Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary (2011)
Chapter: Appendix A: Discussion Forum Agenda
Appendix A
Discussion Forum Agenda
Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
June 21–22, 2010
Washington Plaza Hotel
10 Thomas Circle, NW
Washington, DC
Day 1, June 21
|
8:30 am |
Session 1: IOM Report Recommendations |
|
8:30 am |
Committee member presentations |
|
John R. Ball, Welcome, the Committee’s Work, and Workshop Objective |
|
|
8:50 am |
John A. Wagner, Recommendations 1–2, the Evaluation Framework |
|
9:10 am |
Ronald Krauss and Maria Lopes-Virella, LDL and HDL Case Study |
|
9:30 am |
Roberta Ness, Recommendations 3–6 |
|
9:50 am |
Panel discussion |
|
10:30 am |
Session 2: FDA and NIH Perspectives |
|
10:30 am |
Kathleen Ellwood and Paula Trumbo, CFSAN: Current biomarker processes at FDA and basis for IOM study |
|
10:45 am |
Michael Lauer, Division of Cardiovascular Sciences, NHLBI, NIH |
|
11:00 am |
Paul Coates, NIH Office of Dietary Supplements |
|
11:15 am |
BREAK |
|
11:30 am |
Marc Walton, CDER: Biomarker Qualification in CDER |
|
11:45 am |
Robert Becker, CDRH: Biomarkers for Devices |
|
12:00 pm |
LUNCH |
|
12:15 pm |
Session 2 Panel discussion Moderated by Roberta Ness |
|
1:00 pm |
Session 3: Stakeholder Reaction and Discussion 5-minute presentations from stakeholders |
|
1:05 pm |
Douglas Balentine, Unilever, conventional food |
|
1:10 pm |
Guy Johnson, Johnson Nutrition Solutions, conventional food |
|
1:15 pm |
Andrew Shao, Council for Responsible Nutrition, supplements industry |
|
1:20 pm |
Mary Hager, American Dietetic Association, food and nutrition professional organization |
|
1:25 pm |
Ilene Heller, Center for Science in the Public Interest, food consumer advocacy organization |
|
1:30 pm |
Stephen Williams, Somalogic, pharmaceutical industry |
|
1:35 pm |
Jack Zakowski, Beckman Coulter, diagnostics industry |
|
1:40 pm |
Richard Kuntz, Medtronic, device industry |
|
1:45 pm |
Panel discussion Moderated by John A. Wagner |
|
2:30 pm |
BREAK |
|
2:45 pm |
Invited Overview Presentation, Thomas Fleming |
|
3:30 pm |
Session 4: Implications and Discussion Panel discussion on report recommendations moderated by John R. Ball |
|
5:00 pm |
Wrap-up John R. Ball and the Committee |
|
5:00 pm |
ADJOURN Day 1 |
Day 2, June 22
|
9:00 am |
Welcome and Recap of Day 1 John R. Ball, committee chair |
|
9:30 am |
Session 5: Session for Stakeholder Comments 5-minute reactions to report recommendations |
|
9:45 am |
James Mayne, Pfizer |
|
9:50 am |
Melissa Musiker, Grocery Manufacturers Association |
|
9:55 am |
Federico Goodsaid, Food and Drug Administration |
|
11:45 am |
Wrap-up John R. Ball, committee chair |
|
12:00 pm |
ADJOURN MEETING |
