CERSI-AT Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies
The Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies (CERSI-AT) is funded by MHRA and its fellow funding partners – Innovate UK, the Office for Life Sciences, and the Medical Research Council (MRC) and is coordinated by Cell & Gene Therapy Catapult in collaboration with Birmingham Health Partners Centre for Regulatory Science and Innovation.
Leading the way for regulatory innovation in advanced therapies.
The UK Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies (CERSI-AT) aims to promote collaboration between regulatory bodies, industry, researchers, and other relevant stakeholders to ensure the UK has a world-leading regulatory environment that best supports ATMP innovation.
About the network
Our purpose
The complex and novel characteristics of Advanced Therapy Medicinal Products (ATMPs) present significant regulatory and reimbursement challenges; there is scope for streamlining and improving processes that address the particular challenges of ATMPs and to explore the potential for harmonisation across jurisdictions. Optimisation of regulatory and reimbursement processes can help strengthen the UK's attractiveness for companies seeking to innovate, conduct trials, and launch ATMPs in the UK, ultimately ensuring timely patient access to these life-changing therapies.
Who we are
The UK Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies (CERSI-AT), a newly established virtual network, will drive innovation and scientific research to enhance ATMP regulatory decision-making. Through comprehensive stakeholder mapping, mobilised working groups, and detailed delivery plans, the network will implement pilot projects, analyse data, and disseminate findings via industry meetings, regulatory briefings, and white papers. By fostering collaboration between UK regulatory bodies, industry, researchers, and other stakeholders, the network aims to streamline and improve ATMP regulatory processes, positioning the UK as a global leader in supporting ATMP innovation.
Network Delivery Partners
The Advisory Board consists of stakeholders representing industry, patients and regulators and will inform the strategic direction and outputs of the network. It convenes quarterly.
Network Partners
What we do
Activities
To effectively advance the UK's regulatory landscape for advanced therapies, a multi-faceted approach is essential. This includes actively collating industry challenges and feedback to inform regulatory agency decision-making, while simultaneously strengthening relationships with these agencies to provide dependable and long-term support. The formation of relevant consortia and strategic partnerships further bolsters collaborative efforts. Creating a safe clinical "sandbox" setting facilitates the testing and development of innovative policy. To ensure widespread impact, we will enable knowledge dissemination through training materials, workshops, exemplars, whitepapers and FAQs for educating stakeholders. Furthermore, supporting the identification and implementation of new UK regulatory standards, alongside reviewing and validating international standards through pilot projects, will ensure the UK remains at the forefront of advanced therapy regulation .
Priorities
Cluster 1 - Streamlined Regulatory Processes
Work with UK regulators on how to optimise current regulatory processes for ATMPs with the aim of timely adoption of safe and effective therapies.
Cluster 2 - Real World Evidence (RWE)
Create opportunities for the credible collection and use of RWE which is central to addressing ATMP data uncertainty at launch
Cluster 3 - Patient-Reported Outcomes (PROs)
Assess the potential use of PROs to evaluate ATMP's impact on disease symptoms, adverse events, physical function and patient's quality of life
Cluster 4 - Clinical Development Acceleration and Optimisations
Help optimise the UK clinical development landscape and processes and enhance innovation and patient access to novel treatments with clear benefits
Cluster 5 - Patient Engagement and Involvement (PPIE)
Identify and communicate areas of regulatory processes that would benefit from optimisation of how patientvoice is accounted for
Cluster 6 - Reference Standards
Work with MHRA's Soth Mimms science campus to develop standards to support analytical development and validation for ATMPs
