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 |
