Pre-Conference Workshop Day | Tuesday, December 2
8:00 am Check-In & Coffee
WORKSHOP A
9:00 am Global Regulatory Alignment for Cell & Gene Therapies: Opportunities & Obstacles Beyond the FDA
Synopsis
As advanced therapies progress toward global development and commercialization, regulatory divergence remains a major challenge. This session will explore how developers are navigating inconsistent expectations across regions, and where opportunities lie to optimize patient access and streamline approvals beyond the U.S.
- Key regulatory misalignments between major agencies (e.g., EMA, PMDA, MFDS, NMPA, Swissmedic) and how these impact development timelines
- Strategic considerations for clinical trial design, patient access, and commercialization in ex-FDA countries
- Collaborative pathways, regional trends, and the future of regulatory convergence for advanced therapies
12:00 pm Lunch Break
WORKSHOP B
1:00 pm Potency & Comparability Reimagined: Toward Practical Regulatory Confidence in Complex Modalities
Synopsis
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