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A Working Paper of the 21st century
FDA Task Force

June 2006


Prescription for Progress: The Critical Path To Drug Development

Robert Goldberg, Ph.D. and Peter Pitts
Center for Healthcare and Insurance Studies, University of Connecticut, School of Business

FDA Task Force Members

Robert M. Goldberg
Chairman, Manhattan Institute's 21st Century FDA Task Force

Dr. Goldberg is co-founder, vice president and director of programs for Center for Medicine in the Public Interest. Prior to founding CMPI, he was senior fellow at the Manhattan Institute and director of its Center for Medical Progress. Dr. Goldberg's current research interests include FDA reform and the impact of new medical technologies on making health care more predictive, preventive and personalized. Dr. Goldberg is the author of numerous articles and reports including "Vaccinating Against Disaster," "False Economy on Drugs," "Importation Nightmare," and "Fight AIDS With Reason, Not Rhetoric." He has testified before the Senate Special Committee on Aging, the Senate Small Business Committee, and the House Commerce Committee. He has written for The Wall Street Journal, The Washington Post, the Los Angeles Times, National Review Online, and The Weekly Standard, and he writes regularly for The Washington Times. He received his Ph.D. in politics at Brandeis University in 1984.

Disclosure: None.

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

David Bleich, M.D. is chief, Division of Endocrinology, Diabetes & Metabolism and associate professor of medicine at UMDNJ-New Jersey Medical School. His research interest involves understanding the effects of matrix metalloproteinases and their inhibitors on cell adhesion and migration in type 1 diabetes. He has received research grant support from the NIH and Juvenile Diabetes Research Foundation for this work. He is also funded by the Almond Board of California to evaluate the metabolic effects of almond consumption in pre-diabetes. Dr. Bleich has authored numerous peer-reviewed publications on type 1 diabetes and is a member of the Research Grant Review Committee for the American Diabetes Association.

Disclosure: Dr. Bleich is a member of the Speakers Bureau for Sanofi-Aventis.

Bruce Booth
Principal on the Life Sciences team, Atlas Venture

Bruce Booth joined Atlas Venture in 2005 as a Principal on the Life Sciences team. Prior to Atlas Venture, Bruce was a Principal at Caxton Health Holdings L.L.C., a healthcare-focused investment firm. He focused on the firm's private equity activities, ranging from early stage venture capital through late stage buyouts. Prior to joining Caxton Health, he was an Associate Principal at McKinsey & Company, a global strategic management consulting firm, where he focused on R&D productivity, corporate strategy, and business development issues for several major biopharmaceutical companies. While at McKinsey, he also co-led the Firm’s international scholars recruiting efforts. Bruce works closely with Atlas Venture portfolio companies ARCA Discovery, Archemix, Dynogen and NxStage Medical. As a British Marshall Scholar, Bruce earned a Doctorate in Molecular Immunology from the Oxford University’s Nuffield Department of Medicine and the Weatherall Institute of Molecular Medicine. His research focused on viral and tumor immune surveillance, and how the immune system responds to intracellular pathogenesis. During his graduate studies at Oxford, he also received the Overseas Research Fellowship and served as junior dean of Trinity College. Prior to graduate studies, he worked on President Clinton's Domestic Policy Council in the National Office of AIDS Policy. He received a Bachelor of Science degree with highest honors in Biochemistry from the Pennsylvania State University, where he was an Evan Pugh Scholar. He currently serves on the New York Academy of Medicine Board of Trustees, and is an active member of the Council on Foreign Relations. Bruce has also authored numerous scientific papers and reviews, including several in Nature Reviews Drug Discovery.

Disclosure: None.

Mark Brunswick
Director, Regulatory Affairs, Elan Pharmaceuticals

As regulatory affairs director for Elan, Mark Brunswick directs the group responsible for interactions within Elan and with the FDA for drugs regulated by both the Center for Biologics and the Center for Drugs. He worked as a regulatory affairs consultant for SAIC, dealing with government and commercial contracts, as well as compliance inspection. Previously, Mark accumulated nine years of experience as a reviewer for the FDA, specializing in licensing and facilities inspection. He has conducted extensive research into the human immune system, and holds a Ph.D. in immunology and a B.S. in genetics and zoology from the University of London.

