Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease (2010)
Chapter: Appendix E: Workshop Agenda
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 |
|
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 |
