The Drug Development Paradigm in Oncology: Proceedings of a Workshop (2018)

Chapter: Appendix B: Workshop Agenda

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Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Appendix B

Workshop Agenda

December 12, 2016

7:30 am Registration
8:00 am Welcome and Overview of the Workshop
Richard L. Schilsky, American Society of Clinical Oncology Planning Committee Chair
8:10 am Session 1: Vision for a Seamless Cancer Drug Development Paradigm
Moderator: Richard L. 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
Page 118 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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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
  • Pasi Jänne, Dana-Farber Cancer Institute
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
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Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Panel Discussion – Session speakers and
  • Patricia Keegan, Food and Drug Administration
  • Hedvig Hricak, Memorial Sloan Kettering Cancer Center
3:15 pm Break
3:30 pm Session 4: Continuous Evidence Generation Across the Cancer Therapy Life Cycle
Moderator: Monica Bertagnolli, Dana-Farber Cancer Institute
Clinical Trial Designs to Expedite Drug Development
  • Mary Redman, Fred Hutchinson Cancer Research Center
  • Rajeshwari Sridhara, Food and Drug Administration
The Use of Real-World Evidence in Drug Development
  • Maria Koehler, Pfizer Inc.
  • Amy Abernethy, Flatiron Health
Panel Discussion – Session speakers and
  • Jeffrey Brown, Harvard Pilgrim Health Care Institute
5:30 pm Wrap-Up of Day 1
Richard L. 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
Page 120 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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8:30 am Session 5: Managing Benefit and Risk in Seamless Cancer Drug Development
Moderator: Rebecca Pentz, Emory University School of Medicine
Food and Drug Administration Perspectives on Seamless Drug Development
  • Marc Theoret, Food and Drug Administration
Expanding Eligibility Criteria and Access to Experimental Therapies
American Society of Clinical Oncology, Friends of Cancer Research, and the Food and Drug Administration Working Group to Expand Eligibility Criteria
  • Gwynn Ison, Food and Drug Administration
Expanded Access Programs
  • Steven Lemery, Food and Drug Administration
Patient Protections and Ethical Considerations
  • Steven Joffe, University of Pennsylvania
Data Monitoring Approaches in a Seamless Drug Development Paradigm
  • Frank Rockhold, Duke Clinical Research Institute
Benefit–Risk Analysis of Decision Making in Oncology
  • G. K. Raju, Massachusetts Institute of Technology
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
Page 121 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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  • Lynn M. Matrisian, Pancreatic Cancer Action Network
  • Eric Rubin, Merck
  • Amy McKee, Food and Drug Administration
  • Jeffrey Brown, Harvard Pilgrim Health Care Institute
  • Rebecca Pentz, Emory University School of Medicine
  • Ronald Kline, Centers for Medicare & Medicaid Services
12:45 pm Wrap-Up of the Workshop
Richard L. Schilsky, American Society of Clinical Oncology Planning Committee Chair
1:00 pm Adjourn
Page 122 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Page 118 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Page 119 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Page 119
Page 120 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
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Page 120
Page 121 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
Save
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Page 121
Page 122 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2018. The Drug Development Paradigm in Oncology: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/24742.
Save
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