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



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OCR for page 113
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 11

OCR for page 113
11 BIOMARKER AND SURROGATE ENDPOINT EVALUATION 1:00 pm Session 3: Stakeholder Reaction and Discussion -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 -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