Breakthrough Therapy Designation: Successes, Lessons Learned and Future Strategies
Tuesday, April 12, 2016 – 12:30pm-2:00pm
Capitol Visitor’s Center, Room SVC 212-10
Washington, DC 20515
A Friends of Cancer Research Senate Briefing on the FDA’s breakthrough therapy designation
Limited space is available.
Opening Keynote by Senator Michael Bennet (D-CO)
Janet Woodcock, Director, Center for Drug Evaluation and Research, FDA
Ellen Sigal, Founder and Chair, Friends of Cancer Research
Mathias Hukkelhoven, Senior VP, Global Regulatory, Bristol-Myers Squibb
David Ross, Senior Director, Global Pharmaceutical Affairs, Abbvie
Stephanie Dunn Haney, Patient Advocate
Kate Rawson, Contributing Editor, Prevision Policy
The FDA began granting the breakthrough therapy designation in 2012 to drug development programs for serious and life-threatening diseases that showed promising early clinical evidence of improvement over available therapy. Since that time, FDA has granted over 100 designations and approved over 30 products under the program.
This 90-minute briefing will explore multiple stakeholders’ experience with the breakthrough therapy designation, as well as preliminary evidence of the designation’s impact on oncology development programs. Participants will also have a chance to discuss the role of the breakthrough therapy designation outside of the field of oncology and looking forward, how the program can evolve to incorporate lessons learned in its first years of existence.
Friends is releasing research on the trends of the breakthrough therapy designation in oncology published in the March issue of Nature Reviews Drug Discovery, entitled “Regulatory Watch: Impact of breakthrough therapy designation on cancer drug development.”
Lunch will be provided.