Potency & Comparability Reimagined: Toward Practical Regulatory Confidence in Complex Modalities
Time: 1:00 pm
day: Pre-Conference Workshop Day
Details:
Potency and comparability remain two of the most persistent regulatory hurdles in cell and gene therapy – but industry fatigue is setting in. Rather than reiterating the known difficulties, this workshop takes a fresh, forward-looking lens: how can we reframe expectations, leverage emerging tools, and work toward risk-based approaches that actually move programs forward?
- Reframing Potency Expectations: Can platform-based data or orthogonal tools build regulatory confidence without a single “gold standard” assay?
- Comparability Beyond Assays: Exploring totality-of-evidence frameworks and how to communicate meaningful product sameness post-change
- Agency Engagement Tactics: What has worked, and what hasn’t, in gaining alignment with regulators – including risk-based approaches and early scientific advice
