Discover CERSI-AT Year 1 achievements and insights from ATMP regulatory science clusters, workshops and stakeholder collaboration.
Registration for this event is by invitation. Please register your interest in being invited to this event by joining the waitlist. Please note, expressing interest may not guarantee an invitation to attend. Tickets will be released to those who are successful in securing a spot.
The Centre of Regulatory Science and Innovation for Advanced Therapies (CERSI-AT) is a UK-wide collaborative network led by the Cell and Gene Therapy Catapult in partnership with the University of Birmingham, supported by Innovate UK. It drives collaborative activities between regulators, industry, academia and other stakeholders to enhance regulatory decision-making and patient access pathways:
- To ensure the UK has a world-leading regulatory environment that best supports the development and adoption of safe and effective ATMPs
- To help optimize the interface of regulatory processes with wider therapy adoption processes”
Over its first year, CERSI-AT established and delivered dedicated activity clusters focused on priority regulatory challenges.
- Streamlined Regulatory Processes: Collaborative engagement with UK regulators to identify opportunities to optimise existing regulatory pathways for ATMPs and support timely adoption of safe and effective therapies.
- Real-World Evidence (RWE): Identification of credible approaches for collecting and utilising real-world data to address evidence gaps and reduce uncertainty at launch.
- Patient-Reported Outcomes (PROs): Help optimise use of PROs to evaluate ATMP's impact
- Clinical Development Acceleration and Optimisation: Identify approaches to accelerating path to FIH, without compromising patient outcomes
- Patient Engagement and Involvement (PPIE): Consideration of how patient voice can be most effectively embedded in regulatory processes for ATMPs.
- Reference Standards: Collaboration with MHRA on reference materials and tools to support analytical development and validation for ATMPs.
The event will provide a comprehensive summary of Year 1 achievements across these clusters and communicate key outputs from workshops and stakeholder engagements, as well as emerging opportunities for regulatory science collaboration within the advanced therapies ecosystem.
Who should attend?
Individuals with an interest in regulatory science and innovation and its interface with the wider therapy adoption processes within the advanced therapies ecosystem.