Below are the first 10 and last 10 pages of uncorrected machine-read text (when available) of this chapter, followed by the top 30 algorithmically extracted key phrases from the chapter as a whole.
Intended to provide our own search engines and external engines with highly rich, chapter-representative searchable text on the opening pages of each chapter.
Because it is UNCORRECTED material, please consider the following text as a useful but insufficient proxy for the authoritative book pages.
Do not use for reproduction, copying, pasting, or reading; exclusively for search engines.
OCR for page 97
Appendix B
Participant Biographies
Jeffrey M. Drazen, M.D. (Workshop Chair), was born in Missouri. He
attended Tufts University, with a major in physics, and Harvard Medical
School, and served his medical internship at Peter Bent Brigham Hospital
in Boston. Thereafter, he joined the Pulmonary Divisions of the Harvard
hospitals. He served as Chief of Pulmonary Medicine at the Beth Israel
Hospital, Chief of the combined Pulmonary Divisions of the Beth Israel and
Brigham and Women’s Hospitals, and finally as the Chief of Pulmonary
Medicine at Brigham and Women’s Hospital. Through his research, he
defined the role of novel endogenous chemical agents in asthma. This led
to four new licensed pharmaceuticals for asthma with over 5 million people
on treatment worldwide. In 2000, he assumed the post of Editor-in-Chief of
the New England Journal of Medicine. During his tenure, the Journal has pub-
lished major papers advancing the science of medicine, including the first
descriptions of SARS and papers modifying the treatment of cancer, heart
disease and lung disease. The Journal, which has over a million readers
every week, has the highest impact factor of any journal publishing original
research.
Christopher Beardmore began his career in regulatory affairs, influ-
enced by leading human subject and animal subject protection commit -
tees at large academic institutions. While at the University of Maryland
at Baltimore and the University of California at Los Angeles (UCLA) he
reviewed and improved human subject protection systems, served as an
advisor to streamline research processes, drafted policy and procedure
97
OCR for page 98
98 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE
manuals and developed training and education programs to improve
systems. This included work with IRB members regarding review respon-
sibilities and dealing extensively in issues related to ethical and regulatory
training regarding GCP. Also while at UCLA, he represented all regula-
tory departments on an electronic research-networking database project
designed to integrate regulatory affairs with budget and contract services.
In September 2001, Mr. Beardmore relocated to Fort Detrick, Maryland,
and worked with the U.S. Army Medical Research Institute of Infectious
Disease to improve human subject activities. There he authored a position
paper proposing innovative approaches to developing investigational
biowarfare protective products. Over the years Mr. Beardmore has also
consulted for numerous research hospitals, institutes, and IRBs including
the West Los Angeles VA Medical Center, Friends Research Institute, and
St. Johns Hospital/John Wayne Cancer Institute. All of these experiences
led Mr. Beardmore to recognize a serious need to improve systems and
permit ethical research to be conducted more efficiently. In 2004, he took
on the role of Chief Operating Officer and Co-Founder of Premiere Oncol-
ogy, a medical oncology research and treatment group operating in Santa
Monica, California; San Diego, California; and Scottsdale, Arizona. Work -
ing with this group of practices until 2008, Mr. Beardmore established and
streamlined the efforts of physicians, sites, and ancillary service providers
and matched them with appropriate studies and sponsors to rapidly
become one of the largest private Phase I groups in the United States.
Mr. Beardmore found his vision for a community network of oncologists
needed to be expanded beyond a single entity and left to form Transla -
tional Research Management (TRM) in 2009. TRM is dedicated to the
creation of a community-focused clinical trial network, designed to bring
innovative products to oncologists to potentially treat, ameliorate, or cure
life-threatening or otherwise debilitating chronic disease. Currently TRM
manages over 50 sites and is contracted with over 430 ancillary service
providers who support those sites.
Robert Califf, M.D., graduated from Duke University, summa cum laude
and Phi Beta Kappa, in 1973 and from Duke University Medical School in
1978, where he was selected for Alpha Omega Alpha. He performed his
internship and residency at the University of California at San Francisco
and his fellowship in cardiology at Duke University. He is board certified
in internal medicine (1984) and cardiology (1986) and is a Master of the
American College of Cardiology (2006). He is currently Vice Chancellor
for Clinical Research, Director of the Duke Translational Medicine Insti -
tute (DTMI), and Professor of Medicine in the Division of Cardiology
at the Duke University Medical Center in Durham, North Carolina. For
10 years he was the Founding Director of the Duke Clinical Research Insti-
OCR for page 99
99
APPENDIX B
tute (DCRI), the premier academic research organization in the world.
He is the editor-in-chief of Elsevier’s American Heart Journal, the old-
est cardiovascular specialty journal. He has been author or co-author of
more than 800 peer-reviewed journal articles and a contributing editor for
theheart.org, an online information resource for academic and practicing
cardiologists. He was recently acknowledged as one of the 10 most cited
authors in the field of medicine by the Institute for Scientific Information
(ISI). Dr. Califf led the DCRI for many of the best-known clinical trials
in cardiovascular disease. With an annual budget of over $100 million,
the DCRI has more than 1,000 employees and collaborates extensively
with government agencies, the medical-products industry, and academic
partners around the globe in all therapeutic areas. In cooperation with his
colleagues from the Duke Databank for Cardiovascular Disease, Dr. Califf
has written extensively about the clinical and economic outcomes of
chronic heart disease. He is considered an international leader in the fields
of health outcomes, quality of care, and medical economics. Dr. Califf’s
role as Director of the Duke Translational Medicine Institute, which is
funded in part by an NIH CTSA, includes service as co-chairman of the
Principal Investigators Steering Committee of the CTSA. Dr. Califf has
served on the Cardiorenal Advisory Panel of the FDA and the Pharma-
ceutical Roundtable of the IOM. He served on the IOM committees that
recommended Medicare coverage of clinical trials as well as the removal
of ephedra from the market and on the IOM’s Committee on Identify-
ing and Preventing Medication Errors. He is currently a member of the
IOM Forum on Drug Discovery, Development, and Translation and a
subcommittee of the Science Board of FDA. He was the founding director
of the coordinating center for the Centers for Education & Research on
Therapeutics (CERTs), a public–private partnership among the Agency for
Healthcare Research and Quality, FDA, academia, the medical-products
industry, and consumer groups. This partnership focuses on research and
education that will advance the best use of medical products. He is now
the co-chairman of the CTTI, a public–private partnership focused on
improving the clinical trials system.
Doug Cropper, M.H.A., is President and CEO of Genesis Health System
(GHS) based in the Quad Cities area of Iowa and Illinois. GHS is a not-
for-profit system offering a full continuum of health care services to a
10-county area. With an A1 Bond rating, GHS reported total operating
revenue of $558 million in fiscal year 2010 and employs over 5,000 people.
