Key Takeaways
- Vinay Prasad, M.D., officially stepped down as director of the FDA’s CBER, with Katherine Szarama, Ph.D., named acting director.
- Szarama has extensive experience, having previously worked at ARPA-H and contributing to research at St. Jude’s Children’s Hospital.
- A permanent CBER director is expected to be announced in the coming weeks, according to FDA Commissioner Marty Makary, M.D.
Leadership Changes at CBER
As of May 1, the FDA’s Center for Biologics Evaluation and Research (CBER) has a new leader. Vinay Prasad, M.D., has left his position for the second time, and Katherine Szarama, Ph.D., who served as his deputy, will step in as acting director. The appointment was confirmed by a spokesperson from the Department of Health and Human Services.
Szarama joined CBER in December after a year at the Advanced Research Projects Agency for Health (ARPA-H). Her background includes a Ph.D. earned through a collaborative program with the National Institutes of Health at the Karolinska Institute in Sweden. Following her graduate studies, Szarama spent three years conducting research at St. Jude’s Children’s Hospital and subsequently worked as a fellow and research analyst at the Centers for Medicare and Medicaid Services.
During a press conference, FDA Commissioner Marty Makary, M.D., stated that a permanent director for CBER is expected to be named soon, although no specific timeline was provided.
Prasad’s tenure at CBER was characterized by significant challenges, including a contentious relationship with the biopharma sector. He faced scrutiny after being temporarily removed from the FDA last summer amid a critical regulatory conflict regarding Sarepta Therapeutics’ Duchenne muscular dystrophy gene therapy, Elevidys. This conflict intensified as advocacy groups pressured the White House over Prasad’s regulatory approach.
More recently, Prasad’s leadership faced backlash due to the FDA’s denial of several therapies for rare diseases, particularly a Huntington’s disease gene therapy from Dutch biotech, uniQure. The company claimed that the FDA had previously approved its plan for a single-arm trial based on external controls, but CBER under Prasad seemingly altered its stance, leading to a public dispute.
Following his departure, Makary noted that Prasad will return to the University of California, San Francisco, where he is a faculty member. This transition marks a significant shift at CBER, as the agency continues to navigate complex regulatory challenges in the evolving biopharmaceutical landscape.
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