Appendix C

Participant Biographies

Rafat Abonour, M.D., is a Professor of Medicine, Professor of Pathology and Laboratory Medicine at Indiana University (IU). Dr. Abonour has been active in clinical research for the past 15 years at Indiana University and his work has been published in Nature Medicine and the New England Journal of Medicine, among others. His role as a leader of the Multiple Myeloma program has allowed him to participate in practice-changing research using IMiDs and proteasome inhibitors. He has been facilitating clinical research at IU Simon Cancer Center and IU School of Medicine for the past 4 years.

Deborah D. Ascheim, M.D., is an Associate Professor in the Departments of Health Evidence and Policy and Medicine/Cardiovascular Institute at the Mount Sinai School of Medicine in New York. She is the Clinical Director of Research and Director of the Clinical Research Unit at the International Center for Health Outcomes and Innovation Research (InCHOIR) at Mount Sinai. She was previously an Assistant Professor of Medicine (Cardiology) and Health Policy at Columbia University Medical Center and the Mailman School of Public Health. Dr. Ascheim is a cardiologist with expertise in heart failure and extensive experience in clinical investigation. Her research focuses on the measurement of clinical outcomes and on complex trials evaluating novel device or surgical interventions. She has particular expertise in the design, coordination, and analysis of such multicenter clinical trials. She is the principal investigator of the data coordinating center of a planning grant funded by NHLBI to develop a



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Appendix C Participant Biographies Rafat Abonour, M.D., is a Professor of Medicine, Professor of Pathology and Laboratory Medicine at Indiana University (IU). Dr. Abonour has been active in clinical research for the past 15 years at Indiana University and his work has been published in Nature Medicine and the New England Journal of Medicine, among others. His role as a leader of the Multiple Myeloma program has allowed him to participate in practice-changing research using IMiDs and proteasome inhibitors. He has been facilitating clinical research at IU Simon Cancer Center and IU School of Medicine for the past 4 years. Deborah D. Ascheim, M.D., is an Associate Professor in the Departments of Health Evidence and Policy and Medicine/Cardiovascular Institute at the Mount Sinai School of Medicine in New York. She is the Clinical Direc- tor of Research and Director of the Clinical Research Unit at the Interna - tional Center for Health Outcomes and Innovation Research (InCHOIR) at Mount Sinai. She was previously an Assistant Professor of Medicine (Cardiology) and Health Policy at Columbia University Medical Center and the Mailman School of Public Health. Dr. Ascheim is a cardiologist with expertise in heart failure and extensive experience in clinical inves - tigation. Her research focuses on the measurement of clinical outcomes and on complex trials evaluating novel device or surgical interventions. She has particular expertise in the design, coordination, and analysis of such multicenter clinical trials. She is the principal investigator of the data coordinating center of a planning grant funded by NHLBI to develop a 101

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102 PUBLIC ENGAGEMENT AND CLINICAL TRIALS confirmatory comparative effectiveness trial of hybrid coronary revascu - larization and the co-principal investigator of the coordinating center for the NHLBI Cardiothoracic Surgery Network. Her work has been pub- lished in such journals as the New England Journal of Medicine, the Journal of Cardiac Failure, the Journal of Thoracic and Cardiovascular Surgery, the Annals of Thoracic Surgery, and Thyroid. Dr. Ascheim has served on numer- ous clinical trial oversight and advisory committees for federally- and industry-funded trials. She presently serves as the Vice Chair of the Board of Directors of Physicians for Human Rights, and as a Trustee for the Brearley School in New York. Dr. Ascheim graduated from New York Uni- versity School of Medicine and completed her internship and residency in internal medicine, as well as her fellowship in cardiovascular diseases, at the New York-Presbyterian Hospital/Weill Cornell Medical Center. She completed a postgraduate fellowship at Columbia University College of Physicians & Surgeons (Columbia P&S) and remained on faculty as an attending cardiologist in the Heart Failure Center at Columbia P&S and the Mailman School of Public Health from 1995 to 2008. Leslie K. Ball, M.D., FAAP, is the Acting Director of the Office of Scientific Investigations (formerly known as the Division of Scientific Investiga- tions [DSI]), Office of Compliance, CDER, FDA, where she has served in this role since 2008. While in DSI she has been active in developing a risk model for selecting clinical trial sites for inspection, collaborating with the European Medicines Agency and other international regula- tory authorities, developing approaches to inspecting electronic data, and instituting process improvements for enforcement actions. Beginning in 2003 she served as branch chief of DSI’s Good Clinical Practice Branch II. Dr. Ball joined FDA in 1996 as a medical officer in the Center for Biologics Evaluation and Research, Office of Vaccines Research and Review. From 2001 to 2003 she worked at the Office for Human Research Protections, Department of Health and Human Services (HHS), where she coordinated compliance investigations, participated in inspections of institutions and IRBs, and worked on children’s research issues. Dr. Ball graduated with a B.S. in biology from Georgetown University. She received her M.D. from Georgetown University School of Medicine, where she also completed a residency in pediatrics. She completed a fellowship in pediatric infectious diseases at the Walter Reed Army Medical Center. She served as a pedia- trician at the U.S. Naval Hospital, Subic Bay, Republic of the Philippines, in private practice in Maryland, and in the Department of Pediatrics at the National Naval Medical Center, Bethesda.

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103 APPENDIX C Nina A. Bickell, M.D., M.P.H., is Director of the Mount Sinai School of Medicine’s NIMHD-funded Center to Achieve and Sustain Health in Harlem designed to improve care in minority communities. She is prin- cipal investigator (PI) of randomized trials to reduce disparities in breast cancer treatment using community-based patient assistance programs and a physician-centered tracking and feedback intervention. A practicing primary care general internist in the Mount Sinai Diagnostic and Treat - ment Center, she completed a primary care internal medicine residency at Montefiore Hospital and Medical Center in the Bronx, New York, a pre - ventive medicine residency at the University of North Carolina at Chapel Hill where she received her M.P.H. in epidemiology, and a Robert Wood Johnson Clinical Scholars fellowship at University of North Carolina at Chapel Hill. In addition to academic appointments, Dr. Bickell served as a senior clinical research scientist at the NYS Department of Health in the Office of Quality Improvement. Dr. Bickell’s research includes assessing underlying causes of racial and ethnic disparities in care and improving the quality of care; evaluating approaches to implement sustainable inter- ventions in various clinical settings; access to care for vulnerable popula - tions; determinants and effects of continuity and coordination of care; the relationship of physician beliefs, attitudes and practice; and patient and systems-level barriers to care. Bernadette Boden-Albala, M.P.H., Dr.P.H., is an Assistant Professor of Sociomedical Sciences in Neurology and the Co-Director of the Irving Center for Clinical and Translational Research Community Engagement Core Resource at Columbia University. As a social epidemiologist her work has focused on disparities in risk factors for cardiovascular dis - ease, obesity, and stroke in urban communities with an emphasis on social support and social networks. She has recently focused much of her efforts into understanding and testing the relationship between social networks and vascular disease by conducting an exhaustive investigation of social networks in the Northern Manhattan Study. Indeed this forma - tive research is focused on using social networks to promote effective and sustainable strategies toward vascular wellness. Currently she serves as Director of the 12,000-community-based WICER survey, and PI on the FURRThER study, a complex family network intervention. Other work includes vascular epidemiology and intervention research among blacks in Washington, DC (ASPIRE), as well as among the Alaskan Yupik Native population in rural Alaska. She recently completed the SWIFT interven - tion study focused on acute stroke preparedness behaviors. She was the first recipient of the AHA Heritage Affiliate Women with Heart Grant and also received the Jack Elinson Sociomedical Sciences Award. Research