GHS has been the recipient of numerous awards and recognitions, includ-
ing Thomson Reuters 50 Top Heart Hospitals, Thomson Reuters Top 50
Health Systems, 2010 J.D. Powers and Associates Distinguished Hospital
for Providing “An Outstanding Patient Experience,” a Top 100 IHS, 100
OCR for page 100
100 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE
Most Wired Hospitals and Health Systems, Nursing Magnet designation,
and the Consumer Choice Award from National Research Corporation.
Mr. Cropper has more than 30 years of health care experience, starting out
as a surgical orderly at St. Mark’s Hospital in Salt Lake City, Utah. Prior
to Genesis, he was Executive Vice President of Inova Health System and
Administrator of the Inova Fairfax Hospital Campus in Falls Church, Vir-
ginia. Previous to his 5-year tenure at Inova, he served as Administrator
of St. John’s and St. Joseph’s Hospitals and Vice President of HealthEast
in St. Paul, Minnesota. Mr. Cropper graduated magna cum laude with a
B.S. in history from the University of Utah (1984) and received a master’s
in Healthcare Administration from the University of Minnesota in 1988.
James H. Doroshow, M.D., FACP, has been the Director of the Division
of Cancer Treatment and Diagnosis (DCTD), NCI, NIH, since 2004. He
fosters collaboration with other NCI divisions and offices, as well as extra-
mural scientists and clinicians, patient advocates, and professional cancer
organizations. He leads the DCTD professional staff, who represent a wide
array of scientific specialties, to integrate their insights and skills into a
crossdisciplinary, scientifically driven, cooperative research endeavor to
discover and develop better diagnostic and therapeutic interventions for
cancer. Dr. Doroshow also oversees his own active laboratory program
focusing on two lines of research: discovering the mechanisms that drive
the anthracycline antibiotic cell death program and understanding the
role of oxidative signals in the development and treatment of colon cancer.
From 1983 to 2004, Dr. Doroshow was the Associate Director for Clinical
Research at the City of Hope’s (COH) Comprehensive Cancer Center in
Duarte, California; the Chairman of the COH Department of Medical
Oncology and Therapeutics Research; and the Leader of the COH Cancer
Center’s Clinical and Experimental Therapeutics Program. Through these
roles, he oversaw solid tumor therapeutic research, supervised a staff of
75 involved in investigating novel targeted agents and other therapies,
and directed a program of clinical research that supported more than 150
concurrently active clinical trials. While at COH, he founded an early ther-
apeutics consortium of three NCI-designated cancer centers in California
funded by both NCI’s Phase I and II support grants. He was also the
principal investigator for COH’s membership in the Southwest Oncology
Group (SWOG) and founding Chair of the SWOG Early Therapeutics
Committee. From the time he received his first research grant in 1980,
Dr. Doroshow was funded continuously by NCI and NIH until moving to
NCI in 2004. He is the author of more than 300 full-length publications in
the areas of the molecular and clinical pharmacology of the anthracycline
antibiotics, the role of oxidant stress in signal transduction, and novel
OCR for page 101
101
APPENDIX B
therapeutic approaches to breast, gastrointestinal, lung, and gynecologic
cancer. Dr. Doroshow is a senior editor of Clinical Cancer Research. He is
a member of the editorial boards of the International Journal of Oncology,
Technology in Cancer Research and Treatment, and Oncology. He is also an
associate editor for the widely used Manual of Clinical Oncology published
by the International Union Against Cancer. Dr. Doroshow served from
1995 to 2001 as a member of the Subspecialty Board on Medical Oncology
of the American Board of Internal Medicine, from 1999 to 2000 as Chair of
NCI’s Scientific Review Group-A Cancer Centers, and from 1990 to 1992
as Chair of the NIH Experimental Therapeutics II Study Section. He is
currently a member of the FDA Oncologic Drugs Advisory Committee.
Dr. Doroshow received his bachelor’s degree, magna cum laude, from
Harvard College in 1969 and his medical degree, Alpha Omega Alpha,
from Harvard Medical School in 1973. After completing an internship and
residency at Massachusetts General Hospital in Boston, he spent 3 years
(1975-1978) at NCI as a clinical associate. He is board certified in internal
medicine and medical oncology. Prior to joining COH in 1981, he held
the position of Assistant Professor of Medicine in the Division of Medical
Oncology at the University of Southern California School of Medicine in
Los Angeles.
Paul R. Eisenberg, M.D., M.P.H., FACP, is the Senior Vice President
of Global Regulatory Affairs and Safety at Amgen, effective February
2008. He was promoted after serving as Vice President of Global Regula -
tory Affairs and Safety since January 2007, and Vice President of Global
Safety since December 2005. Prior to joining Amgen, Dr. Eisenberg was
the Vice President of Lilly Global Product Safety. At Lilly he also led
Clinical Development teams in Cardiovascular, Critical Care, and Inflam-
mation Therapeutic Areas as Vice President–Internal Medicine and in
discovery as Executive Director of Cardiovascular Research and Clinical
Investigation. Dr. Eisenberg received his M.D. from New York Medical
College and M.P.H. in Tropical Medicine from Tulane University School
of Public Health. He was a Professor of Medicine at Washington Univer-
sity in St. Louis where his academic career, over 18 years, was focused on
basic and clinical research in cardiovascular disease and thrombosis. This
work led to over 100 publications in peer-reviewed journals and books.
He has been involved in the discovery and development of numerous
new molecular entities (NMEs) in both his academic and industry career.
Dr. Eisenberg has led the development and registration of multiple NMEs
in cardiovascular and critical care. In addition, he has extensive experi -
ence in global safety and risk management programs for drug develop-
ment programs and postmarketing in multiple therapeutic classes.
OCR for page 102
102 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE
Lynn M. Etheredge is an independent consultant on health care and social
policy issues and heads the Rapid Learning Project at George Washington
University. His career started at the White House Office of Management
and Budget (OMB), where he was OMB’s principal analyst for Medicare
and Medicaid and led its staff work on national health insurance proposals.
Mr. Etheredge headed OMB’s professional health staff in the Carter and
Reagan administrations. Later, he was a co-author of the Jackson Hole
Group’s proposals for health care reform. In 2007, he proposed the concept
of the “rapid-learning health system” and is collaborating widely in devel-
oping this approach. Mr. Etheredge’s recent publications include “Creat-
ing a High-Performance System for Comparative Effectiveness Research”
and “Medicare’s Future: Cancer Care.” He serves on the editorial board of
Health Affairs. He is author of more than 85 publications and is a graduate
of Swarthmore College.
