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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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Previous Chapter: Appendix A: Statement of Task

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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.

Appendix B

Workshop Agenda

NOVEMBER 14, 2022

8:30 am	Welcome 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 am	Keynote: 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 am	Session 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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	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 am	Break
10:40 am	Session 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 pm	Break

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1:00 pm	Session 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 pm	Break
2:50 pm	Session 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
2:50 pm	Regulatory and Access Considerations in Mining Big Data Ahmad A. Tarhini, H. Lee Moffitt Cancer Center and Research Institute

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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 pm	Closing Remarks Planning Committee Co-Chairs: Samir N. Khleif, Georgetown University Medical Center George J. Weiner, Holden Comprehensive Cancer Center
4:30 pm	Adjourn

NOVEMBER 15, 2022

8:30 am	Welcome 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 am	Session 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
8:40 am	Novel Immunotherapy Clinical Trial Design Keith T. Flaherty, Massachusetts General Hospital; Harvard Medical School

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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 am	Break
10:20 am	Session 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

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11:50 am	Closing Remarks Planning Committee Co-Chairs: Samir N. Khleif, Georgetown University Medical Center George J. Weiner, Holden Comprehensive Cancer Center
12:00 pm	Adjourn