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Appendix B
Participant Biographies
Barry S. Coller, M.D. (Workshop Co-Chair), is the David Rockefeller Pro-
fessor of Medicine; Head, Laboratory of Blood and Vascular Biology;
Physician-in-Chief of The Rockefeller University Hospital; and Vice Presi-
dent for Medical Affairs at The Rockefeller University. He also serves as
the founding Director of the Rockefeller University Center for Clinical
and Translational Science and the Principal Investigator of the Univer-
sity’s CTSA from the National Center for Research Resources of NIH.
From 1993 to 2001, Dr. Coller was the Murray M. Rosenberg Professor of
Medicine and Chairman of the Samuel Bronfman Department of Medicine
at Mount Sinai School of Medicine in New York City. Dr. Coller received
his B.A. degree, magna cum laude, from Columbia College in 1966, and
his M.D. from New York University School of Medicine in 1970. He com-
pleted his residency in internal medicine at Bellevue Hospital in New
York City and advanced training in hematology and clinical pathology at
NIH. He joined the faculty at Stony Brook in 1976 as an Assistant Profes-
sor of Medicine in the Division of Hematology. During his years at Stony
Brook he was the Clinical Director and Head of the Hematology Division,
and Associate Director for Biomedical Research of the Biotechnology
Center for Advanced Technology. He was awarded the title of Distin-
guished Service Professor of Medicine and Pathology at Stony Brook in
1993. Dr. Coller is a member of Phi Beta Kappa, Alpha Omega Alpha, the
American Society for Clinical Investigation, the Association of American
Physicians, the IOM of the National Academies, and the National Acad -
emy of Sciences. He is a Fellow of the New York Academy of Medicine,
81
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82 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
the American Association for the Advancement of Science, and the Ameri-
can Academy of Arts and Sciences, and a Master of the American College
of Physicians. Dr. Coller served as President of the American Society of
Hematology in 1997-1998 and as the founding President of the Society
for Clinical and Translational Science from 2008 to 2010. He is a member
of the Advisory Council of the National Heart, Lung, and Blood Institute
and the national Principal Investigators’ CTSA Consortium Steering Com-
mittee. Dr. Coller’s research interests have focused on hemostasis and
thrombosis, in particular platelet physiology. He developed a monoclonal
antibody that inhibits platelet function and a derivative of that antibody
(abciximab; ReoPro; Centocor/Eli Lilly) was approved for human use
by FDA in 1994. It is now in clinical use throughout the United States,
Europe, Scandinavia, Australia, and portions of Asia to prevent ischemic
complications of percutaneous coronary interventions such as angioplasty
and stent insertion. More than 4 million patients have been treated with
abciximab. He also developed an assay to assess platelet function, and
automated derivatives of that assay to monitor therapy with abciximab,
aspirin, and clopidogrel (Plavix™) have been approved for human use by
FDA (VerifyNow; Accumetrics). Dr. Coller is the recipient or a co-recipient
of 14 U.S. patents.
Elaine K. Gallin, Ph.D. (Workshop Co-Chair), is currently a partner at
QE Philanthropic Advisors, a consulting firm established in 2010 that
serves nonprofits specializing in biomedical research, science and math
education, and international 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 commit -
ted 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 administrator where she last served as the Deputy
Director of the Office of International Health Programs in the U.S. Depart-
ment 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 Committee 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 the IOM
and NIH. She was a founding member and the first Vice Chair of HRA (an
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APPENDIX B
alliance of not-for-profit, nongovernment 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 the 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.
Kathryn (Kate) N. Ahlport, M.S.P.H., is the Executive Director, HRA. In
the 6 years since she joined the Alliance, Kate Ahlport has overseen the
transformation of an informal network of 15 funders into an indepen-
dent, 501(c)(3) national consortium of 49 not-for-profit, nongovernmental
funders of health research and training, the HRA. HRA member orga-
nizations work together to maximize the impact of investment in bio-
medical research and training to improve human health by fostering open
communication and collaboration among members, by providing com-
prehensive data and analysis about the funding of biomedical research
and training by member organizations, by identifying gaps in funding
and facilitating innovative grantmaking, and by addressing issues key to
accelerating research discovery and its translation. As the chief executive
officer, Kate is responsible for administration, programs, and all other
functions and activities of the Alliance, serving also as a member of the
HRA Board of Directors. Prior to joining the Alliance, Kate served as Vice
President of the Moses Cone-Wesley Long Community Health Founda -
tion in Greensboro, North Carolina, formed as part of the merger of two
community hospitals. Ms. Ahlport’s career has also included the manage-
ment of acute health care facilities, jointly and wholly owned outpatient
health care services, and a managed care plan. Ms. Ahlport received her
M.S.P.H. degree in health care administration from UNC School of Public
Health and is ABD in the doctoral program in health behavior at UNC.
She is a Diplomate of the American College of Healthcare Executives and
has served as an adjunct lecturer in the Department of Health Policy and
Administration at the UNC School of Public Health. Ms. Ahlport has been
involved in numerous statewide and community health and civic initia -
tives throughout her career.
Michael Brennan, Ph.D., is the Senior Advisor for Global Affairs
at the AERAS Global TB Vaccine Foundation. He develops strategies for
the timely introduction of new TB vaccines into low-income countries,
and he works closely with national regulatory authorities that are respon-
sible for clinical trial approval and new product licensure. Brennan also
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84 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
heads projects on the development of correlates and biomarkers for TB
vaccines. Prior to joining AERAS, he spent more than 20 years at FDA,
where he was an associate director at the Office of Vaccines Research and
Review and was also head of the TB vaccine program. In 2001, he worked
in Geneva assisting the World Health Organization (WHO) in its devel -
opment of a new Tuberculosis Vaccine Initiative. Brennan has published
more than 90 scientific articles on vaccines and infectious diseases, and his
early research paved the way for widespread whooping cough immuni-
zations. An authority on vaccine development and regulatory review, he
sits on several international advisory committees, including the Stop TB
Partnership, WHO, and NIH. He received a Ph.D. from Albany Medical
College.
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, 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 Institute
(DCRI), the premier academic research organization in the world. He is
the editor-in-chief of Elsevier’s American Heart Journal, the oldest cardio-
vascular specialty journal. He has been author or co-author of more than
800 peer-reviewed journal articles and a contributing editor for www.
