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Appendix: Workshop Statement of Task and Agenda
Pages 81-86

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From page 81...
... A major goal of the workshop will be to facilitate discussion about potential strategies and actions to address those challenges. Participants will be invited to discuss topics that may include: • Clinical trial designs, the role of registries, and the "N-of-1" approach to evidence development; • Evidentiary needs, regulatory processes, and ethical/legal considerations; • The logistics and funding of multisite studies, including patient participation and coverage of experimental costs (biospecimen acquisition, biomarker test and drug costs)
From page 82...
... Mia Levy, Vanderbilt University Challenges in Analytical Validation of NGS Tests for Clinical Trials Mickey Williams, National Cancer Institute (NCI)
From page 83...
... APPENDIX 83 Tests for Circulating Tumor DNA Matthias Holdhoff, Johns Hopkins University RNAseq Tests Neil Hayes, University of North Carolina at Chapel Hill Group Discussion 10:30 am Break 10:45 am Session 2A: Evidentiary Standards: Regulatory Science Moderator: Adrian Senderowicz, Oncology Drug Development, LLC Overview of Food and Drug Administration (FDA) Regulations for Diagnostics Adrian Senderowicz, Oncology Drug Development, LLC Evolving Paradigm for Companion Diagnostics and Other Diagnostic Tests at FDA David Litwack, FDA Clinical Utility of Diagnostic Tests David Eberhard, University of North Carolina at Chapel Hill Group Discussion 12:15 pm Lunch Break 1:00 pm Session 2B: Evidentiary Standards: Reimbursement Moderator: Robert McDonough, Aetna MolDX Approach Dane Dickson, Palmetto, Teton Cancer Institute Payer's Perspectives Donna Messner, Center for Medical Technology Policy (CMTP)
From page 84...
... 84 BIOMARKERS FOR MOLECULARY TARGETED CANCER THERAPIES 2:00 pm Session 3A: Generating Evidence: Clinical Trial Designs Moderator: Barbara Conley, NCI Lung-MAP Roy Herbst, Yale University Matching Drugs to Mutations for Treating Advanced Cancer Lilian Siu, Princess Margaret Hospital, Ontario Cancer Institute Evaluation of Next Generation Sequencing for Companion Diagnostics Use Anne-Marie Martin, GlaxoSmithKline Group Discussion 3:20 pm Break 3:30 pm Session 3B: Generating Evidence: Other Mechanisms  Moderator: Richard Schilsky, American Society of Clinical Oncology Actionable Genome Consortium David Solit, Memorial Sloan Kettering Cancer Center Coverage with Evidence Development Sean Tunis, CMTP Facilitated Drug Access Program and Registry Richard Schilsky, American Society of Clinical Oncology Benefits and Limitations/Challenges of Registries/Databases Garnet Anderson, Fred Hutchinson Cancer Research Center, University of Washington School of Public Health Group Discussion 5:15 pm Wrap Up Day 1 and Adjourn
From page 85...
... APPENDIX 85 November 11, 2014 7:30 am Registration 8:00 am Session 4: Practice Guidelines and Implementation into Clinical Practice Moderator: Roy Herbst, Yale University Guidelines Development William Gradishar, Northwestern University Treatment Pathways Jennifer Malin, WellPoint Adoption of Genomics in Oncology Care Kathryn Phillips, University of California, San Francisco Return of Sequencing Results to Patients Patricia LoRusso, Yale University Group Discussion 10:00 am Break 10:15 am Session 5: The Business Model for Test Development Moderator: Lisa McShane, NCI Karen Long, Abbott Molecular Federico Monzon, Invitae Group Discussion 11:30 am Workshop Wrap-Up 11:45 am Adjourn

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