The FDA is faced with years of a static budget and a rapidly growing stem cell and cell therapy for-profit sector. It also faces criticisms (some that it has acknowledged are legit) from certain folks in the stem cell field. If you could change just one thing about the FDA in terms of its oversight …
What Would be Your #1 Top FDA Reform on Stem Cells? Take our poll Read More »
Allan Robins of Viacyte (pictured at left–sorry for the fuzzy image) and Paul Simmons of Mesoblast presented this morning at the CIRM Grantee Meeting. Both talks were outstanding. Robins went first. He started by saying how Viacyte had a productive pre-IND meeting with the FDA last year. I believe a target for them is to …
It is always exciting when a biomedical technology as revolutionary as iPS cells is on the cusp of being used in patients for the first time. In the last few days stories have reported about how a proposed clinical trial based on iPS cells has completed several regulatory steps and is closer to starting. This …
A big issue in the stem cell field is that firms increasingly are doing business in multiple countries. Associated with the increasingly international nature of the stem cell for-profit industry are emerging legal and ethical issues related to the transport of stem cell-based biological drugs across international borders. Think you can just FedEx human stem …
I requested of Celltex a copy of the email/letter that they recently sent to their patients. They kindly provided me a copy, which you can read here (snap shot of beginning is above). Thank you, Celltex! I also asked Celltex some questions regarding their plan to start having patients treated in Mexico. Unfortunately, they have …
Celltex on the move: full copy of letter to patients, new slogan, and new video Read More »
In previous years I’ve done yearly predictions for the coming year’s events in the stem cell world (see predictions for 2011 and 2012 predictions). I did pretty well in my predicting stem cell events for this year (see analysis here) scoring a respectable 70%. Isn’t that a C-?,you might ask. No, when it comes to …
My blog’s Stem Cell Person of the Year Award process has gotten off to a very exciting start. I have an amazing bunch of nominees and about 1000 votes were case in about 12 hours. Based on some discussions with people yesterday, I believe a few clarifications are needed about the process: The award is …
Some important rules for Stem Cell Person of the Year Award: please read carefully Read More »
The notion of caloric restriction (CR) as a means to prolong human life is intriguing. The basic idea of CR is that if you eat a lot less than the average person you’ll live longer. You might even live a higher quality, healthier life. But is this true? (update: see my newer post on 5 …
Caloric restriction: dieting monkeys teach human scientists? Read More »
Clinicaltrials.gov is where you want to go for finding a certain clinical trial and studies. Note that this U.S. database Clinicaltrials.gov includes international trials. It is a very powerful tool! Check it out here to do your own searches. Also follow me on Twitter for all the latest info and expert analysis: http://twitter.com/pknoepfler and this patient’s …
Tool to easily search for a stem cell clinical trial for your disease Read More »
A major scandal has erupted further regarding FDA monitoring of its scientists’ emails as reported by the NY Times. The FDA spied on the emails of its own scientists and other scientists. Some of the emails also involved correspondence with Congress and even the White House. Regardless of one’s position on what the FDA did, …