James Norton
Director - Analytical Development MeiraGTx
Seminars
Thursday 7th May 2026
Regulatory Scenario Workshop: Green Light or Red flag? A Regulatoryled Review of a Hypothetical Gene Therapy QC Strategy
1:30 pm
Across gene therapy, companies are being forced to fundamentally rethink QC, validation and analytical strategies under unprecedented cost pressure, while still preparing for late-stage development, MAA/BLA submissions and inspections.
This session uses a hypothetical gene therapy company transitioning from Phase II into Phase III to explore:
- How far analytical and QC innovation can go without triggering regulatory pushback
- Where regulators are genuinely open to new statistical and efficiency-driven approaches
- Where traditional expectations still apply and why
