What is the story about?
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 will focus on the rapidly changing regulatory landscape for cell and gene therapies (CGTs), with new FDA leadership at CBER and intensified scrutiny on potency assays and post-approval CMC requirements. The summit will feature over 80 experts sharing insights on FDA and CBER updates, global harmonization efforts, and strategies for IND-to-BLA planning. Attendees will have the opportunity to benchmark with peers, learn directly from regulators, and explore solutions to challenges in CGT development.
Why It's Important?
The summit is crucial for regulatory professionals in the CGT sector, providing a comprehensive overview of the evolving regulatory expectations that are shaping the industry in 2025 and beyond. With the FDA's new leadership and global agencies like ANVISA and Health Canada joining harmonization efforts, staying aligned with these changes is essential for accelerating approvals and ensuring therapies reach patients safely. The event offers valuable knowledge and frameworks to navigate the complexities of CGT submissions, potentially impacting the speed and efficiency of bringing new therapies to market.
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