The second city’s University-NHS partnership Birmingham Health Partners (BHP) has expanded its membership by welcoming Sandwell and West Birmingham Hospitals NHS Trust (SWBH) on board, joining the University of Birmingham, University Hospitals Birmingham NHS Foundation Trust (UHB), Birmingham Women’s and Children’s Hospitals NHS Foundation Trust (BWC), and West Midlands Academic Health Sciences Network (WMAHSN).

SWBH’s inclusion extends BHP’s research and education capabilities, and builds on many years of successful collaboration between the Trust and BHP members, working on studies and trials in specialties as diverse as cancer immunotherapy, rheumatology and heart disease. The Trust provides acute hospitals and community healthcare services to a population of around 500,000 people across Sandwell, City and Rowley Regis Hospitals, as well as operates the Birmingham and Midland Eye Centre, the regional Sickle Cell and Thalassaemia Centre, and is the regional base for the National Poisons Information Service. It is also currently developing the Midland Metropolitan University Hospital, which will provide acute care services when it opens.

The news also follows publication of a joint report from BHP, Association of the British Pharmaceutical Industry (ABPI) and the Confederation of British Industry (CBI) which showcased the huge potential of the West Midlands’ life science ecosystem and recommended a joined-up approach to regional leadership and collaboration, in order to tackle the specific health burdens of the West Midlands and beyond.

BHP Director Professor David Adams, who is Head of the University of Birmingham’s College of Medical and Dental Sciences, explained: “Our city and region is home to a concentration of multidisciplinary health and life sciences excellence, and has the potential to strengthen the UK’s position as a world leader in the sector. This can only happen if we work inclusively and collaboratively across the Midlands. With a strong track record of research partnership between BHP’s founder-members and SWBH already in place, it is a natural next step to bring the Trust on board as a full member – demonstrating BHP’s regional leadership, commitment to delivering on our recommendations, and dedication to improving the health of our diverse population.”

Professor David Carruthers, Medical Director of SWBH, commented: “We are delighted to be part of BHP and contribute to the development of research in the West Midlands. This will build on the strong track record that SWBH has in delivering research that involves and is relevant to our patients. This partnership will reinforce our commitment to the development of our staff as well as improving the health of our local population through high quality research opportunities.”

BHP is committed to achieving health and economic impact through harnessing the combined strength and expertise of its members.

The University of Birmingham has announced the appointment of an experienced academic and industrial pharmaceutical professional to the position of Managing Director of its new Precision Health Technologies Accelerator (PHTA).

Professor Luigi ‘Gino’ Martini joins PHTA Ltd – a wholly-owned subsidiary of the University that will operate the new facility – from the Royal Pharmaceutical Society (RPS) where he has held the role of Chief Scientist for more than three years. With extensive experience in oncology, rare and infectious diseases, and drug development, Gino also brings expertise in policy development and external advocacy to his new appointment in Birmingham.

Gino’s career began with Senior Scientist roles at Scherer Drug Delivery Systems and SmithKline Beecham, before joining GSK – initially as Drug Delivery and Strategic Technologies Manager – rising to Senior Directorships across a 10-year stint.

An experienced academic, Gino was formerly Professor of Pharmaceutical Innovation at King’s College London, as well as undertaking visiting professorships and PhD supervision alongside his industry roles. Prior to his appointment at the RPS, he held senior development and advisory positions with Shire Pharmaceuticals and Roche.

PHTA will be dedicated to the rapid development and translation of innovative therapies and technologies from concept to clinical evaluation. By creating new opportunities for businesses and entrepreneurs to grow and commercialise their ideas, it will enable advanced drugs, diagnostics and devices to reach patients more quickly. This signature facility will be the focal point of the forthcoming Birmingham Health Innovation Campus (BHIC) development, providing up to 6,000sqm of innovation, co-creation and incubation space within BHIC’s Phase 1 building.

Commenting on his appointment, Gino explained: “I see the PHTA as a place where innovators in health and life sciences will have global impact. I am a great believer in catalysing innovation through creating hubs where like-minded individuals can converge, connect and – in its simplest terms – ‘try things out’.

