What's Happening?
The 2nd Cell & Gene Therapy Regulatory Affairs Summit is set to take place in Washington, D.C., from December 2-4, 2025. This industry-led event focuses on the evolving regulatory landscape for cell and gene therapies (CGTs), with new FDA leadership and global harmonization efforts shaping the field. The summit will feature over 80 experts discussing FDA updates, CMC strategies, and global submission alignment, providing a platform for professionals to benchmark and learn from regulators and peers.
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Why It's Important?
The summit is crucial for regulatory professionals in the CGT sector, offering insights into the latest FDA and global agency requirements. As the industry faces intensified scrutiny on potency assays and post-approval CMC requirements, staying informed is vital for accelerating therapy approvals and ensuring patient safety. The event fosters collaboration and knowledge sharing, helping stakeholders navigate complex regulatory challenges and streamline submission processes.
What's Next?
Participants at the summit will gain practical approaches to IND-to-BLA planning and emerging modality guidance, equipping them to meet evolving regulatory expectations. The event may influence future regulatory strategies and compliance practices, potentially impacting the speed and efficiency of CGT development and approval processes.