Disclosure:Mark Brunswick is director, Regulatory Affairs, Elan Pharmaceuticals.

Paul Coplan, SC.D., MBA
Senior Director, Risk Management, Global Safety Surveillance and Epidemiology, Wyeth Pharmaceuticals

Paul M. Coplan is a senior director of risk management at Wyeth. Dr. Coplan works with cross-functional teams across Wyeth to develop and implement Risk Management plans for marketed products and investigational compounds. In this role, he works with key stakeholders to apply scientifically based methodologies to identify, assess, communicate and minimize risks throughout a drug’s lifecycle so as to establish and maintain a favorable benefit/risk profile in patients.

Dr. Coplan received a Doctorate of Science in Epidemiology from Harvard School of Public Health, a Masters in Business Administration from the Wharton School of Business at University of Pennsylvania, and a Masters of Science in Public Health & Nutrition from the University of Massachusetts. He has over 23 years of experience in the field of public health and drug development. Prior to joining Wyeth, Dr. Coplan was executive director of clinical and regulatory affairs and epidemiology at the International Partnership for Microbicides, a non-profit pharmaceutical company dedicated to the development of microbicides to prevent HIV infection among women in developing countries. In this role he was the leader of the Regulatory Affairs department and in framing the regulatory hurdles for licensure of vaginal microbicides to prevent HIV infection. He also ran several clinical trials in Africa of investigational microbicides and established several new clinical trial sites in developing countries. From 1995 to 2003 Dr. Coplan worked in the Epidemiology and Worldwide Regulatory Affairs departments of Merck & Co. where he worked as regulatory leader for Merck's HIV vaccine, herpes zoster vaccine, and cancer vaccine programs.

Disclosure: None.

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

Dr. DiMasi has been at the Tufts Center for the Study of Drug Development since the fall of 1987. Prior to joining the Tufts Center for the Study of Drug Development, Dr. DiMasi was a member of the Department of Economics at the College of the Holy Cross. Dr.DiMasi received his Ph.D. in Economics from Boston College in 1984. He received a B.A. with honors in both Mathematics and Economics from the University of Massachusetts at Boston in 1975. Dr. DiMasi has authored numerous articles published in economics and medical research journals. He has served on the editorial boards of the Drug Information Journal and the Journal of Research in Pharmaceutical Economics.

Disclosure: The Tufts Center for the Study of Drug Development is supported in part by unrestricted grants from pharmaceutical and biopharmaceutical firms, as well as from companies that provide services and products to this industry. Sponsoring companies have no direct access to any of the Tufts Center's proprietary databases, and they have no direct influence on the group’s research agenda.

Robert Peter Gale, M.D.
Senior Vice President Research, Ziopharm Oncology, Inc. and Center for Advanced Studies in Leukemia

From 1993-1999, Dr. Gale was senior physician and corporate director of bone marrow and stem cell transplantation at Salick Health Care, Inc. in Los Angeles. From 2000-2004 Dr. Gale was senior vice president for medical affairs at Antigenics, Inc. in New York where he was responsible for design, implementation and analysis of clinical trials of anticancer vaccines. Dr. Gale has published over 800 scientific articles and more than 20 books, mostly on leukemia (biology and treatment), transplantation (biology, immunology and treatment), cancer immunology and radiation (biological effects and accident response). He has written on medical topics, nuclear energy and weapons and politics of US-Soviet relations in articles for The NY Times, The Los Angeles Times, The Washington Post, USA Today, and The Wall Street Journal. He is presently visiting professor of haematology at the Imperial College of Science, Technology and Medicine (Hammersmith Hospital, London, UK). Dr. Gale lives in Los Angeles with his wife Laura and six children.

Disclosure: None.

