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Institute of Medicine (US) Forum on Drug Discovery, Development, and Translation. Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary. Washington (DC): National Academies Press (US); 2010.

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Transforming Clinical Research in the United States: Challenges and Opportunities: Workshop Summary.

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Appendix BParticipant Biographies

Barbara Alving, M.D., MACP, is the Director of the National Center for Research Resources (NCRR), which funds the development of new technologies for basic and clinical research, supports training for researchers in the biomedical sciences, develops preclinical models, and provides health and biomedical education for the public. The NCRR is responsible for developing the new Clinical and Translational Science Award (CTSA) program that has evolved from the NIH Roadmap initiative to re-engineer clinical research. Dr. Alving received her M.D. cum laude from Georgetown University School of Medicine in Washington, DC. After an internship in internal medicine at Georgetown University Hospital, she completed a residency in internal medicine and a fellowship in hematology at the Johns Hopkins University Hospital in Baltimore, MD. Dr. Alving then became a research investigator in the Division of Blood and Blood Products at the Food and Drug Administration on the NIH campus. In 1980, she joined the Department of Hematology and Vascular Biology at the Walter Reed Army Institute of Research and became Chief of the Department in 1992. She left the Army at the rank of Colonel in 1996 to become the Director of the Medical Oncology/Hematology Section at the Washington Hospital Center in Washington, DC. In 1999, she joined the National Heart, Lung, and Blood Institute (NHLBI), serving as the Director of the extramural Division of Blood Diseases and Resources until becoming the Deputy Director of the Institute in September 2001. From September 2003 until February 1, 2005, she served as the Acting Director of the NHLBI. From October 2002 until January 2006, she served as the Director of the Women’s Health Initiative, which is funded through the NHLBI. In March 2005, she became the Acting Director of NCRR and was named Director in April 2007. Dr. Alving is a Professor of Medicine at the Uniformed Services University of the Health Sciences in Bethesda, a Master in the American College of Physicians, a former member of the subcommittee on Hematology of the American Board of Internal Medicine, and a previous member of the FDA Blood Products Advisory Committee. She is a co-inventor on two patents, has edited three books, and has published more than 100 papers in the area of thrombosis and hemostasis.

Linda Brady, Ph.D., serves as the Director of the Division of Neuroscience and Basic Behavioral Science at the National Institute of Mental Health (NIMH). During the past 10 years, she has administered programs in the areas of neuropharmacology, drug discovery, and clinical therapeutics and served as a coordinator for the discovery and preclinical development of novel imaging agents and pharmacologic ligands as research tools for use in pathophysiological studies and in drug development. Dr. Brady has organized consortia focused on ways to accelerate the development and clinical application of low-mass, high-specificity radiotracers in clinical research and drug development. She has spearheaded many programs, including: Development and Application of PET and SPECT Ligands for Brain Imaging Studies, National Cooperative Drug Discovery Groups for the Treatment of Mood Disorders and Nicotine Addiction, and has been actively involved in the MATRICS (Measurement and Treatment Research to Improve Cognition in Schizophrenia), and TURNS (Treatment Units for Research on Neurocognition in Schizophrenia) programs. Dr. Brady serves as co-lead for the Molecular Libraries and Imaging Roadmap, a trans-NIH initiative to provide biomedical researchers access to small organic molecules that can be used as chemical probes to study the functions of genes, cells, and biochemical pathways. Dr. Brady has received NIH Director’s Awards and NIH Merit Awards, in recognition of her activities in biomarker development, drug development for mental disorders, and the molecular libraries roadmap, as well as an outstanding supervisor award from NIMH.