Gary L. Filerman, Ph.D., is President of the Atlas Health Foundation, an
organization that addresses rural veteran’s health services access issues
and quality of care in corrections. He is adjunct professorial lecturer at the
George Washington University School of Public Health and Health Ser-
vices. He is also advisor to Joint Commission International, focusing on
global health standards and relationships with international organizations
and is an Open Society Institute faculty mentor. He formerly served at
professor and chairman of the Department of Health Systems Administra-
tion at Georgetown University. Prior to joining Georgetown in 2000 he was
for 2 years professor and interim chairman of the Department of Health
Services and Policy at the George Washington University. Dr. Filerman
joined the Georgetown faculty after a long career as the global leader in
the development of management capacity and competency for health ser-
vices. For 28 years he headed the Association of University Programs in
Health Administration, a consortium of university, institute, and ministry
programs in 30 countries. With the support of the W.K. Kellogg Founda-
tion, Pew Trusts, the Robert Wood Johnson Foundation, the Common-
wealth Fund, the World Health Organization (WHO), the U.S. Agency
for International Development (USAID), and multinational corporations,
his efforts focused upon the assessment of health system management
needs, the design of university programs, and faculty and curriculum
development and evaluation. He later served as vice president for inter-
national development of Planned Parenthood Federation of America,
associate director of the Pew Commission on the Future of the Health
Professions, senior health advisor at the Academy for Educational Devel-
opment, consultant to the World Bank private health sector initiative,
workforce leader for the World Bank Romania health sector reform, and
headed planning for the 1997 Tashkent conference on NIS medical edu-
OCR for page 103
103
APPENDIX B
cation reform. He has served as a consultant to ministries of health, uni -
versities, and health systems in 38 countries. Dr. Filerman has published
widely on health care management development. He earned master’s
degrees in Latin American government and health services administra -
tion and his Ph.D. in health services from the University of Minnesota. He
has been honored by the University of Leuven, the University of Puerto
Rico, The Ohio State University, the University of Chicago, and with the
Distinguished Contribution Award of the Regents of the University of
Minnesota. He serves on several boards, including Volunteers of America.
The endowed Filerman Prize is the highest recognition of leadership and
scholarship in health systems administration education.
Louis Fiore, M.D., M.P.H., was born in Brooklyn, New York, and attended
the State University of New York in Stony Brook (chemistry) and Upstate
Medical Center in Syracuse (M.D.). He completed his residency and fel-
lowships in hematology and oncology at the Boston VA and obtained an
M.P.H. from the Harvard School of Public Health. Dr. Fiore has been an
intramural researcher within the VA for 20 years. He was the Principal
Investigator of the CHAMP Trial, a secondary prevention study of AMI
that enrolled 5,000 subjects to either aspirin alone or in combination with
warfarin. In 1996 he founded the Massachusetts Veterans Epidemiology
Research and Information Center (MAVERIC), an epidemiology center
within the VA Cooperative Studies Program. In 2002 the Center was
expanded to include a clinical trials coordinating center. Since 2009 he
has focused on bringing medical informatics expertise to the Program.
His current interest lies in applying the disciplines of clinical trials, epi -
demiology, and informatics to integrate research into clinical care. To this
end he has established the Point of Care Clinical Trials program in the VA.
Sherine E. Gabriel, M.D., M.Sc., is Professor of Medicine (Rheumatology)
and Professor of Epidemiology, and the William J. and Charles H. Mayo
Endowed Professor. She is currently Co-Principal Investigator and Direc-
tor of Education, Center for Clinical and Translational Sciences, and Medi-
cal Director for Strategic Alliances and Business Development at Mayo
Clinic. She is a Past President of the American College of Rheumatol-
ogy. Dr. Gabriel’s research, which is largely NIH-funded, has resulted
in more than 350 peer-reviewed scientific publications addressing the
risks, costs, determinants, and outcomes of the rheumatic diseases. She
has received numerous research awards in recognition of these contribu-
tions. On January 21, 2011, Dr. Gabriel was appointed by the U.S. Gen-
eral Accountability Office to the Methodology Committee of PCORI and,
soon after, was appointed as its first chair. PCORI was created by the U.S.
Patient Protection and Affordable Care Act of 2010 as a nonprofit, non-
OCR for page 104
104 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE
governmental organization to help patients, clinicians, purchasers, policy
makers, and others make better-informed health decisions by carrying out
research that provides high-quality, relevant evidence about interventions
and strategies to prevent, diagnose, treat, and monitor health conditions.
Dr. Gabriel earned a Doctor of Medicine degree, with distinction, from the
University of Saskatchewan, Canada, completed internal medicine resi -
dency and rheumatology fellowship at Mayo Graduate School of Medi -
cine and a master of science in clinical epidemiology from McMaster
University. She is certified by the American Board of Internal Medicine in
internal medicine and in rheumatology.
Elaine K. Gallin, Ph.D., is currently a partner at QE Philanthropic Advi-
sors, a consulting firm established in 2010 that serves nonprofits special -
izing in biomedical research, science and math education, and interna -
tional health. From 1999 through February 2010, Dr. Gallin served as the
Doris Duke Charitable Foundation’s (DDCF’s) first Program Director for
Medical Research. In that capacity, she led the creation and management
of a portfolio of grant programs that committed more than $185 million
to supporting clinical research. Dr. Gallin also designed and led DDCF’s
$65 million African Health Initiative. Launched in September 2007, this
initiative supports large-scale health services delivery projects designed to
provide integrated primary health care linked to rigorous operations and
implementation research in several sub-Saharan African communities.
Before joining DDCF, Dr. Gallin spent two decades working for the U.S.
government, first as a research physiologist and then as research adminis-
trator where she last served as the Deputy Director of the Office of Inter-
national Health Programs in the U.S. Department of Energy overseeing
health research programs in countries of the former Soviet Union. During
this period, she also spent a sabbatical year working in the Science Com-
mittee of the U.S. House of Representatives as a Congressional Science
Fellow. Dr. Gallin has participated in numerous professional committees
and review panels, including several for IOM and NIH. She was a found-
ing member and the first Vice Chair of the Health Research Alliance (an
alliance of not-for-profit, nongovernmental research funders). Dr. Gallin is
currently a member of the Sickle Cell Disease Advisory Committee at the
National Heart Lung and Blood Institute, the Forum on Drug Discovery,
Development, and Translation at IOM, the Scientific Advisory Board for
the Avon Foundation, and the President’s Council of Cornell Women.
Dr. Gallin received her B.S. from Cornell University and her Ph.D. from
the City University of New York, and completed postdoctoral fellowships
in physiology at Johns Hopkins University Medical School and Columbia
University Medical School.
OCR for page 105
105
APPENDIX B
John I. Gallin, M.D., was appointed director of the NIH Clinical Center
in 1994. The Clinical Center serves the clinical research needs of 17 NIH
institutes and is the largest hospital in the world totally dedicated to
clinical research. During his tenure, Dr. Gallin has overseen the design
and construction of a new research hospital for the Clinical Center, the
Mark O. Hatfield Clinical Research Center, which opened to patients in
2005; the establishment of a new curriculum for clinical research training
now offered globally; and development of new information systems for
biomedical translational and clinical research. While serving as Clinical
Center director, Dr. Gallin has continued to be an active clinician and
researcher. His primary research interest is in a rare hereditary immune
disorder, chronic granulomatous disease (CGD). His laboratory described
the genetic basis for several forms of CGD and has done pioneering
research that has reduced life-threatening bacterial and fungal infections
in CGD patients. A New York native, Dr. Gallin attended public school
in New Rochelle, NY, graduated cum laude from Amherst College, and
earned an M.D. degree at Cornell University Medical College. After a
medical internship and residency at New York University’s Bellevue
Hospital Medical Center, he received postdoctoral training in basic and
clinical research in infectious diseases at NIH from 1971 to 1974. He
then went back to the New York University-Bellevue Medical Center as
senior chief medical resident from 1974 to 1975 before returning to NIH.
