The 2009 Conference on Clinical Cancer Research, hosted by the Engelberg Center for Health Care Reform and Friends of Cancer Research, brought together distinguished members of the cancer community for in-depth discussions of critical issues at the intersection of clinical research and policy.
The all-day event on September 14 convened leaders from the National Cancer Institute (NCI), academia, patient advocacy organizations, the Food and Drug Administration (FDA), and various industry organizations, to discuss specific research and policy issues, as well as build consensus around solutions to critical questions regarding the future of clinical cancer research.
Opening remarks were delivered by NCI Director John Niederhuber, with keynote remarks offered by FDA Commissioner Margaret Hamburg. Interactive panel discussions focused on optimal data collection for clinical trials, development and approval of targeted therapies, and development of combination therapies targeting multiple pathways.
Agenda
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September 14
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Welcome
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 OncologyGwen Fyfe ConsultantJeffrey Abrams National Cancer InstituteRobert Erwin Marti Nelson Cancer FoundationRobert Temple Deputy Director for Clinical Science, Center for Drug Evaluation and Research - U.S. Food and Drug Administration -
Panel 2: Blinded Independent Central Review of PFS Endpoints
Moderator: Daniel Sargent Mayo ClinicWill Bushnell GlaxoSmithKlineOhad Amit GlaxoSmithKlineLori Dodd National Institute of Allergy and Infectious DiseasesNancy Roach C3: Colorectal Cancer CoalitionRichard Padzur Food and Drug Administration -
Keynote Address
Introduction: Ellen Sigal Friends of Cancer ResearchMargaret Hamburg Commissioner - U.S. Food and Drug Administration -
Panel 3: Accelerating Development and Approval of Targeted Cancer Therapies
Anna Barker National Cancer InstituteDavid Epstein NovartisCo-Moderator: Stephen Friend President, Sage BionetworksCindy Geoghegan Patient and PartnersDavid Sidransky The Johns Hopkins University School of MedicineRaymond Woosley Critical Path InstitutePatricia Keegan Food and Drug Administration -
Panel 4: Development of Two Novel Therapeutics Targeting Multiple Pathways
Moderator: Charles Erlichman Mayo ClinicAdam Clark Director, Scientific and Federal Affairs, Faster CuresMatthew Ellis Washington University in St. LouisStuart Lutzker GenentechJames Zwiebel National Cancer InstituteJanet Woodcock Director, Center for Drug Evaluation and Research - US Food and Drug Administration -
Summary and Closing Remarks
Mark B. McClellan Former Brookings Expert, Director, Margolis Center for Health Policy - Duke University
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