Robert Califf, M.D., was born in Anderson, South Carolina, in 1951 and attended high school in Columbia, SC, where he was a member of the 1969 AAAA South Carolina Championship basketball team. He graduated from Duke University, summa cum laude and Phi Beta Kappa, in 1973 and from Duke University Medical School in 1978, where he was selected for Alpha Omega Alpha. He performed his internship and residency at the University of California at San Francisco and his fellowship in cardiology at Duke University. He is board-certified in internal medicine (1984) and cardiology (1986) and is a Master of the American College of Cardiology (2006). He is currently Vice Chancellor for Clinical Research, Director of the Duke Translational Medicine Institute (DTMI), and Professor of Medicine in the Division of Cardiology at the Duke University Medical Center in Durham, North Carolina. For 10 years he was the founding Director of the Duke Clinical Research Institute (DCRI), the premier academic research organization in the world. He is the Editor-in-Chief of Elsevier’s American Heart Journal, the oldest cardiovascular specialty journal. He has been author or coauthor of more than 800 peer-reviewed journal articles and a contributing editor for theheart.org, an online information resource for academic and practicing cardiologists. He was recently acknowledged as one of the 10 most cited authors in the field of medicine by the Institute for Scientific Information (ISI). Dr. Califf led the DCRI for many of the best-known clinical trials in cardiovascular disease. With an annual budget of over $100 million, the DCRI has more than 1,000 employees and collaborates extensively with government agencies, the medical-products industry, and academic partners around the globe in all therapeutic areas. In cooperation with his colleagues from the Duke Databank for Cardiovascular Disease, Dr. Califf has written extensively about the clinical and economic outcomes of chronic heart disease. He is considered an international leader in the fields of health outcomes, quality of care, and medical economics. Dr. Califf’s role as Director of the Duke Translational Medicine Institute, which is funded in part by an NIH Clinical and Translational Science Award (CTSA), includes service as Co-Chairman of the Principal Investigators Steering Committee of the CTSA. Dr. Califf has served on the Cardiorenal Advisory Panel of the U.S. Food and Drug Administration (FDA) and the Pharmaceutical Roundtable of the Institute of Medicine (IOM). He served on the IOM committees that recommended Medicare coverage of clinical trials as well as the removal of ephedra from the market and on the IOM’s Committee on Identifying and Preventing Medication Errors. He is currently a member of the IOM Forum in Drug Discovery, Development, and Translation and a subcommittee of the Science Board of the FDA. He was the founding director of the coordinating center for the Centers for Education & Research on Therapeutics™ (CERTs), a public–private partnership among the Agency for Healthcare Research and Quality, the FDA, academia, the medical-products industry, and consumer groups. This partnership focuses on research and education that will advance the best use of medical products. He is now the Co-Chairman of the Clinical Trials Transformation Initiative (CTTI), a public–private partnership focused on improving the clinical trials system. Dr. Califf has been married to Lydia Carpenter since 1974, and they have three children—Sharon Califf Boozer, a graduate of Elon College; Sam, a graduate student at the University of Colorado–Boulder; and Tom, a recent graduate of Duke University—and one grandchild. Dr. Califf enjoys golf, basketball, and listening to music.

Scott Campbell, Ph.D., received his Ph.D. in basic biomedical sciences in 1985. He spent 16 years in academia where his primary area of research interest was hypertension, heart failure, and the renin-angiotensin system. He is the author of 36 peer-reviewed articles, 8 invited reviews, and 14 book chapters. Dr. Campbell joined the American Diabetes Association in 2001 as National Vice President of Research Programs. In addition to overseeing all research-related programs at the ADA, he is also responsible for helping acquire major donations to the ADA Research Foundation. In 2010, Dr. Campbell joined the Foundation for the National Institutes of Health (FNIH) as Executive Director and CEO.

Renzo Canetta, M.D., Vice President, Oncology Global Clinical Research, Bristol-Myers Squibb Company, Research and Development, Wallingford, Connecticut. During his early years at the Istituto Nazionale Tumori in Milan, Italy (1974–1980), Dr. Canetta’s focus was on clinical trials in lymphomas and gastrointestinal tumors, among others. Since joining Bristol-Myers Squibb (BMS) in 1980, Dr. Canetta has held numerous roles of increasing responsibility and leadership, including head of clinical cancer research; head of development, life cycle management; and, currently, as vice president, oncology global clinical research. His experience can be summarized with the introduction of 16 new BMS chemical entities and the approval of over 50 regulatory dossiers for additional indications/formulations, including some outside of oncology. Education: Universita’ degli Studi, Milan, Italy. Graduate, Medicine and Surgery (M.D.), 1976. Instituto Nazionale Tumori, Milan, Italy, State certification, clinical oncology, 1977. Universita’ degli Studi, Milan, Italy. Board Certification, Clinical and Laboratory Hematology, 1979. Area of expertise: cancer patient care, diagnosis and experimental treatment of hematologic malignancies and solid tumors, methodology of clinical trials, and new drug development.

