2nd Cell and Gene Therapy Regulatory Affairs Summit

Memo

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 With CBER leadership changes, new FDA draft guidance on post-approval CMC, and potency assays facing heightened scrutiny, the environment is rapidly evolving.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 and 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. URLs:Tickets: https://go.evvnt.com/3229089-1?pid=5569Brochure: https://go.evvnt.com/3229089-3?pid=5569 Date and Time: On Tue, 02 Dec 2025 09:00 - Thu, 04 Dec 2025 17:00 Venue Details: Washington Marriott Capitol Hill, 175 L Street Northeast, Washington, District of Columbia, 20002, United States Category: Conferences | Science, Health and Medicine Prices:Drug Developer Pricing - Conference + Pre-Conference Workshop Day: USD 4197.00,Drug Developer Pricing - Conference Only: USD 2999.00,Academic Pricing - Conference + Pre-Conference Workshop Day: USD 3597.00,Academic Pricing - Conference Only: USD 2599.00,Vendor Pricing - Conference + Pre-Conference Workshop Day: USD 5097.00,Vendor Pricing - Conference Only: USD 3699.00 Speakers: Allen Callaway Distinguished Scientist, CMC Regulatory Affairs Johnson and Johnson, Brett Howard Senior Director, Regulatory Policy U.S. Pharmacopeia, Brian Furmanski Chief Regulatory Officer and Head of Global Regulatory Affairs Kriya Therapeutics, Carl Denny Senior Vice President and Head of Regulatory Affairs Abeona Therapeutics, Domingos Savio Silva Junior Partner DSJ Capital America LLC, Francielli Melo Health Regilatory Specialist ANVISA Brazil, Jad Adaimi Vice President, Global Regulatory Affairs Ultragenyx, Jessica Eisenstatt Associate Director - Chemistry, Manufacturing and Control Regulatory Affairs AstraZeneca, Jingying Xu Director of Regulatory Affairs CMC Kite Pharma, Kate Imhoff Vice President, Regulatory Affairs Abeona Therapeutics, Keith Wonnacott Vice President, Regulatory Affairs Lexeo Therapeutics, Matt Campagna Director Global Regulatory Affairs, CMC Bristol Myers Squibb, Omar Tounekti Manager, Cell, Gene Therapies and Radiopharmaceuticals Division Health Canada, Rajesh Thangapazham Director Regulatory Affairs, Specialty GSK, Snehal Naik Independent Expert, So-ching Brazer Executive Directive, Regulatory Affairs Adicet Bio, Uma Raut Product Lifecycle Director Vertex Pharmaceuticals, Yoshiko Stowell Vice President, Regulatory Affairs Kenai Therapeutics