How will things change at the FDA under the second Trump Administration? It’s a key question for our field but not easy to answer. Most likely there will be more instability at the agency. Some leaders, like of CDER, have already left.
in my overall regenerative medicine predictions for 2025, I’ve included more predictions about the FDA. Check it out.
The FDA in an uncertain time
There has been talk for decades about modernizing the FDA. Below is a new piece about the idea, suggesting biotech gets to be involved. Hopefully, “modernization” will not mean defanging the agency. BIO CEO plans to join FDA modernization advisory board under Trump administration, Endpoints News. This is about John Crowley getting a seat at the table as modernization is discussed under Trump 2.0. What does “modernization” mean?
A key stem cell clinic case involving the FDA also remains not entirely resolved, although it’s looking good for the agency. It won a major victory at the 9th Circuit Court.
While the defendants requested that court to hold off on proceeding to next steps while it asks SCOTUS to weigh in on stem cells, that request was just denied. It seems that case will go back to the original court and Judge Bernal where I think the FDA and DOJ are likely to ask for their desired injunction to be put in place. It’s not clear what Bernal will do given his initial ruling that a higher court has now overturned. I’m no attorney, but does he have a choice here? Any legal experts out there?
Pluripotent stem cell trials: have any gotten FDA approval?
Check out this new piece that is a great resource on where things stand with pluripotent stem cell trials. Pluripotent stem-cell-derived therapies in clinical trial: A 2025 update, Cell Stem Cell. So much progress has been made with getting and advancing trials in this space. None are yet FDA-approved, but it’s much easier to see a path now than say a decade ago to a point where we will see approvals.
As a side note, one of the authors is my colleague and friend Heather Main, who has also written a few pieces for The Niche.
More recommended reads
- The genes that grow a healthy brain can also fuel adult glioblastoma, UCSF. This piece struck me as this topic is such a core idea for my lab. For instance, our work suggests that several genes including MYC family genes and ASCL1, which direct normal brain development, also play key roles when altered in glioma. Here’s the original Nature article that is the focus of the UCSF press release: Molecular and cellular dynamics of the developing human neocortex. It was by a team co-led by Arnold Kriegstein, who is a member of The Niche Medical Advisory Board. Remarkably the study is based on many (38) human brain samples.
- Column: A stem cell clinic tees up a Supreme Court challenge to rules protecting patients’ health and safety, LA Times. This is from one of my favorite columnists Michael Hiltzik. I covered this development too where SCOTUS could dictate regulation of stem cells.
- A mortality timer based on nucleolar size triggers nucleolar integrity loss and catastrophic genomic instability, Nat. Aging. Is there such a thing as a mortality timer? When people talk about such things they usually are referring to gradually reduced telomere length as we age. Keep in mind that this new study is in budding yeast, not animals or people. Still, it’s quite interesting.
Blast from the past: who discovered stem cells?
When I first wrote the piece on who discovered stem cells, it sparked some debate. Some of my Canadian friends felt that Till & McCulloch were the clear answer. I get their point. However, in much earlier decades and even more than a century ago, some scientists were aware of stem cells and the concepts behind them.
The above diagram made by Artur Pappenheim more than a century earlier is a cell fate tree that includes stem cells. It is very reminiscent of hematopoiesis diagrams in textbooks today. Also note that some scientists wrote about stem cells in their own languages, not using the English term “stem cells.”
From my earlier article:
“In 1908, a Russian histologist Alexander Maksimov (Maximow), Александр Максимов, coined the phrase…“stem cell” as part of his model of hematopoiesis.”
The great Florence Sabin wrote specifically about stem cells in English in a 1936 article.
Ultimately I believe that the discovery of stem cells was made by multiple people in different places over more than a century. The contributions of each were quite important.