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104 PUBLIC ENGAGEMENT AND CLINICAL TRIALS publications include topics such as metabolic syndrome and stroke risk among women and minorities, sleep and vascular risk, risk perception and health behaviors, social isolation, and outcomes poststroke. She is a board member of the AHA National Stroke Council, member of the National AHA behavioral working group, Chairperson of the Community Education Workgroup of the Northeast Cerebrovascular Consortium, and a longtime speaker for the AHA and National Stroke Association. Joan Finnegan Brooks, President, Patient-Focused Market Research, has worked with organizations involved in CF care and research for over 25 years. She helps organizations develop improved strategies for the CF market environment by providing the voices of the patient, caregiver, and clinician communities in the process. Brooks has consulted for biotech- nology and pharmaceutical companies, research institutions, and patient advocacy groups. Brooks has in-depth knowledge of CF and current sci - entific research, and specialized CF care center and clinical trial networks. Her market research background and contacts among patients, families, clinicians, and researchers in the CF community complements and lever- ages her clients’ resources. She has created data-gathering instruments, designed surveys, and conducted interviews in the CF community. She provides key insights into drug development and marketing programs, and has developed “voice of the customer” outreach strategies. Brooks has worked with clients to maximize patient participation in clinical tri - als and made recommendations to ensure acceptability of new therapies. Brooks has volunteered for the Massachusetts/Rhode Island Chapter of the Cystic Fibrosis Foundation for 26 years and has been involved with the CF community all her life. She is a leader in many CF Foundation initiatives focused on clinical practice guidelines for patient care, CF adult issues, quality improvement efforts in CF care centers, and clinical trial participation. She was appointed co-chair of a task force focused on patient and family participation to improve patient outcomes at CF care centers. Brooks testified before Congress to appeal for increased support for CF research from NIH. She is past President of the Chapter Board of Directors and was a Chapter Trustee on the CF Foundation Board of Trustees. Brooks has been honored and recognized by the national CF Foundation and their chapter offices for exceptional volunteer efforts and achievements throughout the years. Brooks’ story has been featured in many publications and websites. Always an advocate for people with CF and their families, Brooks is a patient representative on the Protocol Review Committee for the clinical trials network sponsored by the CF Foundation. She writes a column addressing the adult perspective for Homeline, a Cystic Fibrosis Services Pharmacy publication, and was a Director for the United States Adult Cystic Fibrosis Association. Brooks

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105 APPENDIX C has been a speaker at annual North American Cystic Fibrosis Conferences and the Biotechnology Industry Organization Convention, and served as a faculty member for an intensive training seminar hosted by the Institute for Patient- and Family-Centered Care. She regularly speaks at a Harvard University course focused on disease pathobiology and treatment. She is a sought-after and inspirational speaker at CF care centers across the country. Brooks graduated from Brown University with a B.A. degree in economics. Prior to establishing her consulting practice, Patient-Focused Market Research, in 2002, she had a 17-year career with a global financial services company. She was a securities trader and investment manager in Treasury, and a product manager in Marketing. BankBoston, now part of Bank of America, recognized Brooks in national press releases and publi- cations as its 1998 Volunteer of the Year. Lawrence D. Brown, Ph.D., is Professor of Health Policy and Manage- ment in the Mailman School of Public Health at Columbia University. A political scientist, he got a Ph.D. in government at Harvard University in 1973. After positions at Harvard, the Brookings Institution, and the Uni- versity of Michigan, in 1988 he came to Columbia, where he chaired the Department of Health Policy and Management for 10 years and the uni- versity’s Public Policy Consortium for 3 years. He is the author of Politics and Health Care Organizations: HMOs as Federal Policy (Brookings Institu- tion, 1983) and of articles on the political dimensions of community cost containment, expansion of coverage for the uninsured, national health reform, the role of analysis in the formation of health policy, and cross- national health policy. Dr. Brown edited the Journal of Health Politics, Policy and Law for 5 years, has served on several national advisory committees for the Robert Wood Johnson Foundation, has an RWJ Investigators in Health Policy award, and is a member of the IOM. Dennis S. Charney, M.D., is the Anne and Joel Ehrenkranz Dean of Mount Sinai School of Medicine and Executive Vice President for Academic Affairs of the Mount Sinai Medical Center. Dr. Charney’s arrival at Mount Sinai in 2004 signaled a new era of innovation in research, education, and clinical care. Since joining the faculty, he has established a culture of excel- lence that has elevated Mount Sinai School of Medicine—an institution founded in 1968—to among the top medical schools in the nation. With an emphasis on translational research, Dr. Charney has accelerated the pace of change at Mount Sinai, streamlined collaboration across disciplines, and facilitated the integration of research, clinical care, and educational innovation. These efforts have produced remarkable results. The Mount Sinai School of Medicine now ranks 18th in NIH funding—an increase from 25th in 2004—and in the past 4 years, its position in U.S. News &

