£6.2 million has been invested across seven Centres of Excellence for Regulatory Science and Innovation (CERSIs) to help drive advancements in healthcare.

Pioneering use of artificial intelligence (AI) could cut the time it takes to bring life-saving treatments to patients.

This represents just one example of innovation being championed by the UK’s seven new regulatory science powerhouses.

Innovate UK, in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA), Office for Life Sciences and the Medical Research Council (MRC), has announced seven CERSIs.

Advancing regulatory science

The projects will be led by academic institutions, independent innovators or regulatory leaders forming collaborative partnerships.

Projects will receive funding up to £1 million each, to lead the way in safer, faster pathways for innovative medicines and devices.

One project, led by Brunel University of London, aims to revolutionise regulation to bring more AI-powered healthcare products to the UK. These include:

• diagnostics, devices that predict and treat ill-health
• software that makes physical devices work
• smartphone apps

Exploring potential

Meanwhile the University of Liverpool will lead on a project which explores the potential of pharmacogenomics.

Pharmacogenomics is the study of how the variation of the human genome affects the efficacy and safety of medicines.

Its uptake in the NHS has been slowed by lack of clear guidelines, a challenge which this project seeks to address.

Patient benefit

This network of centres aims to improve healthcare by simplifying how treatments move from lab bench to patient bedside.

By helping researchers and businesses address regulatory challenges and opportunities, the centres will help accelerate the delivery of pioneering treatments, ensuring patients benefit from cutting-edge innovations.

For the delivery of CERSIs, Innovate UK created the Regulatory Science and Innovation Networks competition, inviting experts from academia, industry and charities to reimagine medical innovation pathways.

Two phases

Supported by MHRA alongside partners including MRC and the Office for Life Sciences, the programme is comprised of two phases.

Discovery

The first, the discovery phase, is now complete.

Seventeen networks received initial funding to explore bold ideas, build relationships and develop their proposals.

Implementation

Now, seven networks have been chosen to move into the implementation phase, where they will use their funding to establish their CERSIs and bring their proposals to life.

These seven CERSIs will tackle key challenges in regulatory science, in areas such as:

• advanced therapies
• precision medicines
• digital healthcare
• drug discovery
• diagnostics

Over the coming year, the CERSIs will develop tools, frameworks and guidance to help shape the development and approval of medical innovations in the UK.

Funded projects

The seven projects are:

• Digital Transformation of Medicines Development and Manufacturing, led by University of Strathclyde, to accelerate the adoption of digital tools in medicine development
• The UK Regulatory Innovation Network for Advanced Therapies, led by Cell and Gene Therapy Catapult, to streamline regulation of advanced therapy medicinal products
• Regulatory Science Empowering Innovation in Transformative Digital Health and AI, led by Brunel University of London, to safely maximise the potential of AI-powered healthcare solutions
• Centre of Excellence on In-silico Regulatory Science and Innovation, led by The University of Manchester, to integrate evidence from computational models into the regulatory process
• Clinical Evaluation and Assessment for Regulation of Diagnostic Tests, led by Psephos Ltd, to help create safe availability of diagnostic tests for patients
• Centre of Excellence for Regulatory Science and Innovation in AI and Digital Health Technologies, led by University of Birmingham, to optimise the regulation of AI and digital healthcare technologies to ensure innovations are safe and effective for patients
• Centre for Excellence in Regulatory Science and Innovation in Pharmacogenomics, led by University of Liverpool, to develop guidelines for using pharmacogenomics in practice and attract further investment in this area

Each CERSI will play a vital role in shaping the future of regulatory science in the UK, driving safer, faster and more innovative healthcare solutions.

Transforming our economy

Science Minister Lord Vallance said:

New technologies are transforming our economy at rapid pace.

Our system of regulation must keep up with that, so that we can quickly and safely seize the economic and social benefits that new innovations could unlock.

This is particularly true for life sciences, where innovative medical technologies, treatments, diagnoses and therapies are just around the corner.

That is why we are launching CERSIs.

They will make a valuable contribution to regulatory innovation – and will complement wider efforts to make the UK’s regulation fit for the future, such as that of our Regulatory Innovation Office.

Landmark healthcare innovation regulation

Ailsa Kennedy-Ballard, Deputy Director Innovation Programmes and Partnerships at Innovate UK said:

Innovate UK is pleased to announce these seven new CERSIs, which represent a landmark in healthcare innovation regulation.

Backed by up to £1 million each, they will drive safer pathways for groundbreaking medicines and devices, ensuring the UK remains at the forefront of global medical advancements.

By fostering collaboration between academia, business and regulators, these centres will pave the way for life-changing innovations to reach patients more swiftly and safely.

Commitment to public health

Dr June Raine, MHRA Chief Executive, said:

The establishment of CERSIs cements the UK’s role at the forefront of regulatory science, driving forward the innovations of tomorrow while upholding our unwavering commitment to public health.

This first-of-its-kind programme embeds innovation at the very heart of our regulatory processes.

By empowering UK academic institutions to shape the future of regulatory science, it ensures medical advancements reach patients more quickly and safely.

Through close collaboration with academic and industry leaders, we are building a regulatory system that doesn’t just keep pace with innovation but actively propels it forward.

World leading research

Dr Glenn Wells, Deputy Executive Chair at MRC said:

We are delighted to partner with Innovate UK and the MHRA to establish new CERSIs.

Regulation plays an essential role in improving the nation’s health, by supporting the MHRA to engage with our community we will help shape the regulatory landscape and leverage the MHRA’s world leading research to advance innovations in healthcare and regulatory science.