Many stem cell clinics are in a bind in 2017 in the new RMAT approval reality. Stem cell clinics say that they only want to help people by providing stem cell therapies to patients in a speedier way that they claim getting FDA approval for a trial just doesn’t allow, but that doesn’t ring true. […]
FDA warp speed RMAT approval nukes stem cell clinic excuses Read More »
The 21st Century Cures Act has some important regenerative medicine language in it. One part of that was attempting to accelerate FDA review of promising investigation regenerative medicine therapies. The mechanism for this was a new designation called Regenerative Advanced Therapy, now renamed Regenerative Medicine Advanced Therapy (RMAT) Designation. I don’t think anyone was sure
Big change for stem cell field with FDA quickly issuing RMATs Read More »
What kind of scientist are you and do you engage in transactional science? I suspect that all of us scientists like to think that most of the work that we do is transformative and that we are a transformative scientist. In science we hear quite a lot about the importance of transformative, innovative science. But can
Is transactional science kicking transformative science’s butt? Read More »
Do you feel frustrated with the current peer review system in science? I have an idea that might help and it involves the revolutionary idea of reviewer accountability. In other words, authors and grant writers in essence review their reviewers. I’ve made this all the easier for you with templates that you can simply and
Transformative idea for peer review: reviewing & grading the reviewers Read More »
If you ever had a really bad day, March 13, 2012 might have been just such a bad day for one Dr. Steven Victor, aka “Dr LookGood”, because he received an official warning letter from the FDA. Why? Dr. Victor, who reportedly greets each patient with the catch phrase “You look so much more beautiful than your picture”, is
Dr Lookgood, dermatologist to the stars, gets FDA warning letter Read More »
A Texas firm called INCELL Corporation has received an FDA warning letter about an amniotic product it manufactures. The letter was addressed to the firm’s founder and leader Dr. Mary Pat Moyer. The letter is somewhat unusual as Dr. Moyer is the Chief Science Officer of INCELL, and is an academic scientist with over 250
NAE member Mary Pat Moyer on FDA Warning Letter to her firm INCELL Corporation Read More »
Biologist and ancient DNA expert Beth Shapiro is becoming more well known for doing de-extinction research. Yet Shapiro used to be a de-extinction skeptic. Ten years ago she wrote “How to Clone a Mammoth.” In the book she mentioned serious challenges related to de-extinction. Now she is the CSO for a firm trying to make
Weekly reads: Beth Shapiro & de-extinction, mice with two dads, stem cell patches Read More »
What are possible side effects of stem cell therapy ? Patients often reach out to ask about such risks They usually refer to unproven stem cell clinics. Today’s post addresses the scope of stem cell therapy side effects and risks based on available hard data. It’s also important to discuss possible unknown risks. I have
Stem cell therapy side effects & risks at clinics Read More »
How seriously should we take tech bro manifestos? Also, what do the tech bros — the billionaires and centimillionaires who made their fortunes founding, running, or investing in tech companies — have to say specifically about the future of biology including regenerative medicine and stem cell research related to AI? A fair bit, as it
Tech Bro Manifestos, AI, and the Future of Biology (& Stem Cells) Read More »
What are the current FDA-approved cell and gene therapies? How many of those involve true stem cells? Many of us have wished for a more specific list of FDA-approved stem cell therapies. Patients and fellow scientists often asked me about such lists. They even wish for annotated lists. For that reason, I’ve made and kept
Updated 2025 List of FDA-Approved Cell and Gene Therapies Read More »