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106 PUBLIC ENGAGEMENT AND CLINICAL TRIALS World Report has risen from 32 to 18. No other medical school in America has achieved this degree of improvement in such a brief period. Early in his tenure at Mount Sinai, Dr. Charney led the creation of the School of Medicine’s Strategic Plan, an organizational restructuring that included the creation of 15 interdisciplinary research institutes. As a medical school embedded in a hospital, Mount Sinai has always integrated research and clinical medicine. These institutes—chosen in the areas where Mount Sinai can truly excel—embody the institution’s mission as a leader in basic and clinical research. A leading investigator on neurobiology and the treatment of mood and anxiety disorders, Dr. Charney has made fun- damental contributions to the understanding of neural circuits and neu - rochemistry related to human anxiety, fear, and mood. He has pioneered research related to the psychobiological mechanisms of human resilience to stress. In addition, his research team has made major contributions to the discovery of novel and more effective treatments for mood and anxiety disorders. Dr. Charney’s distinguished career as a researcher and educator began in 1981 at Yale University School of Medicine, where, within 9 years, he rose from Assistant Professor to Professor of Psychiatry, a position he held from 1990 to 2000. While at Yale, Dr. Charney chaired the National Institute of Mental Health (NIMH) Board of Scientific Coun - selors, which advises the institute’s director on intramural research pro - grams. After nearly two decades at Yale, NIMH recruited Dr. Charney to lead the Mood and Anxiety Disorder Research Program—one of the largest programs of its kind in the world—and the Experimental Thera- peutics and Pathophysiology Branch. That year he was also elected to the IOM of the National Academy of Sciences. His scientific research has been honored by every major award in his field. Dr. Charney remained at NIMH until he was recruited to Mount Sinai in 2004 as Dean of Research. Two years later, he was appointed Dean for Academic and Scientific Affairs for Mount Sinai School of Medicine and Senior Vice President for Health Sciences of the Mount Sinai Medical Center. In 2007, Dr. Charney became the Dean of the Mount Sinai School of Medicine and Executive Vice President for Academic Affairs of the Medical Center. The following year, he was named the Anne and Joel Ehrenkranz Dean of Mount Sinai School of Medicine. A prolific author, Dr. Charney has written more than 700 publications, including groundbreaking scientific papers, chapters, and books. He has authored a dozen books, including Neurobiology of Mental Illness (Oxford University Press, 3rd ed., 2009); The Peace of Mind Prescription: An Authoritative Guide to Finding the Most Effective Treatment for Anxiety and Depression (Houghton Mifflin Harcourt, 2004); and The Physicians Guide to Depression and Bipolar Disorders (McGraw-Hill Profes- sional, 2006). In 2011, Dr. Charney plans to publish his 13th book, which addresses emotional resilience.

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107 APPENDIX C Paul Costello, M.S.W., is the chief communications officer for the Stan- ford University School of Medicine. Prior to joining Stanford in 2004, he was vice president of external affairs for the University of Hawaii System. In Hawaii, he hosted a weekly public affairs program on PBS Hawaii. In government and politics he served as a press spokesman to First Lady Rosalynn Carter, Ohio Governor Richard Celeste, Washington, DC, Mayor Sharon Pratt Kelly, and Kitty Dukakis during the 1988 presidential cam- paign. In the private sector, he was vice president of public affairs at the cable television company Home Box Office and at the Chicago retail company, Marshall Field. He was the managing director of the New York office of the global public relations company, Weber Shandwick. Now at Stanford, he leads the medical school’s communication efforts, overseeing media relations, publications, and social and new media platforms. Kenneth L. Davis, M.D., is the President and Chief Executive Officer of the Mount Sinai Medical Center, and Professor of Psychiatry, Mount Sinai School of Medicine. Dr. Davis received his bachelor’s degree from Yale College, from which he graduated magna cum laude. He received his medical degree from Mount Sinai School of Medicine and was valedicto - rian. He completed an internship, residency, and fellowship in psychiatry and pharmacology, respectively, at Stanford University Medical Center, and thereafter won a career development award from the VA to pursue his research in cholinergic mechanisms and neuropsychiatric diseases. In 1979, Dr. Davis joined the faculty at Mount Sinai, becoming Chief of Psy - chiatry at the Bronx VA Medical Center. He spearheaded Mount Sinai’s research program in the biology of schizophrenia and the therapeutics of Alzheimer’s disease. In 1987 he was appointed Chairman of Psychiatry, Mount Sinai School of Medicine. In January 2003 he was appointed Dean of Mount Sinai School of Medicine and in March 2003 he assumed the additional position of President and Chief Executive Officer of the Mount Sinai Medical Center. Under his leadership, Mount Sinai entered a new era of innovation in research, education, and clinical care. He led what has been characterized as the “largest financial turnaround in academic medicine.” The Medical Center grew in both scope and ambition, acceler- ating the momentum of translational research, intensifying collaboration across all disciplines, and providing the impetus to reach new heights of excellence through closer integration of the research, clinical, and educa - tional dimensions of Mount Sinai’s mission. In 2007, Dr. Davis, who had held the position of both Dean and CEO for 4 years, named a new Dean of Mount Sinai School of Medicine. George D. Demetri, M.D., is the Senior Vice President for Experimen- tal Therapeutics, Dana-Farber Cancer Institute (DFCI); and Director,

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108 PUBLIC ENGAGEMENT AND CLINICAL TRIALS Ludwig Center at Dana-Farber/Harvard Cancer Center; Quick Fam- ily Senior Investigator in Medical Oncology, Dana-Farber Cancer Insti - tute and Harvard Medical School, Boston, Massachusetts. Dr. Demetri received an undergraduate degree in biochemistry from Harvard Uni- versity, followed by a Rotary Foundation Fellowship to do research at the Université de Besancon, France, after which he received his medical degree from Stanford University School of Medicine, California. After completing his internal medicine residency and chief residency at the University of Washington Hospitals in Seattle, Washington, he pursued a fellowship in Medical Oncology at DFCI and Harvard Medical School, where he has served as an attending physician since 1989. Dr. Demetri and colleagues at Harvard have developed a large research-focused multidisciplinary center of excellence for sarcoma patients at the Dana- Farber/Harvard Cancer Center, supporting a number of translational and clinical research projects in sarcomas and focusing on new drug develop - ment through the Ludwig Center at Dana-Farber and Harvard Medical School. He is also directing Dana-Farber’s Center for Novel Experimental Therapeutics (C-NExT). Dr. Demetri’s research and clinical interests have focused on mechanism-based drug development for solid tumors, with a particular emphasis on molecularly-defined subsets of sarcomas such as GISTs. Work from the multidisciplinary team at Dana-Farber/Harvard has contributed to the development of several new drugs for sarcomas and other malignancies, including imatinib (Gleevec), sunitinib (Sutent), trabectedin (Yondelis), and other new rationally designed therapies in development. Dr. Demetri serves as co-chair of the Medical Advisory Board for the Sarcoma Foundation of America as well as several scientific and editorial advisory boards. With an interest in Internet-based medi - cal social network technologies, he also serves as an editor of CancerNet (www.cancer.net) from the American Society of Clinical Oncology. Jeffrey M. Drazen, M.D., is the Editor-in-Chief of the New England Journal of Medicine and co-chairs the IOM’s Forum on Drug Discovery, Devel- opment, and Translation. 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 Pulmo- nary Divisions of the Harvard hospitals. He served as Chief of Pulmonary Medicine at the Beth Israel Hospital, Chief of the combined Pulmonary Divisions of the Beth Israel and Brigham and Women’s Hospitals, and finally as the Chief of Pulmonary Medicine at Brigham and Women’s Hospital. Through his research, he defined the role of novel endogenous chemical agents in asthma. This led to four new licensed pharmaceuticals for asthma with over 5 million people on treatment worldwide. In 2000, he assumed the post of Editor-in-Chief of the New England Journal of Medicine.

