• The Medicines and Healthcare Products Regulatory Agency should work with stakeholders – including the devolved administrations in Scotland, Wales and Northern Ireland – to develop a UK strategy for regulatory science to create a roadmap for national efforts, to maximise the speed of UK medicines regulation and health technology evaluation.
• Major UK funding bodies – including UK Research and Innovation, the National Institute for Health Research and members of the Association of Medical Research Charities – should identify potential funding mechanisms for regulatory science which could deliver major benefits aligned to their respective remits and communities.
• Given challenging timelines around the Brexit transition period, multi-stakeholder work is needed to understand and prioritise specific technological or methodological areas in which the UK’s capability for regulatory innovation could enable a global leadership position, delivering major economic and healthcare benefits. The UK should maintain high levels of regulatory compatibility and fully understand the threats and opportunities posed by any divergence.
• Emerging technologies should be identified through horizon scanning and where uncertainties arise about how to regulate certain emerging technologies; we need joint working processes enabling regulatory bodies and industry to flag where evidence and innovation are required in regulatory science to justify research and development investments.
• Innovation in regulatory science is needed to underpin an R&D environment that mitigates ‘high-risk’ areas of investment with significant promise – for example, antimicrobial resistance or new medications for pregnancy-related conditions.
• Specific consideration should be given to supporting regulatory science aligned to the Accelerated Access Collaborative, establishing how the uptake of innovation within the National Health Service can be better enabled, and how local good practice can help drive wider national behaviours.
• We need to establish coordinated national and international approaches for promotion of new guidance, including development of implementation tools and resources and training and establishing how regulators, industry bodies, funders, healthcare providers and other agencies can act in concert to accelerate implementation.
• An evaluation framework with agreed metrics should be developed to assess the impact of regulatory innovation and implementation.
• International stakeholders must work collaboratively to understand the benefits and challenges of changes in regulation, such as those arising from COVID-19, and how this could be applied to other settings.
• A scoping exercise should be undertaken to more fully understand specific training needs across various stakeholder groups to support regulatory science innovation and improve uptake/use of innovative technologies and medicines.
• The UK should seek to establish clear career pathways in regulatory science, via internships, fellowships or PhDs involving academia, industry, National Health Service, patient partners and regulatory bodies as key collaborators, mentors and beneficiaries.

a Recommendations taken from Birmingham Health Partners Advancing Regulatory Science and Innovation in Healthcare Report, 2020, based on a scoping review and stakeholder input. 4 MHRA: Medicines and Healthcare Products Regulatory Agency; R&D, research and development.

Current context for regulatory science

Life sciences are vital to the UK’s health but also its economic wealth. The industry supports around 482,000 jobs in the country and the activities of life sciences companies directly contributed £14.5bn to the national economy in 2015, with an additional £15.9bn provided through the life sciences supply chain and employee spending. 6 UK life sciences businesses face unprecedented challenges in both near-term viability and long-term sector sustainability due to regulatory uncertainty following Brexit and the global COVID-19 pandemic.

As a European Union member, the UK Medicines and Healthcare Products Regulatory Agency was integrated in the European Union Medicines Regulatory Network, including the European Medicines Agency. Now that the UK has left the European Union, the Medicines and Healthcare Products Regulatory Agency will ‘continue to support the UK Government to deliver its legal obligations under the Withdrawal Agreement and prepare for its new relationships with the European Union and the rest of the world’. To do this, they continue to work closely with the Department of Health and Social Care to ensure the UK regulatory environment works in the best interests of patients, industry and our partners across the health and care system.’ 4 , 7 The Medicines and Healthcare Products Regulatory Agency Business Plan 2020–2021 highlights key strategic areas for change ‘in response to the need to develop a new and effective regulatory model, but this also reflects a new focus on involving and engaging with patients, enabling patient access to new innovative medicines and devices, and speedier response to risks to patient safety and public health.’ 7 A key strategic objective is to improve regulatory science. Post-transition, we should use the European Union–UK negotiations to maintain their current high level of regulatory compatibility, while contributing to advancing global regulations. How should the UK do this? First, it must take account of clear clinical and academic strengths to inform regulatory innovation. Second, it must factor in the opportunity for UK industry to invest in innovation and create a national testbed to drive global progress.

