August 15, 2020

The Niche

Knoepfler lab stem cell blog

Search Results for: stem cell field

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

2 min read

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 how this would play out in terms of how quickly the FDA would give RMAT designations and to how many investigational products. Already it’s clear the FDA seems to …Read More

2 min read

Blood testing biotech Theranos finds itself in a hole that seemingly just keeps getting deeper with the report today that the company is under criminal investigation. Can it bounce back? Some people are really upset with Theranos for allegedly making misleading statements including both to investors and the government about its technologies. It’s no exaggeration to call this an uproar. However, if you think about it, what Theranos is alleged to have done is not so unusual. If one looks at medical testing and …Read More

1 min read

Paolo Bianco reportedly has died at age 60. This is terribly sad news and a huge loss for the stem cell community. Paolo made great contributions both in the science of stem cells itself and also in the area of advocating for responsible science. It is challenging to do both and he did it incredibly well. Last year he received the ISSCR Community Service Award along with Elena Cattaneo and Michele De Luca for their work in Italy on the very difficult Stamina crisis. …Read More