B
Speaker Biographies

Jacob Abarca, PharmD, MS, is an Assistant Research Scientist in the Center for Health Outcomes and PharmacoEconomic Research. Dr. Abarca completed his Doctor of Pharmacy and Master of Science degrees at the University of Arizona, College of Pharmacy, graduating summa cum laude. He completed a pharmacy practice residency at the Southern Arizona VA Health Care System. Dr. Abarca’s research interests include patient safety, pharmacy practice research, and health technology assessment. He is a member of the Pharmaceutical Outcomes Core for the Arizona Center for Education and Research on Therapeutics (Arizona CERT), which is focused on reducing adverse events caused by drug interactions. He also is a Co-Investigator in an NIH-funded research study investigating the use of telemedicine in rural health-care settings and has served as a consultant for research studies evaluating computerized physician order entry and adverse drug events.


Rachel E. Behrman, MD, MPH, is the Deputy Director, Office of Medical Policy in FDA’s Center for Drug Evaluation and Research, and Director of the Task Force on Cross Center Initiatives in the Office of the Commissioner. An internist with a subspecialty in infectious diseases who joined FDA in 1989, Dr. Behrman received her AB in mathematics from Washington University, her MD from Mt. Sinai School of Medicine, and her MPH from The Johns Hopkins School of Hygiene and Public Health.



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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary B Speaker Biographies Jacob Abarca, PharmD, MS, is an Assistant Research Scientist in the Center for Health Outcomes and PharmacoEconomic Research. Dr. Abarca completed his Doctor of Pharmacy and Master of Science degrees at the University of Arizona, College of Pharmacy, graduating summa cum laude. He completed a pharmacy practice residency at the Southern Arizona VA Health Care System. Dr. Abarca’s research interests include patient safety, pharmacy practice research, and health technology assessment. He is a member of the Pharmaceutical Outcomes Core for the Arizona Center for Education and Research on Therapeutics (Arizona CERT), which is focused on reducing adverse events caused by drug interactions. He also is a Co-Investigator in an NIH-funded research study investigating the use of telemedicine in rural health-care settings and has served as a consultant for research studies evaluating computerized physician order entry and adverse drug events. Rachel E. Behrman, MD, MPH, is the Deputy Director, Office of Medical Policy in FDA’s Center for Drug Evaluation and Research, and Director of the Task Force on Cross Center Initiatives in the Office of the Commissioner. An internist with a subspecialty in infectious diseases who joined FDA in 1989, Dr. Behrman received her AB in mathematics from Washington University, her MD from Mt. Sinai School of Medicine, and her MPH from The Johns Hopkins School of Hygiene and Public Health.

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary K. Arnold Chan, MD, ScD, is a Senior Scientist at i3 Drug Safety and an Adjunct Associate Professor at the Harvard School of Public Health. He was the Director of the Harvard Pharmacoepidemiology Program from 2002 through 2005 and was elected a Fellow of the International Society for Pharmacoepidemiology in 2003. Dr. Chan has extensive experience in safety evaluation of pharmaceutical agents and vaccines and has conducted research sponsored by the NIH, FDA, and pharmaceutical companies. Karen R. Cox, RN, PhD, is the Quality Improvement Coordinator in the Office of Clinical Effectiveness and a Senior Investigator in the Center for Health Care Quality at University of Missouri Health Care in Columbia. She is one of four Missourians who is a graduate of the Patient Safety Improvement Corp, a training partnership with the Agency for Healthcare Research and Quality and the Veteran’s Administration. Her areas of practice and research include population-based clinical outcomes improvement; health-care operations redesign; organizational culture change as it relates to patient safety; and faculty, student, and staff curriculum development and instruction in quality improvement, patient safety, and crew training. Beginning in 2000, the Office of Clinical Effectiveness oversaw the design and development of an internal, secure, web-based quality-of-care/patient safety event reporting system. The University of Missouri’s adverse event reporting system, implemented on January 1, 2002, is accessible for reporting by staff, physicians, patients, families, and visitors. Francesca Cunningham, PharmD, is the Director of the Center for Medication Safety PSCI, National Center for Patient Safety (NCPS), and Program Director of Outcomes Research at the Department of Veterans Affairs (VA) Pharmacy Benefits Management/Strategic Healthcare Group (PBM/SHG). Dr. Cunningham was the driving force behind the successful effort of PBM/SHG to establish reliable methods for merging the VA prescription database with other large VA-related databases in order to evaluate the safe and appropriate use of medications in the veteran population. Her focus has been on assessing new agents where safety data is lacking and older drugs when a newly emerging danger requires evaluation. She designed the VAMedSAFE and PBM Drug Safety Quality Improvement (QI) program. Under her direction the program has become a major tool in the evaluation of drug safety in the VA and its role in the formulary decision process. Since her time in the VA, Dr. Cunningham has focused her research efforts in the area of drug safety. Her group has worked independently and with other researchers to perform several drug safety and pharmacoepidemiologic studies. She was awarded a

