Workshop on Combination Therapy for Cancer: Opportunities and Obstacles for Future Development
July 29, 2006
Doubletree Hotel
Rockville, MD
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Leadership Perspectives on Biologic Combinations
Perspectives from NCI
Perspectives from FDA
Perspective from EORTC
Perspectives from NCI
Robert Wiltrout, PhD - National Cancer Institute
Perspectives from FDA
Raj Puri, MD, PhD - Food and Drug Administration
Perspective from EORTC
Alexander Eggermont, MD, PhD - Erasmus University Medical Center
Opportunities and Obstacles to Developing Novel Biologic Combinations
Academic Perspective
Industry Perspective
Regulatory Perspective
Academic Perspective
Michael Atkins, MD - Beth Israel Deaconess Medical Center
Industry Perspective
Geoffrey Nichol, MD, MBA - Medarex, Inc.
Regulatory Perspective
Steven Hirschfeld, MD, PhD - Food and Drug Administration
State of the Art
State of the Art 1: Combination Immunotherapy
State of the Art 2: Combination Immune-Antiangiogenic Therapy
George Coukos, MD, PhD - University of Pennsylvania
Ralph Reisfeld, PhD - Scripps Research Institute
State of the Art 3: Combination Immune Therapy-Modulator of Apoptosis
State of the Art 4: Combination Immune Therapy-Chemotherapy
John Kirkwood, MD - University of Pittsburgh Cancer Institute
State of the Art 1: Combination Immunotherapy
Lead Presenter: Thomas Gajewski, MD, PhD - University of Chicago
Panel:
James Allison, PhD - Memorial Sloan-Kettering Cancer Center
Drew Pardoll, Md, PhD - Johns Hopkins University School of Medicine
Jon Wigginton, MD - Merck
Lead Presenter: Kim Margolin, MD - City of Hope
Kim Margolin, MD - City of HopePanel:
George Coukos, MD, PhD - University of PennsylvaniaRalph Reisfeld, PhD - Scripps Research InstituteRobert Wiltrout, PhD - National Cancer Institute
State of the Art 3: Combination Immune Therapy-Modulator of Apoptosis
Lead Presenter: Craig Slingluff, Jr., MD - University of Virginia
Panel:
James Finke, PhD - Cleveland Clinic Foundation
Crystal Mackall, MD - National Cancer Institute
James Mier, MD - Beth Israel Deaconess Medical Center
State of the Art 4: Combination Immune Therapy-Chemotherapy
Lead Presenter: Elizabeth Jaffee, MD - Johns Hopkins University
Panel:
Jared Gollob, MD - Duke University
John Kirkwood, MD - University of Pittsburgh Cancer InstituteJames Yang, MD - National Cancer Institute
Facilitated Concurrent Breakout Sessions
Breakout 1: Scientific Barriers to Investigation of Novel Combinations
Breakout 2: Clinical Trial Design and Development of Combinations
Breakout 3: Regulatory Issues and the Development of Combinations
Breakout 4: Intellectual Property Barriers to the Development of Combinations
Breakout 1: Scientific Barriers to Investigation of Novel CombinationsLeaders:
Bernard Fox, PhD - Earle A. Chiles Research Institute
Michael T. Lotze, MD - University of Pittsburgh
William Murphy, PhD - University of Nevada School of Medicine
Nicholas Restifo, MD - National Cancer Institute
Breakout 2: Clinical Trial Design and Development of Combinations
Leaders:
Rachel Humphrey, MD - Bristol Myers-Squibb Company
Carl H. June, MD - University of Pennsylvania
Ulrich Keilholz, MD - Charité, CBF, Berlin
Walter Urba, MD, PhD - Earle A. Chiles Research Institute
Breakout 3: Regulatory Issues and the Development of Combinations
Leaders:
Jeffrey Weber, MD, PhD - Norris Cancer Center
Ashok Batra, MD - Food and Drug Administration/CBER
Alexander Eggermont, MD, PhD - Erasmus University Medical Center
David Ross, MD - Food and Drug Administration/CDER
Breakout 4: Intellectual Property Barriers to the Development of Combinations
Leaders:
Kathleen Sybert, PhD, Esq. - Clinical Technology Transfer Group
Edward Berg - Bristol Myers-Squibb Company
Breakout Session Discussion Reports
Breakout 1: Bernard Fox, PhD - Earle A. Chiles Research Institute
Breakout 2: Rachel Humphrey, MD - Bristol Myers-Squibb Company
Breakout 3: Jeffrey Weber, MD, PhD - Norris Cancer Center
Breakout 4: Edward Berg - Bristol Myers-Squibb Company
Breakout 1: Bernard Fox, PhD - Earle A. Chiles Research InstituteBreakout 2: Rachel Humphrey, MD - Bristol Myers-Squibb CompanyBreakout 3: Jeffrey Weber, MD, PhD - Norris Cancer CenterBreakout 4: Edward Berg - Bristol Myers-Squibb Company
Closing Comments
Steven Rosenberg, MD, PhD - National Cancer Institute
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