Christopher P. Cannon, M.D., Senior Investigator, TIMI Study Group, Cardiovascular Division, Brigham and Women’s Hospital, Associate Professor of Medicine, Harvard Medical School, Boston, Massachusetts. Dr. Cannon is a senior investigator in the Thrombolysis in Myocardial Infarction (TIMI) Study Group, leading trials such as TACTICS-TIMI 18, PROVE IT-TIMI 22, and CLARITY-TIMI 28. He earned his M.D. from Columbia University College of Physicians and Surgeons in New York, and after completing his residency in internal medicine at Columbia Presbyterian Medical Center, he was a cardiovascular fellow at Brigham and Women’s Hospital. Dr. Cannon has published over 500 original articles, reviews, book chapters, and electronic publications on the topic of acute coronary syndromes, including works in Circulation, Journal of the American College of Cardiology, Lancet, and the New England Journal of Medicine. He has received numerous awards, including the Alfred Steiner Research Award, and the Upjohn Achievement in Research Award, and he serves as Chairman for several ACC and AHA committees. He is Editor-in-Chief of the ACC’s website, Cardiosource (www.cardiosource.com) as well as the journal Critical Pathways in Cardiology and a 40-book series Contemporary Cardiology. He has authored or edited seven books, including the New Heart Disease Handbook for patients.

Gail H. Cassell, Ph.D., is currently Vice President, Scientific Affairs, and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company, Indianapolis, Indiana. She is former Charles H. McCauley Professor and Chair of the Department of Microbiology, University of Alabama Schools of Medicine and Dentistry at Birmingham, a department that ranked first in research funding from the National Institutes of Health (NIH) during the decade of her leadership. She obtained her B.S. from the University of Alabama in Tuscaloosa and in 1993 was selected as one of the top 31 female graduates of the twentieth century. She obtained her Ph.D. in microbiology from the University of Alabama at Birmingham and was selected as its 2003 Distinguished Alumnus. She is past President of the American Society for Microbiology (the oldest and single largest life sciences organization, with a membership of more than 42,000). She was a member of the NIH Director’s Advisory Committee and of the Advisory Council of the National Institute of Allergy and Infectious Diseases. She was named to the original Board of Scientific Councilors of the Center for Infectious Diseases, Centers for Disease Control and Prevention (CDC), and served as chair of the board. She recently served a 3-year term on the advisory board of the director of CDC and as a member of the Secretary of Health and Human Services’ Advisory Council of Public Health Prepared-ness. Currently, she is a member of the Science Board of the U.S. Food and Drug Administration (FDA). Since 1996, she has been a member of the U.S.–Japan Cooperative Medical Science Program, responsible for advising the respective governments (U.S. State Department/Japanese Ministry of Foreign Affairs) on joint research agendas. She has served on several editorial boards of scientific journals and has authored more than 250 articles and book chapters. Dr. Cassell has received national and international awards and an honorary degree for her research in infectious diseases. She is a member of the Institute of Medicine (IOM) and is currently serving a 3-year term on the IOM Council, the institution’s governing board. Dr. Cassell has been intimately involved in the formulation of science policy and legislation related to biomedical research and public health. For 9 years she was Chair of the Public and Scientific Affairs Board of the American Society for Microbiology; she has served as an advisor on infectious diseases and indirect costs of research to the White House Office of Science and Technology Policy, and has been an invited participant in numerous congressional hearings and briefings related to infectious diseases, antimicrobial resistance, and biomedical research. She has served two terms on the Liaison Committee on Medical Education (LCME), the accrediting body for U.S. medical schools, as well as other national committees involved in establishing policies on training in the biomedical sciences. She recently completed a term on the Leadership Council of the School of Public Health of Harvard University. Currently, she is a member of the Executive Committee of the Board of Visitors of Columbia University School of Medicine, the Executive Committee of the Board of Directors of the Burroughs Wellcome Fund, Research!America, and the Advisory Council of the Johns Hopkins School of Nursing.

Jeffrey M. Drazen, M.D., was born in Missouri. 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, 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. 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.

