Under the Breakthrough Therapy designation, enacted as part of FDASIA, FDA has been working to expedite development and review of drugs that show “substantial improvement” over existing therapies for serious and life-threatening diseases.

As we approach its first birthday, what has been accomplished under Breakthrough Therapy? Catalyst President Nancy Bradish Myers will moderate a panel on June 25 exploring experiences thus far, lessons learned and how these lessons could inform new regulatory changes intended to spur innovation. Panelists will include Earl Dye, Director of Technical Regulatory Policy & Strategy at Genentech; Jeff Allen, Friends of Cancer Research Executive Director; and Urte Gayko, Senior VP Global Regulatory Affairs at Pharmacyclics.
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