Full Event Guide
Download the Brochure to View:
- 18+ senior regulatory leaders driving CGT strategy across nonclinical, clinical and CMC
- Exclusive workshops on potency assays, comparability and global submission hurdles
- Insights on FDA changes, shifting CMC expectations, and real-world evidence impacts
- Next-gen regulatory strategies for in vivo, gene editing, AI, and global filings
- 8+ hours of focused networking - from speed meets to roundtables
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Who's on the Program?
“The FDA has had significant changes in 2025 that are already impacting the cell and gene therapy landscape - and more changes are still unfolding. Navigating this evolving regulatory environment can be challenging, especially when the long-term implications aren't always clear. Staying creative and proactive is essential to ensuring these therapies reach the patients who need them”
2025 Speaker, Vice President, Regulatory Affairs, Ultragenyx