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary grant to establish the VA Center for Medication Safety Patient Safety Center of Inquiry by the NCPS. Jeffrey M. Drazen, MD, is the Editor-in-Chief of the New England Journal of Medicine, a post he has held since 2000. During his tenure, the Journal has published major papers advancing the science of medicine, including the first descriptions of Severe Acute Resiratory Syndrome (SARS) and papers modifying the treatment of cancer, heart disease, and lung disease. The Journal, which has over a million readers every week, has the highest impact factor of any journal publishing original research. He attended Tufts University, with a major in physics, and Harvard Medical School and served his medical internship at Peter Bent Brigham Hospital in Boston. Thereafter, he joined the Pulmonary Divisions of the Harvard hospitals. He served as Chief of Pulmonary Medicine at the Beth Israel Hospital, as Chief of the combined Pulmonary Divisions of the Beth Israel and Brigham and Women’s Hospitals, and finally as Chief of Pulmonary Medicine at Brigham and Women’s Hospital. Through his research, he defined the role of novel endogenous chemical agents in asthma. This led to four new licensed pharmaceuticals for asthma with over 5 million people on treatment worldwide. A. Leander Fontaine, MD, is President of Pharmiceutics LLC, a Pennsylvania-based company that offers labeling and regulatory consulting, expert services, and training. Before founding Pharmiceutics in March 2005, he was Vice President and Head of Global Labeling Division and Vice President, International Labeling Liaison, Wyeth, USA. He started his career in global labeling in 1991 and has served as head of global labeling functions for Hoechst Marion Roussel (USA) and Hoechst (Germany). He has also held positions in clinical development with Behringwerke (Germany). Before joining the pharmaceutical industry, he worked in internal medicine (German Army Hospital Ulm, Germany) as well as in anesthesiology, intensive care, and emergency medicine (University Hospital Ulm, Germany). David Hunt, MD, FACS, works in the Quality Improvement Group, a division of the Office of Clinical Standards and Quality (OCSQ) in the Centers for Medicare and Medicaid Services (CMS). At CMS he leverages his clinical expertise in surgery and over 30 years’ experience in information systems. He is currently the Government Task Leader for the Medicare Patient Safety Monitoring System (MPSMS) as well as the Surgical Care Improvement Partnership (SCIP), two national projects aimed at advancing the CMS quality improvement and patient safety

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary agendas. Dr. Hunt, who is licensed to practice medicine in the District of Columbia, is certified by the American Board of Surgery and has been a Fellow of the American College of Surgeons since 1993. Practicing surgery in both private and academic settings, Dr. Hunt served as a Clinical Assistant Professor of Surgery at Howard University, as well as Chair of surgical peer review at various hospitals in the Washington metropolitan area. Saira A. Jan, PharmD, MS , is the Director of Clinical Programs, Pharmacy Management, at Horizon Blue Cross Blue Shield of New Jersey (BCBSNJ), where she is involved with pharmacy utilization management, formulary management, patient safety initiatives drug information, utilization analysis, research and clinical outcome studies, and disease state management. She is also the Director of the residency program for postgraduate Pharmacy at Horizon BCBSNJ. She is actively involved with research and is the Director of research for Horizon BCBSNJ. Dr. Jan received her Master of Science in Pharmacology from St. John’s University in New York and her PharmD from Rutgers, The State University of New Jersey. Hershel Jick, MD, has since 1966 been Director of the Boston Collaborative Drug Surveillance Program (BCDSP) of Boston University Medical Center, Lexington, Massachusetts and Associate Professor of Medicine, Boston University School of Medicine. He is a graduate of Harvard Medical School. After completing his residency training in internal medicine, he completed a fellowship program in clinical pharmacology and was a Burroughs Wellcome Scholar in Clinical Pharmacology. The BCDSP has pioneered the use of automated databases in drug safety studies. Dr. Jick has together with his colleagues at the BCDSP published more than 300 studies over a 35-year period. In addition, he has organized several international workshops on postmarketing drug studies, the 21st of which was held in France in June 2005, bringing together experts in the field to share information on recent developments in pharmacoepidemiology. Sidney Kahn, MD, PhD, has been a major contributor to U.S. and international developments in pharmacovigilance, risk assessment, and risk management for many years. After 17 years in academic laboratory medicine in the United Kingdom and United States as a laboratory director and basic researcher, he spent the next 13 years at Bristol-Myers Squibb and Johnson & Johnson working on safety assessment of medicinal products throughout their life cycle. He established Pharmacovigilance & Risk Management, Inc., in July 2002. During his industry tenure, Dr. Kahn participated actively in several U.S. and international pharmacovigilance