The life sciences industry has already invested significant effort and funds to prepare for new European Union frameworks, and incompatibility from the UK brings risks around complexity, competence and capacity. Our UK trade associations – providing insight and ongoing engagement – have given us a robust framework that we should harness to mitigate these risks. The Government’s White Paper on ‘Regulation for the Fourth Industrial Revolution’ noted that:

We need to reshape our regulatory approach so that it supports and stimulates innovation that benefits citizens and the economy. At present, only 29% of businesses believe that the government’s approach to regulation facilitates innovative products and services being efficiently brought to market. The need for reform is urgent: 92% of businesses from a range of sectors think they will feel a negative impact if regulators don’t evolve to keep pace with disruptive change in the next two to three years. 1

COVID-19 has severely impacted life sciences research and development, while also demonstrating the impact of a more collaborative effort and regulatory flexibility. The sector is looking at resilient recovery while recognising the continued risk of disruption. During this recovery phase, pharmaceutical and medical technology companies have asked for continued, (national and international) regulatory flexibility. They have used flexibility as they accelerate product development in medicines, devices and vaccines, and move to re-initiate trials, mitigate missing data and implement new models of working (including telehealth and remote monitoring). The unprecedented events of the pandemic have offered a paradigm shift in healthcare regulation. 8 , 9

Strategic leadership and coordinated support

The UK Government’s White Paper, Regulation for the Fourth Industrial Revolution, notes:

As we leave the European Union and forge a new path for ourselves, we will continue to play an important role in shaping how regulation is developed internationally. We will collaborate with like-minded international partners to reduce regulatory barriers to trade, through mechanisms such as the adoption of international standards, mutual recognition agreements and free trade agreements. We will encourage our regulators to play an active role in shaping international thinking on how innovation should be regulated. 1

For the UK to maximise opportunities in the future regulation of healthcare innovation, it must work cohesively and collaboratively while creating an environment that gives innovators faster ways to demonstrate benefit. The UK must leverage the high profile and excellent stakeholder engagement processes of the leading players. These organisations include: the NHS, patient organisations, National Voices, academia, the Medicines and Healthcare products Regulatory Agency, the NICE and Health Research Authority, as well as the Association of the British Pharmaceutical Industry, Association of British HealthTech Industries, Accelerated Access Collaborative, the British In Vitro Diagnostic Association and Health Data Research Alliance, coordinated by Health Data Research UK, which aims to establish best practice around the ethical use of UK health data for research and innovation at scale. 10 Expert regulatory science should support them.

To gain these crucial inputs, we will need collaboration across multiple stakeholders and strategic leadership. Meaningful patient and citizen involvement should be central to all activities (Box 2). Additionally, we require alignment with the new Regulatory Horizons Council. 11 This independent expert committee identifies the implications of technological innovation; it provides the government with impartial, expert advice on the regulatory reform required to support the rapid and safe introduction of new technologies.

The need for meaningful and sustained patient and citizen involvement.

Patients and society are beneficiaries of scientific discoveries, new technologies and improved medications; but they also can and should be able to contribute to these discoveries through participation in clinical studies and in the co-design of research. Patients, as well as our wider, diverse communities, can provide unique insights into which specific healthcare problems and priorities these discoveries, technologies and medications should be targeted; what kind of evidence validates their effectiveness; and what ‘value’ truly means in terms of our health and treatment outcomes. Trust and transparency are more critical than ever. Patients want better treatments as quickly as possible, but not at the cost of safety, privacy or awareness of risk. Laws, regulations and standards play a vital role in enshrining patients’ and citizens’ requirements and innovators’ responsibilities. Where these are adapting – which we recognise they must, to respond to the scale and pace of opportunity in healthcare – it is essential that patients and citizens have a voice and are accepted as true partners in these endeavours. Patients and citizens can provide the lived experience and deeply meaningful insights into all aspects of healthcare and in regulatory science initiatives. ‘We need to develop a more sophisticated model of engagement where ethical and moral issues arise and ensure that issues such as risk and uncertainty are discussed appropriately. We need to build trust and enable consumers to have confidence in innovations and businesses to have confidence in our stable and proportionate regulatory system.’

The growth of the Academic Health Science Networks has complemented the emergence of significant academic–NHS partnerships. 12 Additionally, Life Science Opportunity Zones support major industry-facing centres of gravity. Together, these areas have become ready-made research ‘clusters’ for innovation – and an ideal springboard for regulatory science to flourish in the UK. 13 Through increased ease of collaboration, clusters foster shared knowledge and talent pools, support collaborative cross-sector innovation and generate synergistic value. They provide essential accelerators and testbeds to inform broader systems thinking.

