Enabling Pragmatic Analytical Strategies to Support Gene Therapy Approvals in Today’s Regulatory Environment
1:00 pm - Tuesday 1st December 2026
As gene therapy programs advance toward pivotal development and approval, analytical leaders must balance scientific rigor with practical development realities. This workshop will explore how to build fit-for-purpose analytical packages, establish meaningful potency strategies, and generate the evidence needed to support regulatory decision-making while minimizing unnecessary complexity.
This session provides a platform to delve into:
- Identifying the critical assays needed to characterize product quality, support regulatory submissions, and inform development decisions.
- Determining how and when to evolve potency approaches from early development through approval.
- Demonstrating target engagement and biological activity when clinical datasets are limited.
- Developing analytical strategies that support current milestones while reducing rework later in development.