“COVID-19 has shown us that hybrid and multidisciplinary models of working really do work and this is my vision for the PHTA – an ecosystem which benefits from co-location of experts and budding entrepreneurs which also crosses boundaries and taps into skillsets and best practice of other UK regions. It’s an incredibly exciting time to be joining the project and forging these connections.”

Professor Tim Jones, University of Birmingham Provost and Vice-Principal, commented: “Through Birmingham Health Partners we have an established track record in collaborating with industry partners at start-up, scale-up, and global levels. The Precision Health Technologies Accelerator is the next stage in the journey towards cementing our position as a leader in the translation of research and innovation in health and life sciences.

“Gino’s leadership will be pivotal in achieving this aim, drawing on his considerable experience in both the pharmaceutical industry and in research-intensive academic environments. We are delighted to welcome him to Birmingham.”

Set to open in late 2023, BHIC is ambitious 10-acre, £210m development delivered through a long-term collaboration between the University of Birmingham, as landowner, and experienced investor-developers Bruntwood SciTech. It will be the only science park in the region dedicated to health and life sciences, offering premium laboratory, office and incubation facilities to companies specialising in medtech, precision medicine and digital healthcare.

As one of only six national Life Sciences Opportunity Zones, BHIC is attracting significant new inward investment to the region. This includes significant investment of up to £14m from the Greater Birmingham and Solihull Local Enterprise Partnership (GBSLEP) which will support the design and fit-out of the state-of-the-art PHTA facilities.

Experts within Birmingham Health Partners (BHP) have significantly contributed to a new independent report calling on the UK Government to reform the regulation of medical devices.

Lessons learned from issues around the regulation of diagnostic tests for COVID-19 which led to many substandard tests on the market, and opportunities for the UK to update the way it regulates medical devices now that it has left the EU, form part of the insights outlined in four reports by leading scientists from BHP.

BHP is a strategic alliance between the University of Birmingham, the West Midlands Academic Health Science Network, Birmingham Women’s & Children’s NHS Foundation Trust, and University Hospitals Birmingham NHS Foundation Trust, with members collaborating to bring healthcare innovations through to clinical application.

BHP’s Centre for Regulatory Science and Innovation was commissioned by the Regulatory Horizons Council (RHC), to produce four reports which have formed part of RHC’s ‘Report on Medical Devices Regulation’ calling for action from the government for regulatory reform of medical devices.  RHC is an independent expert committee that identifies the implications of technological innovation, and provides government with impartial, expert advice on the regulatory reform required to support its rapid and safe introduction.

The BHP reports were based on a combination of literature reviews, semi-structured interviews, a multidisciplinary stakeholder workshop and a post-workshop survey.  Stakeholders involved included leading experts from a range of policy and industry organisations such as the National Institute for Health and Care Excellence (NICE), Innovate UK, the Association of British HealthTech Industries (ABHI) and the British In Vitro Diagnostic Association (BIVDA), as well as patient and public contributors.

The reports produced by the BHP team focused on four critical areas defined through cross-stakeholder consultation undertaken by the RHC:

• • • Report 1 – details a study examining lessons learned from COVID-19 in relation to regulations of in vitro diagnostics (IVDs – medical devices intended for use in diagnosis of disease or other conditions), and sets out the regulatory challenges such as the development of substandard diagnostic COVID-19 tests and lack of availability of reliable information during the pandemic. The report also sets out a series of recommendations on how the government could increase efficiency in test development and distribution in the event of a future infectious disease outbreak.
    • Report 2 – details a study consulting on the mitigations for the move to the United Kingdom Conformity Assessed mark from July 2023, as a result of the end to the use of the EU CE mark for medical devices. The cost and complexity of complying with the new UK regulation to medical device companies means companies may prioritise non-UK markets, potentially reducing availability and choice of medical devices for UK healthcare.
    • Report 3 – details a study looking at alternative routes to market for medical devices, probing the UK’s unique opportunity post-Brexit to update the way it regulates medical devices to promote patient outcomes, stimulate innovation, and ensure that the UK remains at the forefront of the global life sciences sector.
    • Report 4 – summarises ideas and evidence around the opportunities and risks for future UK regulatory reform of medical devices in four key areas: patient and public access to high quality medical devices; international investment and innovation; patient and user safety; and global standing in regulation of the life sciences sector.

