5th Applied Biocatalysis & Enzyme Engineering Summit

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 With CBER leadership changes, new FDA draft guidance on post-approval CMC, and potency assays facing heightened scrutiny, the environment is rapidly evolving.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.

Learn more: https://ter.li/c211fx