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Appendix C
Committee Biographies
Jane E. Henney, M.D. (Chair), is Professor of Medicine and Public Health
Sciences at the University of Cincinnati College of Medicine. Previously,
she was Senior Vice President and Provost of Health Affairs at the Univer-
sity of Cincinnati. Her experience and expertise lie in managing complex
organizations that provide direct health services, regulate science-based
products, educate the next generation of health professionals, and con-
duct biomedical research. She has served in a series of senior health
policy leadership positions including Commissioner of the U.S. Food
and Drug Administration (FDA) (1999–2001), Deputy Commissioner for
Operations (1991–1994), Deputy Director of the National Cancer Institute,
Vice Chancellor of Health Programs of Kansas Medical Center, Interim
Dean of the University of Kansas School of Medicine, and the first Vice
President for Health Sciences at the University of New Mexico. Dr. Hen -
ney has served on many boards and committees including the Advisory
Committee to the Director for the National Institutes of Health (NIH), the
National Advisory Research Resources Council, and the American Cancer
Society National Board of Directors. She has served on several Institute
of Medicine (IOM) committees including the planning committee for The
IOM Drug Safety Report: Resource Implications workshop, Committee on
Improving Mammography Quality Standards, and the IOM Membership
Committee. She has served as the Chair of the IOM Committee on Strate-
gies to Reduce Sodium Intake. Dr. Henney received her undergraduate
degree from Manchester College and her medical degree from Indiana
University, and she completed her subspecialty training in medical oncol-
339
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340 STUDIES ON MODIFIED RISK TOBACCO PRODUCTS
ogy at the M.D. Anderson Hospital and Tumor Institute and the National
Cancer Institute. She is an IOM member.
Timothy B. Baker, Ph.D., is a Professor of Medicine in the University of
Wisconsin School of Medicine and Public Health. His principal research
goals are to increase understanding of the motivational bases of addic -
tive disorders and to develop and evaluate treatments for such disorders.
He is also highly interested in developing and using technological and
methodological advances to deliver and evaluate treatments for addic-
tive disorders and cancer. Dr. Baker has served as the editor of the Journal
of Abnormal Psychology, is the Principal Investigator of the University of
Wisconsin Transdisciplinary Tobacco Use Research Center award (NCI/
NIDA), has a K05 Senior Scientist Award from NCI, and is the recipient of
the James McKeen Cattell Award from the Association for Psychological
Science.
Rebecca Bascom, M.D., M.P.H., is a professor of medicine at the Milton
S. Hershey Medical Center at Penn State University. Her areas of exper-
tise include lung diseases and inhalation toxicology. Dr. Bascom led an
analysis team to evaluate the cardiorespiratory health effects on New
York City police officers exposed during the 9/11 terrorist attack. She has
served on three National Research Council committees, the Committee
on the Evaluation of the Department of Defense Comprehensive Clinical
Evaluation Protocol, the Committee on Occupational Safety and Health in
Research Animal Facilities, and the Committee on Health Effects of Indoor
Allergens. Dr. Bascom earned her M.D. from the University of Oregon
Health Sciences Center and her M.P.H. in occupational medicine from the
Johns Hopkins Bloomberg School of Public Health. She trained in internal
medicine, as well as pulmonary and critical care medicine at the Johns
Hopkins Hospital.
Shyam Biswal, Ph.D., is Professor at the Department of Environmental
Health, Division of Toxicology at the Johns Hopkins University Bloomberg
School of Public Health. He also has a joint appointment in the Department
of Oncology, Pulmonary and Critical Care Division, Johns Hopkins Uni-
versity School of Medicine. Dr. Biswal was a Research Associate, Division
of Pharmacology and Toxicology, at the College of Pharmacy, University
of Texas at Austin. Dr. Biswal did his postdoctoral research in the same
department, and he has a Ph.D. in biotechnology from the Indian Institute
of Technology. Dr. Biswal studies the mechanisms of gene-environment
interactions and susceptibility to environmental lung diseases involving
tobacco smoke exposure, such as COPD and lung cancer. His group has
identified that transcription factor, Nrf2, is a critical modifier of inflamma-
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APPENDIX C
tion that determines susceptibility to these diseases based on which novel
therapies are being developed. Dr. Biswal has more than 100 publications
in this area, and he is the principal investigator on several research grants
supported by the National Institutes of Health that are related to COPD
and lung cancer.
