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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 Limits of Monotherapy, and the State of PD-1 and PD-L1 Combination Therapies in Clinical Trials Roy Herbst, Yale Cancer Center 63 PREPUBLICATION COPYâUncorrected Proofs
64 CANCER THERAPIES WITH IMMUNE CHECKPOINT INHIBITORS Criteria for Selecting Preclinical Combinations and Combination Prioritization Strategies in Early-Stage Drug Development â¢ Academic Perspectives Khleif, Georgetown University Samir N. Dan Theodorescu, Samuel Oschin Comprehensive Cancer Institute â¢ Industry Perspectives Schmidt, Merck Emmett Chris Boshoff, Pfizer Inc. 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 Perspectives on Biomarkers for PD-1/PD-L1 Combination Therapies â¢ Naiyer Rizvi, Columbia University Medical Center â¢ Benjamin Izar, Dana-Farber Cancer Institute â¢ Margaret Shipp, Dana-Farber Cancer Institute 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 Panel Discussion 12:45 pm Lunch PREPUBLICATION COPYâUncorrected Proofs
APPENDIX B 65 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 Master Protocols for Immunotherapy Combinations Ahmad Tarhini, Cleveland Clinic and Case Comprehensive Cancer Center 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 Appropriate Endpoints for Evaluating the Efficacy of PD-1/PD-L1 Combination Therapies Elizabeth Jaffee, Johns Hopkins University School of Medicine Panel Discussion Includes speakers and â¢ Linda House, Cancer Support Community â¢ Louise Perkins, Melanoma Research Alliance 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 PREPUBLICATION COPYâUncorrected Proofs
66 CANCER THERAPIES WITH IMMUNE CHECKPOINT INHIBITORS Regulatory Requirements for Site-Agnostic Indications Steven Lemery, Food and Drug Administration Industry Perspectives â¢ Daniel Chen, Genentech/Roche â¢ Katrin Rupalla, Bristol-Myers Squibb Panel Discussion 5:30 pm Adjourn Day 1 JULY 17, 2018 7:30 am Registration 8:00 am 5: Precompetitive Data Sharing and Session Collaboration to Develop PD-1/PD-L1 Combinations Moderator: Martin Murphy, CEO Roundtable on Cancer Overview of How Real-World Evidence, Data An Sharing, and Precompetitive Collaboration May Influence the Development of PD-1/PDL-1 Combination Therapies Amy Abernethy, Flatiron Health Sharing Data to Support Development, Validation, and Standardization of Biomarkers in Patient Selection Used in Immunotherapy Trials Gaurav Singal, Foundation Medicine Precompetitive Use of Algorithms to Predict Adverse Events Sean Khozin, Food and Drug Administration Panel Discussion 10:00 am Break PREPUBLICATION COPYâUncorrected Proofs
APPENDIX B 67 10:15 am Session 6: Stakeholder Perspectives on the Path Forward Moderator: Ramy Ibrahim, Parker Institute for Cancer Immunotherapy â¢ Roger Dansey, Seattle Genetics â¢ Roy Herbst, Yale Cancer Center â¢ Una Hopkins, White Plains Hospital â¢ Linda House, Cancer Support Community â¢ Marc Theoret, Food and Drug Administration 11:30 am Workshop Wrap-Up 11:45 am Adjourn PREPUBLICATION COPYâUncorrected Proofs
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