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109 APPENDIX C During his tenure, the journal has published major papers advancing the science of medicine, including the first descriptions of SARS and papers modifying the treatment of cancer, heart disease, and lung disease. The journal, which has over a million readers every week, has the highest impact factor of any journal publishing original research. Louis Fiore, M.D., M.P.H., has worked for the Department of Veterans Affairs since his internship at the VA Boston Healthcare System in 1981. Following his hematology and oncology fellowships he became a clini - cal investigator for cancer consortiums and began writing clinical trial protocols. In 1998 he published the CHAMP trial, a 5,000-subject trial of combined aspirin and warfarin therapy in survivors of acute myocardial infarction. Dr. Fiore was “re-schooled” in clinical effectiveness at the Harvard School of Public Health and co-directed the Massachusetts Vet- erans Epidemiology Research and Information Center until 2004, when he founded the VA Cooperative Studies Program Coordinating Center in Boston. He has recently completed a sabbatical in biomedical informatics and is currently leading development of VA Informatics resources includ- ing clinical trials and translational medicine platforms. Sanford J. Friedman, M.D., is an Associate Clinical Professor of Cardiol- ogy at the Mount Sinai Hospital (MSH). He is a graduate of Columbia College and Tufts University School of Medicine. Dr. Friedman conducted his internal medicine residency and cardiology fellowship at MSH. He subsequently was full-time head of the coronary care units at MSH. After 2 years he went into private practice. For over 30 years he has been in a two-man practice with Dr. Jose Meller. The practice is huge; they “accept assignment” and they understand the problems of private doctors in this environment. His focus has been 40 percent internal medicine and 60 percent general cardiology. He is known by his colleagues for his interest in preventative cardiology and cardiac rehab. He teaches fellows and resi- dents one month a year in the CCU and supports the MSH cardiac rehab program with seminar sessions with the patients. Angela Geiger is the Chief Strategy Officer for the Alzheimer’s Associa- tion. In this role, she works across the nationwide organization to develop and implement strategy to maximize mission impact. In addition, she leads the effort to develop and deliver program services, marketing, and fundraising at the Association. Geiger has broad experience in strategic marketing and product development for nonprofits. Prior to joining the Alzheimer’s Association, Geiger spent 8 years at the American Cancer Society in a variety of customer-focused leadership roles in the areas of mission delivery, fundraising, and marketing. Geiger also worked for

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110 PUBLIC ENGAGEMENT AND CLINICAL TRIALS the American Lung Association and for higher education institutions. Throughout her career, Geiger has collaborated with field organizations to create and implement successful special events and grassroots programs that reach a wide range of diverse constituents. She has her B.A. and M.B.A. from the University of Pittsburgh and has contributed to a variety of publications and conferences. Annetine C. Gelijns, Ph.D., is the Co-Chair of the Department of Health Evidence and Policy at Mount Sinai School of Medicine, New York, New York. Dr. Gelijns also holds the positions of Professor of Health Policy and Co-Director of the International Center for Health Outcomes and Inno- vation Research (InCHOIR) at Mount Sinai School of Medicine. Before coming to Mount Sinai in 2008, she was Professor of Public Health and Surgical Sciences in the Department of Surgery, College of Physicians and Surgeons, and the Division of Health Policy and Management of the Mailman School of Public Health, Columbia University, New York City. She was also a Division Chief in the Department of Surgery. Prior to her position at Columbia, she directed the Program on Technological Innova - tion in Medicine at the IOM, National Academy of Sciences. From 1983 to 1987, she worked for the Steering Committee on Future Health Scenarios and for the Health Council, the Netherlands. Dr. Gelijns has been a con - sultant to various national and international organizations, including the World Health Organization (WHO) and the Organisation for Economic Co-operation and Development (OECD). Her research focuses on mea- surement of the long-term clinical outcomes and economic impact of clinical interventions, patient safety research, and the factors driving the development and diffusion of medical technology. She has special exper- tise in cardiovascular disease, particularly in the design, coordination, and analysis of multicenter trials. She is the PI or co-PI of several Data Coor- dinating Centers for the NHLBI-sponsored trials, including CT Surgery Clinical Trials Network, the REMATCH trial, and several newer genera- tions of LVAD trials. Dr. Gelijns has published, in such journals as the New England Journal of Medicine, JAMA, and Health Affairs, on the methodology and conduct of complex surgical and device trials, the assessment of quality of life and economic analysis of clinical procedures, and volume- outcome studies, as well as policy studies on technological change. Wayne K. Goodman, M.D., was appointed Professor and Chairman of the Department of Psychiatry at the Mount Sinai School of Medi- cine in July 2009. He is the Esther and Joseph Klingenstein Professor of Psychiatry and Professor in the Department of Neuroscience. He has conducted research on the phenomenology, neurobiology, and treatment of obsessive-compulsive disorder (OCD) and is the principal developer

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111 APPENDIX C of the Yale-Brown Obsessive Compulsive Scale (Y-BOCS), the gold stan - dard for assessing OCD. He is co-founder of the Obsessive Compul - sive Foundation, the international patient advocacy organization for this disorder. Dr. Goodman is a leader in the field of brain stimulation for intractable psychiatric disorders. A graduate of Columbia University with a B.S. in electrical engineering, Dr. Goodman received his medical degree from Boston University and completed his internship, residency, and a research fellowship at Yale University School of Medicine where he remained on faculty until 1993 as an Associate Professor. In 1994, he joined the University of Florida in Gainesville where he served as Chair- man of the Department of Psychiatry for 9 years. Prior to joining Mount Sinai, he served as Director, Division of Adult Translational Research and Treatment Development, at NIMH from 2007 to 2009. Dr. Goodman has published more than 250 articles and is a member of the American College of Neuropsychopharmacology. He has served as Chair of FDA’s Psychopharmacologic Drug Advisory Committee and is currently on FDA’s Neurological Devices Advisory Committee. Harry B. Greenberg, M.D., is the Senior Associate Dean for Research and the Joseph D. Grant Professor of Medicine and Microbiology and Immunology at the Stanford School of Medicine. Dr. Greenberg received his B.A. in history from Dartmouth College in 1966. He received his M.D. from Columbia College of Physicians and Surgeons in 1970. He did his internal medicine house staff and GI fellowship training at Bellevue Hos - pital and Stanford University, respectively. Dr. Greenberg spent 10 years at the NIH in the Laboratory of Infectious Disease as a tenured scientist before returning to Stanford in 1983. He is currently the Joseph D. Grant Professor of Medicine and Microbiology and Immunology and the Senior Associate Dean for Research at Stanford University School of Medicine. He is also a staff physician at the Palo Alto VA hospital. Dr. Greenberg is a member of a variety of scholarly societies, governmental committees, and editorial boards. He is the past President of the American Society of Virology, a consultant for a variety of vaccine manufacturing companies, and the director of Stanford’s NIH-funded CTSA. He has been an active NIH-funded investigator for over 30 years during which time his studies have focused primarily on viruses that infect the GI tract, liver, or respira- tory tree. He has published over 400 articles, chapters, and reviews dur- ing this time. His work has spanned the spectrum from basic studies of viral–host cell interaction to translation work on the immune response to important pathogens in both animal models and humans to clinical tri - als of vaccine safety and efficacy. He has trained a large number of M.D. and Ph.D. postdoctoral students who are now in independent careers in science and academic medicine. He has also carried out a variety of