Judith E. Fradkin, M.D., is Director of the Division of Diabetes, Endocrinology, and Metabolic Diseases in the National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at the National Institutes of Health. In her 30-year career at NIDDK, Dr. Fradkin has created or directed a diverse array of high-impact clinical and basic research programs, including multi-centered clinical trials to evaluate new approaches to prevent and treat diabetes and its complications, scientific consortia to define the genetic and environmental triggers of diabetes, and diabetes research centers. She came to NIDDK as a clinical associate in 1979 after an endocrinology fellowship at Yale University. Dr. Fradkin graduated from Harvard College, earned her M.D. from the University of California at San Francisco in 1975, and completed an internship and residency at Harvard’s Beth Israel Hospital in Boston. In addition to her oversight of major biomedical research programs, she serves as an endocrinology consultant at the National Naval Medical Center in Bethesda, MD. Dr. Fradkin is the 2003 recipient of the American Medical Association’s Dr. Nathan Davis Award for outstanding public service in the advancement of public health.

Mikhail Gishizky, Ph.D., has more than 25 years experience in research and development within the academic, biotechnology and pharmaceutical industry settings where he led efforts in the development of revolutionary signal transduction inhibitor drugs for the treatment of cancers and other diseases. Dr. Gishizky has been instrumental in establishing two biotechnology companies (SUGEN, Entelos) whose technology is helping bring the promise of personalized medicine to the patient’s bedside. Most recently, as the Chief Scientific Officer at Entelos, Dr. Gishizky supervised the development of capabilities and scientific programs that employ computer simulation models to identify patient populations who would benefit most from new medicines and combination therapies. Use of these capabilities result in faster and more cost effective drug development programs by helping drug developers predict patient responses prior to initiation of therapy, thus helping physicians optimize the beneficial outcome and minimize the risk to the patient. Dr. Gishizky has been a member of the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation since 2005. Earlier in his career, Dr. Gishizky held positions of increasing management responsibility at SUGEN, Pharmacia, and Pfizer as Vice President and Research Zone Head, developing targeted therapies and signal transduction pathway analysis tools to identify patients most likely to respond to given therapies (i.e., Sutent, a leader in the class of signal transduction inhibitors marketed by Pfizer). Dr. Gishizky received his degree in endocrinology at the University of California, San Francisco where his work focused on defining the molecular mechanisms responsible for the development and progression of diabetes mellitus. Dr. Gishizky’s post-doctoral training and academic work focused on cancer biology, hematopoietic cell development. His research led to the development of in vitro systems and an animal model for human chronic myeloid leukemia that was instrumental in the development of Gleevec. Dr. Gishizky has published extensively in the areas of diabetes mellitus and oncology research. During his tenure within the biotech/pharma industry Dr. Gishizky has led research efforts across a broad range of therapeutic areas including oncology, immunology, inflammation, CNS, and metabolic diseases.

Carla J. Greenbaum, M.D., is a Member of the Benaroya Research Institute, where she serves as the Director of the Diabetes Program and the Clinical Research Center and is on the Institutional Review Board. She received her undergraduate (1978) and medical (1981) degrees at Brown University, and completed her endocrinology fellowship at the University of Washington. Dr. Greenbaum is a leader in clinical investigations and trials to prevent or intervene with the diabetes autoimmune process. She currently serves as Vice-Chair of Type 1 Diabetes TrialNet, an NIH-sponsored international consortium to conduct multiple clinical trials in type 1 diabetes. In this role, she is responsible for protocol development and clinical issues study wide. Dr. Greenbaum serves as Director of the North American Network of the Type 1 Diabetes Genetics Consortium and is principal or collaborating investigator on clinical trials for the NIH-sponsored Immune Tolerance Network, Type 1 Diabetes TrialNet, as well as Phase I/II pharmaceutical trials. She also conducts investigator-initiated clinical research in translational and human immunology with a focus on autoimmunity. Dr. Greenbaum is an Associate Editor of the journal, Diabetes Care, and a member of the University of Washington’s CTSA leadership group. She serves on various national and international scientific review committees focusing on clinical and translational research. Currently, Dr. Greenbaum is on the board of directors for the Washington State American Diabetes Association and the Benaroya Research Institute.

