KKB Partner Kinsey S. Reagan will be speaking at the American Conference Institute’s (ACI’s) 35th FDA Boot Camp being held March 24-25, 2020, at the DoubleTree by Hilton Metropolitan, in New York, NY. ACI’s FDA Boot Camp is a “go-to” program for pharmaceutical professionals looking to obtain a deep understanding of the fundamentals of FDA law and regulation.
Mr. Reagan’s presentation titled “Exploring the Expedited Approval Process: Applicability and Eligibility,” will provide insight into the pros and cons of the expedited approval pathways, including accelerated approval, breakthrough therapy, surrogate end points, fast track, and priority review. This session will give professionals an in-depth understanding of how to factor expedited approval into drug development strategy.
More information on the ACI FDA Boot Camp and Mr. Reagan’s session can be found here.