An ongoing commitment to international collaboration will also be key. It would be highly damaging for the UK to attempt to operate fully in isolation of other regulatory systems and international excellence in approaches to supporting emerging technologies and regulatory science. 2 Indeed, we can and should learn from global regulatory science initiatives such as the research programmes and centres of excellence supported by the Food and Drug Administration (FDA) in the US and the Clinical Trials Transformation Initiative. 5 , 14

Prioritisation and shared risk

Regulatory science – where appropriately targeted – offers a way to provide clarity and collaboration between stakeholders. There are several emerging technologies and trends in regulation which need collective visions on how best to move forward, as highlighted by recent Regulatory Science Summits organised by the Innovative Medicines Initiative in collaboration with the European Medicines Agency and FDA and the European Medicines Agency’s Regulatory Science to 2025 strategy. 15 , 16 These technologies include: advanced therapy medicinal products, artificial intelligence, digital tools for data collection and analysis, digital therapeutics, immunology and the microbiome, big data and digital health, as well as real-world evidence and clinical trials.

International horizon scanning should proactively identify emerging healthcare technologies. Where uncertainties arise about appropriate regulation, we need joint working processes that enable regulatory bodies and industry to flag where evidence and innovation are required in regulatory science to justify research and development investments. Interaction with patient organisations and enhancing methods to incorporate patient-relevant evidence in benefit-risk evaluation and regulatory decision making is key. Tools include patient-reported outcomes and patient preference data. 15 Products, services and business models with high potential benefit for UK society and the economy should be prioritised. Innovation in regulatory science is vital to underpin a research and development environment that mitigates ‘high-risk’ areas of investment with significant promise, such as antimicrobial resistance or new medications for pregnancy-related conditions, to facilitate the rapid and safe introduction of these products and services. 17 Early engagement of innovative developers with multi-stakeholder scientific advice (for example, joint meetings offered by the Medicines and Healthcare Products Regulatory Agency Innovations Office and NICE), offers benefits to all; facilitating navigation of the regulatory landscape and identifying challenging areas for regulators to address. 18

Implementation and evaluation of regulatory innovation

New tools and methodologies will be needed to properly evaluate the impacts of regulatory change and support continuous iteration – the building blocks for these have already been established nationally and internationally. In 2012, the Organisation for Economic Co-operation and Development (OECD) published a framework for systematically evaluating the performance of regulations and regulatory policies. 19 Measuring regulatory progress in a meaningful and credible way requires indicators to measure relevant outcomes and appropriate research designs. Both are needed to support inferences about the extent to which a regulation or regulatory policy under evaluation has actually caused a change in the measured outcomes. Indicators may include: (1) impact/effectiveness (changes in the problem or other outcomes of concern such as patient safety, mortality); (2) cost-effectiveness (costs for a given level of impact); (3) net benefits (all beneficial impacts minus all cost impacts); and (4) equity/distributional fairness of impacts. In addition to equity or distributional concerns, sometimes other outcomes of interest are used as criteria, such as impacts on technological innovation, macroeconomic growth, and employment. Building on the Organisation for Economic Co-operation and Development framework, the European Medicines Agency has developed a conceptual framework for the review of the impact of regulatory science projects on its regulatory processes and activities – with implications for resources and further iterative improvements (Box 3). 19

We believe that we need ‘parallel not series’ evaluation, regulation and implementation processes, underpinned by training. Additionally, we require development platforms that: bring together innovators, regulators and end-users to map out innovation journeys; create consensus for the use of novel technologies; devolved flexibility to enable real-world testing of regulatory adaptation before scaling nationally.

European Medicines Agency conceptual framework for the review of the impact of regulatory science projects on regulatory processes and activities.

Key considerations include:
(i) When are results of regulatory science projects matured enough to form a basis to implement changes in regulatory or clinical practice?
(ii) Depending on the types of outcomes, to what extent should results/recommendations from regulatory science projects be validated, scrutinised and peer reviewed in the scientific community before their implementation?
(iii) Should there be a trade-off between timing of implementation and scientific replication/validation?
(iv) Which outcomes should be prioritised for implementation? Regulatory science projects delivering both the highest impact and efficient use of resources should be prioritised.

Workforce development

Developing a coherent UK programme of training in regulatory science will be crucial to delivering workforces for industry, the NHS, policy and academia and to support patients and the public involved in regulatory science initiatives. This is an urgent priority to bridge the potential expertise gap resulting from leaving the European Medicines Regulatory Network and to advance regulatory science in the UK. It will provide a sustainable skills pool to ensure that technological innovation in healthcare can be supported successfully – and the corresponding health and economic benefits are realised – while robustly protecting patients. However, we also need to understand what each of these diverse stakeholders in regulatory science need – and what they can offer – so that we can assemble a clear national framework and strategy. Current UK-based training is somewhat limited, comprising master’s level training/apprenticeships and continuing professional development, emerging technologies will require a higher level of capability. 20 To keep pace with innovation and international counterparts, the programme needs to be expanded via internships, fellowships and PhDs involving academia, industry, professional bodies, National Health Service and regulatory bodies as key collaborators, mentors and beneficiaries. The UK should seek to establish clear career pathways in regulatory science.

