Friends-Brookings Conference on Clinical Cancer Research

Friends of Cancer Research & the Brookings Institute:
November 14, 2012 – 8:30am- 3:00pm – The Washington Marriott – Washington, DC
Morning Keynote: Harold Varmus, M.D., Director, National Cancer Institute
Afternoon Keynote: Margaret Hamburg, M.D., Commissioner, U.S. Food and Drug Administration

 Panel One: Re-evaluating Criteria for Accelerated Approval

  • Cheryl Jernigan, CPA, FACHE, Scientific Advisory Board, Susan G. Komen for the Cure
  • David Schenkein, M.D., Chief Executive Officer, Agios Pharmaceuticals
  • Richard Schilsky, M.D., Professor of Medicine, University of Chicago
  • Wyndham Wilson, M.D., Ph.D., Head, Lymphoma Therapeutics Section, National Cancer Institute
  • Janet Woodcock, M.D., Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration

In order for a potential new therapy to qualify for the accelerated approval pathway, the drug must treat a serious disease for which there is “unmet medical need”– defined as providing a therapy where none exists or providing a therapy which may be potentially superior to existing therapy. For some life-threatening cancers, many approved therapies may exist but are marginally effective. Currently, drug sponsors who wish to use the accelerated approval pathway typically test their product in patients who have become refractory to all other options, despite the fact that more heavily pre-treated patients are often less likely to respond to a new therapy. This panel will discuss ways to promote the use of the accelerated approval pathway in earlier disease settings.

 

Panel Two: Developing Standards for Breakthrough Therapy Designation

  • Daniel Haber, M.D., Ph.D., Director, Cancer Center, Massachusetts General Hospital Sandra Horning, M.D., Senior Vice President, Global Head, Clinical Development Hematology/Oncology, Genentech
  • Percy Ivy, M.D., Associate Branch Chief, Investigational Drug Branch, CTEP, National Cancer Institute
  • Charles Sawyers, M.D., Chair, Human Oncology and Pathogenesis Program, Memorial Sloan-Kettering Cancer Center
  • Wendy Selig, President and CEO, Melanoma Research Alliance
  • Robert Temple, M.D., Deputy Director for Clinical Science, U.S. Food and Drug Administration

In follow-up to the 2011 session, Development Paths for New Drugs with Large Effects Seen Early,The Advancing Breakthrough Therapies for Patients Act was proposed to expedite development of new, potential “breakthrough” drugs or treatments that show dramatic responses in early phase studies. In this regulatory pathway, once a promising new drug candidate is designated as a “Breakthrough Therapy”, the FDA and sponsor would collaborate to determine the best path forward to abbreviate the traditional three-phase approach to drug development. While potential abbreviated and condensed trial designs were proposed in the 2011 session, this year’s panel will focus on defining the criteria necessary to define a product as a Breakthrough Therapy.