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