About Event
Why the Gene Therapy Regulatory Summit?
2023 is set to be a record-breaking year of novel gene therapies approved globally, the new FDA super office grows to meet the rapidly accelerating pipeline of transformative therapies, while Peter Marks hails gene editing breakthroughs as game changers meeting regulatory reality; nuanced understanding of the evolving landscape is crucial to regulatory success.
The Gene Therapy Regulatory Affairs Summit united both regulatory bodies and the leading regulatory personnel as the only regulatory meeting dedicated solely to the complex landscape of gene therapies.
Attend in Boston in 2025 to hear about the latest insights with case study presentations, informative panel discussions and deep-dive workshops.
Last January, attendees explored the nuanced global approaches to regulatory affairs, heard about the real-world experience of end-to-end submissions and approvals, discovered key insights and strategies to refine trial design and perfect efficacy purity and comparability.
Join Your Peers in 2025 To:
Understand the nuanced differences and the route to harmonization in global regulation across the EMA, MHRA, FDA & Health Canada, divulging lessons learnt from the new CTR regulations, greater clarification on GMO licensing differences and implications of companion diagnostics with Bridge Bioscience, Opus Genetics and Regeneron Pharmaceuticals
Hone your regulatory intelligence, understand how to use biomarkers as surrogate endpoints and perfect clinical trial strategy for regulatory success with Omega Therapeutics and Ultragenyx Pharmaceutical
Explore the next steps for specific technologies beyond AAV and novel regulatory route with AstraZeneca and 4D molecular Therapeutics
Hear from the regulators in the Health Canada and the FDA to have your queries clarified
Overcome your CMC hurdles to prove the efficacy, purity & comparability of your compound to avoid later setbacks in poor manufacturing preparation with Omega Thearpeutics, Pfizer, Solid Biosciences, Sangamo Therapeutics and Spark Therapeutics
Who Did Attendees Meet?
This summit united both regulatory authorities and leading regulatory personnel across large pharma and biotech, 80+ of the senior decision makers from C-Level executives to senior scientists came together in January 2024 to share key insights to help define and to navigate a regulatory route forward to bring gene therapies to patients.
Join us in 2025, to network with fellow attendees working across regulatory strategy, non-clinical, clinical & CMC regulatory affairs, analytical development and process development while gaining expertise and insights from across gene therapy development to hone your regulatory strategy for successful regulatory approval.
What Have Past Attendees Said?
“Wonderful mix in the audience, great conversations with attendees, ability to see and discuss some of the developments on the forefront.”
Gene Therapy Event Series Attendee, Worldwide Clinical Trials
"I consider this event as an educational and training event for my peers to gain the necessary information to work for gene therapy projects; meanwhile, it helps answer some questions and stimulate new thoughts for my peers who are working on gene therapy fields.”
Gene Therapy Event Series Attendee, AstraZeneca
“The topics of the presentations were fully aligned with my needs and the information from the speakers and the Q&A were very valuable to me. I gained insights that I can implement immediately in my work.”
Gene Therapy Event Series Attendee, UCB