Seven CERSI centres launched to speed regulatory innovation in UK medicine

Launched in partnership with the Medicines and Healthcare products Regulatory Agency (MHRA), Office for Life Sciences, and the Medical Research Council, the centres will each receive up to £1 million in support and be headed by academic institutions, independent innovators and regulatory leaders.  

The new bodies will tackle regulatory science challenges in fields including advanced therapies, precision medicines, digital healthcare, drug discovery and diagnostics, as well as leading in the development and approval of medical innovations in the UK. 

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.”

The seven projects include: 

• 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, to safely maximise the potential of AI-powered healthcare solutions.

• Centre of Excellence on In-silico Regulatory Science and Innovation, led by University of Manchester, to integrate evidence from computational models into the regulatory process.

• Clinical Evaluation & 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 & Digital Health Technologies (CERSI-AI), 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.

CERSIs... will make a valuable contribution to regulatory innovation – and will complement wider efforts to make the UK’s regulation fit for the future

Lord Vallance, science minister

Development of the CERSI system began with Innovate UK’s launch of the Regulatory Science and Innovation Networks (RSINs)?two-phase competition, inviting experts from academia, industry, and charities to “reimagine medical innovation pathways”.  

The first Discovery Phase resulted recently in the award of initial funding to allow 17 networks to develop proposals, from which the final seven were chosen for the second, Implementation Phase. 

MHRA chief executive Dr June Raine commented:  

“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.”?

Pic: Ivan Samkov