Welcome to Regenerative Medicine Guru – the knowledge portal to help regenerative medicine products reach the clinic sooner.
Greetings, I’m Darin Weber and I occasionally post my thoughts on the Regenerative Medicine Guru blog. By the way, I recognize I’m not a ‘guru’ when it comes to all things regenerative medicine, no one is. It is a catchy title for a blog, though don’t you think? However, I do hope that in some small way the information you will find on this blog will help you in your own quest to become a guru in whatever branch of science and/or technology that touches upon regenerative medicine.
My primary goals are to provide some practical information about interacting with regulatory authorities, particularly the U.S. Food and Drug Administration (FDA). Consequently, from time to time I intend to post information I hope will help you become more informed about:
- How scientific research in regenerative medicine is translated into a medical product to benefit patients
- What activities and data are needed to satisfy the requirements of regulatory authorities, such as the U.S. Food and Drug Administration (FDA), so my regenerative medicine product can be administered to patients
- How regenerative medicine products are regulated in the United States
- Some of the common stumbling blocks in the development of regenerative medicine products that can delay or even doom successful commercialization
- The pros and cons of engaging a consultant to work on your regenerative medicine product.
Most of the information you see on this blog comes from my experience as both a product development consultant and from my experiences at the FDA. I hope that by making this information freely available, it will benefit your efforts to successfully develop regenerative medicine products for patients with unmet medical needs.
I would be less than honest if I didn’t state, that a secondary goal of this blog is to showcase my experience in this area and to encourage you to contact me if you have a specific consulting need that I can assist you with.
About Darin Weber
When I’m not blogging about development of regenerative medical products, I work as a Senior Consultant for the Biologics Consulting Group, Inc (BCG), working on specific projects for clients in the field of regenerative medicine. Prior to joining BCG, I spent 7 years at the Center for Biologics Evaluation and Research (CBER) at the U.S. FDA. During my time at the FDA I was very fortunate to work as a FDA reviewer working primarily on cell and tissue based products as well as biologic-device combination products (tissue engineering). If you want to know more about what I did at the FDA please see my curriculum vitae for specific information on my professional qualifications.
If you have suggestions or comments for the Regenerative Medicine Guru blog, please contact me at dweber [at] regenmedguru.com. If you are looking for a consultant in this area, please contact me using the contact form on BCG’s website, which actually works.