Frederick Goodwin
Professor of Clinical Psychiatry, George Washington University

Frederick K. Goodwin, M.D., is research professor of psychiatry at The George Washington University and director of the Center on Neuroscience, Medical Progress, and Society at the George Washington University Medical Center. Dr. Goodwin is the former director of the National Institute of Mental Health (NIMH). Prior to that, he held a Presidential appointment as head of the Alcohol, Drug Abuse, and Mental Health Administration. He joined the NIMH in 1965. He is a member of the Institute of Medicine of the National Academy of Sciences and a fellow of the ACNP. He serves on the editorial boards of key scientific journals, including the Archives of General Psychiatry and The Journal of Clinical Psychopharmacology, and is a founder of Psychiatry Research.

Dr. Goodwin is a recipient of the major research awards in his field. The author of over 430 publications, Dr. Goodwin (with K. R. Jamison, Ph.D.) wrote Manic-Depressive Illness, the first psychiatric text to win the Best Medical Book award from the Association of American Publishers. Dr. Goodwin is a Senior Contributor and guest host of the award-winning "The Infinite Mind" public radio show, a weekly public radio program dedicated to issues relating to the mind, the brain, and mental illness. Dr. Goodwin served as host of "The Infinite Mind" for seven years starting with its premiere in 1998.

Disclosure: Dr. Goodwin works in a research support capacity for Abbott Laboratories, Glaxo, Solvay, Janssen, Pfizer, Lily, Forest, Sanofi, and BMS. He is part of the Speakers Bureau at Glaxo, Pfizer, Lily, and Bristol Myers Squibb. He also works as a consultant for Glaxo, Lily, Pfizer, Bristol Myers Squibb, and Solvay.

Susan Horn, PH.D.
Senior Scientist, Institute for Clinical Outcomes Research

Susan D. Horn, Ph.D., is senior scientist, Institute for Clinical Outcomes Research, and adjunct professor, Department of Medical Informatics, University of Utah School of Medicine, both in Salt Lake City. From 1968-1991, she was a faculty member at The Johns Hopkins University in Baltimore in biostatistics and health policy and management. From 1991-1995, she was senior scientist at Intermountain Health Care in Salt Lake City. Dr. Horn earned a B.A. in mathematics at Cornell University, and a Ph.D. in statistics at Stanford University. She has published over 150 papers in statistics and health services research and developed the Comprehensive Severity Index, used in the conduct of practice-based evidence studies in over 20 clinical areas including nursing home pressure ulcer prevention, post–stroke rehabilitation, hospice, and pediatrics. Findings from these studies have been implemented successfully to improve clinical and operational outcomes.

Disclosure: None.

Mathias Hukkelhoven
Vice President, U.S. Regulatory Affairs, Novartis Pharmaceuticals

Mathias Hukkelhoven, Ph.D. is senior vice president, global head, Drug Regulatory Affairs of Novartis Pharmaceuticals Corporation in East Hanover, New Jersey. In his current role Dr. Hukkelhoven is responsible for global coordination of all regulatory affairs activities and strategies of development projects and marketed products in the Novartis portfolio. From 1999—2001 he was head of the U.S. Regulatory Affairs Department at Novartis. Before this, he was responsible for Regulatory Affairs in the Immunology and Biotech area of Novartis predecessor company Sandoz in East Hanover and Basel (Switzerland). Before joining Novartis and Sandoz he was a group leader in the Regulatory Affairs Department of Hoffmann-La Roche in Basel, Switzerland where he was responsible for biotechnology, oncology and anti-infective projects. From 1984-1990, he worked in various positions in AKZO Pharma in the Netherlands and Belgium, where from 1996-1990 he was Head of the Regulatory Affairs Department of Organon Teknika. Dr. Hukkelhoven graduated in 1979 from the University of Nijmegen, The Netherlands and received his honors Ph.D. degree in Biochemistry from that University in 1984. He is the author of 35 articles on the metabolism of carcinogenic compounds in human tissues. From April 2006 he will be the Chair of the Regulatory Affairs Coordinating Committee at PhRMA.