Daniel Carpenter, Ph.D., is Allie S. Freed Professor of Government and
Director of the Center for American Political Studies in the Faculty of Arts
and Sciences at Harvard University. He taught previously at Princeton
University and the University of Michigan. He joined the Harvard Uni-
versity faculty in 2002.
Dr. Carpenter’s primary interest is in the theoretical, historical, and
quantitative analysis of American political development, public bureau -
cracies, and government regulation, particularly regulation of health
products. His book, The Forging of Bureaucratic Autonomy: Reputations,
Networks and Policy Innovation in Executive Agencies, 1862-1928 (Princeton
University Press, 2001), was awarded the APSA’s Gladys Kammerer Prize
as well as the Charles Levine Prize of the International Political Science
Association. His newly published book on pharmaceutical regulation in
the United States is entitled Reputation and Power: Organizational Image and
Pharmaceutical Regulation at the FDA (Princeton University Press, 2010). He
received his doctorate in political science from the University of Chicago
in 1996.
Constantine Gatsonis, Ph.D., is Henry Ledyard Goddard University Pro-
fessor and Chair of the Department of Biostatistics at Brown University.
He is a leading authority on the design and analysis of clinical evaluations
of screening and diagnostic imaging modalities and has worked exten -
sively on methodological questions in diagnostic medicine and health
services and outcomes research. Dr. Gatsonis is the Network Statistician
for the American College of Radiology Imaging Network (ACRIN), which
conducts multicenter trials of diagnostic imaging in cancer and other dis -
eases. Dr. Gatsonis is the chief statistician of the Digital Mammography
Imaging Screening Trial, of ACRIN’s arm of the National Lung Screening
Trial, and of several other studies of the role of imaging for diagnosis and
staging, monitoring, and prediction of response to therapy.
Dr. Gatsonis has served on the IOM Committee on Comparative Effec-
tiveness Research Prioritization, the IOM Immunization Safety Review
Committee, the NAS Committee on Identifying the Needs of the Forensic
Sciences Community (co-chair), the NAS Committee to Study Engineer-
ing Aviation Security Environments, the NAS Committee on Applied and
Theoretical Statistics, the Commission on Technology Assessment of the
American College of Radiology, the Research Development Committee of
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342 STUDIES ON MODIFIED RISK TOBACCO PRODUCTS
the Radiology Society of North America, the HSDG Study Section of the
Agency for Health Care Policy Research, review panels of the Center for
Devices and Radiological Health of the FDA, and technical expert panels
for the Health Care Financing Administration/Center for Medicare and
Medicaid Services. He is the founding editor-in-chief of Health Services and
Outcomes Research Methodology, an associate editor of the Annals of Applied
Statistics, Clinical Trials, Academic Radiology, and an editor of the Diagnostic
Test Accuracy Reviews of the Cochrane Collaboration. Dr. Gatsonis was
elected fellow of the American Statistical Association. He received his BA
in mathematics, magna cum laude, from Princeton and his Ph.D. in math-
ematical statistics from Cornell.
Gary H. Gibbons, M.D., is the director of the Morehouse Cardiovascular
Research Institute, a NIH-National Heart, Lung, and Blood Institute-
sponsored Research Center of Excellence. He is also an attending cardiolo-
gist in the Division of Cardiology at the Morehouse School of Medicine.
Dr. Gibbons earned his undergraduate degree from Princeton University
and his medical degree from Harvard Medical School. He completed his
residency and cardiology fellowship at the Harvard-affiliated Brigham &
Women’s Hospital in Boston.
Dr. Gibbons has been selected as a Robert Wood Johnson Founda-
tion Minority Faculty Development awardee, a PEW Foundation bio-
medical scholar, and an established investigator of the American Heart
Association (AHA). Dr. Gibbons was a member of the faculty at Stanford
University (1990–1996) and Harvard Medical School (1996–1999) before
becoming director of the Morehouse Cardiovascular Research Institute
in July 1999. He has served on several editorial boards for journals in
cardiovascular medicine as well as grant review committees for the NIH,
Juvenile Diabetes Foundation, and the AHA.
Dr. Gibbons directs NIH-funded research in the fields of vascular
biology and the pathogenesis of vascular diseases. The innovations
derived from his research resulted in the receipt of several U.S. patents.
His bibliography lists more than 70 reviews and original reports in the
fields of vascular biology, gene therapy, hypertension, atherosclerosis,
and cardiovascular medicine.