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary working groups. He represented PhRMA in ICH MedDRA Expert Working Goups, including M1 and Points to Consider; he was a member of the CIOMS-VI Working Group, and is currently active in several DIA SIACs including Clinical Safety and Pharmacovigilance, Terminology Management, and Labeling. He is also a participant in the HL7 SPL Implementation Workgroup. Dr. Kahn is a frequent invited presenter at conferences and workshops in the USA and Europe on all aspects of pharmacovigilance and risk management. Michael Katz, MBA, is a 15-year myeloma survivor. He is Vice President of the International Myeloma Foundation and a member of the Foundation’s Executive Board. He is a past Chair of the National Cancer Institute’s Director’s Consumer Liaison Group and past Chair of the Association of Online Cancer Resources (ACOR). He is Co-Chair of the Eastern Cooperative Oncology Patient Representatives Committee and a member of the Patient Advisory Board of the Coalition of National Cancer Cooperative Groups. Mr. Katz also serves as a patient consultant to the FDA and leads in-person and online multiple myeloma support groups. He has been an active advocate of clinical trials, participating in the design of myeloma trials and working on programs to improve the quality and efficiency of cancer clinical trials at the national level. He is involved in ongoing efforts to improve communications about clinical trials to the advocacy community and to the consumer. Mr. Katz has also been involved in researching post-approval drug safety issues. Peter Kilbridge, MD, worked at Boston Children’s and Massachusetts General Hospital as a pediatrician trained in medical informatics. He then worked as a Practice Director with First Consulting Group, where he founded the company’s patient safety practice. Dr. Kilbridge’s group worked with The Leapfrog Group to develop a method for testing hospitals’ computerized physician order entry systems’ ability to prevent medication errors. He has also published studies on safety in medication management, adverse drug event surveillance, the roles and responsibilities of physicians for patient safety, and the cost to hospitals of computerizing physician order entry. At Duke University, Dr. Kilbridge is working with clinicians to track and measure improvements in patient safety and quality. Current projects include the development of an automated system for detection and tracking of adverse drug events across the Duke University Health System; creation of a computerized safety incident reporting system; and measurement and tracking of safety, quality, and operational benefits resulting from the use of computer systems to aid in patient care.

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary Ronald Krall, MD, is Senior Vice President, Worldwide Development, for GlaxoSmithKline (GSK). His responsibilities include clinical development and regulatory affairs for all GSK compounds in development and products throughout the world. He joined GSK in 2003. Before that, he held positions at AstraZeneca Pharmaceuticals, Abbott Laboratories, and Lorex Pharmaceuticals. He earned a Bachelor’s degree in Mathematics from Swarthmore College and his MD from the University of Pittsburgh, trained as a Staff Associate at the National Institutes of Health Epilepsy Branch, and completed his training in neurology and clinical pharmacology at the University of Rochester. He is board certified in neurology and is Immediate Past President of the National Sleep Foundation, a member of the Board of Directors of the Delaware Valley Science Fairs, and a past Trustee of the American Academy of Pharmaceutical Physicians. Stuart Levine, PharmD, is the Informatics Specialist at the Institute for Safe Medication Practices (ISMP). His primary role is promoting medication safety through the safe use of technology. He also serves as an in-house resource for medication safety for pediatric and neonatal patients based on his 25 years’ experience as the Director of Pharmacy Services at the Alfred I. duPont Hospital for Children in Wilmington, Delaware. He is a member of the consulting team at ISMP and assists in reviewing the medication use process in hospitals around the country. He has served as both member and officer of local pharmacy organizations as well as a member and president of the Delaware State Board of Pharmacy. Nationally Dr. Levine is a member of the board of the Pediatric Pharmacy Advocacy Group (PPAG) and is currently PPAG’s chief operating officer. He received his Bachelor of Pharmacy degree from Temple University and his Doctor of Pharmacy degree from the University of Kentucky. Marvin M. Lipman, MD, FACP, has been Consumers Union’s Chief Medical Adviser since 1967, has been Medical Editor of Consumer Reports, and has been Medical Editor of Consumer Reports on Health since its inception in 1989. He has represented Consumers Union on advisory panels of the Food and Drug Administration and the United States Pharmacopeia (USP). He was a member of the 2000–2005 board of trustees of the USP and represented the public. A graduate of Columbia University’s College of Physicians and Surgeons, Dr. Lipman is a practicing physician, board certified in internal medicine and endocrinology. He is a Fellow of the American College of Physicians and the American College of Endocrinology and is Clinical Professor of Medicine (emeritus) at New York Medical College in Valhalla.