Disclosure: Dr. Hukkelhoven is the Vice President of U.S. Regulatory Affairs at Novartis Pharmaceuticals.

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

Stephen A. Martin is senior vice president and chief technology officer at BG Medicine. Prior to joining BG Medicine in May 2004, Dr. Martin was senior director of the Discovery Proteomics & Small Molecule Research Center (DPSM RC) at Applied Biosystems in Framingham, Massachusetts. The team focused on developing complete workflows with collaborators in a variety of applied markets, identifying gaps in these approaches and conducting basic research to better understand the key technologies that would revolutionize these fields. Prior to forming the Research Center, Dr. Martin was responsible for Research and Development in Mass Spectrometry and Chromatography. He joined PerSeptive Biosystems in 1994, which was later acquired by Applied Biosystems. Before joining Applied Biosystems, Dr.Martin held positions at Genetics Institute, Medical University of South Carolina and the Department of Chemistry at MIT. He received his B.A. in Chemistry from Boston University in 1980 and his Ph.D. in Analytical Chemistry from MIT in 1984.

Disclosure: Stephen Martin is senior vice president & chief technical officer, Beyond Genomics.

Pat McGovern
Associate Director, Regulatory Affairs, Novartis

Patricia McGovern is a director in Drug Regulatory Affairs at Novartis. Trained in chemistry at Columbia University and the University of California, Berkeley, Patricia worked extensively on dermatology and respiratory projects at Novartis prior to assuming her current role as head of Special Projects. The responsibilities of the Special Projects group include coordinating Novartis' activities related to the Critical Path Initiative, and participating in internal efforts that are focused on developing a vision for the future of drug development and implementing aspects of that vision at Novartis.

Disclosure: Pat McGovern is associate director, regulatory affairs, Novartis

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

Dr. Oktem is an adjunct professor at the Operations and Information Management Department and a senior research fellow at Risk Management and Decision Process Center of the Wharton School of University of Pennsylvania. Dr. Oktem's research interests include development of effective nearmiss management systems and identification and mitigation of adverse drug effects. She teaches environmental sustainability and value creation at the Wharton School, MBA program. Prior to her academic life she worked at Rohm and Haas Company for 16 years where she managed large scale product development and manufacturing, including agricultural chemicals. Dr. Oktem holds B.S., M.S., and Ph.D. degrees in chemical engineering.

Disclosure: None.

Peter Pitts
Director, Center for Medicine in the Public Interest

Peter Pitts is director of the Center for Medicine in the Public Interest, a think tank on public health care policy issues and senior vice president, director for Global Health Affairs for Manning, Selvage & Lee. From 2002-2004 Peter was FDA’s Associate Commissioner for External Relations, serving as the agency's chief messaging officer. Before his work with the FDA, Mr. Pitts served as managing partner of Wired World, director of marketing at The New York Post, director of marketing for The Washington Times and Insight Magazine, and in numerous other communications positions. He joined the Hudson Institute in 1995 as vice president of marketing and communications. He has also served as an adjunct professor at Indiana University's School of Public and Environmental Affairs and at Butler University. A graduate of McGill University, Mr. Pitts writes a regularly syndicated national column for United Press International and is frequently interviewed by the business press. His most recent book is Become Strategic or Die.

Disclosure: None.

Gualberto Ruaño, M.D., PH.D.
President & Founder, Genomas

Dr. Ruaño has been an innovator and entrepreneur in the biomedical industry and advocate of personalized medicine for 20 years. He obtained M.D. and Ph.D. degrees from Yale University. He obtained his B.A. degree from Johns Hopkins University, where he was elected to Phi Beta Kappa. Dr. Ruaño founded Genomas (Hartford CT) in 2003, and is the company's president. Dr. Ruaño is director of genetics research at Hartford Hospital. He also holds adjunct professorships in the medical faculties at George Washington University and the University of Puerto Rico. Dr. Ruaño founded Genaissance Pharmaceuticals in 1997, served as chief executive officer and chief scientific officer, and led the company to a public offering in 2001.

