Opening Plenary Lunch: A High-Speed Option at the FDA: Lessons from Veterans of the Breakthrough Therapy Designation Process

Tuesday, October 7, 2014 | 12:00 p.m. - 1:25 p.m. | Twin Peaks North/South

The Breakthrough Therapy Designation (BTD) program instituted under the Food and Drug Administration Safety and Innovation Act (FDASIA) of 2012 has produced its first set of accelerated approvals under this program, dramatically cutting time to market for some cancer, cystic fibrosis, and hepatitis C therapies. The FDA so far has granted BTD status to more than 50 applications; however, that amounts to only about 30% of requests. Research suggests that the advantages vary significantly across therapeutic areas. Our panelists will discuss the characteristics of successful applicants, what lessons they learned from their BTD program experience, and what advice they would give companies seeking to apply.