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Suggested Citation:"Appendix A: Agenda." Institute of Medicine. 2011. Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12968.
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Appendix A
Agenda

Building a National Framework for the Establishment of Regulatory Science for Drug Development


February 26, 2010

National Academy of Sciences Building

Lecture Room

2100 C Street NW

Washington, DC

8:00–8:15

OPENING REMARKS

 

Drug Forum Co-Chairs:

 

Gail Cassell, Eli Lilly and Company

Jeffrey Drazen, New England Journal of Medicine

8:15–8:45

REGULATORY SCIENCE: OVERVIEW

 

Moderator: Jeffrey Drazen, New England Journal of Medicine

 

Garret FitzGerald, Institute for the Translational Medicine and Therapeutics, University of Pennsylvania

8:45–9:15

KEYNOTE SPEAKER

 

Congresswoman Rosa DeLauro (D-CT)

9:15–10:00

FDA INITIATIVES ON REGULATORY SCIENCE

 

Margaret Hamburg, FDA Commissioner

10:00–10:15

Break

Suggested Citation:"Appendix A: Agenda." Institute of Medicine. 2011. Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12968.
×

10:15–11:30

Session I: OPPORTUNITIES FOR ENHANCING REGULATORY SCIENCE

 

Moderator: Mark McClellan, The Brookings Institution

 

The IOM and FDA Science Board Recommendations

 

Gail Cassell, Eli Lilly and Company

 

Academic Perspective

 

Philip Pizzo, Stanford University School of Medicine, Council of Deans, Association of American Medical Colleges

 

A Blueprint from the Patient’s Perspective

 

Ellen Sigal, Friends of Cancer Research

11:30–11:45

Break and Working Lunch

Guests are asked to pick up lunch and return to their seats.

11:45–1:15

Session II: OPPORTUNITIES FOR ENHANCING REGULATORY SCIENCE (cont’d)

 

Moderator: Barbara Alving, National Center for Research Resources, NIH

 

Translational Approaches to Understand and Predict Rare Adverse Reactions to Drugs

 

Paul Watkins, Hamner–University of North Carolina Institute for Drug Safety Sciences

 

A Role for Regulatory Science in Emerging Technologies: Genomics

 

Allen Roses, Deane Drug Discovery Institute, Duke University

 

Opportunities in Statistical Design, Analysis, and Modeling

 

Susan Ellenberg, University of Pennsylvania School of Medicine

 

IT Infrastructure, Informatics and Scientific Computing in Regulatory Science

 

Sangtae Kim, Morgridge Institute for Research

Suggested Citation:"Appendix A: Agenda." Institute of Medicine. 2011. Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12968.
×

1:15–2:15

Panel I: A COMPARISON OF EXISTING AND POTENTIAL MECHANISMS FOR PROMOTING REGULATORY SCIENCE

 

Moderator: Peter Honig, FDA and Merck (ret.)

 

Panelists:

  • Jesse Goodman, FDA

  • Dale Nordenberg, Novasano Health and Science

  • Judith Kramer, Clinical Trials Transformation Initiative, Duke University

  • Margaret Anderson, FasterCures

  • Harry Greenberg, Stanford University School of Medicine

2:15–2:30

Break

2:30–3:15

Panel II: ENERGIZING PUBLIC POLICY TO ADVANCE THE SCIENCE

 

Moderator: Janet Tobias,1 Ikana Media

 

Panelists:

  • Steven Grossman, HSP Group and Alliance for a Stronger FDA

  • Michael Manganiello, HCM Strategists

  • Mary Woolley, Research! America

3:15–3:45

HHS PERSPECTIVE

 

Protecting the Public through Regulatory Science—A National Priority

 

William Corr, HHS Deputy Secretary

3:45–4:00

SUMMARY AND NEXT STEPS

 

Gail Cassell, Eli Lilly and Company

1

Unable to attend the workshop due to weather.

Suggested Citation:"Appendix A: Agenda." Institute of Medicine. 2011. Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12968.
×

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Suggested Citation:"Appendix A: Agenda." Institute of Medicine. 2011. Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12968.
×
Page 57
Suggested Citation:"Appendix A: Agenda." Institute of Medicine. 2011. Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12968.
×
Page 58
Suggested Citation:"Appendix A: Agenda." Institute of Medicine. 2011. Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12968.
×
Page 59
Suggested Citation:"Appendix A: Agenda." Institute of Medicine. 2011. Building a National Framework for the Establishment of Regulatory Science for Drug Development: Workshop Summary. Washington, DC: The National Academies Press. doi: 10.17226/12968.
×
Page 60
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The Food and Drug Administration (FDA) is tasked with ensuring the safety and effectiveness of medicine. FDA's science base must be strong enough to make certain that regulatory decisions are based on the best scientific evidence. The IOM held a public workshop on February 26, 2010, to examine the state of regulatory science and to consider approaches for enhancing it.

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