New Name, Old Problems: US FDA’s Cell And Gene Therapy Office Still Facing Growth Challenges
The group will be called the Office of Therapeutic Products, but needs more people to handle its increasing workload.
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US FDA has not named permanent heads of several offices within the new Office of Therapeutic Products, the only super office in the Center for Biologics Evaluation and Research.
Transformation of former Office of Tissues and Advanced Therapies into a ‘super office’ will provide leadership opportunities for a younger generation, retiring director Wilson Bryan says. CBER head Peter Marks says he is not concerned if agency staff later go to work for industry; suggests increased staffing and reorg could help cut down on gene therapy IND clinical holds.
CBER’s Celia Witten is the latest senior executive to run an office within the center during a leadership transition, a move that can help achieve specific goals, but also create tension.