Interview with Director of FDA’s CBER, Peter Marks

Ben Comer, Chief Editor of Life Science Leader, spoke with Peter Marks, director of the US Food and Drug Administration’s (FDA) Center for Biologics Evaluation and Research (CBER) last year to discuss the Center’s goals for the coming year. The first priority is working through a backlog of vaccine-related submissions and reviewing evidence from vaccines approved via Emergency Use Authorizations (EUAs).

According to Ben Comer, “In addition to focusing on vaccine reviews, the other “major thrust and priority” at CBER this year is to “advance gene therapies and cell-based gene therapies,” says Marks. In mid-September, CBER’s newly reorganized Office Of Tissues And Advanced Therapies (OTAT) became an FDA “super office” with a new name: the Office of Therapeutic Products (OTP).”

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(Source: Life Science Leader, January 3^rd, 2023)