The UK can learn from, and engage with, international initiatives. In the US, the FDA offers a programme of internships and fellowships via its Oak Ridge Institute for Science and Education partnership. 21 The programme allows the FDA to target and accelerate key areas of regulatory science which will support its future activities with successful Fellows often going to work for the regulator and in turn mentoring future Fellows. In the European Union, the European Medicines Agency is currently designing two curricula through the Strengthening Training of Academia in Regulatory Science ‘STARS’ initiative to support both the professional training of clinical scientists and a broader programme to support a shared post graduate educational agenda, 22 while the global association for people working in Regulatory Affairs (TOPRA) offer significant training opportunities for professionals. 23 It will be crucial to leverage their expertise, insights and professional standing to create an appropriately competitive and ambitious, forward-looking training programme for the UK.

Underpinning the advancement of the sector is also a need for people with regulatory skills, across industry, the health service and academia as well as regulators, not only to do the core work of medicines development, regulation and delivery to patients but to be resourced to develop standards for emerging technologies and methodologies. 2

The UK’s current situation brings significant complexities, challenges and risks. However, our uniquely collaborative and dynamic national ecosystem for regulatory science is more than capable of rising to tackle them and ensuring this is the time of unique opportunity and benefit.

Why do these proposals matter? We have recommended actions that – crucially – can put the UK in a leadership position for regulation. This position will attract the most exciting ideas and strategic resources from the global industry. It will further accelerate the co-creation and adoption of innovation by the NHS. Critically for regulators, it will create all-important academic insights into the tools, technologies and methodologies they need. And most importantly, it will give our patients and the public an integral voice in the design, development and delivery of innovative new treatments, diagnostics and medical devices. This is an opportunity to develop our regulatory science strategy for the UK to benefit the world.

Provenance: Provenance: Not commissioned; the paper was revised following peer review comments from another journal

ORCID iD: Melanie J Calvert https://orcid.org/0000-0002-1856-837X

Declarations

Competing interests.

KO states that she has no real or perceived conflicts of interests with regard to her co-authorship of this paper but for the sake of transparency she states the following: Between 2005 and 2020, the IBTA has received unrestricted educational grants and financial support and/or support in kind either as an individual organisation or as part of a wider grouping of patient organisations, from the following companies and trusts: AbbVie, Accuray, Antisense Pharma, Apogenix, Archimedes, Ark Therapeutics, Astra Zeneca, Bayer, Boehringer Ingelheim, Brain Tumor Network (USA), Brain Tumor Resource and Information Network (USA), Bristol-Myers Squibb (BMS) Celldex Therapeutics, Celgene, Crusade, Dijon Designs (UK), Elekta, Eli Lilly, Gerry & Nancy Pencer Brain Trust (Canada), Gosling Foundation (UK), GlaxoSmithKline (GSK), GW Pharmaceuticals, Incyte, Ivy Foundation (USA), Lilly, Link Pharmaceuticals, MagForce, Medac, Merck Serono, Merck, MGI Pharma, MSD Oncology, NeoPharm, Neuroendoscopy (Australia), Northwest Biotherapeutics, Novartis, Novocure, Pediatric Brain Tumor Foundation (USA), Pfizer, Photonamic, Roche, Schering-Plough (Global), Sontag Foundation (USA), Spink (UK), STOPheresetumoren.nl, to-BBB, Vane Percy (UK), VBL Therapeutics and the Wallerstein Foundation (USA). KO, on behalf of Kathy Oliver Consulting, has also in this same period received consultancy fees from Lilly, GSK, Bayer, SPAEN and Novartis. For further details of the IBTA’s sponsorship policy, please see https://theibta.org/become-a-corporate-sponsor/ . MC has received personal fees from Astellas, Takeda, Merck, Daiichi Sankyo, Glaukos, GSK and the Patient-Centered Outcomes Research Institute (PCORI) outside the submitted work.

SH is an employee of the Association of the British Pharmaceutical Industry. MS, BT and SCR declare no conflict of Interest.

The Birmingham Health Partners Advancing Regulatory Science and Innovation in Healthcare Report and this commentary piece were funded by a Quality-related (QR) research grant from Research England.