Disclosure: Gualberto Ruaño, M.D., Ph.D. is president & founder, Genomas.

Ellis Rubinstein
President & CEO, New York Academy of Sciences

As president and chief executive officer of the New York Academy of Sciences since November 2002, Ellis Rubinstein is rejuvenating the 187-year-old institution through a series of novel initiatives. Mr. Rubinstein came to the Academy after more than 13 years with the American Association for the Advancement of Science (AAAS), where he served as editor of Science magazine from 1993-2002, having previously been news editor. Prior to Science, Mr. Rubinstein was editor of The Scientist and a Senior Editor at Newsweek. He also served as managing editor of Science 86 (a much-honored publication that reached over 500,000 readers) and IEEE Spectrum (the principal magazine of the Institute of Electrical and Electronics Engineers). During his 3 decades as a journalist and editor, he was thrice honored by National Magazine Awards.

Disclosure: None.

Stephen Sammut
Venture Partner, Burrill & Company

Mr. Sammut is venture partner, Burrill & Company, a San Francisco based life science merchant bank, and senior fellow, Wharton Entrepreneurial Programs and Health Care Systems. At Burrill & Company, Mr. Sammut manages Asia –Pacific venture activity. At the Wharton School he teaches venture capital management, corporate development, mergers and acquisitions, biotechnology entrepreneurship, intellectual property strategy, and private equity in emerging markets, and a special seminar on private sector participation in international health. He works actively with a student-alumni organization called Wharton Health International Volunteer Program. Mr. Sammut previously held the positions of vice president of development of Teleflex Incorporated and at S.R. One, Ltd., GlaxoSmithKline’s venture capital fund, and also served as managing director of the Center for Technology Transfer at the University of Pennsylvania. He is co-founder and former chief executive officer of the Philadelphia Organ Transplant Program.He holds degrees in biology and humanities from Villanova University, attended Hahnemann Medical College for two years and holds an M.B.A. from the Wharton School.

Disclosure: None.

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

Dr. Shlaes has had a thirty year career in antiinfectives spanning academia and industry with a long standing scientific interest in antimicrobial resistance. Dr. Shlaes graduated from Case Western Reserve University of Cleveland with a Ph.D. in 1975 and an M.D. in 1976. After completing post-graduate training in Cleveland in 1980, he joined the faculty of CWRU in the Division of Infectious Diseases. In 1984 he became chief, Infectious Diseases Section and in 1991 he was appointed professor of medicine at Case Western Reserve University. In 1996, Dr. Shlaes moved to industry where he was vice president for infectious diseases at Wyeth Research for six years. In 2002, Dr. Shlaes became executive vice president, research and development for Idenix, Pharmaceuticals, a company located in Cambridge, MA focused on the discovery and development of antivirals. In 2005, he left Idenix to form a consulting company for the pharmaceutical industry (Anti-Infectives Consulting, LLC). Recent responsibilities have included the IDSA Taskforce on antimicrobial availability, the NIH RCE for Biodefense study section, the Manhattan Institute's Task Force on FDA Reform and the Alliance for Biosecurity of the University of Pittsburgh.

Disclosure: Currently, Dr. Shlaes consults for a number of pharmaceutical companies and investor groups including Idenix Pharmaceuticals, Actelion Pharmaceuticals, and Novexel where he is a non-executive director.

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

John Swen is executive director, U.S. Science Policy and Public Affairs at Pfizer. He co-chairs Pfizer's Research, Science Policy, and Regulatory team and also represents the R&D organization on the U.S. and Global Policy Coordinating Committees. Prior to joining Pfizer in 2001, John held a series of senior posts in the biotechnology industry, as chief operating officer for Modex Therapeutiques, in the computer industry, and in government, where he served for three years in Governor Lincoln Almond's cabinet as director of economic development. John received his B.A. in English from Columbia College, and his M.S. in Management of Information and Technology and Strategy from MIT’s Sloan School of Management.

