One of the big stem cell-related stories of 2013 was the controversy over the Stamina Foundation in Italy and its potential use of largely untested stem cell products on patients, including mostly children. The winner of my 2013 Stem Cell Person of the Year Award was Dr. Elena Cattaneo and one reason she won was the courage […]
Nature Slams Controversial Stamina Foundation: A Dangerous Situation Continues Read More »
Today’s post is an interview I did with Dr. Van Bokkelen covering 10 questions. Dr. Gil Van Bokkelen is Chairman and CEO of Athersys, Inc., a company that has focused heavily on stem cells and regenerative medicine for more than a decade. For more on Dr. Van Bokkelen’s background see additional bio section at the end of
Interview with Gil Van Bokkelen of Athersys Read More »
Over the last few weeks, I have enjoyed talking with and interviewing Dr. Allan Wu, of The Morrow Institute on stem cell cosmetic procedures. I was impressed greatly by his talk at the World Stem Cell Summit last year. Dr. Wu is a fellowship trained Surgical Molecular Biologist with a background in Molecular Embryology and a board
Interview with Regenerative Surgeon, Dr. Allan Wu Read More »
The FDA has a new CBER Director Dr. Vinay Prasad. CBER is the FDA’s biologics branch that handles things like cell therapies and vaccines. The branch has been in near-constant upheaval this year. For a time, Scott Steele was acting CBER Director. It wasn’t clear if he was there in a temporary capacity or would
FDA critic Vinay Prasad to run CBER: more politics than experience? Read More »
The Trump Administration just quickly gutted the FDA including key leadership. What is going to be the impact of this sudden purge? Former Commissioner Robert Califf recently said it is the end of the FDA as we’ve known it. Those are dramatic words, but they seem on the money to me. As a biomedical scientist
Why the FDA & CBER leadership purge will be so bad for biotech Read More »
Most of us want longevity, especially if our quality of life remains generally solid as we age. The combination of length and quality of life is sometimes called “healthspan.” How do we get the maximum health span? Easier said than done. Not all of the obstacles are biological either. Unfortunately, accompanying all the legitimate research
Weekly reads: Topol on longevity biz, Peter Marks out at FDA, timeless NIH grant advice Read More »
I recently looked at the organizational chart at the FDA’s Center for Biologics Evaluation and Research or CBER. Why? I have been anticipating some possible big changes there with the new administration. After all, with HHS Secretary RFK Jr. having previously claimed that the FDA was suppressing various unproven things including at least two kinds
Weekly reads: CBER changes, Parkinson’s, 2-dad mice, NIH woes continue Read More »
There were many reasons for the U.S. Senate not to confirm RFK Jr. as HHS Secretary. Reasons that transcended politics. Nonetheless, Senate Republicans confirmed him today for that post. Some of them had voiced serious concerns before including one physician Senator, Dr. Bill Cassidy, but they all voted for Kennedy anyway. All except Mitch McConnell,
Initial reactions to RFK Jr. being HHS Secretary Read More »
What is Chara Biologics? Why did the FDA just warn them and another firm? FDA’s CBER keeps up fast pace of warnings Before we get into that, the FDA biologics branch, CBER, has more generally kept up an unprecedented pace of warning letters over the past 13 months. I wrote late last year how 2024
Platelet-rich plasma or PRP has become one of the most commonly used regenerative products at unproven clinics. The orthopedics departments at many universities are now offering PRP as well. What is behind this trend? How much data are there to back up all this enthusiasm for platelet-rich plasma? The goal of this post is to
2025 PRP fact-check and review: cost and possible benefits Read More »