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.
