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Appendix B: Workshop Agenda
Pages 117-122

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From page 117...
... Schilsky, American Society of Clinical Oncology • Mark Ratain, The University of Chicago • Mace Rothenberg, Pfizer Inc. • Janet Woodcock, Food and Drug Administration • Ellen Sigal, Friends of Cancer Research Panel Discussion 10:00 am Break 117
From page 118...
... 118 THE DRUG DEVELOPMENT PARADIGM IN ONCOLOGY 10:15 am Session 2: Case Studies and Lessons Learned from Recent Experiences Moderator: Suzanne Topalian, Johns Hopkins University Anti-PD-1 Immunotherapy • Eric Rubin, Merck BRAF Pathway Inhibitors • Keith Flaherty, Massachusetts General Hospital T790M EGFR Inhibitors •  Jänne, Dana-Farber Cancer Institute Pasi Challenges Resulting from Rapid Regulatory Approvals • Donald Harvey, Emory University Panel Discussion – Session speakers and • Gideon Blumenthal, Food and Drug Administration 12:15 pm Lunch 1:00 pm Session 3: Flexible Drug Development and Decision Making: Accommodating New Insights Moderator: Mace Rothenberg, Pfizer Inc. Understanding Biological Activity to Inform Drug Development • Kenneth Anderson, Dana-Farber Cancer Institute • Wolfgang Weber, Memorial Sloan Kettering Cancer Center Assessing Early Signals of Efficacy to Guide Clinical Development • David Feltquate, Bristol-Myers Squibb • Richard Finn, University of California, Los Angeles, Jonsson Comprehensive Cancer Center Dose-Finding Considerations and Strategies for Novel Combination Development • Steven Piantadosi, Cedars-Sinai Medical Center
From page 119...
... Schilsky, American Society of Clinical Oncology December 13, 2016 7:30 am Registration 8:00 am The National Cancer Moonshot Initiative and Seamless Drug Development Moderator: Richard L Schilsky, American Society of Clinical Oncology Blue Ribbon Panel Recommendations • Elizabeth Jaffee, Johns Hopkins University Q&A
From page 120...
... Panel Discussion 11:15 am Break 11:30 am Session 6: Stakeholder Perspectives: Goals of the New Paradigm and Priorities for the Path Forward Moderator: Steven Piantadosi, Cedars-Sinai Medical Center • Howard A Burris, III, Sarah Cannon Research Institute • Elizabeth Jaffee, Johns Hopkins University
From page 121...
... Schilsky, American Society of Clinical Oncology Planning Committee Chair 1:00 pm Adjourn

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