I had the privilege to chair an FDA reform task force for the Manhattan Institute, an undertaking Mark McClellan suggested after I invited him to speak at an MI event when I was an MI senior fellow in 2003. I met with two senior FDA officals — Peter Pitts and Scott Gottlieb — that same year about how the report might help to advance the FDA’s fledgling Critical Path initiative. Peter was — like the rest of the FDAers involved in the project — visionary, supportive and courageous in combatting the negativism surrounding the effort. The Task Force we put together was (and is) dedicated, caring and thoughtful, working for free and giving graciously of their time, effort and insights. The result is a biomedical call to arms to apply the insights of drug discovery to the process of drug develpment to make medicine more predictive, preventive and personalized. The agenda surrounding the rollout of the report is below. We hope you can all attend.
AGENDA & REGISTRATION:
CENTER FOR MEDICAL PROGRESS
Prescription for Progress: The Critical Path for
Drug Development
by Robert Goldberg, PhD and Peter Pitts
M Street Hotel
1143 New Hampshire Avenue, N.W.
Washington, D.C.
Thursday, June 8, 2006
Keynote Speaker:
Andrew C. von Eschenbach, M.D.
Acting Commissioner, U.S. Food and Drug Administration
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
9:10-10:15AM
Panel 1: 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
10:15-10:30 AM
Break
10:30-11:35 AM
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 Alzheimeré¾ Research
Peter Hotez, Ph.D, M.D., Professor and Chair, Department of Microbiology, Immunology and Tropical Medicine, George Washington University Medical Center
11:35-12:15 PM
Keynote Address
Keynote: Andrew von Eschenbach, M.D., Acting Commissioner, FDA
