Why Academic Centers Reach The Clinic Faster
In this segment of Cell & Gene Live, Designing Early Manufacturing For Long-Term Success In CGT, Raymond Luke, Senior Director of MSAT at Verismo Therapeutics and Todd Luman, Executive Director of Process and Product Development at Allogene, Luman explains that academic institutions often move faster in Phase 1 because many trials are investigator-initiated, allowing streamlined oversight and quicker regulatory engagement, though similar pathways for sponsor-led programs don’t yet exist in the U.S. or EU. Luke adds that academic groups such as the University of Pennsylvania benefit from longstanding FDA trust, established drug master files, and a perception of scientific rather than commercial intent, all of which help accelerate IND approvals.
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