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

Center for Biologics Evaluation and Research Director Peter Marks wants people to come work at the US Food and Drug Administration, but he also understands if they leave for industry some day.

“I don't think we should get as crazy about people moving [from] FDA to industry, the back and forth,” Marks said at the recent Prevision

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