In 1985, Dr. Gallin began a 9-year period as scientific director for intra -
mural research activities at the NIAID. Dr. Gallin was the founding chief
of Laboratory of Host Defenses, NIAID, served as chief of the laboratory
for 12 years, and continues as chief of the lab’s clinical pathophysiology
section. He has published more than 325 articles in scientific journals and
has edited two textbooks: Inflammation, Basic Principles and Clinical Cor-
relates (Lippincott, Williams, and Wilkins, 1999, now in its third edition)
and Principles and Practices of Clinical Research (Academic Press, 2002, now
in its second edition). Dr. Gallin is a member of the American Society
for Clinical Investigation, the Association of American Physicians, and
the IOM of the National Academy of Sciences, and he is a Master of the
American College of Physicians.
Annetine C. Gelijns, Ph.D., is the Co-Chair of the Department of Health
Evidence & Policy at Mount Sinai School of Medicine, New York, New
York. Dr. Gelijns also holds the positions Professor of Health Policy, and
Co-Director of the International Center for Health Outcomes and Inno-
vation Research (InCHOIR) at Mount Sinai School of Medicine. Before
coming to Mount Sinai in 2008, she was Professor of Public Health and
Surgical Sciences in the Department of Surgery, College of Physicians
and Surgeons, and the Division of Health Policy and Management of
OCR for page 106
106 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE
the Mailman School of Public Health, Columbia University, New York
City. She was also a Division Chief in the Department of Surgery. Prior
to her position at Columbia, she directed the Program on Technologi-
cal Innovation in Medicine at the IOM, National Academy of Sciences.
From 1983 to 1987, she worked for the Steering Committee on Future
Health Scenarios and for the Health Council, the Netherlands. Dr. Gelijns
has been a consultant to various national and international organiza-
tions, including WHO and the Organisation for Economic Co-operation
and Development (OECD). Her research focuses on measurement of the
long-term clinical outcomes and economic impact of clinical interven -
tions, patient safety research, and the factors driving the development
and diffusion of medical technology. She has special expertise in cardio-
vascular disease, particularly in the design, coordination, and analysis
of multicenter trials. She is the PI or Co-PI of several Data Coordinating
Centers for NHLBI-sponsored trials, including CT Surgery Clinical Trials
Network, the REMATCH trial, and several newer generations of LVAD
trials. Dr. Gelijns has published, in such journals as the New England
Journal of Medicine, the Journal of the American Medical Association, and
Health Affairs, on the methodology and conduct of complex surgical and
device trials, the assessment of quality of life and economic analysis of
clinical procedures, and volume-outcome studies, as well as policy studies
on technological change.
Rebecca D. Jackson, M.D., is the Associate Dean for Clinical Research,
Professor of Medicine and Director of the Center for Women’s Health
at The Ohio State University. She also serves as the founding Director
of the OSU Center for Clinical and Translational Science and the Prin -
cipal investigator of OSU’s CTSA from NIH. Dr. Jackson received both
her undergraduate and medical degree from The Ohio State University
and her internship and residency training in internal medicine at Johns
Hopkins Hospital. She returned to Ohio State in 1981 to complete her fel-
lowship training in endocrinology and joined the faculty as an Assistant
Professor of Endocrinology, Diabetes and Metabolism in 1983. Dr. Jackson
has had a commitment to clinical and translational research throughout
her academic career with a focus on examining and finding solutions to
women’s health issues, particularly osteoporosis and chronic musculo -
skeletal diseases associated with aging. Continuously federally funded
since arriving at Ohio State, her individual and collaborative research
efforts have resulted in peer-reviewed publications in the Journal of the
American Medical Association, the New England Journal of Medicine, Annals
of Internal Medicine, the Journal of Bone and Mineral Research, and other
general medicine and subspecialty journals. She was lead author of the
Women’s Health Initiative analyses that showed that calcium plus vita -
OCR for page 107
107
APPENDIX B
min D had a modest but nonsignificant effect on reducing hip fracture in
postmenopausal women. Based upon its major scientific merit, this paper
was selected for inclusion in the Annual Bibliography of Significant Advances
in Dietary Supplements Research published by the Office of Dietary Supple-
ments and NIH. Her recent efforts have focused on identifying genetic
signatures and biomarkers for predicting risk for hip fracture, osteo-
arthritis, and cardiovascular disease. Her ultimate goal is to leverage this
information to further elucidate the pathophyisology of these common
complex diseases as well as to improve screening, prevention, and treat -
ment. Dr. Jackson has served in leadership roles in both professional and
scientific organizations including vice chair of the WHI Steering Com -
mittee from 2002 to 2010 and national co-chair of the CTSA Consortium
in 2010 and she is currently a member of the Executive Committee of the
NHLBI Exome Sequencing Project, the Executive Committee of the CTSA
Consortium, the Board of Directors of the Clinical Research Forum, the
NIH Advisory Board for Clinical Research, and secretary of the Society of
Clinical and Translational Science. She has been the recipient of numerous
awards and recognitions, including the NIH Physician Scientist Award
and the Kellogg Foundation National Leadership Fellowship, and she is
a member of Alpha Omega Alpha and a fellow of the American Associa -
tion for the Advancement of Science. Dr. Jackson, who for more than a
decade has been named one of “America’s Best Doctors” by U.S. News &
World Report, is also a member of the Ohio Women’s Hall of Fame, has
been recognized as a YWCA Woman of Achievement, and was named an
American Medical Women’s Association Legend.
Michael King Jolly, Pharm.D., is Senior Vice President of Quintiles Drug
Development Innovation, where he leads drug development teams for
partnered programs. Chief among his responsibilities are structuring and
managing drug development collaborations with pharmaceutical com-
panies. Dr. Jolly’s pharmaceutical career began at Burroughs Wellcome
Co. (BW) in 1983. While at BW, he served as Project Leader for over five
new molecular entities in cardiovascular medicine and Brand Leader for
LANOXIN brand digoxin for heart failure. Dr. Jolly first joined Quintiles
in 1995 and led a strategic business unit that provided oversight of more
than 40 cardiovascular product development programs ranging from Pre-
IND to Phase IV. In 2000, he took a position at King Pharmaceuticals as
Executive Vice President, where he formed a multidisciplinary research
and development organization using a “virtual development model” in
which outsourced partners performed all operations work, directed by
a small core of functional experts. In early 2007, Dr. Jolly returned to
Quintiles, joining NovaQuest. Dr. Jolly also teaches at Duke University
Medical School and the School of Pharmacy at the University of North
OCR for page 112
112 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE
completed his Fellowship in Medical Oncology in 1991 at the Dana Farber
Cancer Institute, and completed a postdoctoral fellowship in molecular
oncology in 1994 at the Harvard Medical School/Howard Hughes Medi -
cal Institute under the guidance of Dr. Philip Leder.
