Peter Marks resigned last week as CBER director and now Dr. Scott Steele is the new acting biologics branch director.
Marks resigned under pressure and went out firing back, referring to lies and other issues of HHS Secretary RFK Jr.
One of the first things I thought when I heard about Marks’ departure was, “who could effectively replace him?” Is there a possible new director who could both be seen as kosher by Kennedy and do a robust job at the helm of a key FDA branch?
For me, much of how to envision the future of CBER under Steele will depend on Steele’s core philosophy behind some of his writing about nimble oversight. In addition, how much is his leadership impacted by Kennedy’s views?
CBER directors are usually physicians
Scott Steele got a Ph.D. in molecular biology from Princeton after earlier doing research as a pre-doc at The NIH. Since 2008, he’s been an academic at University of Rochester Medical Center. It’s a strong background in biomedical sciences.
One notable thing right away is that he’s not a physician. Many Ph.D. scientists like Steele have biomedical experience that in theory could be appropriate for being a leader at CBER. Still, it’s atypical for the director to not be a physician.
Marks, an M.D., Ph.D. served from 2016 to 2025. Before that physician Dr. Karen Midthun served from 2011-2016. Physician Jesse L. Goodman served as CBER leader before Midthun.
Scott Steele atop CBER
What experience does Steele have since getting his doctorate? There’s an extensive list.
The FDA has Steele’s NIH biosketch on the web. He has a large variety of both policy and research experience including time working with the White House:
“My previous experience includes 10 years focused on both developing and implementing science policies and plans, and developing government-university-industry collaborations, as well as 10 years conducting research in academia, industry and government labs before transitioning to focus on a career in science policy and research development. This has included national level experience serving as the Executive Director of the President’s Council of Advisors on Science and Technology (PCAST) at the White House Office of Science and Technology Policy (OSTP).”
Earlier he was a policy analyst at the FBI for three years.
Importantly, Steele also has had roles at the FDA and CBER specifically. His LinkedIn page lists a position as senior advisor to CBER for almost 2.5 years. That could be a plus.
Research background suggests a focus on nimble oversight
Does his research background shed any light on his philosophy?
I think I found the right Scott Steele on PubMed and here are the publications. I’m thinking not all of these are from the same Steele, but many appear to be authored by him. The publication record reflects a recent focus on policy and nothing obviously concerning.
This position paper argues for nimble oversight: Advancing an agile regulatory ecosystem to respond to development of innovative technologies. But the paper generally seems reasonable. For example, the end of the abstract “This article outlines approaches that can help provide the flexibility and tools needed to foster innovation, while ensuring the safety and effectiveness of medical products” seems logical. Doesn’t it? I’m curious what readers of The Niche think too.
Why did they pick him & where does CBER go from here?
It’s interesting to ponder why Kennedy or Marty Makary, the new FDA Commissioner, would have tapped Steele to be acting CBER director.
Could his interest in agile regulatory oversight mean CBER will more quickly approve biologics that Kennedy favors like certain kinds of stem cells even without extensive clinical trial data? Could he redefine some stem cells or other cells favored by unproven clinics as no longer drugs? It’s hard to say.
In the same paper I mentioned above, Steele and the other authors do write, “it is also important to weigh the opportunity cost of not preparing for and responding adequately to innovations that can be disruptive to current medical product development.” Could this be extrapolated to the context of CBER to speed approvals of biologics? Maybe, but that’s not clearly the case.
Was this more Makary’s pick than Kennedy’s?
We’ll have to see what Steele actually says and does as acting CBER leader to clarify his likely impact. It’s also possible more information on him will come to light in the next few days or weeks. Another question is whether his tenure as acting director will evolve into being the more long-term director or be relatively short.
Either way, his job is going to be far more challenging given that many key people have left CBER.
I am extremely disappointed in your choice of expert. If you read PubMed you will find that when articles on Phase 1 & 2 Stem Cell Clinical Trials are published, they invariably say that Stem Cells are safe and efficient but need more research. Phase 3 & 4 is not persued . $6.5 billion 21st Century Cures Act money is not spent on cures but on “pure research” . I think it is cruel that FDA does nothing to actually fund Clinical Trials that lead to CURES for diseases that could be cured. ALS, MS, MD and others are examples. Only $30 million was directed to regenerative medicine out of the $6.5 billion. I think half of that should be directed to RMAT (fast track) Phase 3 Stem Cell/ Progenator and exosome Clinical Trials.