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary Richard Platt, MD, MS (Epidemiology), is Professor and Chair of the Department of Ambulatory Care and Prevention at Harvard Medical School and Harvard Pilgrim Health Care, a New England HMO that supports research and teaching. He is also Professor of Medicine at Harvard Medical School and the Brigham and Women’s Hospital, where he is Hospital Epidemiologist. He is a member of the Food and Drug Administration Drug Safety and Risk Management advisory committee, the American Association of Medical Colleges’ Advisory Panel on Research, and the national steering committee for Agency for Healthcare Research and Quality Centers for Education and Research in Therapeutics (CERTs). He is the former Chair of the National Institutes of Health study section Epidemiology and Disease Control 2, former Chair of the Centers for Disease Control and Prevention Office of Health Care Partnerships’ steering committee, former Co-Chair of the Board of Scientific Counselors of the CDC’s Center for Infectious Diseases, and former chair of the executive committee of the HMO Research Network. His research focuses on improving population health through health plans’ providers and data and through health plans’ ability to communicate with their members. Examples include the use of automated record linkage systems to improve the safety and assess the effectiveness of prescription drugs and to detect and control both hospital- and community-acquired infections. Robert Powell, PharmD, is Director, Pharmacometrics, Office of Clinical Pharmacology & Biopharmaceutics, Food and Drug Administration. Previously, he was the Senior Vice President, Drug Development Consulting Services, Pharsight Corp., where he worked with internal consultants and industry partners to increase drug development productivity through modeling and simulation of clinical trials and application of software products. Dr. Powell’s previous positions include Vice President, Pharmacokinetics, Dynamics and Metabolism, at Parke Davis (1996–2001) and Pfizer and Director of Clinical Pharmacology at GlaxoSmithKline (1987–1996). These departments have excelled in the application of pharmacokinetic/dynamic principles from discovery through regulatory approval in better defining dose-response and contributing to development decisions. Dr. Powell has led various committees on drug development project governance and drug development efficiency. He received his pharmacy training at West Virginia University and his clinical pharmacy training at Philadelphia College of Pharmacy and Science, and did a National Institutes of Health postdoctoral fellowship in pharmacokinetics at the University of California at San Franciso. He spent 10 years in academics (Arizona, North Carolina) in clinical pharmacokinetics and clinical pharmacology. He has published over 100 peer-reviewed articles and book chapters.