MJC is a National Institute for Health Research (NIHR) Senior Investigator and receives funding from the National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre and NIHR ARC West Midlands at the University of Birmingham and University Hospitals Birmingham National Health Service Foundation Trust, Health Data Research UK, Innovate UK (part of UK Research and Innovation), Macmillan Cancer Support, UCB Pharma.

AKD receives funding from Health Data Research UK, an initiative funded by UK Research and Innovation, Department of Health and Social Care (England) and the devolved administrations, and leading medical research charities. AKD also receives funding from the Wellcome Trust, the NIHR Biomedical Resource Centre (Moorfields Eye Hospital/UCL) and the Regulatory Horizons Council. The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, the Department of Health and Social Care, the Regulatory Horizons Council or the Department for Business, Energy and Industrial Strategy.

Ethical Approval: Not required

Guarantor: MJC.

Contributorship: This commentary piece is based on the Birmingham Health Partners Advancing Regulatory Science and Innovation in Healthcare Report 2020 4 and recommendations therein, which was co-authored by MS, EM and MJC. MJC prepared the initial draft of this commentary piece. All co-authors critically reviewed the manuscript and approved the final version. MJC is the Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation. KO is a patient advocate and Chair of the International Brain Tumour Alliance (IBTA). AKD is the Artificial Intelligence Lead for the Birmingham Heath Partners Centre for Regulatory Science and Innovation, and Director of INSIGHT, the HDRUK Health Data Research Hub for Eye Health. SH is the Quality, Regulatory Science and Safety policy director of the Association of the British Pharmaceutical Industry and thus represents the views of the research-based pharmaceutical industry in the UK. KO, patient advocate, contributed to writing the article, providing the content for Box 2 and contributing critical revisions to the manuscript at all stages.

Acknowledgements

We would like to thank contributors to the Advancing Regulatory Science and Innovation in Healthcare Report (Reference 4, page 73) from which this commentary is derived.

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Opportunities and Risks of UK Medical Device Reform

Affiliations.

  • 1 Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK.
  • 2 Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK.
  • 3 Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK.
  • 4 National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University of Birmingham, Birmingham, UK.
  • 5 National Institute for Health Research (NIHR) Applied Research Collaborative West Midlands, University of Birmingham, Birmingham, UK.
  • 6 Health Data Research UK, London, UK.
  • 7 University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK.
  • 8 Regulatory Horizons Council, London, UK.
  • 9 Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK. [email protected].
  • 10 Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Edgbaston, Birmingham, UK. [email protected].
  • 11 Centre for Patient Reported Outcomes Research, Institute of Applied Health Research, College of Medical and Dental Sciences, University of Birmingham, Birmingham, UK. [email protected].
  • 12 National Institute for Health Research (NIHR) Birmingham Biomedical Research Centre, University of Birmingham, Birmingham, UK. [email protected].
  • 13 NIHR Surgical Reconstruction and Microbiology Research Centre University Hospitals Birmingham NHS Foundation Trust, University of Birmingham, Birmingham, UK. [email protected].
  • 14 National Institute for Health Research (NIHR) Applied Research Collaborative West Midlands, University of Birmingham, Birmingham, UK. [email protected].
  • PMID: 35416614
  • PMCID: PMC9007047
  • DOI: 10.1007/s43441-022-00394-0

Objectives: To identify the potential opportunities and risks around future UK regulatory reform of medical devices.

Design: A mixed methods approach, comprising a rapid literature review, one-to-one, semi-structured interviews with key stakeholders, a multidisciplinary stakeholder workshop, and a post-workshop survey.

Setting: United Kingdom.

Participants: 32 key stakeholders across the medical device sector were identified both from the public and private sectors.

Results: Opportunities relating to regulatory independence were identified, including the potential to create and implement a regulatory framework that ensures availability of medical devices; innovation and investment potential; and safety to the citizens of the UK. The most significant risks identified included threats to the safety of individual patients and the wider health system arising from the delay in awaiting regulatory approval due to the shortage of approved bodies; and reduced competitiveness of UK market and device manufacturers. Recommendations were identified to mitigate risks, centred on harnessing broader cross-sector collaborations, promoting patient and public partnership, and maximizing international engagement.

Conclusions: The UK's medical device sector is at a time-critical juncture to construct a regulatory framework to navigate its exit of Europe and respond to Europe's transition to new medical device regulations whilst also addressing the ongoing demand for rapid approval for new devices in response to the global pandemic. Investment, capacity-building, and international engagement will play a central role in mitigating risks and maximizing opportunities for medical device regulation.

