New funding initiative expands regulatory science

In a significant move to bolster the UK’s regulatory science capabilities, a new £20 million programme has been unveiled, aimed at establishing four Centres of Excellence for Regulatory Science and Innovation (CERSIs). Each centre will receive funding for a maximum of five years and is designed to adapt to the rapid advancements in healthcare and life sciences. The initiative, which was announced on 22 September, is a collaborative effort between the Medicines and Healthcare products Regulatory Agency (MHRA), the Medical Research Council (MRC), and the Office for Life Sciences (OLS). Applications are now being sought to set up these centres, which will unite leading experts from academia, industry, healthcare, and regulation to devise practical solutions to emerging regulatory issues and ensure that new innovations can be effectively and safely integrated into practice.

The strategic focus of the CERSIs will span four critical areas identified through extensive sector engagement: data-driven approaches and artificial intelligence, prevention and early detection, personalised healthcare and pharmacogenomics, and novel platform technologies. The increasing pace of healthcare innovation makes regulatory science essential for the evaluation and regulation of new technologies, allowing them to translate into tangible benefits for patients. As noted by MHRA Chief Medical and Scientific Officer, Professor Jacob George, "The biggest challenges facing healthcare innovation can’t be solved by any one organisation alone." He emphasised that these centres will harness collective expertise to tackle regulatory challenges and expedite patient access to new technologies.

MRC Executive Chair, Professor Patrick Chinnery, elaborated on the potential benefits of the initiative, stating that "Advances in areas such as artificial intelligence, personalised healthcare and novel technologies are creating exciting opportunities to improve people’s lives." He encouraged collaborations among researchers, regulators, and innovators to ensure that regulation keeps pace with innovation, thereby strengthening the health system and enhancing the UK’s life sciences sector.

OLS Executive Chair, Steve Bates, highlighted the urgency of this initiative by stating, "The UK has a world-class life sciences sector, so we need regulation to keep up with rapid advances in science and technology." The co-investment in this next phase of CERSIs is designed to facilitate synergy across the varied fields of expertise, promoting the safe adoption of innovative technologies.

The establishment of the new programme builds upon a successful pilot phase that has already contributed to regulatory science capabilities. The lessons gleaned from the initial seven centres are expected to inform the next phase of development. The partnership between the MRC and OLS aims to create enduring centres of expertise that can deliver lasting benefits across the healthcare and life sciences landscape.

Researchers, academic institutions, healthcare organisations, and industry innovators interested in regulatory science are urged to engage with this funding opportunity. Further details regarding eligibility and application processes are available on the UK Research and Innovation (UKRI) website, with an applicant webinar scheduled for 13 October.