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary Alison Rein, MS, is the Assistant Director of Food & Health Policy at the National Consumers League (NCL). Founded in 1899 to bring consumer power to bear on marketplace and workplace issues, NCL is the nation’s oldest consumer organization. Ms. Rein designs and coordinates campaigns and other activities around NCL’s priority issues, including food safety and nutrition, medication safety, and health care quality. In the last year, she has expanded NCL’s involvement as a consumer stakeholder in the national discussion about emerging health technologies. Prior to joining NCL, Ms. Rein served as a health care consultant to a number of private and non-profit organizations, for which she conducted strategic evaluations, market studies, and research efforts aimed at evaluating the cost-effectiveness of numerous drug, biologic, and device interventions. She holds a Master’s degree in public policy analysis from the University of Rochester and has coauthored several articles published in peer-reviewed medical journals. Nancy C. Santanello, MD, MS, is a physician-epidemiologist trained in Emergency Medicine and Preventive Medicine with a Master of Science degree in Epidemiology. She is board certified by the American College of Preventive Medicine in Preventive Medicine and Epidemiology. Dr. Santanello received her undergraduate degree in 1971 from Marymount College of Fordham University and her medical degree in 1982 from Howard University School of Medicine. She was a Medical Officer with the National Heart, Lung, and Blood Institute (NHLBI) Prevention and Demonstration Research Branch of the Division of Epidemiology and Clinical Applications (1987–1991). From 1991 to present, she has been in the Department of Epidemiology at Merck Research Laboratories; in 2003 she was appointed to the Head of that department. Her areas of research interest include the development and validation of outcome measures for use in clinical trials; study design; adherence to therapy; satisfaction with and preference for therapy; effectiveness studies; pharmacoepidemiology; and interventions related to chronic diseases, particularly respiratory, migraine, and cardiovascular diseases. Dr. Santanello has published over 45 peer-reviewed manuscripts. She has been invited to speak on outcome measurement issues at several national and international meetings. In 1998 she received the Merck Directors Award, the Company’s highest honor, from the Board of Directors for her work in support of outcomes research measures for asthma. Cary Sennett, MD, PhD, is Senior Vice President for Research and Development at the American Board of Internal Medicine. Prior to that, he led research and development at Ingenix, a UnitedHealth Group company that provides health intelligence to firms in all sectors of health care. Before

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary joining Ingenix, Dr. Sennett was Vice President for Science and Quality Improvement at the American College of Cardiology (ACC), Executive Vice President for Health Information Services at BenefitNation, a provider of Internet applications in the health-care industry, and Executive Vice President at the National Committee for Quality Assurance (NCQA). He also spent five years as a quality leader at Aetna, at US Healthcare, and at Group Health Cooperative of Puget Sound. Dr. Sennett received his MD from Yale University and did his residency training at Harvard’s Brigham and Women’s Hospital. After his clinical training, he completed a Kaiser Foundation Fellowship in Health Policy and Management at the Massachusetts Institute of Technology, from which he received his PhD. Dr. Sennett is a frequent speaker and author on issues of quality improvement in health care. He has been a member of the editorial boards of the Joint Commission Journal on Quality Improvement, Quality Management in Health Care, and the American Journal of Managed Care and served as founding Editor-in-Chief of Preventive Medicine in Managed Care. He was Co-Chair of the Steering Committee on Hospital Measurement for the National Quality Forum (NQF) and currently serves as the Chair of NQF’s Technical Advisory Panel on Cardiovascular Ambulatory Care measures. Ed Staffa, RPh, is the Vice President of Pharmacy Practice and Communications with the National Association of Chain Drug Stores (NACDS). An eight-year veteran of NACDS, Dr. Staffa is involved with the writing and editing of a variety of publications with NACDS, including a weekly communication to CEOs and executive-level chain pharmacy operators and a monthly newsletter for practicing pharmacists. His responsibilities extend to all issues affecting the practice of pharmacy, such as those relating to patient safety, billing for non-dispensing pharmacy services, and medication therapy management services. He is also involved with the chain drug store industry’s efforts to educate the general public about the role of the community pharmacist in health care and improve medication use among patients. Dr. Staffa is a 1981 graduate of the University of Rhode Island School of Pharmacy. Prior to coming to NACDS in 1997, Dr. Staffa served as a practicing pharmacist in a variety of community settings in the Washington, DC, area for 16 years. J. Russell Teagarden, RPh, MA, currently serves as Vice President of Clinical Practices & Therapeutics at Medco Health Solutions, Inc. He joined Medco in July 1993 as Director of Clinical Programs. Prior to joining Medco, he served for 12 years as a Drug Information Specialist and as a clinical pharmacist specializing in critical care in the Chicago teaching hospital community. During this time, Mr. Teagarden held an academic

