<?xml version="1.0" encoding="UTF-8"?><ns2:project xmlns:ns1="http://gtr.rcuk.ac.uk/gtr/api" xmlns:ns2="http://gtr.rcuk.ac.uk/gtr/api/project" xmlns:ns3="http://gtr.rcuk.ac.uk/gtr/api/fund" xmlns:ns4="http://gtr.rcuk.ac.uk/gtr/api/person" xmlns:ns5="http://gtr.rcuk.ac.uk/gtr/api/project/outcome" xmlns:ns6="http://gtr.rcuk.ac.uk/gtr/api/organisation" ns1:created="2026-06-22T07:57:45Z" ns1:href="http://gtr.ukri.org/gtr/api/projects/45561DC6-557B-46C9-AE70-990F5577151A" ns1:id="45561DC6-557B-46C9-AE70-990F5577151A"><ns1:links><ns1:link ns1:href="http://gtr.ukri.org/gtr/api/persons/69395428-0803-4CF1-BCA7-AFF5AC8BC21B" ns1:rel="PM_PER"/><ns1:link ns1:href="http://gtr.ukri.org/gtr/api/organisations/B0D7E9B8-D50A-4D3A-9569-C0F65624E298" ns1:rel="LEAD_ORG"/><ns1:link ns1:href="http://gtr.ukri.org/gtr/api/organisations/47AC5C0C-6553-4E0E-B591-65899B6059E4" ns1:rel="PARTICIPANT_ORG"/><ns1:link ns1:href="http://gtr.ukri.org/gtr/api/organisations/B0D7E9B8-D50A-4D3A-9569-C0F65624E298" ns1:rel="PARTICIPANT_ORG"/><ns1:link ns1:end="2024-08-30T23:00:00Z" ns1:href="http://gtr.ukri.org/gtr/api/funds/FA770B6C-DDF0-44F5-A771-165C17F2D20E" ns1:rel="FUND" ns1:start="2024-03-01T00:00:00Z"/></ns1:links><ns2:identifiers><ns2:identifier ns2:type="RCUK">10111827</ns2:identifier></ns2:identifiers><ns2:title>The UK Regulatory Innovation Network for Advanced Therapies</ns2:title><ns2:status>Closed</ns2:status><ns2:grantCategory>Collaborative R&amp;D</ns2:grantCategory><ns2:leadFunder>Innovate UK</ns2:leadFunder><ns2:abstractText>Advanced Therapy Medicinal Products (ATMP) are innovative therapies with potential to cure, rather than ameliorate, diseases addressing significant unmet needs. The ATMP field is rapidly evolving and growing, with a strong global preclinical and clinical pipeline that's broadening from rare to higher prevalence indications and a wave of approvals anticipated in the next 10 years. This anticipated growth is expected to address significant global healthcare gaps. However, the unique and innovative nature of ATMPs results in challenges in regulating within traditional regulatory frameworks, with regulatory guidance still being defined and lacking global harmonisation. Advances in UK regulatory infrastructure is therefore critical to ensure that the UK remains attractive to companies to innovate, run trials and launch products and hence ensuring patients access to these transformative therapies.

This Discovery phase project will aim to develop a proposal for the UK Regulatory Innovation Network for Advanced Therapies (RINAT) for ATMPs, a virtual network coordinated by Cell and Gene Therapy Catapult, that will promote innovation and scientific research in areas for informing ATMP regulatory decision-making. The project will foster collaboration between regulatory bodies, health technology assessment bodies, industry stakeholders, researchers, and other relevant stakeholders to identify key ATMP regulatory barriers. This will be used to define RINAT's proposal for a network that will promote key stakeholder collaboration to streamline and enhance the ATMP regulatory processes and deliver more integrated approaches which optimise the generation of the evidence needed for successful ATMP adoption by the NHS. The ultimate goal of which will be to ensure that the UK has a world-leading regulatory environment that best supports ATMP innovation.</ns2:abstractText></ns2:project>