Consensus among stakeholders is needed to find solutions to critical questions regarding the future of clinical cancer research. Throughout this day-long conference, panelists sought to address this challenge, discussing pressing scientific and regulatory challenges and opportunities for progress in innovations in cancer therapy. The first three panels discussed options for clinical data standards, alternative methods for demonstrating the efficacy of promising therapies, and approaches to the joint development of cancer drugs and diagnostic tests. The final panel explored the vision for the future of FDA – looking at how FDA can guide innovation and respond to the challenges of a quickly advancing field.
Featured panelists included Dr. Mark McClellan, Dr. David Kessler, Dr. Ellen Sigal, Dr. Janet Woodcock, and others representing the industry, advocacy, regulatory, and academic and government research communities. NCI Director Dr. John Niederhuber made opening remarks, and FDA Commissioner Dr. Andrew von Eschenbach delivered a luncheon keynote address.
The event was convened by the Engelberg Center for Health Care Reform at Brookings in conjunction with the American Society of Clinical Oncology (ASCO), the American Association for Cancer Research (AACR), and Friends of Cancer Research hosted the Conference on Clinical Cancer Research.
Meeting Materials:
Panel 1 Issue Brief »
Panel 2 Issue Brief »
Panel 3 Issue Brief »
Agenda
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September 26
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Welcome and Introductions
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke UniversityJohn Niederhuber Director, National Cancer Institute -
Panel 1: Data Submission Standards and Evidence Requirements
Richard Schilsky Chief Medical Officer - American Society of Clinical OncologyJeffrey Abrams National Cancer InstituteGwen Fyfe ConsultantRobert Erwin Marti Nelson Cancer FoundationJanet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug Administration -
Panel 2: Improved Insights into Effects of Cancer Therapies
Moderator: Raymond DuBois, MD M.D. Anderson Cancer CenterJim Doroshow, MD, FACP National Cancer InstituteDebasish Roychowdhury, MD GlaxoSmithKlineNancy Roach C3: Colorectal Cancer Coalition -
Luncheon Keynote
Andrew von Eschenbach Commissioner, FDA -
Panel 3: Co-Development of Diagnostics & Therapeutics
Moderator: Daniel Hayes, MD University of MichiganRaymond Woosley Critical Path InstituteRichard Simon, DSc National Cancer InstituteNancy Roach C3: Colorectal Cancer Coalition -
Panel 4: Vision for the Future of FDA
Moderator: Robert Young, MD Fox Chase Cancer CenterMark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke UniversityAnna Barker National Cancer InstituteDavid Epstein NovartisEllen Sigal, PhD Friends of Cancer Research -
Final Questions & Closing Comments
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
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