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary appointment at the University of Illinois College of Pharmacy as Assistant Professor of Clinical Pharmacy. He serves as a member of the Board of Trustees of the Institute for Safe Medication Practices and as a member of the Board of Trustees of the Pharmacy & Therapeutics Society. He also serves on the Oversight Body of the American Medical Association Ethical Force Program. Mr. Teagarden received a Bachelor of Science degree in Pharmacy from the University of Illinois College of Pharmacy, and he completed a residency in hospital pharmacy at Northwestern University Medical Center in Chicago. He also holds a Master of Arts degree in Research Methodology from Loyola University of Chicago and is currently a candidate for a Doctorate in Medical Humanities at the Caspersen School of Graduate Studies of Drew University. He has published several papers on significant medical, pharmacy, and ethics issues. Micky Tripathi, PhD, MPP, is the President and Chief Executive Officer of the Massachusetts eHealth Collaborative (MAeHC), a non-profit collaboration of 34 leading Massachusetts organizations. He is also a member of the Board of Directors of MA-SHARE, a community utility service for statewide clinical data exchange in Massachusetts. Prior to joining MAeHC, Dr. Tripathi was a manager in the Boston office of the Boston Consulting Group (BCG), a leading strategy and management consulting firm. While at BCG, he served as the founding President and CEO of the Indiana Health Information Exchange, an Indianapolis-based non-profit company partnered with the Regenstrief Institute to create a statewide health information infrastructure in the state of Indiana. As a manager in BCG’s health care practice, Dr. Tripathi also served a variety of U.S. and international clients in the non-profit sector as well as in the bioinformatics, biotechnology, and pharmaceutical industries. He holds a PhD in political science from the Massachusetts Institute of Technology, a Master of Public Policy from Harvard University, and an AB in political science from Vassar College. Prior to receiving his PhD, he was a Senior Operations Research Analyst in the Office of the Secretary of Defense in Washington, DC, for which he received the Secretary of Defense Distinguished Civilian Service Award. Anne E. Trontell, MD, MPH, is the Deputy Director of the Office of Drug Safety (ODS) in the FDA Center for Drug Evaluation and Research. Since coming to FDA in 1996, she has served as the Director of the Division of Surveillance, Research, and Communication Support in ODS, the Deputy Director and Acting Deputy Director of the Divisions of Drug Risk Evaluation I and II, and a medical reviewer in the Division of Pulmonary and Allergy Drug Products. Prior to 1996, Dr. Trontell was Chief Scientist in the Office of Research and Demonstrations at the Health Care Financing

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary Administration (HCFA), where she conducted and supervised outcomes research on preventive services use by Medicare beneficiaries. While at HCFA, she managed a national public health outreach campaign to promote use of the Medicare mammography benefit. Her experience in epidemiology includes work with the Centers for Disease Control and Prevention, where she served as an Epidemic Intelligence Service Officer at the National Center for Health Statistics and the Office on Smoking and Health. Prior to obtaining her advanced degrees, she did contract research in environmental health and toxicology for the Environmental Protection Agency and other federal agencies. Dr. Trontell trained in pediatrics at The Children’s Hospital in Boston, in medicine at the University of Pennsylvania, and in public health at the Harvard School of Public Health. Daniel E. Troy, JD, a partner in Sidley Austin Brown & Wood LLP’s Life Sciences Practice as well its Appellate Litigation group, is the former chief counsel of the Food and Drug Administration (FDA). In addition to providing strategic counseling on FDA-related matters, Mr. Troy practices administrative and constitutional law and litigation, with particular focus on the pharmaceutical, biotechnology, food, medical device, cosmetic, and media industries. Mr. Troy, who will head the ABA’s Section of Administrative Law and Regulatory Practice beginning in September 2006, was the first appointee to the FDA made by President George W. Bush. In that capacity, he reviewed and approved major regulations and important guidances issued during that time. He played a key role in the drafting of the rule modifying the process by which generic drugs come to market and successfully argued two Hatch-Waxman cases for the FDA. Mr. Troy has testified before the Senate and House Judiciary Committees and the House Committee on Science, as well as before many state and local bodies. He has given more than 140 speeches on topics that include Hatch-Waxman reform, preemption, a variety of First Amendment and other constitutional issues, telecommunications, the role of the courts, and administrative law. Scott Weingarten, MD, MPH, is the President, Chief Executive Officer, and Co-Founder of Zynx Health. Additionally, he is a Clinical Professor of Medicine (Step II) at the UCLA School of Medicine and the Director of Health Services Research at Cedars-Sinai Health System. Dr. Weingarten was also a tenured Professor of Medicine (in residence) at the UCLA School of Medicine. After graduating from the UCLA School of Medicine, he completed his internship, residency, and fellowship in internal medicine at Cedars-Sinai Medical Center. He later participated in a National Center for Health Services Research Fellowship at the RAND/UCLA Center for

