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PAPERBACK price:$47.00 add to cart Rights & Permissions Free PDF Access Sign in to download PDF book and chapters Free Resources PDF SUMMARY PDF Report Brief Display this book on your site! Related Titles Perspectives on Biomarker and Surrogate Endpoint Evaluation:Discussion Forum Summary Ethical and Scientific Issues in Studying the Safety of Approved Drugs Other Related Titles Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease (2010) Board on Health Care Services (HCS) Board on Health Sciences Policy (HSP) Food and Nutrition Board (FNB) Citation Manager Export the bibliographic data for this book in your chosen format Web Search Builder Use this book's key terms to search within this book, across our collection, or across the Web. Skim This Chapter Skim this chapter and use this chapter's key terms to search within this book. Reference Finder Paste in your own text to find books that relate to your topic. Citation Manager . "Appendix E: Workshop Agenda." Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press, 2010. Please select a format: Page 305   E-mail Share on facebook Facebook Share on delicious Delicious Share on stumbleupon Stumble Share on twitter Twitter More Sharing ServicesMore The following HTML text is provided to enhance online readability. Many aspects of typography translate only awkwardly to HTML. Please use the page image as the authoritative form to ensure accuracy. 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 Page 305 Front Matter (R1-R20) Summary (1-16) 1 Introduction (17-32) 2 Review: Evaluating and Regulating Biomarker Use (33-96) 3 The Biomarker Evaluation Process (97-130) 4 Case Studies (131-196) 5 Strengthening Evidence-Based Regulation (197-234) Acronyms (235-238) Glossary (239-252) Appendix A: Table of Papers About Biomarker Qualification (253-278) Appendix B: Recommendations from Related IOM Reports (279-286) Appendix C: Committee Member and Consultant Biographies (287-298) Appendix D: Staff Biographies (299-304) Appendix E: Workshop Agenda (305-306) Appendix F: Speaker Biographies (307-314)

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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