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Suggested Citation:"Appendix A: Discussion Forum Agenda." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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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

Suggested Citation:"Appendix A: Discussion Forum Agenda." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
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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

Suggested Citation:"Appendix A: Discussion Forum Agenda." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
×
Page 113
Suggested Citation:"Appendix A: Discussion Forum Agenda." Institute of Medicine. 2011. Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary. Washington, DC: The National Academies Press. doi: 10.17226/13038.
×
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Perspectives on Biomarker and Surrogate Endpoint Evaluation: Discussion Forum Summary Get This Book
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In 2010 the Institute of Medicine (IOM) recommended a framework for the evaluation of biomarkers in the chronic disease setting. Published in the book Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease, the framework is intended to bring consistency and transparency to the previously disparate process of biomarker evaluation.

Following the book's release, the IOM convened a 2-day discussion forum in Washington, DC, in order to provide an opportunity for stakeholders to learn about, react to, and discuss the book. Presentations reviewed the authoring committee's work process, recommendations, and provided perspectives on the book from the point of view of participants. Thomas Fleming, professor of biostatistics and statistics at the University of Washington, gave a keynote presentation on the critical issues in the validation of surrogate endpoints, a specific use of a biomarker.

The present volume recounts the discussion forum proceedings, focusing in turn on each represented sector. A summary of Dr. Fleming's presentation then sets the committee's recommendations within the context of biomarker utilization. Lastly, this summary examines the main themes raised by stakeholders, and the challenges and opportunities presented to stakeholders by the book's recommendations.

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