Richard K. Murray, M.D., FACP, joined Merck & Co., Inc. in November
1994, where he was a founding member of the Regional Medical Director
Program. Over the subsequent 17 years, he assumed increasing responsi-
bility within U.S. Human Health Medical and Scientific Affairs, including
head of U.S. Academic and Professional Affairs, and he was promoted
to Vice President, External Medical and Scientific Affairs, in August of
2007. He became Head of the Global Center for Scientific Affairs in May
2010, including responsibility for the Merck Investigator-Initiated Studies
Program. Dr. Murray, a native Washingtonian, graduated from Clark
University (Worcester, Massachusetts) with an A.B. in psychology and
an M.A. in chemistry. He graduated from Howard University College
of Medicine (Washington, DC) and subsequently was an intern, medical
resident, Chief Medical Resident, and Pulmonary and Critical Care Fel-
low at the University of Pennsylvania in Philadelphia. Prior to joining
Merck, Dr. Murray was assistant professor of medicine at the University
of Pennsylvania, where he was an investigator in the area of reactive
airways disease, smooth muscle function, and calcium signaling. He was
also Co-Director of the Adult Asthma Program at the Hospital of the Uni-
versity of Pennsylvania. Dr. Murray is board certified in internal medicine
and pulmonary diseases. He is a Fellow of the American College of Physi-
cians, a Fellow of the American College of Chest Physicians, and a Fellow
of the College of Physicians of Philadelphia. He serves on the boards of
directors for the Merck Childhood Asthma Network and the Southeast
Pennsylvania Chapter of the American Heart Association. Dr. Murray has
previously represented Merck at the IOM Clinical Research Roundtable
and the Roundtable on Health Disparities.
Richard Platt, M.D., M.Sc., is a professor and chair of the Department of
Population Medicine at Harvard Medical School and Executive Director
of the Harvard Pilgrim Health Care Institute. He is principal investigator
of the AHRQ HMORN DEcIDE Center, a CDC Prevention Epicenter, and
a CDC Center of Excellence in Public Health Informatics. He also leads
the FDA’s Mini-Sentinel program and contracts with FDA’s Center for
Drug Evaluation and Research (CDER) and Center for Biologics Evalu -
ation and Research (CBER) to conduct postmarketing studies of drugs’
and biologics’ safety and effectiveness. He chaired FDA’s Drug Safety and
Risk Management Advisory Committee, is a member of the Association
of American Medical Colleges’ Advisory Panel on Research, and the IOM
OCR for page 113
113
APPENDIX B
Roundtable on Value & Science-Driven Health Care. Dr. Platt was co-chair
of the Board of Scientific Counselors of CDC’s Center for Infectious Dis -
eases. Additionally, he has chaired the NIH study section Epidemiology
and Disease Control 2, and the CDC Office of Health Care Partnerships
steering committee.
Ihor W. Rak, M.D., was born in New York City, graduated from The
City College of New York, and earned his medical degree at the College
of Physicians and Surgeons at Columbia University, New York City. He
completed his internship, residency, and fellowship at the Hospital of the
University of Pennsylvania and the Children’s Hospital of Philadelphia.
He has earned several medical board certifications (pediatrics, neurology,
pediatric neurology, and clinical neurophysiology). After serving in the
U.S. Air Force as Chief of Pediatric Neurology and Neurology Services in
the U.S. Air Force Medical Corps, Wright-Patterson Air Force Base, Ohio,
Dr. Rak was an assistant professor of neurology and research associate at
the University of Virginia, Charlottesville, Virginia. Dr. Rak was Founder
and Medical Director of the Epilepsy Center and Co-Director of the Sleep
Disorders Center at Sacred Heart Hospital, Allentown, Pennsylvania.
As Principal Investigator he continued his clinical research activities,
contributing to many investigational antiepileptic drugs. Since joining
AstraZeneca Global Clinical Research in 1996, he has provided medical
and project team leadership for a number of clinical projects, including
SEROQUEL. As Global Product Director for Emerging Neuroscience, he
successfully led the global neurologic, psychiatric, and overactive bladder
early development projects. In 2005 Dr. Rak was appointed Vice President,
Global Clinical Development for the Neuroscience Therapy Area. In his
current role, he oversees the development and delivery of the clinical
contributions for both emerging products and established brands in the
Global Neuroscience Therapy Area. Dr. Rak attended executive develop -
ment programs at the University of Pennsylvania’s Wharton School of
Business and R&D Executive Leadership Program at Harvard Business
School. He has held numerous leadership roles, including President and
Chairman of the Board of Trustees with the American Academy of Phar-
maceutical Physicians (AAPP, now APPI, the Academy of Pharmaceutical
Physicians and Investigators) and Vice President of Strategic Planning the
National Alliance for the Mentally Ill (NAMI), Delaware Chapter.
Jean L. Rouleau, M.D., is the Scientific Director of the Institute of Circu-
latory and Respiratory Health of the Canadian Institutes of Health and
Research (CIHR). Dr. Rouleau was Dean of the University of Montreal’s
Faculty of Medicine from 2003 to 2010. He practices cardiology at the
Montreal Heart Institute. He has also served as a member of the CIHR
OCR for page 114
114 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE
Governing Council from 2005 to 2010. A respected cardiologist and world-
famous researcher, Dr. Rouleau previously taught at the University of
Toronto and served as Director of the Cardiac Program and the Cardiol-
ogy departments at Toronto’s University Health Network (UHN) and
at Mount Sinai Hospital from 1999 to 2003. With experience in many
university hospitals, Dr. Rouleau possesses a vast understanding of the
worlds of teaching, research, and care settings. He earned his M.D. degree
from the University of Ottawa and completed his clinical training at
McGill University followed by postdoctoral research in San Francisco.
Dr. Rouleau has published over 355 scientific articles in journals such as
the American Journal of Medicine, the American Journal of Cardiology, the
Canadian Medical Association Journal, Lancet, and the New England Journal
of Medicine. He has been awarded the Canadian Centennial Medal, the
Exceptional Merit Award given by the Fonds de la Recherche en Santé du
Québec (FRSQ), the Canadian Henry Friesen Award, and the Canadian
Cardiovascular Society’s Career Research Achievement Award.
Arthur H. Rubenstein, M.B.B.Ch., is Professor, Department of Medicine,
Division of Endocrinology at the Raymond and Ruth Perelman School
of Medicine at the University of Pennsylvania. Previously, Dr. Ruben -
stein was the Executive Vice President of the University of Pennsylvania
for the Health System and Dean of the Raymond and Ruth Perelman
School of Medicine from September 2001 to July 2011. Together, these
entities make up Penn Medicine, a $3.6 billion enterprise dedicated to the
related missions of medical education, biomedical research, and excel -
lence in patient care. Founded in 1765, Penn’s Perelman School of Medi-
cine received over $397.4 million in NIH research funds in fiscal year 2010.