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
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APPENDIX B
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 Identifying
and Preventing Medication Errors. He is currently a member of the IOM
Forum on Drug Discovery, Development, and Translation and a subcom -
mittee of the Science Board of FDA. He was the founding director of
the coordinating center for the Centers for Education and 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 Clinical Trials Transformation Initiative (CTTI), a
public-private partnership focused on improving the clinical trials system.
William W. Chin, M.D., is the Executive Dean for Research at Harvard
Medical School (HMS). In this role, Dr. Chin spearheads efforts to design
and implement the vision for research at HMS, with special emphasis on
interdisciplinary and translational research that crosses departmental and
institutional boundaries. Chin is a Harvard-trained endocrinologist and
longstanding faculty member. He was Professor of Medicine, HMS; Chief,
Division of Genetics and Senior Physician, Brigham and Women’s Hospi-
tal; and Investigator, Howard Hughes Medical Institute. His impressive
career is exemplified in part by his extensive bibliography of nearly 300
papers, chapters, and books, most of which were generated during his
25 years at HMS. As a pioneering molecular endocrinologist at HMS,
Dr. Chin embraced the early use of emerging DNA technology to make
important discoveries regarding the structure, function, and regulation
of hormone genes. His investigations often demonstrated a translational
research theme, connecting basic laboratory discoveries to their physi -
ologic relevance in animal models and humans. He has been honored
with numerous awards for research, mentorship, and leadership. Prior to
HMS, Dr. Chin was at Eli Lilly & Co., where he had worked for the last
decade, most recently as Senior Vice President for Discovery Research and
Clinical Investigation.
Andrew M. Dahlem, Ph.D., was named Vice President and Chief Oper-
ating Officer for Lilly Research Laboratories (LRL) and LRL Europe in
February 2007. He has previously served as Vice President of Toxicology,
Drug Disposition, Pharmacokinetics, and Lilly Research Laboratories in
Europe since January 2003 and a member of Lilly senior management.
Dr. Dahlem received a bachelor of science degree in wildlife biology from
The Ohio State University in 1982 and a doctor of philosophy degree
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86 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
in toxicology from the University of Illinois at Urbana-Champaign in
1989. Dahlem joined Lilly in 1990 as a senior pharmacologist. He became
head of biochemical toxicology in 1992. He was named Director of Drug
Disposition and Biochemical (investigative) Toxicology in 1993. He was
promoted to Executive Director for Toxicology and Drug Disposition in
1998, and he assumed responsibility for LRL in Europe in 1999 and for
discovery operations in 2000. In December 2001 he was promoted to Vice
President. Dr. Dahlem serves as adjunct professor of toxicology in the
College of Veterinary Medicine at Purdue University, the University of
Illinois at Urbana-Champaign, and at The Ohio State University. He is
also a member of the Ohio State University College of Pharmacy Cor-
porate Council and the Illinois Professional Science Master’s Board. Dr.
Dahlem currently serves on the board of directors for Indigo Biosystems,
the YourEncore board of advisors, and is a member of the Indiana State
Museum Foundation Board. He is a member of the IOM Forum on Drug
Discovery, Development, and Translation and the Translational Research
and the Critical Path for Tuberculosis Drug Regimens for the Gates Foun -
dation. He is a member and past president of Indianapolis/Cincinnati
Discussion Group of the American Association of Pharmaceutical Sci -
entists. He is also a member of the International Society for the Study of
Xenobiotics, the Society of Toxicology, and the American Association for
the Advancement of Science.
David L. DeMets, Ph.D., is currently professor and former Chair of the
Department of Biostatistics and Medical Informatics at the University of
Wisconsin-Madison. Since receiving his Ph.D. in 1970 from the University
of Minnesota, he has been active in the design, conduct, and analysis of
clinical trials in several disease areas. He spent 10 years (1972-1982) at
the National Heart, Lung, and Blood Institute at NIH. In 1982, he joined
the University of Wisconsin-Madison and developed the Department
of Biostatistics and Medical Informatics. He has co-authored or edited
four texts, Fundamentals of Clinical Trials, Data Monitoring in Clinical Tri-
als: A Case Studies Approach, Data Monitoring Committees in Clinical Trials:
A Practical Perspective, and Statistical Methods for Clinical Trials. He has
served on numerous NIH and industry-sponsored Data Safety and Moni -
toring Committees for clinical trials in diverse disciplines. He served on
the board of directors of the American Statistical Association, as well as
having been President of the Society for Clinical Trials and President of
the Eastern North American Region (ENAR) of the Biometric Society. In
addition he was Elected Fellow of the International Statistics Institute in
1984, the American Statistical Association in 1986, the Association for the
Advancement of Science in 1998, the Society for Clinical Trials in 2006,
and the American Medical Informatics Association in 2008.
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APPENDIX B
Lawrence Deyton, M.D., M.S.P.H., described by FDA Commissioner
Margaret Hamburg as “the rare combination of public health expert,
administrative leader, scientist, and clinician,” became the Center for
Tobacco Product’s first director on August 19, 2009. Prior to joining FDA,
Dr. Deyton was Chief Public Health and Environmental Hazards Offi-
cer for the U.S. Department of Veterans Affairs. Previously, Dr. Deyton
served for 11 years in leadership positions in the NIAID at NIH, 6 years
in the Office of the Assistant Secretary for Health at HHS, and as a leg -
islative aide with the House of Representatives Subcommittee on Health
and the Environment in the 1970s. He was a founder in 1978 of the
Whitman Walker Clinic, a community-based AIDS service organization
in Washington, DC. He is a graduate of the University of Kansas, the
Harvard School of Public Health, and the George Washington University
School of Medicine. Dr. Deyton’s postdoctorate medical training was at
USC/Los Angeles County Medical Center. He is board certified in internal
medicine and continues to care for patients on a regular basis.
Uros V. Djekic, Ph.D., is a Senior Regulatory Scientist and Policy Analyst
at CBER’s Office of Blood Research and Review. Dr. Djekic focuses on
regulatory review of blood donor screening assays and HIV diagnostics
while simultaneously developing policy at the center and agency levels.
He is a member of FDA’s Transparency Task Force which evaluates cur-
rent agency practices, regulations, and policies in order to facilitate trans -
parency and improve public health. In 2008, he matriculated to the FDA
CFP during which he developed and implemented a variety of policies
related to approval and use of CBER-regulated in vitro diagnostics as well
as initiated and drafted guidance documents. Dr. Djekic was instrumen-
tal in contributing to the Blood Products Advisory Committee discus -
sion on home-use HIV test kits. During his tenure at the Pharmaceutical
Research and Manufacturers of America (PhRMA) Division of Scien-
tific and Regulatory Affairs, Dr. Djekic drafted a variety of pamphlets
on potential bioterrorist agents, provided analyses of bioequivalence of
generic drugs, and contributed to discussions relating to preparedness
response to emerging and reemerging infections. Dr. Djekic completed
his Ph.D. and postdoc at the University of Alabama at Birmingham. The
former focused on HIV replication and primer selection, while the latter
investigated the underlying principles of inflammation in the lung with
a neutrophilic component.
