Search Results for: peter marks

Highlights of Science Writers DC Stem Cell Panel with FDA’s Peter Marks

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I’m enjoying attending and speaking at the annual Science Writers 2018 meeting in D.C. where I spoke this morning on a panel about stem cells. The session was specifically on the Wild West of stem cells. You can follow the meeting events on Twitter with the #sciwri18 hashtag. I had three wonderful fellow panelists, Marilynn Marchione of […]

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Striking FDA Hahn & Marks JAMA pub on regenerative clinics

Dr-Stephen-Hahn-Commissioner-of-FDA

It was fascinating to read a new JAMA piece by the FDA on unproven stem cell clinics and other regenerative medicine firms. Many of these guys are profiteering off of buzz about exciting, but mostly unproven technologies. While the JAMA opinion piece reiterates the agency’s commitment to evidence-based regenerative medicine, it also makes some other

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Silence from FDA Commissioner Robert Califf on stem cell clinics is a problem

Robert Califf, FDA Commissioner

FDA Commissioners including Robert Califf have radically different approaches to the job including oversight of marketing of unproven stem cells. As to stem cell clinics, some have been very engaged, while others seem the opposite. During his second go as FDA Commissioner, Robert Califf has been vocal about many topics. However, as best as I

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Recommended reads: gov scientists fear Trump 2nd term, MYCT1 in HSCs, in vivo editing

Trump

I’ve only met one scientist who was openly a Trump fan, but I’m sure there are more out there. Still, it seems most scientists are no fans of the former president. A new WaPo piece highlights how federal scientists are worrying about a possible second term for the former president. Government scientists & a second

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Weekly reads: Sarepta, epigenomics, FDA on eyedrops

Sarepa CEO interview.

The biotech Sarepta has had a complicated go of it with the FDA sometimes related to their Duchenne muscular dystrophy (DMD) gene therapy efforts. In late 2016 I wrote about how there was some controversy as the FDA approved the Sarepta drug eteplirsen (Exondys 51) also for DMD, going against an advisory panel that had

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Weekly reads: UC Davis Medical School diversity, CRISPR, Parkinson’s

UC Davis Medical School

It’s been almost seventeen years that I’ve been a professor here at UC Davis Medical School. It feels like home. I enjoy teaching our first-year medical students each year. Some end up doing research in my lab. Our school recently got a nice write-up over at STAT News by Usha Lee McFarling on the diversity

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FDA leader Stephen Hahn was pressured to aid Texas firm Direct Biologics

Former FDA Commissioner Stephen Hahn.

An FDA FOIA dump of text messages of former Commissioner Stephen Hahn suggests that a Texas regenerative firm called Direct Biologics benefited from political pressure on him in mid-2020. Then he was asked again to help in early 2021. This was shortly before he resigned at the start of the Biden Administration. The push came from

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One size doesn’t fit all? FDA may soften some cell therapy regs

dr. peter marks fda, cell therapy

The Pink Sheet just broke the story that the FDA may change up its oversight of the cell therapy space. This possible shift could drop the oversight bar somewhat for certain products. Most likely it’d be those with lower anticipated risks. The Pink Sheet piece by Sue Sutter is titled US FDA To Explore New Regulatory Pathways

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Grading my 21 stem cell & regenerative medicine predictions for 2021

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The world of stem cell research and regenerative medicine is unpredictable but it’s fun to be a part of it and try to do predictions. Each year in late December or early January I make prognostications for the coming year for stem cell research and regenerative medicine. I made 21 such predictions for the current

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