Bonnie L. Halpern-Felsher, Ph.D., is a Professor in the Division of Ado-
lescent Medicine, Department of Pediatrics at the University of California,
San Francisco (UCSF). She is also a faculty member at UCSF’s Psychology
and Medicine Postdoctoral Program, the Center for Health and Commu-
nity, and the UCSF Helen Diller Family Comprehensive Cancer Center.
Dr. Halpern-Felsher is a developmental psychologist whose research has
focused on health-related decision making, perceptions of risk and vul-
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APPENDIX C
nerability, and health communication. She has also conducted research
on the relationships among parenting practices, peer relationships, ado-
lescents’ self-perceptions, and risky behavior, including tobacco use.
She has served as a consultant to a number of community-level ado-
lescent health promotion programs and has been a member on several
national campaigns to understand and reduce adolescent risk behavior.
Dr. Halpern-Felsher served on the National Research Council Committee
on Developing a Strategy to Prevent and Reduce Underage Drinking, the
IOM Committee on Reducing Tobacco Use: Strategies, Barriers, and Con -
sequences, and the Committee on Contributions from the Behavioral and
Social Sciences in Reducing and Preventing Teen Motor Crashes.
Stephen S. Hecht, Ph.D., is Wallin Professor of Cancer Prevention and
American Cancer Society Professor at the Masonic Cancer Center, and Pro-
fessor in the Department of Laboratory Medicine and Pathology, Univer-
sity of Minnesota. Dr. Hecht serves as head of the Carcinogenesis and
Chemoprevention Program of the Masonic Cancer Center. He is also a
member of the Medicinal Chemistry graduate program. The focus of
the Hecht laboratory is mechanisms and prevention of tobacco-induced
cancer. The Hecht laboratory studies mechanisms by which carcinogens
are metabolically activated and detoxified in humans, and uses this
knowledge to develop practical strategies for cancer prevention, includ -
ing the validation of tobacco carcinogen and toxicant biomarkers, with
a particular focus on nitrosamines, aldehydes, and polycyclic aromatic
hydrocarbons. Studies in laboratory animals are used to understand meta-
bolic pathways. Then methods are developed to quantify metabolism of
these carcinogens in humans, typically by employing GC-MS, LC-MS, or
related methods to analyze carcinogen metabolites in urine, or carcinogen
DNA or protein adducts in tissue or blood. These methods are applied
in molecular epidemiology studies designed to determine factors that
influence susceptibility to cancer development in people who use or are
exposed to tobacco products, or who are exposed to carcinogens via other
routes.
Peter K. Honig, M.D., M.P.H., is currently Head, Global Regulatory Affairs
at AstraZeneca. Dr. Honig received his baccalaureate, medical, and public
health degrees from Columbia University in New York. He has postgradu-
ate training and is board-certified in internal medicine and clinical phar-
macology and has authored numerous peer-reviewed publications and
book chapters. He has held senior leadership positions at the U.S. Food
and Drug administration and Merck Research Laboratories. He is and has
been the PhRMA representative to the International Conference on Harmo-
nization (ICH) Steering Committee since 2002 and the current co-chair of
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344 STUDIES ON MODIFIED RISK TOBACCO PRODUCTS
the ICH Global Cooperation Group (GCG) whose mission it is to promote
regulatory harmonization in non-ICH countries and regions. Dr. Honig is
also an Associate Editor of Nature Clinical Pharmacology and Therapeutics.
Richard J. O’Connor, Ph.D., is Associate Member in the Department of
Health Behavior, Division of Cancer Prevention and Population Sciences,
Roswell Park Cancer Institute. Dr. O’Connor’s research focuses on the
interaction between tobacco products and consumers, from how ciga-
rettes are designed and how those designs affect smokers’ perceptions
and use of the product, to how best to inform policy makers crafting
tobacco product regulations. Ongoing work includes developing and
applying filter-based methods for assessing cigarette smoke exposure,
characterizing physical properties and design features of international
tobacco products, assessing smokers’ interest in alternative nicotine deliv-
ery systems, and smokers’ reactions to novel tobacco products. He is a
co-investigator on the International Tobacco Control Policy Evaluation
Project (ITC Project), which is an international collaboration of tobacco
control researchers seeking to evaluate the psychosocial and behavioral
effects of national-level tobacco control policies throughout the world.
He is also a co-investigator on an NCI-funded Program Project, directing
research to evaluate the impact of tobacco product regulations on product
design and performance, as well as smoking behavior. He is Principal
Investigator on an NCI grant examining approaches to assessing current
smokers’ interest in using alternative nicotine sources, such as smokeless
tobacco and nicotine replacement.