Keywords: CE mark; In vitro diagnostics; Medical devices; Regulations; UKCA.

© 2022. The Author(s).

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Conflict of interest statement

OLA receives funding from the NIHR Birmingham Biomedical Research Centre (BRC), NIHR Applied Research Centre (ARC), West Midlands at the University of Birmingham and University Hospitals Birmingham NHS Foundation, Innovate UK (part of UK Research and Innovation), Gilead Sciences Ltd, and Janssen Pharmaceuticals, Inc. OLA declares personal fees from Gilead Sciences Ltd, GlaxoSmithKline (GSK) and Merck outside the submitted work. MC is Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, Director of the Centre for Patient-Reported Outcomes Research and is a National Institute for Health Research (NIHR) Senior Investigator. She receives funding from the NIHR Birmingham Biomedical Research Centre, the NIHR Surgical Reconstruction and Microbiology Research Centre and NIHR ARC West Midlands at the at the University of Birmingham and University Hospitals Birmingham NHS Foundation Trust, Health Data Research UK, Innovate UK (part of UK Research and Innovation), Macmillan Cancer Support, UCB and GSK Pharma. MC has received personal fees from Astellas, Aparito Mltd, CIS Oncology, Takeda, Merck, Daiichi Sankyo, Glaukos, GSK and the Patient-Centred Outcomes Research Institute (PCORI) outside the submitted work. AD is employed by University Hospitals Birmingham NHS Foundation Trust. He is also a Member of the Regulatory Horizons Council, Honorary Professor at University of Birmingham and Artificial Intelligence Theme Lead for the Birmingham Health Partners Centre for Regulatory Science and Innovation. His work undertaken on behalf of the Regulatory Horizons Council is funded by the Department for Business, Energy and Industrial Strategy. His research outside the submitted work is supported by grant funding from University Hospitals Birmingham NHSFT, NIHR HTA awards, the NIHR Biomedical Research Centre (Moorfields Eye Hospital NHSFT/University College London), Health Data Research UK, Medical Research Council and the Wellcome Trust. The views expressed in this article are those of the author(s) and not necessarily those of the NIHR, the Department of Health and Social Care or the Department of Business, Energy and Industrial Strategy. Other authors declare no competing interests.

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New specialist centre puts Wirral on the map for clinical research

New specialist centre puts Wirral on the map for clinical research

The launch of a new specialist research and innovation centre at Wirral University Teaching Hospital (WUTH)’s Clatterbridge site has put the trust firmly on the map as a growing centre of excellence for clinical research.

The Wirral Research and Innovation Centre will advance medical research at WUTH for the benefit of current and future patients, by embedding research into the care it provides.

Dr Nikki Stevenson and Chris Smith of NIHR standing in front of the Wirral Research and Innovation Centre

WUTH’s Executive Medical Director, Dr Nikki Stevenson, said: “Clinical research is what drives improvements in healthcare. It’s one of our priorities as a hospital to try to find answers to healthcare challenges. It is our pledge to the Wirral population to play our part in finding new treatments and helping to address health inequalities. The Wirral Research and Innovation Centre is a major stride forward in our commitment to research.”

This new development has been made possible with funding from the North-West Coast Clinical Research Network (NWC CRN), which is the delivery arm of The National Institute for Health and Care Research.

NWC CRN’s Chief Operating Officer, Dr Chris Smith, said: “The Wirral Research and Innovation Centre will improve access to research that is relevant to people's healthcare conditions, and also act as a catalyst for further collaboration across Wirral and the wider Cheshire and Merseyside system. WUTH has a proud history of participating in nationally important research, and the launch of the centre today is a further step in delivering its strategy to improve healthcare through cutting edge research and innovation.”

The new centre has been designed to make the experience of research participants smooth, pleasant and safe, and the patient’s journey through the centre has been thought through carefully to ensure they are looked after in the most efficient and effective way.

The purpose-built facilities will be an attractive offering for life sciences companies looking to place research studies. It also provides a further opportunity to undertake research in combination with GPs and Wirral Community Health and Care NHS Foundation Trust, thus expanding the volume and breadth of study types carried out by WUTH.

Patients who attend the new centre will be those taking part in outpatient studies. Free parking will be provided, and participants will enter through a dedicated main entrance, and exit from another part of the building. The research and administrative staff area is located in a separate part of the centre to avoid any disruption to patients.