With 1,823 full-time faculty and nearly 3,000 students, trainees, residents,
and fellows, the school is recognized worldwide for its superior educa-
tion and training of the next generation of physician-scientists and lead-
ers of academic medicine. The University of Pennsylvania Health System
(UPHS) includes its flagship hospital, the Hospital of the University of
Pennsylvania (HUP); Pennsylvania Hospital, the nation’s first hospital;
Penn Presbyterian Medical Center; and Penn Medicine at Rittenhouse.
In addition, it encompasses a primary care provider network, a faculty
practice plan, home care, hospice, and nursing home and three multispe-
cialty satellite facilities. Before joining Penn, Dr. Rubenstein served for
four years as Dean of Mount Sinai School of Medicine and Gustave L.
Levy Distinguished Professor. Earlier, he was the Lowell T. Coggeshall
Distinguished Service Professor of Medical Sciences and Chairman of the
Department of Medicine at the University of Chicago Pritzker School of
Medicine. Dr. Rubenstein is an internationally prominent endocrinologist
recognized for clinical expertise and groundbreaking research in dia-
OCR for page 115
115
APPENDIX B
betes. Well known for his inspired teaching, Dr. Rubenstein has served
in numerous professional leadership positions during his career. These
include President of the Association of Professors of Medicine, President
of the Association of American Physicians, President of the Central Soci -
ety for Clinical Research, Chairman of the American Board of Internal
Medicine, Chairman of the Board of the Association of Academic Health
Centers, and Chair of the National Diabetes Advisory Board. He has been
a member of a study section and of the Advisory Council of the National
Institute of Diabetes and Digestive and Kidney Diseases. Author of more
than 350 publications, Dr. Rubenstein has held editorial advisory posi -
tions with several respected journals, including service on the editorial
boards of the Annals of Internal Medicine, the Journal of Diabetes and Its
Complications, Medicine, and Clinical Trials Advisor. He was also a con-
sulting editor to the Journal of Clinical Investigation. Dr. Rubenstein is the
recipient of many awards and prizes, including the highest honor from
the Association of Professors of Medicine, the Robert H. Williams Distin-
guished Chair of Medicine Award. Among his other honors are the John
Phillips Memorial Award from the American College of Physicians; the
Banting Medal from the American Diabetes Association; and the David
Rumbough Scientific Award from the Juvenile Diabetes Association. In
2009, Dr. Rubenstein was awarded the prestigious Abraham Flexner
Award for Distinguished Service to Medical Education from the Associa -
tion of American Medical Colleges. Born in South Africa, Dr. Rubenstein
received his medical degree from the University of the Witwatersrand in
Johannesburg. In 2001, he was honored by his alma mater when an honor-
ary degree, Doctor of Science in Medicine, was conferred upon him. He
is a Fellow of the College of Medicine of South Africa and of the Royal
College of Physicians of London; a Master of the American College of
Physicians; American Academy of Arts and Sciences; and a member of
the IOM of the National Academy of Sciences.
Richard A. Rudick, M.D., Professor of Medicine, Cleveland Clinic Lerner
College of Medicine Hazel Prior Hostetler Chair of Neurology, Cleveland
Clinic Director, Mellen Center for Multiple Sclerosis Treatment and
Research, Cleveland Clinic Vice Chairman, Research and Development
in the Neurological Institute, Cleveland Clinic. Dr. Rudick graduated from
Case Western Reserve University School of Medicine in 1975. Following
internship and residency in medicine at the University of Connecticut,
Dr. Rudick trained in neurology at the University of Rochester. During a
postdoctoral research fellowship in the Center for Brain Research at the
University of Rochester, studies focused on neurologic consequences of
immune complex disease in animal systems and immunologic abnormali-
ties in multiple sclerosis (MS) patients. Dr. Rudick’s subsequent studies
OCR for page 116
116 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE
on cerebrospinal fluid in MS were supported by an NIH clinical investi-
gator career development award. In 1987, Dr. Rudick became Director of
the Mellen Center. He has played key roles in several MS clinical trials,
including pivotal registration trials of IFNb-1a (Avonex) and natalizumab
(Tysabri) for relapsing remitting MS. He continues studies on immuno-
logic changes in MS patients, has led development of new clinical and
imaging measures for MS trials, and maintains a consultative clinical
practice at the Mellen Center. Dr. Rudick has maintained continuous com-
petitive grant funding from NIH and National Multiple Sclerosis Society
for over 25 years. In addition to being Director of the Mellen Center,
Dr. Rudick is Vice Chairman of Research and Development in the Neuro -
logical Institute and Co–Principal Investigator of a citywide Clinical and
Translational Science Collaborative.
Kevin A. Schulman, M.D., M.B.A., is a professor of medicine and the
Gregory Mario and Jeremy Mario Professor of Business Administration at
Duke University. He is an associate director of the Duke Clinical Research
Institute at the Duke University School of Medicine. At Duke’s Fuqua
School of Business, he serves as director of the Health Sector Manage -
ment Program, the Master of Management in Clinical Informatics, and
the Center for the Study of Health Management. His other university
affiliations include the Trent Center for Bioethics, Humanities and His -
tory of Medicine; the Duke Translational Research Institute Pilot Project
Advisory Committee; and the Duke Global Health Institute. Dr. Schulman
is a distinguished researcher who has received more than $34 million in
research grants. His research interests include health services research
and policy, including access to care and the impact of reimbursement and
regulatory policies on clinical practice; health economics and economic
evaluation in clinical research; and medical decision making, especially
in patients with life-threatening conditions. He regularly teaches courses
in biotechnology, health policy, and health IT strategy. Dr. Schulman has
published more than 350 papers and book chapters; his peer-reviewed
articles have appeared in the New England Journal of Medicine, the Journal
of the American Medical Association, and Annals of Internal Medicine. He
is a member of the editorial/advisory boards of the American Journal of
Medicine, the American Heart Journal, Health Services Research, and Value in
Health. A recipient of numerous awards, Dr. Schulman is a fellow of the
American College of Physicians and an elected member of the American
Society for Clinical Investigation. He has served as session chair and
panelist at dozens of medical and health care conferences. Dr. Schulman
has also served on numerous grant review committees for the NIH, the
Robert Wood Johnson Foundation, and other bodies. He is a member of
the advisory board for the Centre for Healthcare Policy and Management
OCR for page 117
117
APPENDIX B
at the China Europe International Business School. In 2010–2011, he was
a mentor for the Commonwealth Fund’s Harkness Fellowships in Health
Care Policy and Practice. He is a voting member of the Medicare Evi-
dence Development and Coverage Advisory Committee. Dr. Schulman
received his M.D. from the New York University School of Medicine
and his M.B.A., with a concentration in health care management, from
the Wharton School of the University of Pennsylvania. He completed a
residency in internal medicine at the Hospital of the University of Penn -
sylvania and is board certified in internal medicine.
