Katherine Szarama, PhD, named Acting CBER Director: who’s next?

Yesterday was Vinay Prasad’s last day as the Director of CBER, the FDA’s biologics branch and as of today Katherine Szarama is Acting Director.

Is there some significance to Szarama being acting director?

It’s hard to say. Most signs seem to suggest someone else will become the permanent leader.

Katherine Szarama, FDA
Katherine Szarama is the Acting CBER Director as of today. ASGCT meeting material.

Katherine Szarama background

From Politico:

“Szarama joined the FDA late last year after stints at the Centers for Medicare and Medicaid Services, Emerson Collective, Arnold Ventures and Advanced Research Projects Agency for Health, according to her LinkedIn. She previously worked as the deputy director of CBER under Prasad.”

She’s a biologist. I think this is her publication record.

STAT has more background too: Katherine Szarama named acting director of FDA’s vaccines and biologics center.

Here’s Szarama’s LinkedIn page. It’s interesting that both she and Makary are from Hopkins.

Future of CBER: who’s next?

I haven’t seen any indication that Szarama is in the running to be the permanent CBER leader.

So far, frequent Fox News fixture and ophthalmologist Houman Hemmati is supposedly the favorite to take the helm long term.

Another named being floated is Dr. Stefan Baral of Hopkins. Baral may have the advantage of that Hopkins history and having written two papers on COVID with Marty Makary and Tracy Hoeg, CDER Director.

If it’s down to Hemmati or Baral for CBER boss, who do you think has the best chance? Or do you know of someone else you think will get the job?

As I’ve written before, I believe the new permanent CBER director is going to face a very tough time unless they are at least half a politician at heart. Coming after Prasad’s chaotic dual-tenure doesn’t help.

Also, with RFK Jr. hovering in the background pulling the strings, how can the long-term CBER lead put their own stamp on the branch?

Another challenge is that CBER has shrunk, but the branch’s job is just as tough as ever.

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