Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter. Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 305
Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease 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
OCR for page 306
Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease 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 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