Simon Rogers, Clinical Lead for Research at the Trust, said: “Research provides the evidence that health professionals need to make the right decisions. It improves the quality of care we can provide. I’d like to say thank you to all the staff in the Trust who give their time to support the research studies we carry out. We’re also grateful to all the patients who take part in our research studies and influence the progress of new medical treatments. Without them none of it would be possible.”

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  2. Francis Crick Institute, formerly the UK Centre for Medical Research

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  3. Francis Crick Institute, formerly the UK Centre for Medical Research

    uk centre for medical research and innovation

  4. Francis Crick Institute, formerly the UK Centre for Medical Research

    uk centre for medical research and innovation

  5. Francis Crick Institute, formerly the UK Centre for Medical Research

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COMMENTS

  1. Francis Crick Institute

    The Francis Crick Institute (formerly the UK Centre for Medical Research and Innovation) is a biomedical research centre in London, which was established in 2010 and opened in 2016. [1][2][3][4] The institute is a partnership between Cancer Research UK, Imperial College London, King's College London (KCL), the Medical Research Council ...

  2. Medical Research Council (MRC)

    You must be based at a UK research organisation eligible for UK Research and Innovation (UKRI) funding. ... Medical Research Council (MRC) Polaris House, North Star Avenue, Swindon, SN2 1FL. MRC content. ... Online and at Rothamsted Conference Centre, West Common, Harpenden, AL5 2JQ.

  3. Medical Research Council (United Kingdom)

    The Medical Research Council (MRC) is responsible for co-coordinating and funding medical research in the United Kingdom.It is part of United Kingdom Research and Innovation (UKRI), which came into operation 1 April 2018, and brings together the UK's seven research councils, Innovate UK and Research England. UK Research and Innovation is answerable to, although politically independent from ...

  4. The Francis Crick Institute

    Discover job opportunities at the Crick. Explore the marvellous and mysterious world in your head. Professor Edith Heard appointed new Director and Chief Executive of the Francis Crick Institute. Working to discover the biology of health and disease. We are a biomedical discovery institute researching the biology underlying human health.

  5. Who MRC is

    The heart of our mission is to improve human health through world-class medical research. To achieve this, we support research across the biomedical spectrum, from fundamental lab-based science to clinical trials, and in all major disease areas. We work closely with the NHS and the UK health departments to deliver our mission, and give a high priority to research that is likely to make a real ...

  6. About MRC

    The Medical Research Council (MRC) improves the health of people in the UK - and around the world - by supporting excellent science, and training scientists. ... About UK Research and Innovation; Our vision and strategy; How we're governed; Who we fund; How we're doing; Policies, standards and data; Work for us: jobs and advisory roles;

  7. MRC Impact Showcase

    Our mission at the Medical Research Council (MRC), part of UK Research and Innovation, is to improve human health through world-class medical research. To achieve this, we invest public money into some of the best medical research in the world across every area of health. Our work has led to some of medicine's biggest breakthroughs - from ...

  8. UK Research and Innovation

    Department for Science, Innovation and Technology. Staff. 7,463 (2019/20) Website. www.ukri.org. UK Research and Innovation (UKRI) is a non-departmental public body of the Government of the United Kingdom that directs research and innovation funding, funded through the science budget of the Department for Science, Innovation and Technology.

  9. NIHR awards £42m to new centres to develop innovative technology

    The NIHR has awarded almost £42 million (£41,790,690) to establish 14 new centres across England that will drive life-changing research into health technologies. From 1 April 2024, the 14 new NIHR HealthTech Research Centres (HRCs) will work with businesses to support the development of medical devices, diagnostics and digital technologies.

  10. Plans approved for UK Centre for Medical Research and Innovation

    The UK Centre for Medical Research and Innovation (UKCMRI), designed by the architects HOK with PLP Architecture, will have 1500 staff, including 1250 scientists. 17 December 2010 2-minute read. ... UKCMRI is founded by the Medical Research Council, Cancer Research UK, the Wellcome Trust and UCL (University College London). ...

  11. Centre for Cardiovascular Medicine and Devices

    The Centre for Cardiovascular Medicine and Devices has been created to bridge the gap between academics and clinicians in their endeavour to innovate in translational medicine. The Centre houses a productive transatlantic relationship with Yale University which focuses on research and innovation ...

  12. MRC Centres of Research Excellence

    Email: [email protected]. Last updated: 25 July 2023. The Medical Research Council (MRC) is changing the way we fund long-term research through units and centres, to adopt a new challenge-led, time-limited approach through MRC Centres of Research Excellence (CoRE). The first investments to be made under the new funding model will start in 2024.

