CBER chief Prasad steps aside, deputy takes the reins as search for successor continues

As the calendar turned from April to May, a big change came to the FDA. Vinay Prasad, M.D., director of the Center for Biologics Evaluation and Research, officially departed from the agency for the second time. His deputy, Katherine Szarama, Ph.D., will take over as CBER director in an acting capacity.

A spokesperson from the Department of Health and Human Services confirmed Szarama’s appointment to Fierce. 

Szarama joined CBER as Prasad’s deputy in December, after a year-long stint as a program manager at the Advanced Research Projects Agency for Health. Her government experience extends back to her school days; she earned her Ph.D. at the Karolinska Institute in Sweden through a partnership program with the National Institutes of Health.

Following her graduate education, Szarama spent three years doing research at St. Jude’s Children Hospital before returning to Washington as a fellow and research analyst at the Centers for Medicare and Medicaid Services.

Asked when a permanent director will be named, the spokesperson referred Fierce to the remarks of FDA Commissioner Marty Makary, M.D., during a press conference on Tuesday. At that event, Makary said he expects a new CBER director to be announced “in the coming weeks.” 

Prasad’s tenure at the helm of CBER was marked by a tumultuous relationship with the biopharma industry. He was briefly ousted from the FDA last summer following a high-stakes regulatory dispute over Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy Elevidys. Back then, Prasad departed as Duchenne advocacy groups reportedly escalated their opposition to his restrictive policies all the way to President Donald Trump.

More recently, Prasad came under fire for the FDA’s rejection of multiple rare disease therapies, most notably a Huntington’s disease gene therapy from Dutch biotech uniQure. The company said the FDA had previously okayed its plan of using a single-arm trial based on external control. CBER under Prasad seemingly reversed course, igniting a heated back-and-forth.

In announcing Prasad’s departure, Makary said that the former CBER chief will be returning to the University of California, San Francisco, where he is a professor.