Entries Tagged 'tissue engineering' ↓

Stem Book – An Excellent Information Resource

For anyone looking for a credible source of information on stem cell biology, I highly recommend checking out StemBook from the Harvard Stem Cell Institute. As is states on it’s website:

Stem Book is an open access collection of invited, original,
peer-reviewed chapters covering a range of topics related to stem cell biology written by top researchers in the field at the Harvard Stem Cell Institute and worldwide

The site covers a variety of topics ranging from basic stem cell biology, to potential therapeutic uses.  Granted, most of the information is from a basic research and academic perspective, but I think it  could be a potentially useful resource resource for those wearing product development hats.  For example the section on genomics and proteomics provides a sense of the possibilities for characterization of stem cells and therapies derived from stem cells that regulatory authorities are always interested in.  Hope you find it useful as well.  If you are aware of other  useful websites on stem cells and/or regenerative medicine, please let me know in the comments.


What the Heck is a Regenerative Medicine Therapy?

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 human4Rs.jpg 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.

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How Does the FDA View the World of Regenerative Medicine?

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.

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FDA Regulation of Regenerative Medicine Products

Welcome to the Regenerative Medicine Guru Blog

The focus of this blog will be to provide information on how regenerative medicine products are regulated in the U.S.

It is intended to be a knowledge portal for those interested in the development of regenerative medicine.

We will go in depth into the process to successfully develop a regenerative medicine product in the U.S. including common pitfalls to avoid.

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