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114 PUBLIC ENGAGEMENT AND CLINICAL TRIALS sity 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 University of the Northeast, Corrientes, Argentina, and the Graduate School, Department of Pharmacology, Tulane Univer- sity. 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 fellow - ship at the University of Iowa. He was Assistant Professor of Medicine and Pharmacology, Clinical Pharmacology Center, Northwestern Univer- sity in Chicago (1977-1981) and received a Faculty Development Award from the Pharmaceutical Manufacturers Association Foundation (now the PhRMA Foundation). Dr. Lertora serves on the editorial board of Clinical Pharmacology and Therapeutics, the FDA Advisory Committee for Phar- maceutical Sciences and Clinical Pharmacology, and the Board of Direc- tors 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 and II safety and efficacy clinical trials and stud- ied pharmacokinetics-pharmacodynamics, drug metabolism, pharmaco - genetics, and drug interactions of antiretroviral drugs. Previous 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. Kathryn Maitland, M.D., is based at the KEMRI-Wellcome Trust Pro- gramme in Kilifi, Kenya, and is a Professor of Paediatric Tropical Infec - tious Diseases and Honorary Consultant in Paediatric Infectious Disease, Imperial College, London; and Honorary Fellow at the MRC Clinical trials Unit, London. Over the past 11 years she has been based full time in East Africa, where she leads a research group whose major research portfolio includes severe malaria, bacterial sepsis, and severe malnutrition. Her work focuses upon understanding the pathophysiology of severe malaria and severe malnutrition and includes clinical trials of emergency inter- ventions to improve outcome. Her research group has recently completed the largest trial of critically ill children ever undertaken in Africa (FEAST trial: http://www.feast-trial.org) examining fluid resuscitation, which is likely to lead to major changes in health policy in children with severe illness in sub-Saharan Africa.

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115 APPENDIX C Robert E. Michler, M.D., is Surgeon-in-Chief; Samuel I. Belkin Endowed Chair; Chairman and Professor, Department of Cardiovascular and Tho - racic Surgery; Chairman and Professor, Department of Surgery; and Co- Director, Center for Heart and Vascular Care at the Montefiore Medical Center/Albert Einstein College of Medicine, New York, New York. Dr. Michler is a nationally noted heart surgeon who specializes in complex aortic and mitral valve repair. His research interest in repairing the injured heart has led to clinical trials in autologous skeletal myoblast and cardiac stem cell transplantation. He is an NIH-funded investigator and leader in clinical trial enrollment. Dr. Michler and his teams have advanced mini - mally invasive cardiothoracic surgery procedures and surgical robotics. This work led to FDA approval for selective cardiac robotic procedures including mitral valve repair and coronary bypass surgery. Dr. Michler has authored hundreds of peer-reviewed publications, recently publishing in the New England Journal of Medicine, Circulation, and the Proceedings of the National Academy of Sciences. He is a frequent editor on cardiac surgery topics and lectures extensively, both nationally and abroad. Formerly, he was the John G. and Jeanne B. McCoy Endowed Chair, Professor of Sur- gery, and Chief of Cardiothoracic Surgery and Transplantation at The Ohio State University Medical Center in Columbus, Ohio. Before joining The Ohio State University, Dr. Michler was a tenured Associate Professor of Surgery at Columbia University and served as the Director of the Car- diac Transplant Program, one of the largest cardiac transplant programs in the nation, at Columbia-Presbyterian Medical Center in New York. Dr. Michler received his undergraduate education magna cum laude from Harvard University. He received his medical education at Dartmouth Medical School where he was a Leopold Schepp Scholar. Dr. Michler completed his residency in general surgery, a fellowship in cardiotho - racic transplantation, and a residency in cardiothoracic surgery at the Columbia Presbyterian Medical Center in New York. He was awarded the Blakemore Research Prize for 3 consecutive years. He completed a chief residency in pediatric cardiothoracic surgery with Dr. Aldo Castaneda at the Harvard Medical School, Boston Children’s Hospital. Dr. Michler is the Chairman and Founder of a not-for-profit foundation, Heart Care International, which performs pediatric heart surgery in underserved regions of the world. To date, Heart Care International has helped over 1,000 children with heart disease and performed heart surgery on over 600 children. He has received numerous honors including “Person of the Week” by Peter Jennings of ABC World News Tonight, the Pace Humani- tarian Award, and “The Order of Christopher Columbus” by Hippolito Mejia, President of the Dominican Republic.

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116 PUBLIC ENGAGEMENT AND CLINICAL TRIALS Ramon Murphy, M.D., M.P.H., is a Clinical Professor of Pediatrics and Preventive Medicine; Vice-Chair of Department of Pediatrics, Voluntary Affairs; Associate Director, Mount Sinai Global Health Center; and Direc - tor, Off-Site Pediatric Residency Program at the Mount Sinai School of Medicine. Dr. Murphy trained in pediatrics and preventive medicine. Ramon Murphy is currently in charge of an eight-doctor private prac- tice, closely affiliated with Mount Sinai School of Medicine. The practice, Uptown Pediatrics, has approximately 10,000 patients, 29 employees, and 4 pediatric residents who do all of their outpatient work there. The prac- tice has electronic records and has a diverse population of patients from the entire New York community including East Harlem. He also serves as Vice-Chair of Pediatrics, Voluntary Affairs, and Associate Director of the Global Health Center at Mount Sinai which he founded in 2003. He is active in teaching at the practice, hospital, and medical school and has been listed in America’s Top Doctors for the past 12 years. Richard Murray, M.D., joined Merck & Co., Inc. in November 1994, where he was a founding member of the Regional Medical Director Pro- gram. Over the subsequent 17 years, he assumed increasing responsibil - ity within U.S. Human Health Medical and Scientific Affairs, including head of U.S. Academic and Professional Affairs, and he was promoted to Vice President, External Medical and Scientific Affairs, in August of 2007. He became Head of the Global Center for Scientific Affairs in May 2010, including responsibility for the Merck Investigator-Initiated Stud - ies Program. Dr. Murray, a native Washingtonian, graduated from Clark University (Worcester, Massachusetts) with an A.B. in psychology and a M.A. in chemistry. He graduated from Howard University College of Medicine (Washington, DC) and subsequently was an intern, medical resi- dent, Chief Medical Resident, and Pulmonary & Critical Care Fellow at the University of Pennsylvania in Philadelphia. Prior to joining Merck, Dr. Murray was Assistant Professor of Medicine at the University of Pennsyl- vania where he was an investigator in the area of reactive airways disease, smooth muscle function, and calcium signaling. He was also Co-Director of the Adult Asthma Program at the Hospital of the University of Pennsyl- vania. Dr. Murray is Board Certified in Internal Medicine and Pulmonary Diseases. He is a Fellow of the American College of Physicians, a Fellow of the American College of Chest Physicians, and a Fellow of the College of Physicians of Philadelphia. He serves on the boards of directors for the Merck Childhood Asthma Network, and the Southeast Pennsylvania Chapter of the AHA. Dr. Murray has previously represented Merck at the IOM Clinical Research Roundtable and the Roundtable on Health Disparities.

