* TIME CHANGE

CENTER FOR MEDICAL PROGRESS

CONFERENCE AGENDA

Prescription for Progress:

The Critical Path for Drug Development

Thursday, June 8, 2006
9:00 AM - 12:30 PM
Washington, D.C.

Keynote Speaker:

Andrew C. von Eschenbach, M.D.
Acting Commissioner, U.S. Food and Drug Administration

The U.S. Food and Drug Administration (FDA) is taking steps to streamline drug development by incorporating new technologies, including genetic tools, faster computers, new imaging techniques, and electronic medical records, into the drug evaluation process. This program, the Critical Path Initiative, while still in its infancy, holds the potential to break down barriers between regulators and industry and to expedite the journey of lifesaving medical innovations from researchers to regulators to patients.

In support of the Critical Path Initiative, the Center for Medical Progress at the Manhattan Institute convened experts with wideranging experience across industry, government, and the scientific community in a task force on the 21st century FDA. This working paper reflects the Task Force's discussions on how advances in genomics and other disciplines might be used to optimize the drug approval process, and what tools and resources the FDA needs to achieve this outcome.

Confirmed participants include Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs, FDA; Janet Woodcock, M.D., Deputy Commissioner for Operations, FDA; and Peter Hotez, M.D., Ph.D., Professor and Chair, Department of Microbiology, Immunology and Tropical Medicine, George Washington University Medical Center.

Please join us as we discuss how the biomedical research community can help advance the next generation of medical miracles. Please contact: Lindsay Young Craig, Executive Director, Communications, Manhattan Institute for Policy Research Office at: 212-599-7000 ext. 315

8:30-9:00 AM

Registration

9:00-9:10 AM

Introduction and Overview

Robert Goldberg, Ph.D., Chairman, 21st Century FDA Task Force, Vice President & Co-Founder, Center for Medicine in the Public Interest
Peter Pitts, Director, Center for Medicine in the Public Interest

9:10-10:00 AM

Keynote Address

Keynote: Andrew von Eschenbach, M.D., Acting Commissioner, FDA

10:00-11:00 AM

Panel I: Roundtable on Prescription for Progress: The Critical Path to Drug Development

Moderator: Michael Weber, M.D., Professor of Medicine, SUNY Downstate College of Medicine

Panelists:
Jeffrey Cossman, M.D., Chief Scientific Officer, The Critical Path Institute
Gualberto Ruano, M.D., Ph.D., President, Genomas, and Director of Cardiovascular Research, Hartford Hospital
Robert McBurney, Ph.D., Senior Vice President, Research and Development, and Chief Scientific Officer, BG Medicine, Inc.
Scott Gottlieb, M.D., Deputy Commissioner for Medical and Scientific Affairs, FDA

11:00-11:10 AM

Break

11:10-12:15 PM

Panel II: The Critical Path Today and Tomorrow: Challenges and Opportunities

Moderator: Steve Usdin, Senior Editor, BioCentury Publications

Panelists:
Janet Woodcock, M.D., Deputy Commissioner for Operations, FDA
Meryl Comer, Patient Advocate for Alzheimer’s Research
Peter Hotez, Ph.D, M.D., Professor and Chair, Department of Microbiology, Immunology and Tropical Medicine, George Washington University Medical Center

12:30 PM

Adjornment