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Innovate UK, in partnership with the MHRA, Office for Life Sciences and the Medical Research Council (MRC), has announced £6.2 million in funding for seven CERSIs (Centres of Excellence for Regulatory Science and Innovation).

Each of the seven CERSIs will receive up to £1 million each. The funding will help to develop advancements in healthcare, including the use of AI, to provide faster pathways to innovative medicines and diagnostics for patients.

Seventeen networks were initially funded to explore ideas and develop proposals. Now seven have been chosen, they will begin implementing their ideas.

They 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.

Excitingly, one of the projects chosen includes CLEARED (Clinical Evaluation and Assessment for Regulation of Diagnostic Tests), led by Psephos Ltd and co-developed with BIVDA’s Head of Regulatory Strategy, Professor Mike Messenger.

Their project is a pioneering initiative to drive innovation in regulatory science for in vitro diagnostics, with an initial focus on regulatory documentation (including standards) and post-market surveillance and follow-up.

Ben Kemp