Disclosure: Mr. Swen is executive director, U.S. Science Policy & Public Affairs, Pfizer Global Research.

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

Michael A. Weber, MD is professor of medicine at the SUNY Downstate College of Medicine in Brooklyn, New York. He received his medical degree from Sydney University in Australia. His career has been focused primarily on hypertension and preventive cardiology. He has published numerous research articles in the medical literature and has authored or edited 16 books. Together with Dr. Suzanne Oparil, he is responsible for the widely used reference volume, Hypertension. Dr. Weber was one of the founders of The American Society of Hypertension and has served as its President. He also served as chair of the ASH Hypertension Specialists Program. He is a fellow of The American College of Physicians, The American College of Cardiology and The American Heart Association. He has served on the Cardiovascular and Renal Drugs Advisory Board of the Food and Drug Administration, and continues as a consultant to that Agency. He has also served for ten years as Chairman of the Formulary Committee of a major pharmacy benefits provider serving many of the leading health plans in the United States.

Disclosure: Dr. Weber serves as a consultant and provides medical education services for members of the pharmaceutical industry.

Ray Woosley
President & CEO, Critical Path Institute

Raymond L. Woosley earned a Ph.D. in Pharmacology from the University of Louisville and an M.D. from the University of Miami. Dr. Woosley specialized in Internal Medicine and Clinical Pharmacology at Vanderbilt University where he rose to the rank of professor of medicine. At Georgetown University he served as chairman of the Department of Pharmacology and associate dean for clinical research. In 2001 he became vice president for health sciences at the University of Arizona and Dean of the College of Medicine. In January of 2005 he assumed the position as president and chief executive officer of The Critical Path Institute (C-Path), a publicly funded, non-profit corporation formed to work with the FDA on the critical path initiative.

Disclosure: None.

Brian Zambrowicz
Senior Vice President, Genomics, Lexicon Genetics

Brian P. Zambrowicz, Ph.D. has been the executive vice president of research at Lexicon Genetics since August 2002. Dr. Zambrowicz served as senior vice president of Genomics from February 2000 to August 2002, vice president of research from January 1998 to February 2000 and senior scientist from April 1996 to January 1998. While at Lexicon, Dr. Zambrowicz has been in charge of the large-scale genetics program involving the production and phenotypic analysis of knockouts to identify novel mechanisms for treating human disease. This work has resulted in numerous small molecule and antibody-based drug development programs. Dr. Zambrowicz has been leading Lexicon's antibody drug development efforts. From 1993 to April 1996, Dr. Zambrowicz served as a National Institutes of Health, or NIH, postdoctoral fellow at The Fred Hutchinson Cancer Center in Seattle, Washington, where he studied gene trapping and gene targeting technology. Dr. Zambrowicz received his B.S. in Biochemistry from the University of Wisconsin. He received his Ph.D. from the University of Washington, where he studied tissue-specific gene regulation using transgenic mice.

Disclosure: Dr. Zambrowicz is vice president of Genomics at Lexicon Genetics, a drug discovery company.

 


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WHAT THE PRESS SAID:

FDA Chief Speaks at Critical Path Conference Pharma Marketletter, 6-13-06

FDA Trying to Shift Approach to Encourage Personalized Drugs FDA Week (Vol. 12, No. 23), 6-9-06

TABLE OF CONTENTS:

EXECUTIVE SUMMARY

The Critical Path to Personalized Medicine

Public Health and the Critical Pat

Shortcomings of the Current Drug Development and Approval Process

Promoting Collaboration

Bayesian Analysis

Genomics and Postmarket Drug Safety

Eploratory INDS and Validating Biomarkers

Post-Market Drug Evaluation

DISEASE REGISTRIES, BIOBANKS, AND ELECTRONIC PATIENT RECORDS

Accelerating Approval

The 21ST CENTURY FDA

APPENDIX

ENDNOTES

FDA Task Force Members


Manhattan Institute 21st Century FDA Task Force.

JUNE 8th CONFERENCE AGENDA
Prescription for Progress:
The Critical Path for Drug Development

 


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