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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease (2010)

Chapter: Appendix E: Workshop Agenda

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Suggested Citation:"Appendix E: Workshop Agenda." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
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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

Suggested Citation:"Appendix E: Workshop Agenda." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
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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

Suggested Citation:"Appendix E: Workshop Agenda." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
×
Page 305
Suggested Citation:"Appendix E: Workshop Agenda." Institute of Medicine. 2010. Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease. Washington, DC: The National Academies Press. doi: 10.17226/12869.
×
Page 306
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Many people naturally assume that the claims made for foods and nutritional supplements have the same degree of scientific grounding as those for medication, but that is not always the case. The IOM recommends that the FDA adopt a consistent scientific framework for biomarker evaluation in order to achieve a rigorous and transparent process.

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