June 4, 2020

The Niche

Knoepfler lab stem cell blog

Scott Gottlieb FDA

3 min read

Maybe the announcement that Commissioner Scott Gottlieb will be leaving the FDA soon shouldn’t have caught us all off-guard, but it did. Gottlieb isn’t a perfect Commissioner, but he brought a sensible, open approach to running the FDA that was very refreshing. Amongst all the top leadership in the Trump administration, Scott Gottlieb stood out as being particularly supportive of his agency and its core mission. If anything he was the anti-politician in the room. Is that what did him in? It’d be helpful …Read More

6 min read

Are fat stem cells a drug? Today the FDA definitively indicated “yes” without leaving much of any room for exceptions on this question. This morning the FDA made a major announcement on stem cell policy regarding its current thinking on oversight of regenerative medicine and issued four guidances, including two each in final and in draft form. There will be a 90-day comment period for the latter. Are today’s developments a good thing overall? I’d say “yes”, although there are still some ambiguities and …Read More

3 min read

New FDA Commissioner Dr. Scott Gottlieb, M.D., has in the past touched on stem cells and regenerative medicine therapies in speeches or written comments prior to starting his tenure at the agency. Now that he is Commissioner, he is poised to have direct impact on our field rather quickly and potentially with major changes in store. How might that unfold? In one of his first statements that includes stem cells and regenerative medicine as Commissioner, Gottlieb perhaps gave us some hints within a new …Read More

1 min read

The FDA warning letter to Richard Burt of Northwestern related to noncompliance issues with his stem cell clinic trial for MS has dominated the news recently, but some other notable things have happened as well on stem cells and more generally in science. I’ve posted some notable news bites below. More insights on molecular mechanisms of control of cancer stem cells and potential ties to metastasis from Nature paper and interesting Nature cover depicting cancer stem cells above: A distinct role for Lgr5+ stem cells in …Read More

5 min read

The Trump FDA commissioner nominee Dr. Scott Gottlieb could dramatically alter how the agency regulates investigational stem cell therapies. How might such changes unfold? There are potential upsides and downsides to  the seismic shift that could be in the offing. Gottlieb has written in the past about his perception of FDA over-regulation of stem cells such as in this piece in the WSJ. There he made a number of assertions that signal his view at least back then that when it comes to regulation of stem …Read More