Meeting Agenda

Agenda: Meeting 2. Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease

Monday, April 6
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 - Bob Temple

9:30 am            CDER biomarker qualification efforts- Marc Walton

9:40 am            Panel of FDA/CDER experts – Bob Temple, Marc Walton, Aliza Thompson

10:15 am          BREAK

10:30 am          Existing frameworks for biomarker qualification - PhRMA - Jim Mayne

11:15 am          Decision Analysis - Rebecca Miksad

12:00pm           LUNCH – Discussion

1:00 pm            Analogous Environment: Process standards for manufacturing, businesses - David Dilts

1:45 pm            NIH biomarker qualification/cancer perspective - Arthur Schatzkin

2:15 pm            Risk Factor to Surrogate Endpoint Pathway - Phil Greenland

2:45 pm            Discussion

3:15 pm            BREAK

3:30 pm            Troponin - James de Lemos

4:00 pm            CRP and Inflammatory Markers - Christie Ballantyne

4:30 pm            HDL/LDL - Bryan Brewer

5:00 pm           Case Studies Discussion - Speakers and Committee

5:30 pm            ADJOURN

 
CLOSED SESSION
6:30 pm                  Discussion of Workshop over Dinner (Committee and Staff)

Tuesday, April 7
7:45 am-1:00 pm     Committee deliberations

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