Mary Dwight, M.D., is Vice President of Government Affairs for the
Cystic Fibrosis Foundation. Dr. Dwight directs the Foundation’s public
policy agenda and grassroots activities. She has been a catalyst for accel -
erating efforts to remove barriers to clinical drug development. Dwight
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88 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
also leads the strategic development of the Foundation’s efforts to enable
and expand access to CF care, integrating the organization’s public pol-
icy, advocacy, strategic communications, and medical research and care
delivery programs. Prior to coming to the Foundation, Dwight was a
Vice President at Spitfire Strategies where she crafted successful policy
strategy for clients such as the David and Lucile Packard Foundation, the
Robert Wood Johnson Foundation, First Focus, and the Juvenile Diabetes
Research Foundation. Dwight began her career with Representative Diana
DeGette (D-CO), a member of the House Energy and Commerce Commit-
tee. Dwight graduated cum laude from Williams College.
Steven K. Galson, M.D., M.P.H., is Vice President of Global Regulatory
Affairs at Amgen as of October 2010. He was the Senior Vice President for
Civilian Health Operations and Chief Health Scientist at Science Applica -
tions International Corporation. In October 2009, he completed 23 years
of government service, most recently—for 2 years—as Acting Surgeon
General of the United States. Previously, he served as Director of FDA’s
CDER from July 2005, where he provided leadership for the center’s
broad national and international programs in pharmaceutical regulation.
Dr. Galson began his Public Health Service (PHS) career as an epide -
miological investigator at CDC after completing a residency in internal
medicine at the Hospitals of the Medical College of Pennsylvania. He
has held senior-level positions at the Environmental Protection Agency
(EPA); the Department of Energy, where he was Chief Medical Officer;
and the Department of Health and Human Services. Prior to his arrival
at FDA, he was Director of EPA’s Office of Science Coordination and
Policy, Office of Prevention, Pesticides and Toxic Substances. Dr. Galson
joined FDA in April 2001 as CDER Deputy Director. He is the recipient of
numerous awards, including the Surgeon General’s Medallion and three
Secretary of Energy Gold Awards. Dr. Galson has been a board member of
the National Board of Medical Examiners and a peer reviewer for medi-
cal journals. He holds a B.S. from Stony Brook University, an M.D. from
Mt. Sinai School of Medicine, and an M.P.H. from the Harvard School of
Public Health. He is board certified in preventive medicine and public
health and occupational medicine.
Kathy Giacomini, Ph.D., is Professor and Co-Chair of the Department of
Bioengineering and Therapeutic Sciences at UCSF. Dr. Giacomini received
her Ph.D. in pharmaceutical science from the State University of New
York at Buffalo and completed a postdoctoral fellowship at Stanford Uni-
versity. She is considered a leader in the field of pharmacogenomics of
membrane transporters, having led the discovery and functional char-
acterization of genetic variants in over 100 membrane transporters that
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APPENDIX B
play a role in drug response in ethnically diverse populations. Her studies
link genetic variants to clinical drug response. Dr. Giacomini has co-
authored over 150 manuscripts, mentored over 20 Ph.D. students and
several junior faculty, and has received many awards for her research
including the Dawson Award of the American Association of Colleges of
Pharmacy, and, most recently, the Scheele Award of the Swedish Academy
of Pharmaceutical Scientists. In 2007, she was inducted into the IOM of
the National Academies.
William Greenlee, Ph.D., is President and Chief Executive Officer of The
Hamner Institutes for Health Research (formerly CIIT Centers for Health
Research) and Chief Executive Officer of the Health Research and Educa-
tion Foundation in Research Triangle Park, NC. He received his B.S. and
M.S. degrees in chemistry from San Jose State University and a Ph.D.
degree in pharmacology from the University of Rochester. After complet -
ing a postdoctoral fellowship at CIIT in 1980, Dr. Greenlee was appointed
Assistant Professor of Toxicology at the Harvard School of Public Health
and held a joint appointment in the Program in Cellular and Developmen-
tal Biology at the Harvard Medical School. He later returned to CIIT as a
member of the senior scientific staff and in 1988 was appointed Head of
the Department of Cellular and Molecular Toxicology. He was recruited
to Purdue University in 1991 as Professor and Head of the Department
of Pharmacology and Toxicology. From 1995 to 1999, Dr. Greenlee was
Professor and Chair of the Department of Pharmacology and Molecular
Toxicology at the University of Massachusetts Medical School in Worces-
ter, Massachusetts. Dr. Greenlee is widely recognized for his research
and education contributions in molecular toxicology and has published
benchmark studies on the molecular basis of dioxin actions in humans. He
has served on editorial boards of several journals and government advi-
sory panels. In 2009, Dr. Greenlee was recognized as one of the 50 most
powerful NC Business Leaders by Business Leader magazine and received
the Benjamin Rush Award from Dickinson College for exceptional lead-
ers in business or government who uphold humanistic values and whose
accomplishments exemplify the value of a liberal arts education.
Gigi Hirsch, M.D., brings nearly 30 years of clinical and business experi-
ence in the health care industry to MIT’s Center for Biomedical Innova -
tion (CBI). She joined CBI in March 2006 as Senior Advisor, and became
Executive Director in 2007. Her current efforts at CBI are focused largely
on leading NEWDIGS, a unique collaboration focused on transforming
the global health care innovation system to deliver greater value to all
stakeholders and to ensure its sustainability. Dr. Hirsch has held a number
of leadership roles that leverage her broad clinical background (internal
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90 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
medicine, emergency medicine, and psychiatry) along with her passion
for innovation, entrepreneurship, and improving patient care. Prior to
joining CBI, she served as Director of Academic and Professional Rela-
tions in a biopharmaceutical company (Millennium Pharmaceuticals)
and was founder and CEO of a boutique entrepreneurial venture (MD
IntelliNet) that spun out of an academic research and consulting firm that
she founded in partnership with Boston’s Beth Israel Hospital. Dr. Hirsch
completed her residency training in internal medicine and psychiatry, and
practiced full-time emergency medicine for nearly 5 years at Brigham
and Women’s Hospital in Boston. She was an instructor in psychiatry at
Harvard Medical School from 1992 to 1997. She previously held appoint -
ments in internal medicine at Harvard Medical School and Brown Uni-
versity after receiving her medical degree at the University of Cincinnati
in 1981.
