About Event
The Ultimate Chance to Tackle Regulatory Challenges in the Cell & Gene Therapy Space
This summit was the premier gathering of cell and gene therapy regulatory experts, serving as a pivotal hub for C-Level Executives, Vice Presidents, and Directors of regulatory affairs and CMC. In October, we delved into all aspects of cell and gene therapy regulation, from pre-IND to post-BLA, to benchmark best practices and prepare for all significant regulatory milestones.
2024 Agenda Highlights
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Uncovering the challenges in finding a regulatory pathway for in vivo gene editing and consider what first-in-human data packages and clinical follow-up plans should look like with Verve Therapeutics |
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Discussing comparability protocols to understand the expectations of regulatory bodies and hear experiences from Bristol Myers Squibb and Vivet Therapeutics |
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Benchmarking best practices for handling batch failures from a global perspective with the National Health Institute |
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Comparing regulatory hurdles in the USA and Europe to plan for worldwide expansions with Quell Therapeutics and Orchard Therapeutics |
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Breaking down Project Optimus to gain insights on translating pre-clinical dosing to efficacious doses in humans with Voyager Therapeutics |
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Navigating designation assignments to understand the criteria for each designation and illuminate the advantages and differences between them with Prime Medicine |
Download the 2024 Agenda for More Information on:
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- 8+ Hours of Industry Networking
- 20+ Regulatory Expert Speakers
- 2 Interactive Deep-Dive Workshops
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- & Much More!
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