Heather M. Snyder, Ph.D., assists with oversight of the Alzheimer’s
Association International Research Grant Program, the world’s largest
nonprofit initiative to advance Alzheimer’s research. Since 1982, the
Association has committed $292 million to more than 2,000 best-of-field
investigators worldwide. In addition to assisting with smooth review of
proposals and distribution of awards to successful applicants, Dr. Snyder
assumes primary responsibility for metrics and qualitative assessments
to enhance the program’s effectiveness and impact, and for communi-
cating program results to a wide range of audiences. After earning an
undergraduate degree in biology and religious studies at the University
of Virginia, Dr. Snyder moved on to graduate and postgraduate studies
in Chicago, completing her Ph.D. at Loyola University Chicago Stritch
School of Medicine and a postdoctoral fellowship at Children’s Memorial
Research Center of Northwestern University.
Scott J. Steele, Ph.D., M.A., serves as the Director of Research Alliances
at the University of Rochester. In this role he fosters strategic research
partnerships between the University’s research community and indus -
try, government agencies and laboratories, and other academic institu -
tions. He is actively involved with the University of Rochester Clinical
and Translational Science Institute, serving as the Director of the Public–
Private–Partnerships Key Function. Additionally, he holds an adjunct
appointment in the Department of Community and Preventive Medi-
cine. Prior to joining the University of Rochester, Dr. Steele served in the
White House Office of Science and Technology Policy (OSTP), initially
as a policy analyst and later designated as the Executive Director of the
President’s Council of Advisors on Science and Technology (PCAST). Dr.
Steele coordinated PCAST studies addressing issues in personalized med-
icine, nanotechnology, energy technologies, and approaches to enhance
university–private sector research partnerships. Previously, Dr. Steele
served as a senior policy specialist and intelligence analyst at the Federal
Bureau of Investigation (FBI), within the FBI’s Weapons of Mass Destruc-
tion program. Dr. Steele received his B.S. with honors in biology from
OCR for page 118
118 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE
Union College in Schenectady, New York. Following this, he performed
research at the General Electric Center for Research and Development and
was a fellow at NIH in Bethesda, Maryland. Dr. Steele completed his M.A.
and Ph.D. in molecular biology at Princeton University.
Janet Tobias is a technology/media executive specializing in health care,
and an Emmy Award–winning director/producer/writer. Ms. Tobias
started her career at CBS’ 60 Minutes as Diane Sawyer’s associate pro-
ducer. At 60 Minutes she distinguished herself working on a wide range
of domestic and international stories including a portrait of the Yakuza,
the Japanese organized crime syndicate, and investigations into the lack of
regulation in infertility treatment and the abuse of boys in a Guatemalan
orphanage. Ms. Tobias moved with Ms. Sawyer to ABC News to launch
Prime Time Live. At ABC she produced and directed both domestic and
international stories ranging from a case study of organ donation to a
portrait of the Kuwaiti royal family after the first Gulf War. After a short
stint away from the networks to write a feature film screenplay, Ms. Tobias
returned to NBC and moved into management at Dateline NBC. As a
national producer at Dateline NBC, she supervised pieces on medical
ethics and the home health care industry. She also continued to produce
and direct her own stories, ranging from a historical look back at Soviet
misinformation campaigns to an investigation into oil development in
the Ecuadoran rainforest. Ms. Tobias left NBC News to become an Execu -
tive Producer at VNI (which became New York Times Television). There
she supervised the production of a foreign news show and reporting on
a variety of foreign stories including an award-winning piece on rape
as a war crime in Rwanda that appeared on Nightline. Ms. Tobias then
returned to ABC News to head up editorial activities at its newly created
Law and Justice Unit where she reported, directed, and supervised legal
and criminal justice stories for all ABC news programs: Nightline, 20/20,
World News Tonight, and Good Morning America. In 1998 Ms. Tobias began
working as an executive with PBS, where she developed and produced
programming not only for PBS but also joint projects with ABC and
Discovery. She continued her directing and writing career, winning two
American Bar Association silver gavels for a 4-hour Frontline/Nightline
project on the juvenile justice system in California. In 2001, she launched
Life 360, a weekly PBS series hosted by Michel Martin that combined doc-
umentary pieces with dramatic and comic monologues. Life 360 launched
just after 9/11 to laudatory reviews and won an Emmy in its first season.
It was also one of two programs picked to pilot interactive television at
PBS. In 2001, Ms. Tobias founded her own television/film production
company, Sierra/Tango Productions. Sierra/Tango has produced over a
dozen documentaries on social issues ranging from medical ethics to the
OCR for page 119
119
APPENDIX B
life of teenagers in America. Currently, Ms. Tobias is directing a film for
worldwide theatrical release, and television broadcast, on the longest ever
recorded uninterrupted survival underground in a cave. In addition to
her National Emmy and American Bar Association awards, other awards
include two Cine Golden Eagles, the George Foster Peabody Award, two
Casey medals for meritorious journalism, a National Headliner Award,
a Sigma Delta Chi Award, and honorable mention Robert F. Kennedy
Journalism and Overseas Press Awards. Ms. Tobias is a member of the
Writers Guild of America. In 2002, Ms. Tobias moved into the technology
world full time when she joined Sawyer Media Systems, a Sequoia Capital
backed creator of video technology for the web. Ms. Tobias was a member
of the executive committee at Sawyer Media Systems, where she super-
vised the web design and video teams. Cisco Systems bought the video
portal Sawyer developed and incorporated it into their technical offerings.
In 2004, Ms. Tobias was one of the founding partners of Ikana Media,
now Ikana Health. In 2009, Ms. Tobias became the CEO of Ikana Health,
which focuses on the mobile web, social media, and video as it relates to
health care information and outcomes. Clients include AARP, Babycenter.
com, Johnson & Johnson, St. Luke’s Roosevelt Hospital, Mount Sinai
School of Medicine, Cisco Systems, Time Inc., and WGBH. A graduate
of Yale University, Ms. Tobias served from January to September 2009
as a senior fellow at the University of British Columbia, Sauder School
of Business Centre for Sustainability and Social Innovation. In 2009, she
was appointed to the Forum on Drug Discovery, Development, and Trans-
lation of the IOM, National Academy of Sciences. In 2010, Ms. Tobias
became an adjunct assistant professor of Medicine in the Department of
Health Evidence and Policy at Mount Sinai School of Medicine.