Story C. Landis, Ph.D., has been Director of NINDS since September 1,
2003. As the Director of NINDS, Dr. Landis oversees an annual budget
of $1.5 billion and a staff of more than 900 scientists, physician-scientists,
and administrators. The Institute supports research by investigators in
public and private institutions across the country, as well as by scien-
tists working in its intramural laboratories and branches in Bethesda,
Maryland. Since 1950, the Institute has been at the forefront of U.S.
efforts in brain research. Dr. Landis joined NINDS in 1995 as Scientific
Director and worked with then-institute director Zach W. Hall, Ph.D., to
coordinate and reengineer the Institute’s intramural research programs.
Between 1999 and 2000, under the leadership of NINDS Director Gerald
D. Fischbach, M.D., she led the movement, together with NIMH Scientific
Director Robert Desimone, Ph.D., to bring some sense of unity and com-
mon purpose to 200 laboratories from 11 different NIH Institutes, all of
which conduct leading-edge clinical and basic neuroscience research. A
native of New England, Dr. Landis received her undergraduate degree in
biology from Wellesley College in 1967 and her master’s degree (1970) and
Ph.D. (1973) from Harvard University, where she conducted research on
cerebellar development in mice. After postdoctoral work at Harvard Uni -
versity studying transmitter plasticity in sympathetic neurons, she served
on the faculty of the Harvard Medical School Department of Neurobiol-
ogy. In 1985 she joined the faculty of Case Western Reserve University
School of Medicine in Cleveland, Ohio, where she held many academic
positions including Associate Professor of Pharmacology; Professor and
Director of the Center on Neurosciences; and Chairman of the Depart-
ment of Neurosciences, a department she was instrumental in estab-
lishing. Under her leadership, Case Western’s Neuroscience Department
achieved worldwide acclaim and a reputation for excellence. Throughout
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APPENDIX B
her research career, Dr. Landis has made many fundamental contributions
to the understanding of developmental interactions required for synapse
formation. She has garnered many honors and awards and is an elected
fellow of the Academy of Arts and Sciences, the American Association for
the Advancement of Science, and the American Neurological Association.
In 2002, she was named the President-Elect of the Society for Neurosci-
ence. In October of 2009, she was elected to the membership of the IOM.
H. Clifford Lane, M.D., is Deputy Director, Clinical Research and Special
Projects, NIAID, NIH. Dr. Lane, a native of Detroit, Michigan, received his
M.D. degree from the University of Michigan in 1976. He then completed
an internship and residency at the University of Michigan Hospital, Ann
Arbor, Michigan. In 1979, Dr. Lane came to NIH as a clinical associ-
ate in the Laboratory of Immunoregulation (LIR) at NIAID. In 1985, he
was appointed Deputy Clinical Director, NIAID, and in 1989 he became
the Chief of the Clinical and Molecular Retrovirology Section (CMRS)
of the LIR, a position he still holds. In 1991, Dr. Lane became Clini-
cal Director of NIAID and, in 2006, Director of the Division of Clinical
Research and Deputy Director for Clinical Research and Special Projects.
In the laboratory, Dr. Lane’s early work involved studies aimed at dissect-
ing the normal immunoregulatory mechanisms controlling the human
immune response to specific antigen challenge. Within a brief time, the
AIDS epidemic emerged and Dr. Lane became one of the first investi-
gators to study immunopathogenic mechanisms of HIV disease, ulti-
mately making seminal observations that helped establish the field of
HIV immunopathogenesis. In the clinical arena, Dr. Lane has studied
innovative approaches to therapy and has used experimental therapeutic
interventions as a means of furthering our understanding of HIV patho-
genesis. As Clinical Director of NIAID he has led efforts to identify and
reduce barriers to clinical research. Dr. Lane is a member of the IOM,
the American Federation for Clinical Research, the American Society for
Clinical Investigation, the Association of American Physicians, the Ameri-
can Association of Immunologists, the American College of Physicians,
the Infectious Diseases Society of America, and the Clinical Immunology
Society. He has served on the editorial boards of The Journal of Clinical
Immunology and AIDS Research and Human Retroviruses. He is currently
on the editorial boards of PLoS Medicine, the Journal of Acquired Immune
Deficiency Syndromes, Clinical Immunology and Immunopathology, and AIDS
Patient Care and STDs.
Juan J. L. Lertora, M.D., Ph.D., has been Director, Clinical Pharmacology
Program, Office of Clinical Research Training and Medical Education, NIH
Clinical Center since July 2006. Previously, he was Professor of Medicine
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92 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
and Pharmacology and Section Head of Clinical Pharmacology at Tulane
University School of Medicine in New Orleans, Louisiana (1981-2006). He
was Program Director, Tulane-Louisiana State University-Charity Hospital
General Clinical Research Center (1998-2005) and Principal Investigator,
Tulane-LSU Adult AIDS Clinical Trials Unit (1996-2005), both funded by
NIH. Dr. Lertora is a graduate of the Faculty of Medicine, National Uni-
versity of the Northeast, Corrientes, Argentina, and the Graduate School,
Department of Pharmacology, Tulane University. He received a Merck Sharp
and Dohme International Fellowship in Clinical Pharmacology at Tulane,
completed training in internal medicine at the University of Connecticut,
and a clinical pharmacology fellowship at the University of Iowa. He was
Assistant Professor of Medicine and Pharmacology, Clinical Pharmacology
Center, Northwestern University in Chicago (1977-1981) and received a
Faculty Development Award from the Pharmaceutical Manufacturers Asso-
ciation Foundation (now the PhRMA Foundation). Dr. Lertora serves on the
editorial board of Clinical Pharmacology and Therapeutics, the FDA Advisory
Committee for Pharmaceutical Sciences and Clinical Pharmacology, and
the Board of Directors of the American Society for Clinical Pharmacology
and Therapeutics (2007-2011). He is Adjunct Professor of Medicine at Duke
University. Dr. Lertora conducted phase I-II safety and efficacy clinical
trials and studied pharmacokinetics-pharmacodynamics, drug metabolism,
pharmacogenetics, and drug interactions of antiretroviral drugs. Previ-
ous research included erythropoietin’s role in the anemia of chronic renal
disease, the dose-related cardioselectivity of practolol, the antiarrhythmic-
inotropic actions of NAPA (N-acetylprocainamide), the cardiovascular
actions of NAPADE (desethyl-N-acetylprocainamide), CYP2E1, and
chlorzoxazone metabolism, and pharmacokinetics of ribavirin and peg-
interferon alfa-2a in HIV-infected patients.