Joel L. Schwartz, D.M.D., D.M.Sc., is Professor and Director of Oral
Maxillofacial Pathology in the Colleges of Dentistry and Medicine at the
University of Illinois at Chicago. Dr. Schwartz’s research interests include
screening and prevention of tobacco- and environment-induced head
and neck cancers and associated cancers. Dr. Schwartz develops various
oral cancer models to understand and quantify the earliest genetic and
molecular events that change a normal cell to a cancer cell following
exposure to a virus or chemical carcinogen. First, in laboratory models
Dr. Schwartz studies viral and chemical oral carcinogenesis using normal,
transformed premalignant, and malignant cells. Second, in animals such
as hamster, rat, and mouse, he validates laboratory findings and further
assesses genetic and molecular progression as he changes a normal cell
to a cancer cell. His approach also involves noninvasive screening of this
process using oral cytology samples and RNA microarray. This method is
unique because he harvests from the identical animal samples throughout
the process of oral carcinogenesis. An identical approach is translated to
clinical human populations to validate findings, to study early prevention,
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APPENDIX C
or to monitor various therapies to improve the quality of life for the oral
cancer patient. Methods include human cells and various animal models
(hamster, rat, mouse) to prevent carcinogenesis and tumorigenesis follow-
ing administration of carotenoids/tocopherols/polyphenols, or specific
genetic regulation using peptide/viral vector vehicles. Dr. Schwartz also
has previous experience as a senior pathology core expert to enhance
epidemiology or basic chemistry approaches to study tobacco product
activities in an NIH-funded cancer center.
Donna-Bea Tillman, Ph.D., M.P.A., joined Microsoft in 2010 after 16 years
at the U.S. Food and Drug Administration. She held numerous positions
within the FDA’s Center for Devices and Radiological Health, culminat -
ing in her 2004 appointment to the position of Director of the Office of
Device Evaluation, where she oversaw the medical device premarket
review program. During her tenure at the FDA, she played a pivotal role
in the development of guidance documents, standards, and policy frame -
works for medical device software and health information technology. At
Microsoft she is the Director of Policy and Regulations in the Health Solu -
tions Group. Dr. Tillman received her B.S.E. in engineering from Tulane
University, her Ph.D. in biomedical engineering from the Johns Hopkins
University, and her Master’s in Public Administration from the American
University.
Alastair J. J. Wood, M.D., FACP, was Professor of Medicine and Phar-
macology, Assistant Vice Chancellor, and Associate Dean at Vanderbilt
Medical School before being appointed Emeritus Professor of Medicine
and Emeritus Professor of Pharmacology in 2006. His current academic
appointments 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 National Academies’ Institute of Medicine; the American
Association of Physicians (AAP); the American Society for Clinical Inves -
tigation (ASCI), Honorary Fellow; American Gynecological and Obstetri -
cal Society (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 chapter 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. He
previously served as a member of the FDA’s Cardiovascular and Renal
Advisory Committee, and the Nonprescription Drugs Advisory Com-
mittee. His research interests have been focused on understanding the
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346 STUDIES ON MODIFIED RISK TOBACCO PRODUCTS
mechanisms for interindividual variability in drug response and toxicity.
His research has resulted in more than 300 publications.
Anna H. Wu, Ph.D., received her undergraduate degree in physiology at
the University of California, Berkeley and her doctoral degree in public
health (Epidemiology) from the University of California, Los Angeles in
1983. She became Assistant Professor at University of Southern California
in 1984, Associate Professor in 1994, and Full Professor with tenure in
2002. Early in her career, she conducted a series of lung cancer studies to
determine the role of indoor air pollution from passive smoking, cooking
and heating fuels/fumes, and other factors in explaining the high rates
of lung cancer in Chinese women when few were active smokers. She
continues to have a strong interest in lung cancer research, particularly to
better understand hormone-related effects on lung diseases. Dr. Wu’s cur-
rent research activities are focused in two main areas. One area is devoted
to studying the etiology of breast and ovarian cancers. A second area of
Dr. Wu’s current research is cancers of the gastrointestinal tract, including
adenocarcinomas of the colon, stomach, and esophagus. These studies
are aimed at identifying environmental and genetic determinants of these
cancers. Although most of these studies are aimed at understanding causes
of cancers, Dr. Wu is now expanding her work to also identify lifestyle and
genetic factors that may influence treatment response and cancer outcome.