Neil J. Weissman, M.D., FACC, is President of MedStar Health Research
Institute, Professor of Medicine at Georgetown University School of Medi-
cine, and he directs the Cardiovascular Core Laboratories at Washington
Hospital Center in Washington, DC. Dr. Weissman’s research interests
include valvular heart disease, left ventricular remodeling, and intra-
vascular imaging. His ultrasound core laboratory has served as a site for
over 150 multicenter trials, including multiple studies on pharmacologic
effects of valvular and ventricular function, prosthetic valve assessments,
and intracoronary therapies. Additionally, Dr. Weissman has served as
principal investigator (PI) for numerous national and international multi-
center trials; he recently was the national PI on a series of cardiac safety
studies with over 8,000 participants. Dr. Weissman has published hun-
dreds of abstracts and original reports in such well-regarded journals as
the New England Journal of Medicine, the Journal of the American Medical
Association, Annals of Internal Medicine, the American Journal of Cardiology,
OCR for page 120
120 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE
the American Heart Journal, and the Journal of the American College of Cardi-
ology. He also has written several review articles and book chapters and
wrote a textbook on cardiac imaging. Dr. Weissman received his medical
degree from Cornell University Medical College in New York City. He
then completed his internship, residency, and chief residency in internal
medicine at the New York Hospital in New York City. He followed his
residency training with a clinical and research fellowship in cardiology
and a fellowship in cardiac ultrasound at Massachusetts General Hospital
in Boston, Massachusetts. Prior to moving to the Washington Hospi-
tal Center, he was the director of the clinical echo lab at Georgetown
University. Dr. Weissman is internationally recognized as an expert in car-
diac ultrasound and served on several national organizations, including
Chair of the Guidelines and Standards, Board of Directors and Executive
Committee of the American Society of Echocardiography, Chair of the
Program Committee for Imaging for the American College of Cardiology,
and Chair of the Scientific Sessions for the American Society of Echo-
cardiography. Dr. Weissman is often an invited expert on FDA Advisory
Committee and NIH commissions.
Alastair J. J. Wood, M.D., was Professor of Medicine and Pharmacol-
ogy, Assistant Vice Chancellor and Associate Dean at Vanderbilt Medical
School before being appointed Emeritus Professor of Medicine and Emeri-
tus Professor of Pharmacology in 2006. His current academic appoint -
ments are Professor of Medicine and Professor of Pharmacology at Weill
Cornell Medical College, New York. He is a Partner at Symphony Capital
LLC, a New York–based Private Equity Company. Dr. Wood is a mem-
ber of the National Academy of Sciences IOM, the American Associa-
tion of Physicians (AAP), the American Society for Clinical Investigation
(ASCI), Honorary Fellow, American Gynecological and Obstetrical Soci -
ety (AGOS), and Fellow of the American College of Physicians. Dr. Wood
served on the New England Journal of Medicine Editorial Board and was
the NEJM Drug Therapy Editor for many years. He authored the chap-
ter in Harrison’s Principles of Internal Medicine on Adverse Drug Reactions
from the 9th through the 15th edition. He was the chairman of the FDA’s
Nonprescription Drugs Advisory Committee until 2006, and chaired the
2005 FDA Advisory Committee on Cox-2 inhibitors. He previously served
as a member of the Cardiovascular and Renal Advisory Committee of
FDA and the FDA’s Nonprescription Drugs Advisory Committee. His
research interests have been focused on understanding the mechanisms
for interindividual variability in drug response and toxicity. His research
has resulted in over 300 articles, reviews, and editorials.
OCR for page 121
121
APPENDIX B
Janet Woodcock, M.D., is the Director of the Center for Drug Evaluation
and Research (CDER) at FDA. She also served as CDER Director from
1994 to 2005. Dr. Woodcock has held various positions within the Office
of the Commissioner, FDA, from October 2003 to April 1, 2008. Prior to
her 2008 reappointment to CDER, she served as Deputy Commissioner
for Operations and Chief Operating Officer, where she was responsible for
overseeing agency operations and crosscutting regulatory and scientific
processes. She previously served in other positions at FDA, including
Director, Office of Therapeutics Research and Review, and Acting Deputy
Director, Center for Biologics Evaluation and Research. Dr. Woodcock
received her M.D. from Northwestern Medical School and completed
further training and held teaching appointments at the Pennsylvania State
University and the University of California, San Francisco. She joined
FDA in 1986.
Clyde W. Yancy, M.D., M.Sc., FACC, FAHA, MACP, is the newly
appointed Chief of Cardiology at Northwestern University, Feinberg
School of Medicine, and Associate Director of the Bluhm Cardiovascular
Institute at Northwestern Memorial Hospital. He holds the Magerstadt
Endowed Professor of Medicine Chair. Formerly he was the Medical
Director, Baylor Heart and Vascular Institute at Baylor University Medi-
cal Center in Dallas, Texas, and Chief of Cardiothoracic Transplantation
at Baylor University Medical Center, Dallas, Texas. He is board certified
in internal medicine with a subspecialty in cardiovascular disease. He is
a Fellow of the American College of Cardiology, a Fellow of the American
Heart Association (AHA), and a Master of the American College of Physi-
cians. He is also a member of the International Society of Heart and Lung
Transplantation (ISHLT), the American Society of Hypertension (ASH),
the Heart Failure Society of America (HFSA), and the Association of Black
Cardiologists (ABC). He has previously served on the Executive Council
of the HFSA, is past chair of the Education Committee of the HFSA, and
past chair the Council of Clinical Cardiology’s Heart Failure and Trans-
plantation Sub-Committee of the AHA. Dr. Yancy has served two terms
on the national Board of Directors for the AHA and was recognized as the
AHA National Physician of the Year in 2003. He sits on the ACC/AHA
Guideline Writing Committee for chronic heart failure and is a member of
the ACC Guideline Taskforce which oversees all ACC/AHA guidelines.
In 2009–2010, he served as President of the American Heart Association.
Peter Paul Yu, M.D., is in clinical practice at the Palo Alto Medical Foun-
dation (PAMF), a multispecialty medical group serving the San Francisco
Bay area. Dr. Yu is Director of Cancer Research at PAMF and gradu-
OCR for page 122
122 ENVISIONING A TRANSFORMED CLINICAL TRIALS ENTERPRISE
ated from the combined undergraduate and medical school program in
medicine at Brown University. His residency was at St. Luke’s-Roosevelt
Medical Center in New York City, where he was Chief Resident. After
a fellowship at Mount Sinai Medical Center, Dr. Yu completed a post-
doctoral fellowship at Memorial Sloan-Kettering Cancer Center in the
laboratory of Dr. John Mendelsohn. He is board certified in both medical
oncology and hematology. He has served as President of the Association
of Northern California Oncologists, Chief of Medicine at El Camino Hos -
pital in Mountain View, member of the Board of Directors of Pathways
Homecare and Hospice, and is a member of the Audit Committee of
the Cancer and Leukemia Group B (CALGB). He is currently a member
of the board of directors of the American Society of Clinical Oncology
(ASCO) and Chair of the ASCO HIT Work Group. Past ASCO activities
have included Chair of the Clinical Practice Committee; member of the
Cancer Research, Information Technology, Grant Selection, Audit and
Nominating Committees; Chair of the Best of ASCO San Francisco 2005;
Chair ASCO EHR Symposium 2009; Annual Meeting Educational Session
Chair 2007, 2009, and 2010; and faculty of the Clinical Trials for the Com -
munity Oncology Team Workshop 2005. Dr. Yu has served as co-chair
of the Commission for Certification of Health Information Technology
(CCHIT) Oncology work group, co-chair of the AMA-RAND Clinical
Decision Support Oncology work group under contract to the Office of
the National Coordinator for Health Information Technology, and co-chair
of the ASCO-NCI CORE project, and has participated in several IOM
health information technology workshops.
