The FDA is reportedly down to a handful of final candidates to lead CBER, with a potential selection expected in the coming month or two. For now, the appointment of acting director Katherine Szarama has not allayed the industry’s concerns.
Katherine Szarama, a deputy to the now-departed Center for Biologics Evaluation and Research Director Vinay Prasad, was tapped by the FDA last week to step up in an acting capacity. While Prasad’s exit came as a relief to many in the biopharma industry, Szarama’s appointment has left lingering concerns about the agency’s leadership.
“We’re encouraged that Szarama has some government experience compared to Prasad,” analysts at Capital Alpha Partners pointed out in a May 3 note to investors, but she “lacks the clinical experience . . . or depth of background that’s more typical for an FDA center director.”
Moreover, her appointment as acting CBER head is a reminder to the industry that “many of his hires who likely share his views . . . remain in key agency positions,” Capital Alpha continued. After all, Szarama was picked by Prasad himself, according to Capital Alpha, and joined the Center in December to be his deputy.
Another concern is the fact that Szarama has stepped up in an acting capacity, the third time in a year that CBER has lacked a permanent leader. “It’s unclear whether Szarama will be named permanent CBER director and, if not, how long it will take to find someone else who wants the job,” Capital Alpha wrote.
That search may be nearing its end, with the FDA reportedly down to its final three or four candidates for the role, according to Endpoints News, whose anonymous source said the FDA could announce a permanent Prasad replacement in the coming month or two. Szarama was not among these finalists, the publication reported Monday.
In its search for a CBER director, the FDA has been putting emphasis on contenders with management and drug development experience, according to the source. Outside of her government experience—which includes a stint at the Centers for Medicare and Medicaid Services and the Advanced Research Projects Agency for Health—Szarama was a director of clinical trials at Arnold Ventures, according to her LinkedIn profile.
RBC Capital Markets in a March 6 note offered possible CBER heads after Prasad, including Stefen Baral, infectious disease expert from Johns Hopkins School of Public Health, and psychiatric expert Chris Palmer.
No matter who takes up the post, CBER will face a tough road ahead to rebuilding trust with the industry and the public. “With Prasad gone, there may be less drama, less personnel angst, and perhaps a more informed regulatory approach to FDA decisions,” Capital Alpha wrote on Monday. “However, we think that many of the underpinnings and views that led to some of his questionable actions remain, along with the overall damage done to agency capabilities and experience.”
The analysts concluded, “[W]e think it’s obvious that much of the uncertainty we’ve seen over the past year will continue.”
