Califf's FDA reforms and Polaris' Schulman

FDA Commissioner Rob Califf’s biggest legacy could be his reform of the agency’s advisory committee process — that is, if he can build enough consensus among agency leaders to drive meaningful change, said Washington Editor Steve Usdin on the latest BioCentury This Week podcast.

Usdin and colleagues discuss the aspects of the U.S. regulator’s advisory committee process where there is the most and least agreement on needed changes, and what could make this time different from a lengthy history of calls for change. 

BioCentury’s editors preview an upcoming discussion with Polaris Partners’ Amy Schulman on the VC’s interest in Singapore, the funding environment, and what progress there is – and isn’t – being made in women in leadership.

Usdin also discusses why it won’t be simple to reimburse the recently approved Duchenne muscular dystrophy gene therapy from Sarepta Therapeutics Inc. (NASDAQ:SRPT) through state Medicaid plans.