Paul C. Hébert, M.D., FRCPC, MHSc, is a Critical Care Physician at the Ottawa Hospital and a Senior Scientist in the Clinical Epidemiology Program at the Ottawa Health Research Institute (OHRI). He also holds the rank of Full Professor in the Department of Medicine (Critical Care) at the University of Ottawa, with cross-appointments to the Departments of An-esthesiology and Surgery as well as Epidemiology & Community Medicine. During his 16 years on the faculty at the University of Ottawa, Dr. Hébert established the Clinical Epidemiology Program at the General Campus of the Ottawa Hospital (1998) and the University of Ottawa Centre for Transfusion Research (1999). In his role as Vice-Chair of Research from 2003 to 2007, he was responsible for the overall strategic direction of research for the Department of Medicine at the University of Ottawa. Among other awards, Dr. Hébert was honored with the “Researcher of the Year Award” from the OHRI (2001) and also received a “Premier’s Research Excellence Award” from the Ontario Ministry of Health and Long-Term Care (2002). On January 2, 2007, Dr. Hébert was appointed Editor-in-Chief of the Canadian Medical Association Journal (CMAJ). Dr. Hébert’s research interests center on the examination of transfusion practice (when and what to transfuse), including the use of alternatives to transfusion, blood conservation and resuscitation fluids, as well as on cardiac resuscitation and trauma. He led a groundbreaking trial titled Transfusion Requirements in Critical Care (TRICC), which was published in the New England Journal of Medicine. This trial showed that patients treated aggressively with transfused blood had a greater rate of organ failure and a higher rate of death during hospitalization than patients whose doctors waited to order a transfusion. As a result, this trial has impacted how clinicians approach blood transfusions worldwide and has generated a significant research agenda around the world. Based upon this seminal trial, Dr. Hébert has undertaken more than 30 research projects with a focus on transfusion practice and bleeding control. To date, he has published in excess of 200 articles, obtained a large number of peer-reviewed grants (with a combined value in excess of $31 million) and trained and mentored numerous individuals. He continues to participate on national peer-review panels, including Canadian Institutes of Health Research (CIHR), National Sciences and Engineering Research Council of Canada (NSERC), and Canada Foundation for Innovation panels. Dr. Hébert is also leading the National Strategy on Patient-Oriented Research (NSPOR), an initiative to set up a new patient-oriented clinical research program for Canada through CIHR. This is a part-time role in addition to his other roles.

Peter K. Honig, M.D., M.P.H., joined AstraZeneca as Head of Global Regulatory Affairs in 2010. Dr. Honig served as Executive Vice President for Worldwide Regulatory Affairs and Product Safety within Development at Merck Research Laboratories since March of 2002. In this role, he is responsible for Global Regulatory Affairs, Worldwide Product Safety and Quality Assurance, Preclinical Pharmacology/Toxicology as well as Worldwide OTC Development. He is former Director of Office of Drug Safety in the FDA’s Center for Drug Evaluation and Research (CDER). He received his baccalaureate, medical, and public health degrees from Columbia University in New York. He has post-graduate training and is board certified in internal medicine and clinical pharmacology and is a Fellow of the American College of Physicians (FACP). Dr. Honig retains faculty appointments at the Uniformed Services University of the Health Sciences and George-town University Medical School. He recently served as President-Elect of the American Society of Clinical Pharmacology and Therapeutics (ASCPT) and has previously served as a Vice President and Chair of its section on Pharmacoepidemiology, Drug Safety, and Outcomes Research. He is the PhRMA representative to the International Conference on Harmonization (ICH) Steering Committee. Dr. Honig joined CDER as a medical officer in the Division of Oncology and Pulmonary Drug Products in 1993. He also served as the FDA representative to the CERTs Steering Committee (Centers for Education and Research on Therapeutics), CDER liaison to the Harvard Clinical Investigators fellowship training program and CDER representative to the MedDRA Management Board, Maintenance and Support Services Organization (MSSO) and the ICH E2B Expert Working Group.

Steven E. Kahn, MB, ChB, is a Professor of Medicine in the Division of Metabolism, Endocrinology, and Nutrition at the University of Washington and VA Puget Sound Health Care System in Seattle. Additionally, he is Associate Director of the Diabetes Endocrinology Research Center at the University of Washington. Dr. Kahn’s research interests include islet β-cell function in normal subjects and the pathogenesis of hyperglycemia in patients with type 2 diabetes. He has also done extensive work on the role of islet amyloid in the pathogenesis of the islet lesion in type 2 diabetes. He continues to be actively involved in two NIH clinical trials—Diabetes Prevention Program Outcomes Study and Look AHEAD—and in A Diabetes Outcome Progression Trial (ADOPT), which he has co-chaired. Among his awards are the Herman Ostrum Memorial Award, the Dana Foundation Feasibility Award, the Novartis Award in Diabetes, the American Diabetes Association Distinguished Clinical Scientist Award, and the R.H. Williams–Rachmiel Levine Award. He has been elected to membership in the American Society for Clinical Investigation and the American Association of Physicians. He has been a member of the National Council of the American Federation of Medical Research (AFMR) and the board of directors of the American Diabetes Association. He currently serves as Deputy Editor of the Journal of Clinical Endocrinology and Metabolism.

