| 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 |
| 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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