  13. Opportunities and Risks of UK Medical Device Reform

    MC is Director of the Birmingham Health Partners Centre for Regulatory Science and Innovation, Director of the Centre for Patient-Reported Outcomes Research and is a National Institute for Health Research (NIHR) Senior Investigator. ... Health Data Research UK, Medical Research Council and the Wellcome Trust. The views expressed in this article ...

  14. Advancing UK regulatory science and innovation in healthcare

    Current context for regulatory science. Life sciences are vital to the UK's health but also its economic wealth. The industry supports around 482,000 jobs in the country and the activities of life sciences companies directly contributed £14.5bn to the national economy in 2015, with an additional £15.9bn provided through the life sciences supply chain and employee spending. 6 UK life ...

  15. Opportunities and Risks of UK Medical Device Reform

    6 Health Data Research UK, London, UK. 7 University Hospitals Birmingham NHS Foundation Trust, Birmingham, UK. 8 Regulatory Horizons Council, London, UK. 9 Birmingham Health Partners Centre for Regulatory Science and Innovation, University of Birmingham, Birmingham, UK. [email protected]. 10 Institute of Applied Health Research, College of ...

  16. Uk Centre for Medical Research and Innovation Limited

    People for UK CENTRE FOR MEDICAL RESEARCH AND INNOVATION LIMITED (03375849) More for UK CENTRE FOR MEDICAL RESEARCH AND INNOVATION LIMITED (03375849) Registered office address Angel Building, 407 St. John Street, London, EC1V 4AD . Company status Dissolved Dissolved on 12 June 2012. Company type ...

  17. Uk Centre for Medical Research and Innovation (Ukcmri)

    The Science and Technology Committee today agrees with, and commends, the scientific vision for the new UK Centre for Medical Research and Innovation, but expresses reservations about the project's location. It says the case for the centre's central London location near St Pancras station was not overwhelming and it could have been sited elsewhere.

  18. List of UK government scientific research institutes

    Pirbright Institute. Institute of Food Research. Institute of Grassland and Environmental Research. John Innes Centre. Earlham Institute. Roslin Institute. Rothamsted Research. Silsoe Research Institute (ceased operations in 2006 [1])

  19. New specialist centre puts Wirral on the map for clinical research

    The launch of a new specialist research and innovation centre at Wirral University Teaching Hospital (WUTH)'s Clatterbridge site has put the trust firmly on the map as a growing centre of excellence for clinical research. The Wirral Research and Innovation Centre will advance medical research at WUTH for the benefit of current and future ...

  20. MRC list of institutes, units and centres

    Units: MRC Biostatistics Unit (BSU), Cambridge. MRC Clinical Trials Unit (CTU), UCL. MRC Epidemiology Unit (EU), University of Cambridge. MRC Integrative Epidemiology Unit (IEU), University of Bristol. MRC Unit for Lifelong Health and Ageing, UCL. MRC Metabolic Diseases Unit (MDU), University of Cambridge.

  21. UK Centre for Medical Research and Innovation : Great Britain

    UK Centre for Medical Research and Innovation, Biomedical Research, Great Britain Publisher London : The Stationery Office Collection wellcomelibrary; ukmhl; medicalheritagelibrary; europeanlibraries Contributor Wellcome Library Language English Rights You have permission to make copies of this work under an Open Government license.

  22. US

    Exeter Innovation is a partner for transformative innovation. We harness the world leading research and education of the University of Exeter to create real and lasting impact, by working with organisations of all types and sizes on their innovation journey. ... Activities between the University of British Columbia and Exeter include a joint ...

  23. Contact MRC

    General enquiries. Email: [email protected]. Telephone: 01793 416200. MRC is not able to offer medical advice. You must contact NHS choices instead.

  24. UK CENTRE FOR MEDICAL RESEARCH AND INNOVATION

    UK Centre for Medical Research and Innovation Latest Breaking News, Pictures, Videos, and Special Reports from The Economic Times. UK Centre for Medical Research and Innovation Blogs, Comments and Archive News on Economictimes.com

  25. Oxford Entrepreneurship Policy Roundtable

    About the event Annual event bringing together senior policy makers, industry players and academics. The event was established in 2015 and is led by Professor Thomas Hellmann. The event takes a deep dive into one focal topic every year, with the aim of producing valuable insights that participants can take back into their professional activities. We discuss in a small circle of experts the ...

  26. UKRI

    We invest £8 billion of taxpayers' money each year into research and innovation and the people who make it happen. We work across a huge range of fields - from biodiversity conservation to quantum computing, and from space telescopes to innovative health care. We give everyone the opportunity to contribute and to benefit, bringing together ...