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Big change for stem cell field with FDA quickly issuing RMATs

May 5, 2017 / Professor Paul Knoepfler, Ph.D. / 2 Comments

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 […]

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Is transactional science kicking transformative science’s butt?

August 13, 2014 / Professor Paul Knoepfler, Ph.D. / 2 Comments

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

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Transformative idea for peer review: reviewing & grading the reviewers

July 9, 2012 / Professor Paul Knoepfler, Ph.D. / 7 Comments

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

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Dr Lookgood, dermatologist to the stars, gets FDA warning letter

March 29, 2012 / Professor Paul Knoepfler, Ph.D. / 3 Comments

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

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ISCT launches new resource on unproven cell & gene therapies

October 3, 2024 / Professor Paul Knoepfler, Ph.D. / 1 Comment

The International Society for Cell & Gene Therapy or ISCT is a great organization in our field. They have launched a new guide to help healthcare providers navigate this complex area. Click on the image below to check it out. This new resource is important because healthcare providers, researchers, and the public need authoritative information.

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Big spike in FDA warning letters to unproven biologics firms

October 1, 2024 / Professor Paul Knoepfler, Ph.D. / 2 Comments

Dr. Peter Marks, Director of CBER, FDA warning

This year already appears to be a record one for cell and tissue therapy-related warning letters the FDA. Directly or indirectly, these come from the FDA’s Center for Biologics Evaluation and Research or CBER. Something unusual seems to be happening. FDA’s CBER has been exceptionally active in 2024 including on cell & tissue products I’ve

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Neuralink on the brain: another person gets implant

August 8, 2024 / Professor Paul Knoepfler, Ph.D. / 3 Comments

Neuralink has had a rollercoaster ride in the last few years with many ups and downs. They just recently deployed a brain implant into a second clinical trial participant. So it’s a good time to update where things stand. This more general area of science is often called brain-computer interface (BCI) research. The implants are

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On the road to Cylons? Robots with human brain tissue reported

July 9, 2024 / Professor Paul Knoepfler, Ph.D. / Leave a Comment

What if we could make robots that possess human brain-like structures? Chinese scientists have reportedly made such robots that are each guided at least in part by a small amount of lab-grown brain tissue. These cyborg-like creations, which are being trained to perform specific tasks, also have standard computer chips. How much does the human

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Google AI overviews on stem cells are a bust so far & endanger public health

May 22, 2024 / Professor Paul Knoepfler, Ph.D. / 8 Comments

I’ve been wondering how the new Google AI overviews feature on its search platform would turn out for various stem cell searches. Frankly, I had a bad feeling that Google was going to blow this. Unfortunately, it seems even worse than I anticipated. Let’s go through three examples and talk about why this is so

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