A FOIA request that I made with the FDA in mid-December 2012 has at long last revealed letters from Celltex to the FDA that previously were not in the public domain. The reason for the FOIA and for these blog posts is to shed some light on important issues that particularly relate to patient safety. I …
When you want to both know the real history of the pluripotent stem cell-based biotech industry and perspectives on its future, there are only a handful of people to turn to and one of them is definitely Dr. Michael West, CEO of BioTime. I’m doing a several part series of blog posts on a lengthy …
BioTime CEO Mike West Interview Part 2: Geron & hESC Read More »
It was my pleasure recently to talk at length with Dr. Michael West, CEO of the Stem Cell Biotech, BioTime (BTX). West has been at the helm of BioTime since 2007 and is a true pioneer in the stem cell field. He founded Geron (GERN) and was a top leader at Advanced Cell Technology (ACT; stock …
Interview with BioTime CEO Michael West Part 1: a little stem cell history Read More »
By Dr. Susan Lim A record 4100 delegates attended the 11th Annual Meeting of the International Society for Stem Cell Research (ISSCR), held at the Convention and Exhibition Center in Boston from 12-15 June 2013. Co-sponsored by the Harvard Stem Cell Institute, the Meeting featured 7 Plenary sessions including a Presidential Symposium, 20 concurrent scientific …
Delightful overview of ISSCR 2013 by guest blogger Dr. Susan Lim Read More »
Over at the Harvard Law “Bill of Health” blog, Mary Ann Chirba and Alice A. Nobel posted a piece entitled “Our Bodies, Our Cells” a few days ago that has generated a lot of discussion about FDA regulation of stem cell interventions. Their piece really has two parts. In the first part they go through …
My response to ‘Our Bodies, Our Cells’ Harvard post on deregulation 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 …
It’s difficult to make it as a biotech company, I would say stem cell biotechs in general may have an even rougher time, and one such company, Intellicell (Intellicell Biosciences, Inc), is showing a number of signs of distress in my opinion. An online financial tool predicts the probability of companies going bankrupt within the next …
Stem cell company Intellicell facing new financial wrinkles Read More »
One of the more exciting stem cell biotechs out there today is Advanced Cell Technology (ACT). At this time ACT has the only two ES cell-based FDA-approved clinical trials ongoing and so far they have looked quite promising in terms of preliminary safety data. However, ACT has much more in the pipeline including potentially iPS …
Interview with Gary Rabin of Advanced Cell Technology (ACT) Read More »
Back-to-back papers (here and here) in Nature Biotechnology report the transdifferentiation (now often simply referred to as “direct reprogramming”) of plain old fibroblasts into brain cells called oligodendrocyte progenitor cells (OPCs). OPCs are a remarkably useful kind of brain cell that generates myelin, which insulates nerves. OPCs are thought to have great therapeutic potential for …
It has been a tough year for Korean stem cell biotech RNL Bio in my opinion. It is involved in litigation with former patients and its former partner, Celltex. It is also reportedly under investigation by the Korean Government for alleged stem cell smuggling. The stock of this publicly-traded company has also been battered. On …