Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
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Appendix B
Workshop Agenda
JULY 16, 2018
| 7:30 am | Registration |
| 8:00 am | Welcome from the National Cancer Policy Forum and Workshop Overview Roger Dansey, Seattle Genetics Samir N. Khleif, Georgetown University Planning Committee Co-Chairs |
| 8:15 am | Session 1: Overview of PD-1/PD-L1 Therapy and the Need for Combination Therapies Moderator: Roger Dansey, Seattle Genetics |
| The State-of-the-Art of PD-1/PD-L1 Development and Clinical Use/Outcomes Ramy Ibrahim, Parker Institute for Cancer Immunotherapy |
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| Limits of Monotherapy, and the State of PD-1 and PD-L1 Combination Therapies in Clinical Trials Roy Herbst, Yale Cancer Center |
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
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Criteria for Selecting Preclinical Combinations and Combination Prioritization Strategies in Early-Stage Drug Development
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| Panel Discussion | |
| 10:30 am | Break |
| 10:45 am | Session 2: The Role of Biomarkers in Developing PD-1/PD-L1 Combinations Moderator: David Rimm, Yale University School of Medicine |
| Overview of Biomarker Development for Immune PD-1/PD-L1 Checkpoint Blockade Combinations David Rimm, Yale University School of Medicine |
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Perspectives on Biomarkers for PD-1/PD-L1 Combination Therapies
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| The Unique Challenges in Developing Biomarker-Driven, Site-Agnostic Therapies Richard L. Schilsky, American Society of Clinical Oncology | |
| The Microbiome in Cancer Immunotherapy Christian Jobin, University of Florida |
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| Panel Discussion | |
| 12:45 pm | Lunch |
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
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| 1:30 pm | Session 3: Clinical Trial Design for PD-1/PD-L1 Combination Therapies Moderator: George Weiner, University of Iowa Holden Comprehensive Cancer Center |
| Combination Trial Design Strategies Adil Daud, University of California, San Francisco, Helen Diller Family Comprehensive Cancer Center |
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| Master Protocols for Immunotherapy Combinations Ahmad Tarhini, Cleveland Clinic and Case Comprehensive Cancer Center |
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| Strategies for Incorporating Biomarkers in Clinical Trials for PD-1/PD-L1 Combination Therapies Lisa Butterfield, University of Pittsburgh and the Society for Immunotherapy of Cancer |
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| Appropriate Endpoints for Evaluating the Efficacy of PD-1/PD-L1 Combination Therapies Elizabeth Jaffee, Johns Hopkins University School of Medicine |
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Panel Discussion Includes speakers and
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| 3:25 pm | Break |
| 3:35 pm | Session 4: Regulatory Challenges with Developing PD-1/PD-L1 Combination Therapies Moderator: Roy Herbst, Yale Cancer Center |
| Overview of Regulatory and Labeling Challenges with Developing Immune Checkpoint Blockade Combination Therapies Amy McKee, Food and Drug Administration |
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
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| Regulatory Requirements for Site-Agnostic Indications Steven Lemery, Food and Drug Administration |
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Industry Perspectives
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| Panel Discussion | |
| 5:30 pm | Adjourn Day 1 |
JULY 17, 2018
| 7:30 am | Registration |
| 8:00 am | Session 5: Precompetitive Data Sharing and Collaboration to Develop PD-1/PD-L1 Combinations Moderator: Martin Murphy, CEO Roundtable on Cancer |
| An Overview of How Real-World Evidence, Data Sharing, and Precompetitive Collaboration May Influence the Development of PD-1/PDL-1 Combination Therapies Amy Abernethy, Flatiron Health |
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| Sharing Data to Support Development, Validation, and Standardization of Biomarkers in Patient Selection Used in Immunotherapy Trials Gaurav Singal, Foundation Medicine |
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| Precompetitive Use of Algorithms to Predict Adverse Events Sean Khozin, Food and Drug Administration |
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| Panel Discussion | |
| 10:00 am | Break |
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
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| 10:15 am |
Session 6: Stakeholder Perspectives on the Path Forward Moderator: Ramy Ibrahim, Parker Institute for Cancer Immunotherapy
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| 11:30 am | Workshop Wrap-Up |
| 11:45 am | Adjourn |
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
×
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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
×
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
×
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
×
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
×
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
×
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2019. Advancing Progress in the Development of Combination Cancer Therapies with Immune Checkpoint Inhibitors: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/25405.
×