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary Health Policy Study. During the fellowship, he earned a Master of Public Health degree at the UCLA School of Public Health. Dr. Weingarten has also worked as a primary care physician at Kaiser Permanente. He is a Fellow of the American College of Physicians. He has published more than 100 articles, editorials, and book chapters on quality improvement and related topics and serves on the editorial boards of five publications. He was a member of the Disease Management Advisory Committee of NCQA and has represented the American College of Physicians on health care issues in Washington, DC, and Sacramento. Dr. Weingarten won the President’s Award and the Golden Apple Teaching Award at Cedars-Sinai Medical Center, as well as the Society of General Internal Medicine Award for Outstanding Educational Workshop. He has given more than 250 presentations on evidence-based medicine, computerized physician order entry, quality improvement, disease management, outcomes measurement, and related subjects throughout the United States and internationally. Dr. Weingarten was a Quality Leader for the American College of Physician Executives and was on the Executive Committee of the Board of Directors of the Institute for Medical Quality. He currently serves on the Steering Committee for the American Heart Association “Get With The Guidelines,” the Healthcare Information and Management Systems Society Patient Safety and Quality of Care Committee, and the Quality Improvement Committee of the Board of Directors of St. Joseph’s Health System (14 acute care hospitals). Alastair J. J. Wood, MD, is a tenured Professor of both Medicine and Pharmacology and an attending physician at Vanderbilt Medical School, where he is also Associate Dean. Dr. Wood is a member of many societies and has received numerous honors, including election to membership of the American Association of Physicians (AAP) and the American Society for Clinical Investigation (ASCI); Honorary Fellow, American Gynecological and Obstetrical Society (AGOS); Fellowship of the American College of Physicians; Fellowship of the Royal College of Physicians of London; and Fellowship of the Royal College of Physicians of Edinburgh. He was the 2005 recipient of the Rawls-Palmer Award in recognition of “drug investigation that brings the effects of modern drug research to the care of patients” from the American Society for Pharmacology and Therapeutics. Dr. Wood serves on a number of editorial boards, most notably that of the New England Journal of Medicine; he was the Drug Therapy Editor of the New England Journal of Medicine from 1985 to 2004. He is also on the editorial board of Clinical Pharmacology and Therapeutics. He has previously served on the editorial board of the British Journal of Clinical Pharmacology. Dr. Wood is currently the Chairman of the FDA’s Nonprescription Drugs Advisory Committee and recently chaired the

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Adverse Drug Event Reporting: The Roles of Consumers and Health-Care Professionals - Workshop Summary FDA Advisory Committee on COX-2 drugs. His research interests have been focused on understanding the mechanisms for inter-individual variability in drug response, with a particular focus on the molecular genetics of adrenergic receptors, ethnic differences in drug response, vascular response, and the genetics of drug metabolism. His research has been continuously funded by NIH and has resulted in over 250 articles, reviews, and editorials. Raymond L. Woosley, MD, PhD, earned a PhD in Pharmacology from the University of Louisville and an MD from the University of Miami. Dr. Woosley specialized in Internal Medicine and Clinical Pharmacology at Vanderbilt University, where he rose to the rank of Professor of Medicine. At Georgetown University he served as Chairman of the Department of Pharmacology and in 2000 was appointed Associate Dean for Clinical Research. In 2001 he became Vice President for Health Sciences at the University of Arizona and Dean of the College of Medicine. In January 2005 he assumed the position of President of The Critical Path Institute (C-Path), a non-profit corporation formed by the Food and Drug Administration, SRI International, and the University of Arizona to accelerate the development of safe innovative medicines. Since 1999, he has directed one of seven federally funded Centers for Education and Research on Therapeutics (CERT). Dr. Woosley’s research has been published in over 260 publications and has investigated the basic and clinical pharmacology of drugs for the drug treatment of arrhythmias and the cardiac toxicity of drugs. His research discovered the mechanism of the toxicity of the antihistamine Seldane, which contributed to its subsequent removal from the market. For his contributions to medicine, he received the Rawls-Palmer Award from the American Society of Clinical Pharmacology and Therapeutics and the FDA Commissioner’s Special Citation for his work to advise the agency on the toxicity of dietary supplements containing ephedra. In addition, Dr. Woosley is a Past President of the Association for Medical School Pharmacology and the American Society for Clinical Pharmacology and Therapeutics. His current research is on the prevention of adverse drug interactions.