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 | |
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Immune modulators | |
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Therapeutic vaccines | |
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Adoptive cell transfer | |
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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 | |
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Panel Discussion – Speakers Plus: | |
Allen Wensky, FDA Center for Biologics Evaluation and Research | |
12:15 pm | Lunch Break |
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 | |
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Biomarker integration in clinical trials for immunotherapies | |
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Strategies for personalized vaccines | |
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Strategies for personalized cell therapy | |
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FDA perspectives | |
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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 | |
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Issues in data integration and sharing for novel therapies | |
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Infrastructure for clinical data exchange | |
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Bio/pharma collaboration in the precompetitive space | |
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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 | |
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Technology assessment | |
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Addressing adverse events in immunotherapy | |
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Clinical practice and physician training needs for immunotherapy | |
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Patient and family education | |
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Panel Discussion | |
10:00 am | Break |
10:15 am | Session 6: Value of Immunotherapy and Combination Therapies |
Moderator: Samir N. Khleif, Georgia Cancer Center at Augusta University | |
Industry perspectives | |
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Centers for Medicare & Medicaid Services perspective | |
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Private payer perspective | |
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Health economist perspective | |
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Patient advocacy perspective | |
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11:30 am | Workshop Wrap-Up |
11:45 am | Adjourn |
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