The Knowledge Portal to Help Regenerative Medicine Products Reach the Clinic Sooner
February 19th, 2009 — FDA, OCTGT
I usually avoid commenting on current events occurring in the field of regenerative medicine, primarily because I can’t keep up! In this case, I believe the recent publication by Amariglio et al, has FDA regulatory implications for the clinical development of therapies based on stem cells. The under-lined portion of the title of the publication says it all:
“Donor-Derived Brain Tumor Following Neural Stem Cell Transplantation in an Ataxia Telangiectasia Patient”
December 28th, 2008 — 4Rs, FDA, GTPs, OCTGT
2008 was an extremely busy year for me, as I am sure it was for you as well. The net result is that I have been slow to post updates and thoughts regarding translation of regenerative medicine products to the clinic. In the ‘better late than never” category, I thought I would share some of the presentations and relevant articles I have written over the past year.
Links are provided for most of the presentations and articles I have generated over the past year.
October 1st, 2007 — 4Rs, combination product, FDA, OCTGT, tissue engineering
My favorite working definition for regenerative medicine is any medical intervention that is intended to repair, replace, restore or regenerate (the 4 R’s) the cellular, tissue or organ systems in the human
body. As described by one of my former FDA colleagues, Dr. Steven Bauer, cellular therapies represent one branch of regenerative medicine that on their own can fulfill the 4 R’s. However, it is clear that many other medical technologies will contribute to the field of regenerative medicine. See my post on how the FDA views the world of regenerative medicine.
July 1st, 2007 — combination product, FDA, GTPs, OCTGT, tissue engineering
A major focus of the Regenerative Medicine Guru Blog is the development of new medical interventions based on regenerative medicine.
Therefore, it is important to understand how the ‘gatekeepers’ view this field. In the U.S., the Food and Drug Administration (FDA) is the key gatekeeper. You may be surprised to learn that there is not a specific regulatory pathway spelled out for regenerative medicine products.
Instead, the FDA’s approach is to examine each specific regenerative medicine product and determine the regulatory pathway based on the most important component(s) of the regenerative medicine product. To accomplish this, the FDA essentially conducts a thought experiment in which the regenerative medicine product is ‘de-constructed’ in order to identify the key components and ask the question, which component(s) are most important in providing benefit to the patient.