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



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OCR for page 305
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 0

OCR for page 305
0 EVALUATION OF BIOMARKERS AND SURROGATE ENDPOINTS 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 —James James 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