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Appendix E: Workshop Agenda
Pages 305-306

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From page 305...
... Appendix E Workshop Agenda Institute of Medicine Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, Meeting 2 Workshop The Keck Center of The National Academies 500 Fifth Street, NW Washington, DC 20001 April 6, 2009 OPEN SESSION 8:00 am Breakfast 8:30 am Welcome and Opening Remarks John Ball, Committee Chair 9:00 am Analysis of Task -- General Guidance -- Robert Temple 10:00 am BREAk 10:15 am Quantitative Decision Analytical Modeling Tools -- Rebecca Miksad 11:15 am Existing Frameworks for Biomarker Qualification -- CDER -- Marc Walton and Aliza Thompson 12:15 pm BREAk 12:30 pm LuNCH -- Analogous Environment -- Process Standards for Manufacturing, Businesses -- David Dilts 0
From page 306...
... 0 EVALUATION OF BIOMARKERS AND SURROGATE ENDPOINTS 1:30 pm Existing Frameworks for Biomarker Qualification -- PhRMA -- James Mayne 2:00 pm NIH Biomarker Qualification/Cancer Perspective -- Arthur Schatzkin 2:30 pm Risk Factor to Surrogate Endpoint Pathway -- Philip Greenland 3:00 pm Discussion 3:30 pm BREAk 3:45 pm Troponin -- James de Lemos -- James James 4:15 pm CRP and Inflammatory Markers -- Christie Ballantyne 4:45 pm HDL/LDL -- Bryan Brewer 5:15 pm Case Studies Discussion Speakers and Committee 5:45 pm ADJOuRN

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