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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
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Appendix B

Workshop Agenda

FEBRUARY 29, 2016

7:30 am Registration
8:00 am Welcome from the National Cancer Policy Forum
Michael Caligiuri, The Ohio State University
Comprehensive Cancer Center
Chair, National Cancer Policy Forum
Overview of the Workshop
Samir N. Khleif, Georgia Cancer Center at Augusta University
Planning Committee Chair
8:15 am Session 1: Overview of the State of the Science and Unique Policy Challenges in Developing Immunotherapies for Cancer
Moderator: Deborah Schrag, Dana-Farber Cancer Institute
Personalized immunotherapy
  • Steven Rosenberg, National Cancer Institute
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Immune modulators
  • Naiyer Rizvi, Columbia University
Therapeutic vaccines
  • Jay Berzofsky, National Cancer Institute
Adoptive cell transfer
  • Malcolm Brenner, Baylor College of Medicine
10:00 am Break
10:15 am Session 2: Challenges with Preclinical Models for Immunotherapies
Moderator: Lee Krug, Bristol Myers-Squibb
Limitations of preclinical models
  • Immune modulators
    • Alexandra Snyder Charen, Memorial Sloan Kettering Cancer Center
  • Adoptive cell transfer
    • Helen Heslop, Baylor College of Medicine
  • Vaccines
    • Bernard Fox, Earle A. Chiles Research Institute
  • Preclinical data needs to justify the launch of clinical trials
    • Whitney Helms, Food and Drug Administration (FDA) Center for Drug Evaluation and Research
Panel Discussion – Speakers Plus:
Allen Wensky, FDA Center for Biologics Evaluation and Research
12:15 pm Lunch Break
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
1:00 pm Session 3: Challenges in Trial Design for Immunotherapies and Combinations
Moderator: Michael Caligiuri, The Ohio State University Comprehensive Cancer Center
Novel trial designs to assess early clinical efficacy of immunotherapies
  • Rich Simon, National Cancer Institute
Biomarker integration in clinical trials for immunotherapies
  • Lisa Butterfield, University of Pittsburgh
Strategies for personalized vaccines
  • Harpreet Singh, Immatics Biotechnologies
Strategies for personalized cell therapy
  • David Porter, University of Pennsylvania
FDA perspectives
  • Rajeshwari Sridhara, FDA Center for Drug Evaluation and Research
  • Peter Bross, FDA Center for Biologics Evaluation and Research
Panel Discussion
3:10 pm Break
3:25 pm Session 4: Expanding Opportunities for Collaboration and Information Exchange
Moderator: Amy Abernethy, Flatiron Health
Trans-IT interoperability
  • Erik Perakslis, Takeda Pharmaceuticals
Issues in data integration and sharing for novel therapies
  • Mary Horowitz, Medical College of Wisconsin
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Infrastructure for clinical data exchange
  • Amy Abernethy, Flatiron Health
Bio/pharma collaboration in the precompetitive space
  • Steve Averbuch, Bristol Myers-Squibb
Panel Discussion
5:25 pm Day 1 Wrap-Up

MARCH 1, 2016

7:30 am Registration
8:00 am Session 5: Implementation in Clinical Practice
Moderator: Malcolm Brenner, Baylor College of Medicine
Scaling cellular therapies for clinical use
  • Mark Dudley, Novartis
Technology assessment
  • Angela Thomas, UK National Health Service
Addressing adverse events in immunotherapy
  • Ramy Ibrahim, AstraZeneca
Clinical practice and physician training needs for immunotherapy
  • Jedd Wolchok, Memorial Sloan Kettering Cancer Center
Patient and family education
  • Lee Schwartzberg, Association of Community Cancer Centers
Panel Discussion
10:00 am Break
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
10:15 am Session 6: Value of Immunotherapy and Combination Therapies
Moderator: Samir N. Khleif, Georgia Cancer Center at Augusta University
Industry perspectives
  • David Kaufman, Merck
  • Lee Krug, Bristol Myers-Squibb
  • Greg Rossi, AstraZeneca
Centers for Medicare & Medicaid Services perspective
  • James Rollins, Office of Clinical Standards and Quality
Private payer perspective
  • Lee Newcomer, UnitedHealthcare
Health economist perspective
  • Scott Ramsey, Fred Hutchinson Cancer Research Center
Patient advocacy perspective
  • Gwen Darien, Cancer Support Community
11:30 am Workshop Wrap-Up
11:45 am Adjourn
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×

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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
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Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page 107
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page 108
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page 109
Suggested Citation:"Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2016. Policy Issues in the Clinical Development and Use of Immunotherapy for Cancer Treatment: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/23497.
×
Page 110
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Immunotherapy is a form of cancer therapy that harnesses the body’s immune system to destroy cancer cells. In recent years, immunotherapies have been developed for several cancers, including advanced melanoma, lung cancer, and kidney cancer. In some patients with metastatic cancers who have not responded well to other treatments, immunotherapy treatment has resulted in complete and durable responses. Given these promising findings, it is hoped that continued immunotherapy research and development will produce better cancer treatments that improve patient outcomes.

With this promise, however, there is also recognition that the clinical and biological landscape for immunotherapies is novel and not yet well understood. For example, adverse events with immunotherapy treatment are quite different from those experienced with other types of cancer therapy. Similarly, immunotherapy dosing, therapeutic responses, and response time lines are also markedly different from other cancer therapies. To examine these challenges and explore strategies to overcome them, the National Academies of Sciences, Engineering, and Medicine held a workshop in February and March of 2016. This report summarizes the presentations and discussions from the workshop.

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