US FDA Cell/Gene Therapy Office ‘Aggressively Recruiting’ Amid Reorg, Senior Staff Departures
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.
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FDA’s Center for Biologics Evaluation and Research saw IND clinical holds for gene and cell therapies dropped to 70 in calendar year 2022, a 52% decline from 2018. Center for Drug Evaluation and Research’s total clinical holds in fiscal year 2022 were 380, the highest number in the past 12 years.
Nicole Verdun, who had been running the CBER Office of Blood Research and Review, now is director of the center’s Office of Therapeutic Products. She will manage OTP’s growing head count, as well as its increasing workload.
Regenerative Medicines: Development Slowed By Lack of Standardization, Regulatory And Manufacturing Challenges
A Government Accountability Office report identifies 10 policy options aimed at speeding development and boosting the use of regenerative therapies, but breaks little new ground, highlighting the continuing difficulties in the space.