Video

Dr. Nicole Verdun Shares How Patient Data Impacts CMC Robustness

When CGT products demonstrate dramatic improvements with minimal safety concerns in a Phase 2 study, Sponsors may want to modify the protocol mid-study to increase patient enrollment and convert it to a pivotal study. Here, Dr. Nicole explains how the Agency evaluates patient data from a clinical endpoint and CMC robustness perspective from patients enrolled before and after the change.

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