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Appendix B: Workshop Agenda
Pages 105-110

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From page 105...
... 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 Deborah Schrag, Dana-Farber Cancer Institute Moderator: Personalized immunotherapy • Steven Rosenberg, National Cancer Institute 105
From page 106...
... W Center for Drug Evaluation and Research Panel Discussion – Speakers Plus:  Allen Wensky, FDA Center for Biologics Evaluation and Research 12:15 pm Lunch Break
From page 107...
... APPENDIX B 107 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 • National Cancer Institute R  ich Simon, Biomarker integration in clinical trials for immunotherapies •  Lisa Butterfield, University of Pittsburgh Strategies for personalized vaccines • Singh, Immatics Biotechnologies H  arpreet Strategies for personalized cell therapy • avid Porter, University of Pennsylvania D FDA perspectives • ajeshwari Sridhara, FDA Center for Drug Evaluation R and Research • eter Bross, FDA Center for Biologics Evaluation and P 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 • rik Perakslis, Takeda Pharmaceuticals E Issues in data integration and sharing for novel therapies •  ary Horowitz, Medical College of Wisconsin M
From page 108...
... 108 POLICY ISSUES FOR CANCER IMMUNOTHERAPY Infrastructure for clinical data exchange • my Abernethy, Flatiron Health A Bio/pharma collaboration in the precompetitive space •  Averbuch, Bristol Myers-Squibb Steve 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 •  ark Dudley, Novartis M Technology assessment • ngela Thomas, UK National Health Service A Addressing adverse events in immunotherapy • amy Ibrahim, AstraZeneca R Clinical practice and physician training needs for immunotherapy •  Wolchok, Memorial Sloan Kettering Cancer Center Jedd Patient and family education • ee Schwartzberg, Association of Community Cancer L Centers Panel Discussion 10:00 am Break
From page 109...
... APPENDIX B 109 10:15 am Session 6: Value of Immunotherapy and Combination Therapies Moderator: Samir N Khleif, Georgia Cancer Center at Augusta University Industry perspectives • avid Kaufman, Merck D • ee Krug, Bristol Myers-Squibb L • reg Rossi, AstraZeneca G Centers for Medicare & Medicaid Services perspective •  James Rollins, Office of Clinical Standards and Quality Private payer perspective • ee Newcomer, UnitedHealthcare L Health economist perspective •  Ramsey, Fred Hutchinson Cancer Research Center Scott Patient advocacy perspective • wen Darien, Cancer Support Community G 11:30 am Workshop Wrap-Up 11:45 am Adjourn


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