Regenerative Medicine: Key Developments in Regulation & Commercialization

 November 29, 2012  

Hosted by Squire Sanders LLP

Washington, DC, 11:00 am E.T. | San Francisco, CA, 8:00 am P.T.

This Conference is being held via live satellite between Washington, DC and San Francisco, joining East and West coast speakers and participants. Choose your location during the registration process. 

Audience: Human and Veterinary Medicine, Drugs, Biologics, Medical Devices

Course Level: Intermediate/Advanced

This video is for background and educational purposes about the subject matter of FDLI's conference on regenerative medicine. This conference is not endorsed by CBS News or 60 Minutes.

If you are having difficulty viewing the full video, it is also available on the CBS News Web Site.





Program Description

The use of regenerative therapies is growing exponentially in the United States and internationally. No longer is regenerative medicine limited to test tube experiments, nascent pilot studies and parlor political debates about stem cells; today, it’s on the cutting edge of health care and personalized medicine. Regenerative medicine involves an array of advanced therapies that allow the body to repair, replace, restore and regenerate damaged cells, tissues, genes and organs. This conference focused on FDA’s current and evolving regulation of veterinary and human regenerative products, the agency’s new product approval pathway; and successful corporate strategies for the commercialization of products in this burgeoning area. Attendees learned about factors to consider when bringing a veterinary or regenerative medicine product to market and developed a better understanding of FDA’s labeling, promotional and advertising requirements applicable to the market and sale of regenerative products. Attendees also learned about the essential patent rules and pertinent regulatory issues related to commercializing products, including product qualification for appropriate government incentives and strategies to secure research and development funding.

This conference was designed for professionals and regenerative medicine stakeholders in regulatory affairs, legal and compliance departments at vet med, drug and biologics firms; start-up biotech companies, veterinarians, academics, government representatives and consultants. 

Companion Product

Personalized Medicine: Prescriptions and Prospects by Joanne Hawana and Deborah Runkle

Personalized medicine means targeting the right treatment to the right patient. It encompasses pairing state-of-the-art diagnostics with drug development and raises issues related to bioethics, reimbursement, professional and patient education, regulation, and public policy. This book, published by The Food and Drug Law Institute in partnership with the American Association for the Advancement of Science, discusses these facets of personalized medicine in an accessible, user-friendly way. The book is designed for professionals in all areas of the healthcare industry, to give a broad-based understanding of the scope, impact and reach of personalized medicine as well as of the challenges that lie ahead as we move forward into this exciting new era of medical care.

Publication Pricing

$ 129 Member
$ 179 Non-Member