Xavier Luria, M.D., is a qualified medical doctor, postgraduate fellow
in internal medicine, and postgraduate qualifications in pharmaceutical
medicine, in biostatistics, and in clinical pharmacology, drug develop -
ment, and regulation. Dr. Luria worked in Barcelona (Spain) as an internal
medicine physician, as assistant of physiology, and assistant in gastro-
intestinal and psychosomatic disorders. In 1987, he joined a pharmaceuti -
cal company as a medical doctor in clinical research and in 1990 became
Head of Clinical Research. In 1995 he was nominated Medical Direc-
tor with responsibility for international clinical development, biometry,
pharmacovigilance, and global medical affairs. He has been a member
of working groups in the Spanish (Farmaindustria) and European phar-
maceutical industry associations (EFPIA). He participated in a number
of ICH initiatives and was also a member of the DIA Steering Committee
Europe until 2004. He has been involved in a number of activities with
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APPENDIX B
FDA, Japanese health authorities, and European national regulatory bod-
ies. He has contributed as a speaker in several training courses and con -
ferences and as a lecturer in some university master’s degree programs.
He joined the EMA, London, in December 2005 as Head of Safety and
Efficacy of Medicines.
Emma Meagher, M.D., was born in Dublin, Ireland. She graduated with
her medical doctorate degree from the Royal College of Surgeons in
Ireland and following completion of a residency in internal medicine she
was appointed as Senior Registrar/Lecturer of Cardiovascular Medicine
at Mater Hospital, University College Dublin, Ireland. She joined the fac -
ulty at the University of Pennsylvania in 1995 and is currently Associate
Professor of Medicine and Pharmacology and Director of the Translational
Research Training Programs at the University of Pennsylvania School of
Medicine. In addition she serves as a Co-PI on the Penn CTSA and is the
Executive Chair of the University of Pennsylvania IRB.
Annette Mollet, Ph.D., received her M.Sc. in pharmacy in 1989 from the
University of Basel. She worked on her thesis in developmental neuro-
biology at the Swiss Federal Institute of Technology (ETH) in Zurich,
where she received her Ph.D. in 1994. During that time she taught phar-
macology and toxicology at the School of Oral Hygiene in Zurich. Dr.
Mollet worked at F. Hoffmann-La Roche in the Clinical R&D depart-
ment until 1996. Subsequently she conducted clinical trials in the field
of AIDS and anticoagulation therapeutics and worked as a medical and
product manager responsible for oncology at Roche Pharma (Schweiz).
Dr. Mollet’s present position is Head of Education and Training at the
ECPM at the University of Basel. She became a member of the Expert
Committee for the Evaluation and Registration of Radioactive Drugs at
the Swissmedic (Swiss Agency for Therapeutic Products) and the BAG
(Swiss Federal Office of Public Health) in 1993 and was elected president
in 2008. Since 1999, Dr. Mollet has been a member of the board of the
Swiss Association of Pharmaceutical Professionals (SwAPP) and special -
ized in pharmaceutical medicine in 2000. She chaired the commission for
specialty training and continuous education (CPD) of SwAPP until 2009.
Dr. Mollet is also involved in the creation of a European Specialist title
in Pharmaceutical Medicine and a Master title in Drug Development Sci-
ences within the IMI joint undertaking, PharmaTrain.
Carl Peck, M.D., obtained a B.A. in mathematics and chemistry from the
University of Kansas in 1963 and an M.D. in 1968. Following training in
internal medicine, he undertook a research fellowship in clinical pharma -
cology at the University of California, San Francisco (1972-1974). From
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94 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
1974 to 1980, Dr. Peck was employed at the Letterman Army Institute of
Research, San Francisco, California, as Chief of the Army Blood Preser-
vation Research Program. In 1980, Dr. Peck became Director of the Divi -
sion of Clinical Pharmacology and Professor, Departments of Medicine
and Pharmacology, Uniformed Services University, Bethesda, Maryland.
Dr. Peck joined FDA as Director, CDER, in October 1987. He was promoted
to Assistant Surgeon General in the Public Health Service in October 1990.
Retiring from FDA in late 1993, Dr. Peck was appointed “Boerhaave” Pro-
fessor of Clinical Drug Research at Leiden University in The Netherlands.
In 1994 Professor Peck joined the faculty of the Georgetown Univer-
sity Medical Center as the founding Director of the Center for Drug
Development Science. In 1999, Dr. Peck received the FDA Distinguished
Alumnus Award. Sweden’s University of Uppsala conferred an honorary
doctorate degree (Doctor Honoris Causa) to Dr. Peck in January 2002 in
recognition of “outstanding contributions to the science of drug develop -
ment.” Dr. Peck founded NDA Partners LLC in 2003 and, in 2004, CDDS
moved to UCSF, located in the UC-Washington Center. Throughout his
career, he has mentored more than 40 postdoctoral fellows and gradu-
ate students and co-founded the American (2007) and Chinese (2009)
Courses in Drug Development and Regulatory Science (ACDRS, CCDRS).
Dr. Peck’s research interests center on optimizing informativeness, effi-
ciency, speed, and economy of drug development and regulation using
advanced concepts and techniques of clinical pharmacology, trial designs,
and pharmacostatistical modeling and simulation to generate causal evi-
dence of effectiveness and safety. He is an author of more than 150 origi -
nal research papers, chapters, and books.
Munir Pirmohamed, Ph.D., qualified in medicine in 1985, undertook a
Ph.D. in pharmacology in 1993 and was appointed consultant physician
at the Royal Liverpool University Hospital in 1996. He was awarded a
Personal Chair in Clinical Pharmacology at the University of Liverpool in
2001, and in 2007, was appointed to the NHS Chair of Pharmacogenetics.
He is Director of the Wolfson Centre for Personalised Medicine, Deputy
Director of the Medical Research Council CDSS in Liverpool, and Head of
the Department of Molecular and Clinical Pharmacology at the University
of Liverpool. Professor Pirmohamed is a Member of the Commission on
Human Medicines and Chair of its Pharmacovigilance Expert Advisory
Group. His main area of research is in pharmacogenetics and drug safety.
