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 reviewers get to look 'beneath the hood' of every cell and gene therapy development program, Peter Marks says. • Source: Shutterstock

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