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117 APPENDIX C Brian Naughton, Ph.D., joined 23andMe at its founding and over the past 5 years has drawn on his experience in bioinformatics, statistics, and genetics to analyze data, develop algorithms, and translate scientific research to drive the world’s first personal genome service. Among other projects, he has worked on the design of the 23andMe custom chip, and the development of tools related both to risk estimation and ancestry. Dr. Naughton is a graduate of the Trinity College, Dublin, and received his Ph.D. from the Biomedical Informatics program at Stanford University, where he worked with Professors Doug Brutlag and Serafim Batzoglou. His thesis work included novel methods for the detection of transcription factor binding sites. James R. O’Dell, M.D., is Larson Professor of Internal Medicine, Vice- Chairman of Internal Medicine and Chief of Rheumatology at the Univer- sity of Nebraska Medical Center (UNMC) in Omaha. He also has served as Director of the Internal Medicine Residency Training Program at UNMC for the past 25 years, where he has directed the training of over 500 internal medicine residents. Dr. O’Dell received his undergraduate degree at the University of Nebraska-Lincoln in electrical engineering and his medical degree and completed a residency and chief residency in internal medicine at the University of Nebraska College of Medicine. He completed a clinical and research fellowship in rheumatology at the University of Colorado in Denver in 1984 and is board certified in both internal medicine and rheu- matology. Dr. O’Dell founded and has directed RAIN for the past 22 years. RAIN is a group of rheumatologists who conduct investigator-initiated trials to find better treatments for rheumatoid arthritis (RA). This research network has pioneered the use of combinations of medications to treat RA, was one of the first groups to describe genetic factors that predict response to therapy, and has done extensive work with the use of minocycline in the treatment of RA. Dr. O’Dell is the PI of the large multinational RA research study based at the VA. This trial that also has NIH funding is comparative effectiveness research at its best in a double-blind placebo-controlled ran- domized trial. Dr. O’Dell has published extensively, mostly in the area of RA and recently authored “Drug Therapy: Rheumatoid Arthritis” for the New England Journal of Medicine. He has presented frequently at national and international meetings and has more than 100 published articles in top-level journals. He has received many awards for teaching excellence, was recently honored with the Nebraska ACP Laureate Award, and as a distinguished Scientist at UNMC. In 2008 he received the Department of Internal Medicine Career Research award. He has served on numerous American College of Rheumatology (ACR) committees over the past 20 years, including time on both the ACR and REF BOD, as well as a 2-year

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118 PUBLIC ENGAGEMENT AND CLINICAL TRIALS term as President of the Research and Education Foundation of the ACR. He was recently Secretary of the College and is currently President-Elect. Michael K. Parides, Ph.D., is Professor of Biostatistics in the Department of Health Evidence and Policy, and Director of the Center for Biostatistics at the Mount Sinai School of Medicine in New York City. Dr. Parides is an expert in the design, execution, and analysis of clinical trials; having advised academic, government, and industry sponsors for the past 25 years. He has spent his career focusing on quantitative methods in clini- cal and translational research, including the development and application of novel adaptive, Bayesian, and sequential approaches for both explor- atory and confirmatory clinical trials. Dr. Parides has served as principal statistician and PI for many large multicenter randomized clinical trials in neurology, cardiology, cardiac surgery, HIV, and psychiatry, and on numerous NIH Data Monitoring Committees and clinical trial study sec- tions. He is also dedicated to teaching and mentoring; teaching graduate students at Mount Sinai, and young clinical and statistical investiga- tors through the National Institute of Neurological Disorders and Stroke (NINDS)-funded week-long Clinical Trials Methods Course, and through educational activities of the American Academy of Neurology and the Society for Clinical Trials. Peggy Peck, Vice President/Executive Editor, MedPageToday.com, began her career in journalism at The Record, a New Jersey daily newspaper. In 1980, she started writing for the medical trade press with a column in Physician’s Management. Since then, her byline has been ubiquitous, appearing in Modern Medicine, Medical Tribune, Medical World News, Physi- cian’s Weekly, Internal Medicine News, Family Practice News, Pediatric News, Clinical Psychiatry News, Skin and Allergy News, and ObGyn News. As a freelancer, she has contributed to a wide range of publications and web - sites including WebMD, Medscape, Reuters Health, UPI, Good Housekeeping, Oncology Times, Neurology Today, Neurology Now, and AMNews. Eric Rose, M.D., is an academic physician and entrepreneur with interests in drug discovery, biodefense, clinical evaluative research, and health policy. Since 2007 he is the Executive Vice President for Life Sciences at MacAndrews & Forbes and CEO of Siga Technologies, Inc., a developer of antiviral drugs directed at potential agents of bioterror. He was appointed in 2007 to the National Biodefense Scientific Board which advises the HHS Secretary on biodefense, influenza, and emerging diseases. In 2008, he assumed the chairmanship of the Department of Health Evidence & Policy at the Mount Sinai School of Medicine. From 1994 through 2007, he served as Surgeon-in-Chief at New York-Presbyterian Hospital/Columbia

