Understand guidance, streamline submissions, obtain approval
Navigate New FDA Leadership, Harness AI-Powered Submissions & Align Technical Innovation with the Latest Nonclinical, Clinical & CMC Guidance to Overcome Regulatory Challenges and Accelerate Your Path to Clinic & Market
With major FDA changes already reshaping the regulatory landscape - and global agencies ramping up scrutiny - 2025 is a pivotal year for cell and gene therapy regulatory professionals. With CBER leadership changes, new FDA draft guidance on post-approval CMC, and potency assays facing heightened scrutiny, the environment is rapidly evolving. Global efforts to align expectations are also gaining momentum, with ANVISA and Health Canada joining harmonization initiatives, and ICH Q12 implementation for CGTs underway.
The 2nd Cell & Gene Therapy Regulatory Affairs Summit is the only industry-led event focused exclusively on CGT regulatory strategy. Join 80+ experts this December in Washington, D.C. for real-world case studies, insights from regulators, and deep dives into IND-to-BLA planning, global alignment, and emerging modalities.
If you're navigating nonclinical, clinical, or CMC submissions, this is your essential forum to stay ahead of shifting expectations and accelerate CGT approvals in 2025 and beyond.
Download the Full Event Guide
- 18+ senior regulatory leaders shaping CGT strategy across nonclinical, clinical, and CMC areas
- 2 pre-conference workshops focused on potency assay development, comparability, and global submission challenges
- 8+ hours of targeted networking opportunities
Sneak Peek at the Speaker Faculty
Jessica Eisenstatt
Associate Director - Chemistry, Manufacturing & Control Regulatory Affairs
AstraZeneca
Companies on the Program Include:
“With the ever-evolving regulatory framework for ATMPs and recent leadership changes at FDA, this summit represents a unique opportunity for regulatory professionals to share our experiences and learnings, and collectively support the efforts of sponsors to bring the best cell and gene therapies forward for patients.”
2025 Speaker, Independent Expert
“With the fast pace of the cell and gene therapy environment, it is important to have a forum to share regulatory experiences with global agencies from early phases through commercialization.”
2025 Speaker, CMC Regulatory Affairs Associate Director, AstraZeneca
Other Events in the Series:
