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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.
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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
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.
×
Criteria for Selecting Preclinical Combinations and Combination Prioritization Strategies in Early-Stage Drug Development
  • Academic Perspectives
    • Samir N. Khleif, Georgetown University
    • Dan Theodorescu, Samuel Oschin Comprehensive Cancer Institute
  • Industry Perspectives
    • Emmett Schmidt, Merck
    • 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
  • Naiyer Rizvi, Columbia University Medical Center
  • Benjamin Izar, Dana-Farber Cancer Institute
  • 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
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.
×
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
  • Linda House, Cancer Support Community
  • 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
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.
×
Regulatory Requirements for Site-Agnostic Indications
Steven Lemery, Food and Drug Administration
Industry Perspectives
  • Daniel Chen, Genentech/Roche
  • Katrin Rupalla, Bristol-Myers Squibb
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
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
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.
×
10:15 am Session 6: Stakeholder Perspectives on the Path Forward
Moderator: Ramy Ibrahim, Parker Institute for Cancer Immunotherapy
  • Roger Dansey, Seattle Genetics
  • Roy Herbst, Yale Cancer Center
  • Una Hopkins, White Plains Hospital
  • Linda House, Cancer Support Community
  • Marc Theoret, Food and Drug Administration
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.
×
Page 63
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.
×
Page 64
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.
×
Page 65
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.
×
Page 66
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.
×
Page 67
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.
×
Page 68
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In recent years, significant progress has been made in the clinical development and use of various types of cancer immunotherapy, all of which rely on the immune system to fight cancer. The majority of new cancer drug applications submitted to the Food and Drug Administration (FDA) are for immunotherapies or combinations involving immunotherapies. One type of immunotherapy is an immune checkpoint inhibitor. Cells in the human body have proteins that regulate the immune system response to foreign invaders (e.g., cancer cells, microorganisms). However, cancer cells can coopt these “checkpoint” proteins and thwart the immune system’s ability to recognize and attack cancer cells. To help promote an immune response to cancer, researchers have developed immune checkpoint inhibitors that enable T-cells to recognize cancer cells as foreign and to prevent deactivation of an immune system response.

To examine the challenges and opportunities to develop combination cancer therapies that include immune checkpoint inhibitors, the National Cancer Policy Forum held a workshop on July 16–17, 2018, in Washington, DC. This workshop convened stakeholders with a broad range of expertise, including cancer researchers, clinicians, patient advocates, and representatives from industry, academia, and government. This publication summarizes the presentations and discussions from the workshop.

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