Reports author Xiao Liu, a leading post-doctoral researcher at the University of Birmingham and an ophthalmologist at University Hospitals Birmingham NHS Foundation Trust, said: “With the UK’s exit from the EU, Europe’s transition of its regulatory framework, and the global urgency of the COVID-19 pandemic, now more than ever we need to identify how we can reform regulation so the UK can encourage international investment, innovation and improve safety of medical devices.”

Reports author Melanie Calvert, Professor of Outcomes Methodology and NIHR Senior Investigator at the University of Birmingham, and Director of the Birmingham Health Partners’ Centre for Regulatory Science and Innovation, added: “Among our findings is a clear need to build a patient-centred regulatory system that accelerates innovation, captures outcomes that matter to patients, protects patient safety and has increased patient engagement in medical device development and regulation.  We are proud to have made such a significant contribution to RHC’s report and we hope it will lead to wide-ranging reform of the regulation of medical devices.”

In the foreword of RHC’s report, Sir Bruce Keogh, Chair of Birmingham Women’s and Children’s NHS Foundation Trust which is part of BHP, says: “This report from the Regulatory Horizons Council is a timely call for action.  Importantly this report is firmly patient-centred: accelerating innovation, assuring safety, and increasing engagement of patients with the process of development and regulation.  The opportunities are enticing. Effective implementation of the recommendations will bring tangible economic benefits and enable our patients to benefit from the very best of UK and global innovations more rapidly than at present.”

Recommendations within RHC’s report are centred on:

• • • Building a regulatory system for medical devices that works for patients
    • Increasing capacity to address present needs and emerging opportunities
    • International leadership and partnership in medical devices
    • Using medical devices as a template to help enable regulatory innovation that improves patient safety, system efficiency and UK growth
    • Building resilience and preparing for future threats

A spokesperson for the Regulatory Horizons Council (RHC) said: “We are very grateful to Birmingham Health Partners for the stakeholder engagement and four reports they produced, which provided a useful evidence base for our recommendations.”

ENDS

1. 1. 1. Lessons learned from COVID-19 in relation to IVD regulations – https://www.birminghamhealthpartners.co.uk/wp-content/uploads/2021/08/Lessons-learned-from-COVID-19-in-relation-to-IVD-regulations.pdf
      2. Mitigations for the move to the UKCA mark from 01 July 2023 – https://www.birminghamhealthpartners.co.uk/wp-content/uploads/2021/08/Mitigations-for-the-move-to-the-UKCA-mark-from-01-July-2023.pdf
      3. Alternative routes to market for medical devices – https://www.birminghamhealthpartners.co.uk/wp-content/uploads/2021/08/Alternative-Routes-to-Market-for-Medical-Devices.pdf
      4. Opportunity and risks around future UK regulatory reform of medical devices – https://www.birminghamhealthpartners.co.uk/wp-content/uploads/2021/08/Opportunities-and-risks-around-future-UK-regulatory-reform-of-medical-devices.pdf

The second city’s University-NHS partnership Birmingham Health Partners (BHP) has made three high-profile appointments to its leadership board – announcing Professor Sir Robert Lechler and Dame Yve Buckland as Non-Executive Directors and former Chairman of NHS Improvement and Deputy Chairman of NHS England, Ed Smith, as independent Chair.

BHP is a strategic alliance which aims to rapidly translate healthcare research findings into new diagnostics, drugs and devices for patients. Its members are: University Hospitals Birmingham, England’s largest acute NHS Trust; Birmingham Women’s and Children’s Hospitals – the first NHS Foundation Trust of its kind; the University of Birmingham; and the West Midlands Academic Health Science Network.

Having recently stepped down from his roles as Senior Vice-President (Health) at King’s College London and Executive Director of King’s Health Partners Academic Health Sciences Centre, Professor Sir Robert Lechler brings a wealth of health research experience to the role of Non-Executive Director of BHP. A strong advocate of university-NHS partnership, Sir Robert was awarded a knighthood for Services to Academic Medicine in 2012 following a research career focused on clinical transplantation tolerance. His work has led to pioneering cell therapies to aid the immune tolerance of kidney and liver transplant recipients.

