Pre-Conference Workshop Day - January 23, 2023
9:00 am Workshop A
9:05 am Getting the Most Out of Your Regulatory Interactions Sharing Best Practice & Ideal Ways of Working
Join us for an interactive workshop where where leading regulatory experts come together to explore the art of optimizing regulatory interactions in the rapidly evolving field of gene therapy.
This session aims to provide attendees with valuable insights, best practices, and practical strategies to foster effective and successful interactions with regulatory agencies.
- Clarifying best practice for early interactions with regulatory bodies, exploring timelines
- Learn how to prepare effectively for various types of regulatory interactions, such as pre-IND meetings, end-of-Phase 2 meetings, and pre-BLA meetings
- Differentiating how type C and type D meetings can be used and the nature of topics that we should provide feedback on
- Navigating regulatory hurdles and gain insights into common regulatory hurdles faced by gene therapy developers and strategies to overcome them
- Discuss real-world case studies and share experiences of successfully addressing challenges during regulatory interactions
12:00 pm Lunch & Networking
1:00 pm Workshop B
1:05 pm How Can We Move Towards Harmonization Between Regulatory Bodies to Streamline Global Approval?
- Scott Burger Principal, Advanced Cell & Gene Therapy
- Jim Wang Vice President, Regulatory Affairs, Genetic Medicines, Regeneron Pharmaceuticals Inc
Global approval for a gene therapy is something very few drug candidates have achieved, and with many diseases remaining untreated, widening patient access is crucially important. A concerted effort of international collaboration from stakeholders across regulatory authorities and industry is needed to align on safety, efficacy and quality regulations. Regulatory convergence on policies and further clarification of differences in requirements will allow industry to prepare their trial strategy to meet the standards of multiple regions. Thus, harmonization looks to streamline efforts for efficiency, equity and consistency of access while reducing compliance burden for industry. So how can we achieve this?
Come together to be a part of the discussion on:
- Exploring the similarities and differences in regulatory approach
- Understanding which countries require further testing to design your trial early for global trial success
- Identify the bottlenecks to establishing consistency in enrolment rate and approval timelines
- Strategizing on how to facilitate discussions between different regulatory bodies and industry to streamline regulatory strategy that meets the requirements of various regulatory authorities
- Harnessing consortia and collaboration to define best practice across product development, trials, manufacturing and quality control
- Closing the gap between FDA and EMA approvals
- Exploring international regulatory partnerships as a strategy to streamline approvals