A new £20m programme to create four new Centres of Excellence for
Regulatory Science and Innovation (CERSIs), with each funded for
up to five years, is set to strengthen the UK's capability and
agility in regulatory science and help ensure regulation keeps
pace with rapid advances in healthcare and life sciences.
Developed through a partnership between the Medicines and
Healthcare products Regulatory Agency (MHRA), the Medical
Research Council (MRC) and the Office for Life Sciences (OLS),
the funding opportunity, launched today (22 September), is
inviting applications to establish the four centres.
The CERSIs will bring together world-leading expertise from
across academia, industry, healthcare and regulation to develop
practical solutions to emerging regulatory challenges and help
ensure new innovations can be safely adopted in
practice.
Following extensive engagement across the sector, four strategic
areas have been identified where regulatory science capability is
required to support the next generation of healthcare
innovation:
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Data driven approaches and artificial
intelligence
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Prevention, early detection and novel evidence
approaches
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Personalised healthcare and
pharmacogenomics
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Novel platform technologies
As healthcare innovation continues to advance, regulatory science
plays an increasingly important role so that new technologies can
be evaluated, regulated and translated into patient
benefit.
Through the new programme, CERSIs will help develop the evidence,
expertise and methods needed to support regulatory preparedness
for emerging technologies and address complex challenges across
the health and life sciences system.
MHRA Chief Medical and Scientific Officer, Professor
Jacob George, said:
The biggest challenges facing healthcare innovation can't be
solved by any one organisation alone.
These centres of excellence in regulatory science will bring
together the right expertise from across the system to help us
address emerging challenges in regulation, keep pace with
advances in science and technology, and ultimately help patients
benefit from new innovations more quickly and safely.
The programme also supports the UK's wider life sciences
ambitions by helping to strengthen the expertise and partnerships
needed to maintain the UK's position as a leading destination for
scientific research, innovation and investment.
MRC Executive Chair, Professor Patrick Chinnery,
said:
Advances in areas such as artificial intelligence, personalised
healthcare and novel technologies are creating exciting
opportunities to improve people's lives.
Through this partnership with the MHRA and Office for Life
Sciences, we are inviting applications that bring together
researchers, regulators and innovators to help ensure regulation
keeps pace with innovation to deliver benefits for patients,
strengthen the health system and support the UK's world-leading
life sciences sector.
OLS Executive Chair, Steve Bates, said:
The UK has a world-class life sciences sector, so we need
regulation to keep up with rapid advances in science and
technology. The Office for Life Sciences' new co-investment in
the next phase of CERSIs will bring together expertise from
across academia, healthcare, industry and regulation to address
emerging challenges and support the safe adoption of innovative
technologies.
By strengthening the UK's regulatory science capability, the
CERSIs will help bring transformative technologies to patients
sooner and support the UK's continued leadership in innovative
life sciences research, development and investment.
The new programme follows the pilot phase, which has helped build
regulatory science capability across a range of emerging and
established areas. The pilot is now nearing its end, with the
experience and learning from the seven centres informing the
development of the next phase.
The MRC and OLS are co-funding the four new CERSIs, supporting
the development of stronger and more sustainable centres of
expertise capable of delivering lasting value across the health
and life sciences system.
The programme combines the MRC's expertise in funding and
supporting world-leading research with the MHRA's regulatory
science expertise, creating a leading-edge partnership to address
emerging challenges in healthcare innovation.
Further information on the funding opportunity eligibility
criteria, research themes, assessment criteria and funding
arrangements are available on the UK Research
and Innovation (UKRI) website. An applicant webinar will also
be held on Tuesday 13 October from 10am to 11am, hosted by the
MRC with participation from the MHRA.
Researchers, academic organisations, healthcare organisations,
industry and innovators with an interest in regulatory science
are encouraged to engage with the funding opportunity and
consider applying.
Notes to editors:
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The CERSI pilot established seven centres working across
areas including AI, digital health, in-vitro diagnostics,
advanced therapies, chemistry, manufacturing and controls,
and pharmacogenomics.
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The new programme will build on the pilot and focus on
strengthening UK capability in regulatory science and
addressing emerging challenges across health and life
sciences.
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Further information on the new funding opportunity, including
the application guidance, will be available through
the UKRI
website.
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