Commenting on his appointment to the BHP board, Professor Sir Robert commented: “The organisations which make up BHP could not be closer – either in their physical locations or their ethos. The ecosystem has been designated a Life Sciences Opportunity Zone by Government, and will soon begin work on the latest addition – the Birmingham Health Innovation Campus. BHP and its wider regional partners are already working to address pressing health challenges and deliver economic growth, and the refreshed board are ready to mobilise further advancements.”

Also joining BHP as Non-Executive Director is the outgoing chair of Birmingham’s Royal Orthopaedic Hospital NHS Foundation Trust, Dame Yve Buckland. Her appointment to BHP coincides with her new role as Chair of Birmingham and Solihull integrated care system (ICS), which will forge closer links between primary, secondary and mental health care providers. She was appointed Dame Commander for services to public health in 2003 and has held the chair of the Health Education Authority, Health Development Agency, and the NHS Institute for Innovation and Improvement. Dame Yve explained: “The West Midlands has a large, diverse and stable population with many incredible health and education institutions, and both BHP and the new ICS enable integration of these organisations to benefit our citizens. In the wake of COVID-19, we have a valuable opportunity to rethink care pathways and streamline research delivery to ensure innovations reach patients more quickly. It’s a privilege to be part of both teams at such a crucial point in time.”

Ed Smith served as Pro Chancellor at the University of Birmingham for 10 years as well as leading roles with the NHS and holding the chair of a number of healthcare organisations and committees. He is passionate about delivering positive change for patients who rely on the NHS, having overseen the establishment of NHS Improvement and supporting the performance of a number of Trusts. He commented: “Excellence and innovation in the NHS is driven by research – from basic science in University laboratories to clinical trials in our hospitals. Birmingham Health Partners is a powerhouse of research at the heart of an ambitious city and region, with a strong track record of scaling innovation from the bench to the bedside at pace.

“COVID-19 has emphasised the critical importance of collaboration between NHS, academia and industry and, in these unprecedented times, the strength of the existing BHP alliance enabled us to adapt, collaborate and tackle the pandemic head-on. It is an incredibly challenging yet exciting time to join the partnership and direct its research strategy.”

BHP is committed to achieving health and economic impact through harnessing the combined strength and expertise of its members.

New study published in Therapeutic Innovation & Regulatory Science today (17th February 2021) from the Birmingham Health Partners Centre for Regulatory Science and Innovation

Background

The UK’s transition from the European Union creates both an urgent need and key opportunity for the UK and its global collaborators to consider new approaches to the regulation of emerging technologies, underpinned by regulatory science. This survey aimed to identify the most accurate definition of regulatory science, to define strategic areas of the regulation of healthcare innovation which can be informed through regulatory science and to explore the training and infrastructure needed to advance UK and international regulatory science.

Methods

A survey was distributed to UK healthcare professionals, academics, patients, health technology assessment agencies, ethicists and trade associations, as well as international regulators, pharmaceutical companies and small or medium enterprises which have expertise in regulatory science and in developing or applying regulation in healthcare. Subsequently, a descriptive quantitative analyses of survey results and directed thematic analysis of free-text comments were applied.

Results

Priority areas for UK regulatory science identified by 145 participants included the following: flexibility: the capability of regulations to adapt to novel products and target patient outcomes; co-development: collaboration across sectors, e.g. patients, manufacturers, regulators, and educators working together to develop appropriate training for novel product deployment; responsiveness: the preparation of frameworks which enable timely innovation required by emerging events; speed: the rate at which new products can reach the market; reimbursement: developing effective tools to track and evaluate outcomes for “pay for performance” products; and education and professional development.

Conclusions

The UK has a time-critical opportunity to establish its national and international strategy for regulatory science leadership by harnessing broader academic input, developing strategic cross-sector collaborations, incorporating patients’ experiences and perspectives, and investing in a skilled workforce.

Read the full study on the publication website (opens as PDF).