Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics: Proceedings of a Workshop (2024)

Chapter: Appendix B: Workshop Agenda

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Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27517.
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Appendix B

Workshop Agenda

NOVEMBER 14, 2022

8:30 amWelcome from the National Cancer Policy Forum
Planning Committee Co-Chairs:
  • Samir N. Khleif, Georgetown University Medical Center
  • George J. Weiner, Holden Comprehensive Cancer Center
8:40 amKeynote: Implications of Scientific Innovations on High-Quality Cancer Care and Patient Outcomes
  • Elizabeth M. Jaffee, President’s Cancer Panel, Johns Hopkins University (Virtual)
9:00 amSession 1: Criteria to Move Single Agents into Clinical Trials
Co-Moderators:
  • Samir N. Khleif, Georgetown University Medical Center
  • Tom Curran, Children’s Mercy Research Institute, Kansas City University
Single Agent Activity Anti-PD-1
  • Suzanne L. Topalian, Johns Hopkins University
Single Agent Activity Anti-Lymphocyte Activation Gene-3 Antibody
  • Hussein Tawbi, MD Anderson Cancer Center
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Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27517.
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Challenges in the Development of Agonist T Cell Antibody Therapy
  • John Janik, Cullinan Oncology
Perspective on Resistance to CAR T: Lessons from Blood Cancer
  • Stephan A. Grupp, Children’s Hospital of Philadelphia (Virtual)
FDA Regulatory Perspective: What Has Changed and What Is Missing?
  • Peter F. Bross, Center for Biologics Evaluation and Research, Food and Drug Administration
Panel Discussion
10:30 amBreak
10:40 amSession 2: Current Challenges and Opportunities: Selection of Experimental Agents in Combinations
Co-Moderators:
  • Gideon Blumenthal, Merck
  • Marc Theoret, Oncology Center of Excellence, Food and Drug Administration
Understanding Immune Therapy Efficacy, Preclinical Models, and Combination Resistance
  • Samir N. Khleif, Georgetown University Medical Center
Clinical Trials in PD-1/L1 Refractory Cancers
  • Jane A. Healy, Merck Research Labs
Anti-PD-1 and Epacadostat vs. IDO Inhibition: Lessons Learned
  • Jason J. Luke, University of Pittsburgh Medical Center
Intralesional Approaches: Regulatory Issues
  • George J. Weiner, Holden Comprehensive Cancer Center
Panel Discussion
12:00 pmBreak
Page 63 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27517.
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1:00 pmSession 3: Current Challenges and Opportunities: Biomarkers and Surrogate Endpoints
Co-Moderators:
  • Kimryn Rathmell, Vanderbilt University Medical Center
  • Chris Boshoff, Pfizer Inc (Virtual)
Genetic Biomarkers: 9p21 Loss Drives Immune-Cold, Checkpoint-Inhibitor Resistance in HPV Head and Neck Squamous Cancer
  • Teresa Davoli, NYU Langone Health (Virtual)
Diagnostic Imaging
  • Marius Mayerhoefer, Memorial Sloan Kettering Cancer Center
Immune Metabolism
  • Hildegund C.J. Ertl, The Wistar Institute
Novel Surrogate Biomarkers for Immune Therapy Response and Resistance
  • Kimryn Rathmell, Vanderbilt University Medical Center
Biomarkers and Imaging: Current Regulatory Landscape
  • Reena Philip, Oncology Center of Excellence, Food and Drug Administration
Surrogate Endpoint Development
  • Nicole Gormley, Oncology Center of Excellence, Food and Drug Administration
Panel Discussion
2:40 pmBreak
2:50 pmSession 4: Current Challenges and Opportunities: The Role of Data and Computational Tools
Co-Moderators:
  • Nancy E. Davidson, Fred Hutchinson Cancer Center
  • Julie R. Gralow, American Society of Clinical Oncology
Regulatory and Access Considerations in Mining Big Data
  • Ahmad A. Tarhini, H. Lee Moffitt Cancer Center and Research Institute
Page 64 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27517.
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Advanced Computing Tools
  • Jack D. Hidary, SandboxAQ (Virtual)
Data-Driven Approaches for Modeling Response and Resistance
  • Dana Pe’er, Memorial Sloan Kettering Cancer Center
Leveraging Real-World Data to Characterize Immune Related Adverse Events
  • Prakirthi Yerram, Flatiron Health
AI, Data Science, and Big Data Approaches to Accelerate and Expand Research and Evaluation
  • Usama Fayyad, Institute for Experiential Artificial Intelligence at Northeastern University
Panel Discussion
4:20 pmClosing Remarks
Planning Committee Co-Chairs:
  • Samir N. Khleif, Georgetown University Medical Center
  • George J. Weiner, Holden Comprehensive Cancer Center
4:30 pmAdjourn