Adverse reactions to drugs are a major cause of illness in the popula-
tion. The research aims to maximize the benefits of drugs and minimize
their harms. This is being achieved through the use of different strategies
ranging from improvements in prescribing to the development of genetic
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APPENDIX B
and other tests for predicting and monitoring individual susceptibility to
toxicity.
Theodore F. Reiss, M.D., was born in New Jersey. He attended the Uni-
versity of Pennsylvania, with majors in history and biology, and Vander-
bilt Medical School, where he served his medical internship. His medical
residency was performed at Columbia University and he performed his
clinical training in pulmonary and critical care and his research training
in airway pharmacology at UCSF. Thereafter, he joined Merck Research
Laboratories, where he worked for 18 years, ultimately serving as Vice
President, Clinical Research. He was responsible for development across
a number of therapeutic areas including bone/muscle, gastroenterology,
urology, and most importantly respiratory and allergy, where he led
the team responsible for the development of the leukotriene antagonist
montelukast. He also made significant scientific contributions to other
therapies, notably alendronate and aprepitant. In 1998 he received the
Merck Directors’ award, the company’s highest award for scientific
achievement, for his work on montelukast. Following his time at Merck,
he served as Corporate Vice President, Global Integrated Drug Develop-
ment, at Covance and has taught translational science and drug devel-
opment at the University of Pennsylvania School of Medicine. He cur-
rently serves as Research Professor of Medicine at Vanderbilt University
School of Medicine and is a candidate for a master of bioethics at the
University of Pennsylvania.
Vicki L. Seyfert-Margolis, Ph.D., is Senior Advisor within Science Innova-
tion and Policy for the FDA Commissioner’s Office. Dr. Seyfert-Margolis
focuses on initiatives in regulatory science, personalized medicine, and
scientific computing and informatics. Previously, she served as Chief
Scientific Officer at Immune Tolerance Network (ITN), a nonprofit con-
sortium of researchers seeking new treatments for diseases of the immune
system. At ITN, she oversaw the development of more than 20 centralized
laboratory facilities and the design and execution of biomarker discovery
studies for over 25 Phase II clinical trials. As part of the biomarker efforts,
she established construction of a primer library of 1,000 genes that may be
involved in establishing and maintaining immunologic tolerance and co-
discovered genes that may mark kidney transplant tolerance. Dr. Seyfert-
Margolis was also an adjunct associate professor with the Department of
Medicine at UCSF. Prior to academia, she served as Director of the Office
of Innovative Scientific Research Technologies at NIAID, NIH, where she
worked to integrate emerging technologies into existing immunology and
infectious disease programs. Dr. Seyfert-Margolis completed her Ph.D.
in immunology at the University of Pennsylvania’s School of Medicine.
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96 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
Dr. Seyfert-Margolis co-authored an article in the New England Journal of
Medicine July 15, 2010, issue titled “Rituximab versus Cyclophosphamide
for ANCA-Associated Vasculitis.”
Ellen V. Sigal, Ph.D., is Chairperson and Founder of Friends of Cancer
Research (“Friends”), a cancer research thinktank and advocacy organiza-
tion based in the Washington, DC, metropolitan area. Friends is dedicated
to accelerating the nation’s progress toward prevention and treatment
of cancer by mobilizing public support for cancer research funding and
providing education on key public policy issues. For more than 14 years,
Friends has pioneered innovative public-private partnerships, organized
critical policy forums, educated the public, and brought together key
communities to develop collaborative strategies in the field of cancer
research. Dr. Sigal is Vice Chair of the inaugural board of directors of the
Reagan-Udall Foundation, a partnership designed to modernize medical
product development, accelerate innovation, and enhance product safety
in collaboration with FDA. She serves on the NIH Foundation Board
chairing its Public-Private Partnerships Committee, the American Asso -
ciation for Cancer Research Foundation Board, and the Research!America
Board. Dr. Sigal is a member of the Stand Up To Cancer (SU2C) Advocate
Advisory Council, and she is one of two Council members nominated
to the SU2C Scientific Advisory Committee. She holds leadership posi-
tions with a broad range of cancer advocacy and public policy organiza -
tions, and leadership positions with academic health centers including
the M.D. Anderson Cancer Center External Advisory Board, the Duke
University Cancer Center Board of Overseers, and the Sidney Kimmel
Comprehensive Cancer Center Advisory Council. She serves on the
C-Change Research Committee and the Entertainment Industry Founda-
tion Oversight Committee for the Biomarker Discovery Project. Dr. Sigal
was recently named to the Patient-Centered Outcomes Research Institute
(PCORI) Board of Governors as a representative of patients and health
consumers. During her more than 20-year commitment to cancer research,
Dr. Sigal has served in a number of critical public positions. She served
on the NCI Board of Scientific Advisors from 2003 to 2009, and the NIH
Director’s Council of Public Representatives from 2003 to 2006. She was
a Presidential Appointee to the National Cancer Advisory Board from
1992 to 1998, where she chaired the Budget and Planning Committee that
oversees the federal cancer budget. In 1998, Dr. Sigal was named Vice
Chairman of the Board of The March, a national grassroots advocacy
group that brought thousands of volunteers to Washington to liaise with
Congress and to set a new advocacy agenda for cancer research and treat-
ment. She is a past member of the American Society of Clinical Oncology
Foundation Board. Dr. Sigal has also been instrumental in harnessing the
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APPENDIX B
energies of Hollywood on behalf of cancer research, serving as President
of the Creative Community Task Force for Cancer Research.
Ralph Snyderman, M.D., served as Chancellor for Health Affairs and
Dean of the School of Medicine at Duke University from 1989 to July
2004 and led the transition of this excellent medical center into an inter-
nationally recognized leader of academic medicine. During his tenure,
the medical school and hospital achieved ranking among the nation’s
best. He oversaw the development of the Duke University Health Sys -
tem, one of the most successful integrated academic health systems in
the country, and served as its first President and Chief Executive Officer.
