I recently looked at the organizational chart at the FDA’s Center for Biologics Evaluation and Research or CBER.
Why?
I have been anticipating some possible big changes there with the new administration.
After all, with HHS Secretary RFK Jr. having previously claimed that the FDA was suppressing various unproven things including at least two kinds of biologics (peptides and stem cells), it seems likely that CBER could see some upheaval. For example, the biologics branch of the FDA expects excellent preclinical and clinical trial data yet there are no such data on the peptides or the types of stem cells that I think Kennedy has in mind. This sets up a potential inherent conflict.
When I looked a few weeks ago at the CBER leadership chart, nothing seemed to have changed. Even so, I had a feeling that some change was inevitable. Endpoints looked at the chart after I did and caught some notable departures. Let’s start there.
Big changes at the FDA’s CBER
Here’s the Endpoints report on the departures of some key leadership at CBER.
Now if you look at the new CBER organizational chart, there are some gaps where good people used to be. Most worrisome to me is the loss of Deputy Director Celia Witten, who reportedly retired.
Fortunately, Peter Marks continues as Director.
CBER also held a public workshop this week on cell and tissue biologics. I zoomed in for most of it so I’ll be writing something about that soon. One question came to mind for me shortly before the meeting: how was this public meeting within the domain of HHS even allowed to happen when almost all public meetings under that umbrella have been cancelled? I don’t know, but I’m glad it did. Great meeting.
Other recommended reads
- Pre-clinical safety and efficacy of human induced pluripotent stem cell-derived products for autologous cell therapy in Parkinson’s disease, Cell Stem Cell. I believe we’re likely to see an approved cell therapy for Parkinson’s somewhere in the world within a decade. People have been making such predictions for a long time, but the field has come a long way and more teams are working on this.
- How quickly are you ageing? What molecular ‘clocks’ can tell you about your health, Nature (news feature). This is a nice article by excellent science writer Heidi Ledford. I like how she doesn’t just accept the aging clock fad. Some of these clocks have real science behind elements of their workings, but it’s early days still. My favorite quote from it is: “Millions of followers of The Kardashians now know what DNA methylation is.” I’m not sure they really do, but maybe sort of?
- Inside the Collapse at the NIH, The Atlantic. Another great article from another wonderful science writer, Katherine J. Wu. But more bad news on the NIH front. Despite its own lawyers and the courts saying to restart research funding, pressure from above has made the NIH leadership mostly hold off. A few awards have been issued and some scheduled grant-related meetings are back up on the federal register. The longer this goes on, the more harmful it gets. Wu’s article shines light on some very troubling things and decisions.
Elements of human reproduction in the lab
- 3D Bioprinted Coaxial Testis Model Using Human Induced Pluripotent Stem Cells:A Step Toward Bicompartmental Cytoarchitecture and Functionalization, Advanced Healthcare Materials. This one also brings to mind my post this week on IVG or in vitro gametogenesis, and efforts to complete human reproduction even more fully in vitro than standard IVF.
- Adult bi-paternal offspring generated through direct modification of imprinted genes in mammals, Cell Stem Cell.
Pain-in-the-neck headline of the week
BioRestorative Announces FDA Clearance of IND for Phase 2 Trial of BRTX-100 in Chronic Cervical Discogenic Pain, Stock Titan. I decided not to even link to this one. The problematic part here, in my opinion, is not the product or the news. It’s the different headline that is listed on Google News for this item. Check it out above.
The news here is an IND. Getting a cleared IND is great, but it’s a long way from a drug approval. This is not a treatment yet. Also, there’s a risk that saying “green light” without more context could lead some readers to believe this has drug approval from the FDA. Finally, “revolutionary” is grossly premature. Overall, the headline on Google News feels like hype to me.