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119 APPENDIX C and Chairman of the Department of Surgery at the Columbia University College of Physicians and Surgeons, where he held a distinguished pro- fessorship. An accomplished heart surgeon, researcher, and entrepreneur, Dr. Rose grew one of the nation’s premier departments of surgery while managing, investigating, and developing complex medical technologies ranging from heart transplantation and novel approaches to Alzheimer’s disease to bioterrorism. He has authored or co-authored more than 300 scientific publications and has received more than $25 million in NIH sup- port for his research. Dr. Rose pioneered heart transplantation in children, performing the first successful pediatric heart transplant in 1984, and has investigated many alternatives to heart transplantation, including cross- species transplantation and man-made heart pumps. Siga has received more than $100 million in federal research support since he joined the company, developing antiviral drugs for smallpox, dengue, and Lassa fever. In May 2011, Siga was awarded a $433 million contract to provide 2 million courses of its novel oral smallpox antiviral drug to the Strategic National Stockpile to protect the civilian population in the event of a smallpox outbreak, a recognized material threat to U.S. national security. He received both his undergraduate and medical degrees from Columbia University. Hugh A. Sampson, M.D., is a Professor of Pediatrics and Immunology at the Mount Sinai School of Medicine in New York, and is the Director of the Jaffe Food Allergy Institute, Dean for Translational Biomedical Research, and PI and Director of Conduits; Institutes for Translational Sciences at the Mount Sinai Medical Center. Dr. Sampson’s research inter- ests have focused on food allergic disorders including the immunopatho - genic role of food hypersensitivity in atopic dermatitis and anaphylaxis, characterization of food allergens, and immunotherapeutic strategies for treating food allergies. Dr. Sampson’s group is conducting a number of clinical trials to treat food allergy and to understand basic immunologic mechanisms accounting for the eventual development of tolerance. His research has been funded continuously by a number of grants from NIH and private foundations. He has published over 350 articles and 60 book chapters on food allergic disorders and co-edited 4 books, and was elected to membership in the IOM of the National Academies for his work on food allergies. Roger Sergel is the Managing Editor of the Medical Unit for ABC News. In the role, he oversees ABC News’ Medical Unit and provides editorial guidance for all medical reporting on World News Tonight, Good Morning America, Nightline, and 20/20, as well as other broadcasts and platforms. Sergel has more than 36 years’ experience in broadcast journalism and

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120 PUBLIC ENGAGEMENT AND CLINICAL TRIALS nearly 30 years’ experience in medical reporting. In 1996, Sergel created the ABC News Medical Unit, which evaluates medical information for all broadcasts and also develops story ideas. As part of that unit, Sergel established a unique system of e-mailing doctors and public relations contacts throughout the medical field in order to obtain feedback about developing stories. The e-mail network today includes over 4,000 doctors in 200 specialty areas and over 1,000 public relations professionals at the federal government health agencies, medical centers, hospitals, specialty organizations, pharmaceutical companies, and managed care companies. No other news organization covering medicine has a comparable network of contacts. The Medical Unit also produces a daily memo, which evalu - ates studies and news releases. It is distributed throughout ABC News and to over 50 medical producers and reporters at ABC-affiliated stations. Sergel also created OnCall, a video Internet resource on ABCNews.com, where leading experts provide video answers in dozens of specialty areas. Sergel joined ABC News in 1984 with Dr. Timothy Johnson, formerly ABC News’ Medical Editor. As Dr. Johnson’s primary producer, Sergel has pro- duced medical segments for all ABC News broadcasts. Sergel currently works with Rich Besser, ABC News’ current Health and Medical Editor. In 1982, prior to joining the network, he teamed with Dr. Johnson as execu - tive producer of a syndicated health program. Previously, Sergel was a general assignment reporter in Charlotte, North Carolina; a writer for WCPO-TV, the ABC affiliate, in Cincinnati; a show producer for WDIV- TV, the NBC affiliate, in Detroit; and a medical producer for five years with the NBC-owned station WMAQ-TV in Chicago. Sergel has won the AHA’s Blakeslee Award three times, and was part of the ABC News teams that won the duPont-Columbia Award on two occasions. Greg C. Simon is Senior Vice President for Patient Engagement at Pfizer, Inc. In that role he engages with people worldwide to help Pfizer develop policies, practices, and medical solutions to improve health, happiness and productivity. Specifically he is focused on how to engage patients more productively in the research and clinical trial process. From June 2009 to February 2010, Simon was head of Pfizer’s Worldwide Policy group. In that capacity he led a global team of professionals in (1) world - wide government policy, (2) science policy, (3) economic policy and research, and (4) international policy. He served as an advisor to the CEO in coordinating the company’s efforts in Healthcare Reform. Prior to join - ing Pfizer, Simon was the founding president of FasterCures/The Center for Accelerating Medical Solutions, an independent, nonpartisan orga - nization that is a center of the California-based Milken Institute. There he led efforts to reform policies governing biopharmaceutical discovery and development, with the goal of bringing a greater number of lifesav -

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121 APPENDIX C ing medicines more quickly to doctors and patients. The journal Nature Medicine named Simon one of “Ten People to Watch” in health care policy, noting that he was among “a handful of influential people who quietly keep the wheels of biomedical science turning.” In 2010 he received the Genetic Alliance’s “Art of Advocacy” award. Simon was Chief Domestic Policy Advisor to Vice President Al Gore from 1993 to 1997. He oversaw a number of key initiatives, including programs at NIH, the National Cancer Institute, FDA, and the Human Genome Project. He was also instrumental in crafting the regulatory framework that is now the founda- tion for the biotechnology industry. From 1985 to 1991, Simon was Staff Director of the Investigations and Oversight Subcommittee of the U.S. House of Representatives Committee on Science, Space and Technology. He served as Senator Gore’s Legislative Director from 1991 to 1993. Imme- diately prior to joining FasterCures, Simon was CEO of Simon Strategies, a consulting firm focusing on science and technology issues. He received his law degree from the University of Washington in 1983. He has a B.A. in history from the University of Arkansas. Nancy Sung, Ph.D., is a Senior Program Officer with the Burroughs Well- come Fund (BWF; www.bwfund.org), an independent foundation whose mission is to support the advance of biomedical research and education. BWF’s major strategy is to invest in the career development of young scientists. Dr. Sung directs BWF’s grantmaking in the areas of Interfaces in Science and Translational Research. This portfolio has included indi - vidual bridging awards for postdoctoral fellows, midcareer awards for clinical investigators conducting translational research, and institutional awards for interdisciplinary training programs that bridge the physical/ mathematical and biological sciences. She also represents BWF’s interests in consideration of national science policy issues related to BWF’s grant - making, and is a leader in the community of biomedical research funders. Dr. Sung is founding board chair of the Health Research Alliance (www. healthra.org), a growing consortium of private foundations and voluntary health agencies. Dr. Sung has served as a member of several IOM panels, most recently the Forum on Drug Discovery, Development, and Transla- tion, and Committee on Accelerating Rare Diseases Research. She serves on the Board of Directors of the Samaritan Health Center (Durham, NC) and of Justice Ventures, Intl. (Washington, DC). Dr. Sung earned a B.A. from the University of Pennsylvania and a Ph.D. in microbiology from the University of North Carolina at Chapel Hill (UNC-CH), where she was named a Lineberger Fellow for excellence in research. She conducted postdoctoral research in tumor virology at the Lineberger Comprehensive Cancer Center at UNC-CH. Prior to joining the Fund’s staff, Dr. Sung was a visiting fellow at the Chinese Academy of Preventive Medicine’s Insti -