Dr. Snyderman has played a leading role in the conception and develop -
ment of Prospective Care, a novel approach to personalized health and
an evolving model of national health care delivery. He was among the
first to envision and articulate the need to move the current focus of
health care from treatment of disease events to personalized, predictive,
preventative, and participatory care. His approach, termed Prospective
Care, embraces strategic health planning rather than reactive responses
to late-stage chronic disease. Dr. Snyderman has been widely recognized
for his contributions to the development of more rational, effective, and
compassionate models of health care. He was awarded the first Bravewell
Leadership Award for outstanding achievements in the field of integrative
medicine in 2003. Dr. Snyderman received the 2007 Leadership in Person-
alized Medicine Award in November 2007 from the Personalized Medicine
Coalition for his efforts in advancing predictive and targeted therapies
on a national scale. In May 2008, he received the prestigious Industrial
Research Institute’s Medal for his outstanding accomplishments in tech-
nological innovations that contribute to the development of industry and
to the benefit of society. In November 2008, Dr. Snyderman received Frost
& Sullivan’s North American HealthCare Lifetime Achievement Award
for his pioneering spirit and contributions to medicine. In March 2009, he
received the Triangle Business Journal’s Healthcare Lifetime Achievement
Award. In February 2010, Procter & Gamble named Dr. Snyderman an
honorary member of the Victor Mills Society for his leadership and impact
on innovation. In April, he was awarded the Clinical Research Forum’s
2010 Leadership in Academic Health Centers award. Dr. Snyderman was
recognized as a Bioscience Leader Emeriti by the North Carolina Associa -
tion for Biomedical Research in 2010, honoring North Carolina research
leaders for their outstanding leadership in research and development and
in the transformation of the state through scientific discovery and innova-
tion. Dr. Snyderman has played a prominent role in the leadership of such
important national organizations as the Association of American Physi -
cians, the IOM, and the Association of American Medical Colleges. He is
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98 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
a member of the IOM and the American Academy of Arts and Sciences.
He served as Chair of the AAMC in 2001-2002 and President of AAP in
2003-2004. He chaired the IOM’s National Summit on Integrative Medi-
cine and the Health of the Public held in February 2009. Dr. Snyderman
accepted his first faculty appointment at Duke in 1972 and, by 1984,
he was the Frederic M. Hanes Professor of Medicine and Immunology.
His research contributed to the understanding of how white blood cells
respond to chemical signals to mediate host defense or tissue damage
and he is internationally recognized for his contributions in inflamma-
tion research. In 1987, Snyderman left Duke to join Genentech, Inc., the
pioneering biomedical technology firm, as Senior Vice President for Medi-
cal Research and Development. While at Genentech, he led the develop -
ment and licensing of several major biotechnology therapeutics. He is the
recipient of numerous other honors, including the CIBA GEIGY Award
in 1992, the highest prize in inflammation research; the 1993 Bonazinga
Award for Excellence in Leukocyte Biology Research; and the award of
designation as the American College of Rheumatology Master in 2005.
Snyderman was honored with the Lifetime Achievement Award from
the Arthritis Foundation in 1997. In 1995, Downstate Medical Center of
the State University of New York awarded him with their Distinguished
Alumni Achievement Award and, in 1996, an honorary doctor of science
degree. In 2003, he received the Ellis Island Medal of Honor presented to
outstanding Americans who have distinguished themselves among their
specific ethnic groups and have made significant contributions to our
country. Snyderman received the George Eastman Medal from the Uni-
versity of Rochester School of Medicine in May 2003 and, in 2004, received
an honorary doctor of science degree from Washington College. A gradu-
ate of Washington College in Chestertown, Maryland (1961), Snyderman
received his M.D., magna cum laude, in 1965 from the Downstate Medical
Center of the State University of New York. He served his internship and
residency in medicine at Duke and later worked as a Public Health Officer
doing research in immunology at the NIH (1967-1972). His bibliography
exceeds 375 manuscripts as well as numerous books.
Henrietta N. Ukwu, M.D., FACP, FRAPS, is Senior Vice President,
Global Regulatory Affairs, PPD Inc. Dr. Ukwu is a physician-internist
and infectious disease specialist. She completed her fellowship in infec -
tious diseases at Vanderbilt University, Nashville, Tennessee; her res-
idency in internal medicine at Baptist Hospital, Nashville, Tennessee;
and her internship in internal medicine at Meharry–Hubbard Hospital,
Nashville, Tennessee. Dr. Ukwu holds medical and surgical degrees from
the University of Jos, Nigeria. Dr. Ukwu, an internist and infectious dis -
ease physician, is a biopharmaceutical industry executive and industry
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APPENDIX B
thought leader with extensive global regulatory experience across many
biopharmaceutical therapeutic platforms and all regions. Currently, she is
Senior Vice President and Head of Global Regulatory Affairs for PPD Inc.
Dr. Ukwu recently authored Global Regulatory Systems: A Strategic Primer
for Biopharmaceutical Products Development and Registration—a landmark
first-of-its-kind textbook for regulatory and biopharmaceutical industry
professionals. Beginning her pharmaceutical industry career at Merck &
Co. in 1992, Dr. Ukwu became Vice President and Head of Vaccine World-
wide Regulatory Affairs in 1998, and Vice President of Global Regulatory
Policy in 2002. She joined Wyeth Pharmaceuticals in 2004 as Vice Presi -
dent of Global Regulatory Affairs, with responsibility for all therapeutic
areas across all platforms—vaccines, biologics, and pharmatherapeutics.
In 2009, she became Vice President of Worldwide Regulatory Affairs for
Pfizer Inc. Dr. Ukwu has led regulatory efforts for vaccines, biologics, and
pharmatherapeutics platforms in the United States, Canada, Europe, Asia
Pacific, Latin America, Middle East, Africa, and the WHO. She has been
responsible for overseeing strategic product development and registra -
tion plans, regulatory interactions with boards of health, human subject
protection for clinical/preclinical development, rigorous regulatory stan -
dards, and successful registration of new drugs/biologics. She has been
involved in many product development activities and has directly led the
successful original regulatory development, filings, and approvals of 14
new products. Dr. Ukwu has built strategic regulatory teams, led major
initiatives to drive regulatory excellence, and made significant contri -
butions to developing and enriching the regulatory profession. Under
Dr. Ukwu’s leadership, PPD’s global regulatory affairs organization,
which encompasses global regulatory development, global regulatory
consulting, and strategic intelligence, global chemistry, manufacturing
and controls, global medical writing, global devices/diagnostics, and
global regulatory operations is strengthening its focus on the provision
of strategic regulatory intelligence and expertise to enable Bio-Pharma
to successfully navigate today’s dynamic and complex global regulatory
landscape. A fellow of both the American College of Physicians (ACP) and
RAPS, Dr. Ukwu is an adjunct professor at the Graduate School of Phar-
macy, Division of Quality Assurance and Regulatory Affairs, at Temple
University in Pennsylvania. She has received numerous awards for her
outstanding contributions to medicine, science, and industry, including
recent recognition as one of 100 most inspiring leaders by PharmaVoice,
July 2011. She has authored professional and scientific publications and
has given many lectures, keynote speeches, and presentations.
