NEW REPORT

Prescription for Progress: The Critical Path for Drug Development by Robert Goldberg, Ph.D. and Peter Pitts AVAILABLE IN REALVIDEO

ARTICLES BY ROBERT GOLDBERG, PhD: New FDA leadership, The Washington Times, 10-4-05 Accelerate drug approval, The Washington Times, 6-14-05 The 'European disease' The Washington Times, 4-28-05 The FDA and drugmakers should think small USA Today, 2-28-05 The New Frontier for Drug Safety: Personalized Medicine with Gualberto Ruaño, Medical Progress Today, 2-17-05 Vioxx Backlash Could Derail Future of Medicine with Paul Howard, Health Care News, January 2005 The Right Road To Safe Drugs New York Post, 12-28-04 Medical progress Washington Times, 12-7-04  SUGGESTED READING: Pazdur's Cancer Rules The Wall Street Journal, 7-6-05 The FDA vs. Cancer Patients The Wall Street Journal, 5-19-05 Kianna's Legacy The Wall Street Journal, 3-29-05 How About a 'Kianna's Law'? Wall Street Journal, 3-24-05 FDA Guidance for Industry: Pharmacogenomic Data Submissions U.S. Department of Health and Human Services, March 2005 Treatment Tailor-Made For You, By Dianne Hales, Parade, 9-19-04 Personal Medicine Gets, By Marc Wortman, Technology Review, January/February 2001  PRESS: BG Medicine Participates as a member of the "21st Century FDA Task Force"-Focus on FDA Critical Path Initiative BioProcess International, March 2005 FDA task force By Julius A. Karash, The Kansas City Star Press Release BG Medicine Press Release  MEDIA INQUIRIES: For general or media inquiries, please contact Communications Department at 212/599-7000.

Over the past 50 years, new medicines have been largely responsible for improving health care quality, lowering medical costs, and lengthening life-spans. However, recent controversies regarding the safety of FDA approved medicines have called into question the agency's longstanding regulations for approving safe and effective new drugs.

The 21st Century FDA Task Force believes that science-based FDA reform is the surest route to improving the safety and efficacy of new medicines. The clinical trials currently relied upon by the FDA to demonstrate drug safety and efficacy are enormously expensive, time consuming, and unable to identify rare but serious side effects that may not emerge until years after a drug is released onto the market.  As a result of this "one size fits all" approach to drug approval, trial and error is the primary way doctors prescribe drugs to patients and try to avoid tragic adverse events.

The FDA should instead rely on new gene-based screening tests and computer technologies to spur the development of personalized medicines, treatments that can be matched to an individual's unique genetic background or disease history, thereby avoiding dangerous side effects and ensuring that doctors can provide the right treatment, to the right patient, at the right time.

TASK FORCE MEMBERS:

Robert M. Goldberg, Chair
Senior Fellow, Manhattan Institute for Policy Research

David Bleich
Associate Professor of Medicine, University of Medicine & Dentistry of New Jersey

Bruce Booth
Principal, Life Sciences, Atlas Ventures

Mark Brunswick
Director, Regulatory Affairs, Elan Pharmaceuticals

Paul Coplan
Director of Clinical & Regulatory Affairs, International Partnership for Microbicides

Joseph DiMasi
Director of Economic Analysis, Tufts Center for the Study of Drug Development

Robert Peter Gale
Chief Scientific Officer & Head of Research, Ziopharm, Center for Advanced Studies in Leukemia

Frederick Goodwin
Professor of Clinical Psychiatry, George Washington University

Susan Horn
Senior Scientist, Institute for Clinical Outcomes Research

Matt Hukkelhoven
Vice President, U.S. Drug Regulatory Affairs, Novartis Pharmaceuticals

Joshua Lederberg
Professor Emeritus, Rockefeller University

Stephen Martin
Senior Vice President & Chief Technical Officer, Beyond Genomics

Pat McGovern
Associate Director, Regulatory Affairs, Novartis

Philip Noguchi
Regulatory Affairs Director, Amgen

Ulku Oktem
Senior Fellow, Risk Management & Decision Process Center, Wharton School at the University of Pennsylvania

Peter Pitts
Senior Fellow in Health Care Studies, Pacific Research Institute

Hugh Rosen
Director, Translational Research, Scripps Research Institute

Gualberto Ruano
President & Founder, Genomas

Ellis Rubinstein
President & CEO, New York Academy of Sciences

Stephen Sammut
Venture Partner, Burrill & Company

David Shlaes
Executive Vice President, Research & Development, Idenix Pharmaceuticals

John Swen
Senior Director, U.S. Science Policy & Public Affairs, Pfizer Global Research

Michael Weber
Associate Dean, Professor of Medicine, State University of New York

Raymond Woosley
President and Chief Executive Officer, Critical Path Institute

Brian Zambrowicz
Senior Vice President, Genomics, Lexicon Genetics