NOVEMBER 15, 2022

8:30 amWelcome and Overview of Day 2
Planning Committee Co-Chairs:
  • Samir N. Khleif, Georgetown University Medical Center
  • George J. Weiner, Holden Comprehensive Cancer Center
8:40 amSession 5: Criteria to Assess Cancer Immunotherapy Combinations in Early-Phase Clinical Trial Designs Needed for Regulatory Approval
Co-Moderators:
  • Roy S. Herbst, Yale Comprehensive Cancer Center (Virtual)
  • Hedvig Hricak, Memorial Sloan Kettering Cancer Center
Novel Immunotherapy Clinical Trial Design
  • Keith T. Flaherty, Massachusetts General Hospital; Harvard Medical School
Page 65 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27517.
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Public–Private Partnership Perspective
  • Roy Herbst, Yale Comprehensive Cancer Center (Virtual)
Selected Regulatory Considerations for Cancer Immunotherapeutic Combinations: Contribution of Individual Components to Effect of Combination
  • Marc Theoret, Oncology Center of Excellence, Food and Drug Administration
National Cancer Institute Perspective on Novel Trial Designs for Immunotherapy Resistance
  • Elad Sharon, NCI Cancer Therapy Evaluation Program
An Industry Perspective
  • Alexandra Snyder, Generate Biomedicines
Challenges of Trial Design: Incorporating Pharmacodynamics
  • Jedd Wolchok, Weill Cornell Medicine (Virtual)
Panel Discussion
10:10 amBreak
10:20 amSession 6: Panel Discussion
Reflections on the Workshop and Next Steps to Overcome Resistance to Immune Modulator Therapies for Cancer Treatment
Co-Moderators:
  • George J. Weiner, Holden Comprehensive Cancer Center
  • Scott M. Lippman, University of California, San Diego
Panelists:
  • Session 1: Samir N. Khleif and Tom Curran
  • Session 2: Gideon Blumenthal and Marc Theoret
  • Session 3: Kimryn Rathmell and Chris Boshoff (Virtual)
  • Session 4: Nancy E. Davidson and Julie R. Gralow
  • Session 5: Roy S. Herbst (Virtual) and Hedvig Hricak
Open Discussion
Page 66 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27517.
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11:50 amClosing Remarks
Planning Committee Co-Chairs:
  • Samir N. Khleif, Georgetown University Medical Center
  • George J. Weiner, Holden Comprehensive Cancer Center
12:00 pmAdjourn
Page 61 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27517.
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Page 62 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27517.
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Page 63 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27517.
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Page 64 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27517.
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Page 65 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27517.
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Page 65
Page 66 Cite Bookmark
Suggested Citation: "Appendix B: Workshop Agenda." National Academies of Sciences, Engineering, and Medicine. 2024. Addressing Treatment Resistance in the Development of Cancer Immune Modulator Therapeutics: Proceedings of a Workshop. Washington, DC: The National Academies Press. doi: 10.17226/27517.
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