Melinda Wharton, M.D., M.P.H., was appointed Deputy Director of the
National Center for Immunization and Respiratory Diseases at CDC in
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100 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
August 2006. Dr. Wharton is a Captain in the U.S. Public Health Service
(USPHS). She holds an M.D. from Harvard Medical School and an M.P.H.
from the Johns Hopkins School of Hygiene and Public Health. She com -
pleted internship and residency in internal medicine at the University of
Michigan Medical Center and her infectious diseases fellowship at the
Duke University Medical Center. Dr. Wharton was commissioned as a
CDC epidemic intelligence service officer in 1986 and was assigned to
the Tennessee Department of Health and Environment in Nashville. In
1989, she joined CDC as a Medical Epidemiologist in the Epidemiology
Program Office. She joined the National Immunization Program (NIP) in
1992, holding chief positions in the Infant Immunization Section, the Sur-
veillance, Investigations, and Research Branch, and the Child Vaccine Pre-
ventable Diseases Branch, Epidemiology and Surveillance Division. She
also served as Director of the Epidemiology and Surveillance Division.
In January 2004, she became Acting Deputy Director of NIP. Dr. Wharton
has authored or co-authored more than 80 scientific journal articles, book
chapters, and CDC publications, including Morbidity and Mortality Weekly
Report articles.
Leslie D. Wheelock, M.S., R.N., is the Director of the Office of Scientific
Professional Development (OSPD) in the Office of the Chief Scientist at
FDA. The OSPD manages FDA-wide scientific training and professional
development programs to include the CFP, professional development
activities, scientific exchanges, and scientific achievement award. Prior
to her position as OSPD Director, she was the Director of the Division of
Manufacturers Assistance and Training at the CBER, FDA, for 6 years.
Previously, Leslie worked for the FDA’s CDER, where she was as an
Associate Director for Safety Outreach and Communication co-leading
FDA’s Mid-Progress Review for Healthy People 2010 Focus Area Chapter
17, Medical Product Safety. At CDER, she also worked as a Regulatory
Health Education Specialist Team Leader serving as the Program Man -
ager for CDER’s Competency Based Training Program, which received
the federal government’s 2000 W. Edward Deming Outstanding Training
Award. Before joining FDA in 1997, Leslie was Nurse Director of the Clini-
cal Research Department at the Washington Cancer Institute, Washington
Hospital Center, and she also worked as a Clinical Nurse Specialist and
Clinical Nurse Educator at the NIH Clinical Center supporting the NCI’s
Intramural Research Program. As an oncology nurse, she held certifica -
tions from the Oncology Nursing Society as an Oncology Certified Nurse
(OCN) and Advanced Oncology Certified Nurse (AOCN). Leslie earned
a B.A. in biology from Hood College and M.S. in nursing from the Uni-
versity of Maryland. She additionally has graduate education in adult
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APPENDIX B
learning and human resource development from Virginia Polytechnic
Institute and State University.
Jonathan S. Wiest, Ph.D., obtained a bachelor’s degree in analytical chem-
istry from the University of Wisconsin-Milwaukee in 1980. He worked as
a production chemist synthesizing oligonucleotides for P-L Biochemicals
until he began graduate school in 1982 at the Medical College of Ohio in
Toledo. Dr. Wiest received a Ph.D. in biochemistry in 1988 and then did a
postdoctoral fellowship at the National Institute of Environmental Health
Sciences in Research Triangle Park, North Carolina. He rose to the rank
of Senior Staff Fellow and then assisted in establishing a Cancer Research
Institute in western Colorado. In 1996 he became an assistant professor
at the University of Cincinnati, Department of Environmental Health,
School of Medicine. Dr. Wiest joined the Center for Cancer Research at the
NCI as the Associate Director for Training and Education in November
2001. In 2007 Dr. Wiest was appointed by the NCI Director to serve as the
Acting Director for the Cancer Prevention Fellowship Program and in
early 2008 the NCI Director also appointed Dr. Wiest to lead the forma-
tion of the Center for Cancer Training (CCT) as the director. The CCT is
charged with coordinating the major training activities in the NCI in both
the intramural and extramural communities. In 2003, Dr. Wiest received
the NIH Director’s Award for Mentoring as well as the NCI Outstanding
Mentor award. In November 2007 he received an NIH Award of Merit for
mentoring. The major focus of his research involves genetic alterations in
lung tumorigenesis. He is involved in studies to identify tumor suppres -
sor genes and altered signaling pathways in lung cancer.
Carolyn Wilson, Ph.D., received her Ph.D. in genetics from George
Washington University while working in the laboratory of Dr. Robert
Gallo for her dissertation research. For her postdoctoral fellowship, she
worked in the laboratory of Dr. Maribeth Eiden identifying viral and cel -
lular factors influencing viral entry. She joined the Division of Cellular
and Gene Therapies (DCGT) at CBER, FDA, in 1993. As a researcher-
reviewer in DCGT, she reviewed INDs and developed policy and guid-
ance documents in two novel product areas: gene therapy and xenotrans-
plantation. More recently, Dr. Wilson has served as the Associate Director
for Research (ADR) at CBER. As ADR, Dr. Wilson ensures that CBER’s
research is relevant, high quality, and provides CBER with the appropriate
scientific expertise, tools, and data to support regulatory decision making
and policy development. Dr. Wilson still maintains her own laboratory
program studying retroviruses which are either used as vectors for gene
therapy clinical trials or are of concern in the xenotransplantation setting.
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102 STRENGTHENING A WORKFORCE FOR INNOVATIVE REGULATORY SCIENCE
Alastair J. J. Wood, M.D., was Professor of both 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 member
of the IOM, the American Association of Physicians (AAP), the Ameri -
can Society for Clinical Investigation (ASCI); Honorary Fellow, American
Gynecological and Obstetrical Society (AGOS); and Fellow of the Ameri -
can College of Physicians. Dr. Wood served on the New England Journal of
Medicine (NEJM) Editorial Board and was the NEJM Drug Therapy Editor
for many years. He authored the chapter in Harrison’s Principles of Internal
Medicine on adverse drug reactions from the 9th through the 15th editions.
He was the chairman of the FDA’s Nonprescription Drugs Advisory Com-
mittee 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 the Food and Drug Administration, 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.