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122 PUBLIC ENGAGEMENT AND CLINICAL TRIALS tute of Virology in Beijing, with the support of the WHO and the NIH- NCI. Beginning in August 2011, she is on a 1-year sabbatical leave from BWF, while serving as a Program Director in the Office of International Science and Engineering of the National Science Foundation. Douglas C. Throckmorton, M.D., is the Deputy Director for Regulatory Programs CDER, FDA. In this role, he shares responsibility for oversee- ing the regulation of research, development, manufacture, and marketing of prescription, over-the-counter, and generic drugs in the United States. From aspirin to cancer treatments, CDER works to ensure that the benefits of approved drug products outweigh their known risks. Dr. Throckmorton is board-certified in internal medicine and nephrology, having received his training at the University of Nebraska Medical School, Case Western Reserve University, and Yale University. Prior to coming to FDA he prac- ticed medicine at the Medical College of Georgia in Augusta, Georgia. Janet Tobias has two careers: the first in health care, the second in tele- vision and film. At Ikana Health and as an adjunct assistant professor at Mount Sinai’s School of Medicine, Tobias works at the intersection of technology, information, media, and design to create better health care experiences for patients and their caregivers. Past and present cli - ents include Babycenter.com, AARP, Johnson & Johnson, Bristol-Meyers Squibb, St. Luke’s Roosevelt Hospital, Genentech, and Cisco Systems. As CEO of Sierra/Tango Productions, Tobias produces, directs, and writes content for theatrical release, television, and the web. An Emmy and Peabody award winner, Tobias has worked for all three American net - works, PBS, MSNBC, Discovery, and the History Channel. She is currently directing a film for worldwide theatrical/broadcast release based on the longest-ever-recorded uninterrupted underground survival. Bruce C. Vladeck, Ph.D., is Senior Advisor to Nexera Inc., a wholly owned consulting subsidiary of the Greater New York Hospital Asso- ciation, which he joined in June 2009. His long and varied career has included senior leadership roles in the public, nonprofit, academic, and business communities. He is a widely recognized expert in health care policy and finance, Medicare, Medicaid, long-term care, and health care for the homeless, and a much-sought-after speaker and writer in all of those areas. In the health care community, Dr. Vladeck is perhaps most widely known for his tenure as Administrator of the Health Care Financ - ing Administration (HCFA) from 1993 through 1997, a period that encom- passed Health Reform, the Contract with America Congress and budget stalemates, and the Balanced Budget Act. Dr. Vladeck’s time at HCFA was marked by significant innovation in statewide Medicaid programs

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123 APPENDIX C through demonstration waivers; the development of Medicare prospec - tive payment systems for hospital outpatient services, skilled nursing facilities, and home care agencies; implementation of the first quantita - tive quality measures for managed care plans; major initiatives to combat fraud and abuse; and significant improvements in beneficiary services. His work at HCFA was recognized in 1995 by a National Public Service Award. He remained closely involved in Medicare policy in 1998-1999 as a Presidential Appointee to the National Bipartisan Commission on the Future of Medicare. After leaving HCFA, Dr. Vladeck spent 6 years at Mount Sinai Medical Center, as Professor of Health Policy and Geriatrics and Senior Vice President for Policy of the Medical Center. In that latter role, he successfully undertook a wide variety of administrative assign - ments, from managing the medical school’s affiliation with New York’s public hospital system to acting as interim chair of the Department of Geriatrics. Dr. Vladeck joined Ernst & Young’s Health Sciences Advisory Services in 2004. He left that position for 16 months in 2006-2007 to serve, at the request of Governor Jon Corzine, as Interim President of the Uni- versity of Medicine and Dentistry of New Jersey (UMDNJ) after it had entered into a Deferred Prosecution Agreement with the U.S. Attorney. While at UMDNJ, Dr. Vladeck restored fiscal stability to the system, rebuilt its governance, compliance, and internal control processes, and laid the groundwork for restoration of full academic accreditation. A graduate of Harvard College and the University of Michigan, Dr. Vladeck has held full-time faculty positions at Columbia University and Mount Sinai, and has served as adjunct faculty at Rutgers, Princeton, New York University, and the Aquinas Institute of Theology. He is a member of the IOM and the New York Academy of Medicine, and serves on the boards of the Medicare Rights Center and Ascension Health, and on the New York City Board of Health. Heather Won Tesoriero is a medical producer for the CBS Evening News with Scott Pelley. She covers a wide range of health care and medical stories, producing both breaking news and features. Prior to joining CBS in 2008, she was a staff reporter at The Wall Street Journal, where she covered health care and medical-legal issues. She broke several stories on the Vioxx litigation and health care fraud investigations. She’s also been a reporter at Time and Newsweek. In 2010, Won Tesoriero attended the Salzburg Global Seminar on informed medical decision making as a Knight Fellow. Christina Zarcadoolas, Ph.D., Associate Professor, City University of New York (CUNY) School of Public Health at Hunter, is a sociolinguist and internationally recognized expert in health literacy and public under-

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124 PUBLIC ENGAGEMENT AND CLINICAL TRIALS standing of health and science. Her research focuses on analyzing and closing the gaps between expert knowledge and public understanding. Her critically acclaimed book, Advancing Health Literacy: A Framework for Understanding and Action (co-authored with Dr. Andrew Pleasant and Dr. David S. Greer, Jossey-Bass/Wiley, 2006), was reviewed by the New England Journal of Medicine, which called it “required reading” for public health professionals responsible for developing new tools for commu- nicating with patients and the general public. Dr. Zarcadoolas recently joined the CUNY School of Public Health at Hunter to launch a Health Literacy initiative. Prior to this, she was an Associate Professor in the Preventive Medicine Department at Mount Sinai School of Medicine, and had a long tenure as a faculty member of Brown University’s Center for Environmental Studies. Dr. Zarcadoolas’ work is presently focused in three areas of research and teaching: chronic disease management, health informatics, and communicating complex emergencies. She is currently working on a new book entitled The Simplicity Complex, which explores the limits of simplification in a complex world. Bram Zuckerman, M.D., is a graduate of the Boston University Medical School. He completed postgraduate training in internal medicine at Balti - more City Hospital and cardiology at the Johns Hopkins program. Prior to joining FDA in 1992, he was involved in basic research in hemodynamics at the University of Colorado Medical School and practiced noninvasive and invasive cardiology in Denver, Colorado, and Northern Virginia. He joined the FDA Division of Cardiovascular Devices (DCD) as a Medical Officer in 1992 and has been actively involved in development and review of clinical trials for many new cardiovascular devices. In May 2001 he was appointed a Deputy Director in DCD. He was appointed to his current position as Director of the FDA Division of Cardiovascular Devices in September 2002.