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 |
"This summit represents a pivotal opportunity to share insights, learn from industry leaders, and continue advancing the regulatory landscape to ensure the highest standards of safety and efficacy for these transformative treatments"
2024 Speaker, Global Senior Director, Analytical Sciences CMC, Cell & Gene Therapy, Orgenesis