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Developing regulatory science to advance healthcare

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 new Centres of Excellence for Regulatory Science and Innovation (CERSIs) to help drive advancements in healthcare.

The projects will be funded by an investment of £6.2 million and 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.

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

The first, the discovery phase, is now complete and saw 17 networks receiving initial funding to explore ideas, build relationships and develop their proposals.

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 and 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.

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.

 

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