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 University 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 conduct 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. Henney 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 Strategies 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 oncology



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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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341 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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343 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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345 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.