Why the FDA May Need to Rethink Its Approach to Gene and Cell Therapy


Manage episode 187558982 series 49047
By Discovered by Player FM and our community — copyright is owned by the publisher, not Player FM, and audio streamed directly from their servers.
Regenerative medicine is rapidly moving from the lab to the clinic, but as life-saving therapies advance to the marketplace, there are questions about whether the U.S. Food and Drug Administration needs to modernize its regulatory approach to gene and cell therapies. We spoke to Michael Werner, executive director of the Alliance for Regenerative Medicine, about the state of the industry, the regulatory environment today, and whether it will ultimately be payers who are more demanding of data to convince them of the worth of a therapy.

215 episodes available. A new episode about every 7 days averaging 23 mins duration .