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Beyond CAR-Ts: Cell-Based Gene Therapy Sponsors Are ‘Branching Out,’ CBER’s Marks Says

 
• By Kate Rawson

As sponsors explore development in autoimmune and infectious diseases, plus a range of hematologic and solid tumors, manufacturing processes can be centralized or decentralized, but Marks says the FDA is ‘neutral’ on that decision.

no diving - pool sign
The gene therapy water is fine, Marks says, but the CBER director encourages step-wise, toe-first development. • Source: Shutterstock

Seven years after the approval of the first chimeric antigen receptor T-cell therapies, the Center for Biologics Evaluation and Research is starting to see a “branching out” within cell-based gene therapies into “much more complicated constructs,” CBER Director Peter Marks said during a 6 May webinar sponsored by the Friends of Cancer Research and Parker Institute for Cancer Immunotherapy.

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