It has been a turbulent few months for the US Food and Drug Administration (FDA), with redundancies, leadership changes and government shutdowns affecting its work.
Since the Trump Administration took power in January 2025, there have been several leadership changes at the FDA, with recent reports suggesting that current leader Marty Makary is also facing possible dismissal.
Go deeper with GlobalData
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Vinay Prasad also left his role as the head of the Center for Biologics Regulation and Evaluation (CBER) in April 2026 following a one-year sabbatical from academia. Prasad was responsible in part for the recent plausible mechanism and single clinical trial pathways.
There have been numerous policy changes under Makary, along with the release of new guidance documents, prompting questions about what potential shifts could follow under new leadership.
While there have been reports about staffing concerns at the FDA linked to the shutdown and US Department of Government Efficiency (DOGE) cuts, there has been comparatively little coverage of what it is currently like for biotech companies collaborating with the agency on clinical trial designs in 2025 and 2026.
Dr Robert Sikorski, managing director of Woodside Way Ventures and chief medical officer (CMO) of CERo Therapeutics, says that based on his recent experiences, the FDA’s technical staff and review timelines have not been impacted by recent events.
This interview has been edited for length and clarity. This interview was conducted prior to news reports suggesting the potential dismissal of Marty Makary.
Abigail Beaney (AB): Could you talk a little bit on the ground level about what it’s been like as a biotech to work and collaborate with the FDA on clinical trials?
Robert Sikorski (RS): I work with smaller companies that are bringing new things to mostly Phase I and sometimes into Phase II. One company I work with is CERo Therapeutics, which entered the clinic with a novel cell therapy. Anytime you do something that is novel, obviously, safety is paramount, and it’s uncharted territory a lot of times. We worked with the FDA to get the therapy into the clinic, and in the first interaction, the FDA spelled out some scientific experiments that we had to do.
We worked closely with them, and they were very clear about what they needed for us to get into the clinic, and nothing changed from the initial discussions to the time we went to the clinic; everything was consistent.
Once we went to the clinic for acute myeloid leukaemia (AML), we dosed four patients and noticed that the second patient, who also had myelodysplastic syndrome, had some interesting activity. The patient had failing blood counts, and their platelets started recovering, which was unusual – we hadn’t expected that. They also stayed on the trial much longer than we would have expected, so we were intrigued by this single patient and decided to change the trial to focus on more patients like that.
We approached the FDA, and rapidly, within about a month, we were able to change the focus – that change was made within 30 days.
AB: There have recently been some negative opinions about the staffing cuts that the FDA saw last year. Have you seen any impact from these?
RS: I have not, in fact, our work with CERo was around the government shutdown, and they still responded quickly. While it goes against the grain of what you’re hearing, we have not noticed anything based on our real boots-on-the-ground story.
The technical staff at the FDA are very dedicated, and we’ve seen that – whether it’s the toxicology reviewers, the statisticians, the clinical reviewers, they have all been very involved.
AB: We have also seen artificial intelligence (AI) tools introduced in the FDA. Is this something you have had experience with yet?
RS: I have probably interacted with the FDA at least four times in the past month, and it has always been a human interaction. I have not interacted with anything that could be AI, but of course, this could be happening in the background. There’s nothing in the foreground yet in communications.
AB: How does the FDA compare currently with the European Medicines Agency (EMA)?
RS: The EMA has such a very different structure. The EMA, in my opinion, is much more structured and formal. The FDA has recently moved toward being less formal and a bit more experimental. An example of this is the Plausible Mechanism Framework that they published in the New England Journal of Medicine. It is very much an FDA-specific programme, while the EMA has a structure they stick to, but if you follow the structure, it works.
AB: With the anticipated upcoming changes at the FDA, do you hope that this will accelerate this movement that we’re seeing in the agency?
RS: I guess it will depend on who comes in. We all know there will be new leadership, and I think that that’s something we all have to keep an eye on. I am certainly intrigued as to its impact, but you have to consider there are a couple of layers at the FDA, and I think there’s a middle layer that really is a bit of vacuum now.
That vacuum will get filled over the next few months, and we’ll get to see what the tone is. Right now, it’s very engaged at the Phase I and Phase II level.
The technical staff really know these diseases and the mechanisms, and you can tell that in the way they respond. We’ve been able to have discussions right down to the individual patient level, disease, and mechanism that have helped a lot in moving the project forward. Whether that continues – I don’t know.
There are, of course, questions over what the policies will be going towards: registration trials, single-arm trials? What are the policies going to be towards accelerated approval trials? Is it going to get easier, harder, or are certain things going to get removed? Those are things that we’re going to watch out for.
With rare diseases, there are questions about how that’s going to play out. How much evidence is going to be required? That’s something that will probably be impacted by who comes in.
My hope is that the FDA retains the people who are there that are in the technical group so that those staff can keep doing what they’re doing, because we have worked extremely well together, so I would like that to continue, but everything else, we’ll just have to see.