Amir Kalali, M.D., is currently Vice President, Medical and Scientific Services, and Global Therapeutic Team Leader CNS, at Quintiles, Inc., focusing on developing novel compounds for the treatment of disorders of the central nervous system (CNS). He is globally responsible for the medical and scientific aspects of development programs in psychiatry and neurology. He is also Professor of Psychiatry at University of California, San Diego. He was the Founding Chairman of the Executive Committee of the International Society for CNS Drug Development (ISCDD), and currently the Executive Secretary. Dr. Kalali is also Chair of the Membership Committee of the International Society for CNS Clinical Trials and Methodology (ISCTM), as well as a member of the Scientific Committee. In these roles he is active in facilitating scientific collaboration between academia, government, and pharmaceutical industry scientists. Dr. Kalali received his M.D. from the University of London, United Kingdom. He completed his psychiatry training at University College and Middlesex School of Medicine, London University. He was then appointed to a clinical research faculty position at the University of California, Irvine, where he also held several positions, including Director of the Mood and Anxiety Disorders Clinical Research Program and the Director of the Consultation-Liaison Psychiatry Program at the Clinical Cancer Research Center. He was also involved as an investigator on several NIH center research programs, including the Center for Neuropathological and Genetic Abnormalities in Depression and the Center for Neuroscience and Schizophrenia, investigating neurobiological brain abnormalities in schizophrenia. Dr. Kalali has been an academic investigator in over 70 psychopharmacological clinical trials and at Quintiles has had medical and scientific responsibility for more than 200 clinical trials. He is an expert in CNS clinical trial methodology, including clinical rating scales, and has trained investigators from over forty countries. Dr. Kalali is the Editor of the journal Psychiatry, and is on the editorial board of several other journals. He has published widely in journals such as the Archives of General Psychiatry, the American Journal of Psychiatry, and the British Journal of Psychiatry. Dr. Kalali regularly presents at national and international scientific meetings, and lectures frequently on psycho-pharmacological and drug development topics. He is particularly interested in educating clinicians worldwide, and is facilitating this currently by being the Chairman of the Educational Committee of the Collegium Internationale Neuro-Psychopharmacologicum (CINP). Dr. Kalali is an active member of the scientific advisory boards of many pharmaceutical companies and sits on the board of directors of Cypress Bioscience. In 2005, 2006, and 2008 PharmaVOICE magazine named Dr. Kalali as one its 100 most inspiring leaders in the life sciences. Dr. Kalali is an active member of many professional societies, including the American Association for the Advancement of Science, the American Association of Pharmaceutical Physicians, the American Society for Clinical Psychopharmacology, the American Psychiatric Association, the Canadian College of NeuroPsychopharmacology, the Collegium Internationale Neuro-Psychopharmacologicum, the Drug Information Association, the International Society for CNS Drug Development, the International Society for CNS Clinical Trials and Methodology, the Royal College of Psychiatrists, United Kingdom, and the Society for Neuroscience.

Ronald L. Krall, M.D., holds a B.A. in mathematics from Swarthmore College and an M.D. from the University of Pittsburgh and completed his training in neurology and a fellowship in clinical pharmacology at the University of Rochester. Over 25 years in the pharmaceutical industry, Dr. Krall worked for four companies (Lorex Pharmaceuticals, Abbott Laboratories, Zeneca/AstraZeneca, and GlaxoSmithKline), holding a variety of positions responsible for drug development and safety of medicines. He concluded his career as Senior Vice President and Chief Medical Officer for GlaxoSmithKline. Over his career he has overseen in some capacity the development of over 20 medicines, including: Ambien; Hytrin for benign prostatic hypertrophy; Depakote for migraine and bipolar disorder; Nolvadex, Arimidex, and Faslodex for breast cancer; Seroquel; Accolate; Diprivan; Iressa; Tykerb; and Entereg. Dr. Krall is a member of the Executive Board of the Observational Medical Outcomes Partnership and of the Advisory Board of the University of Pennsylvania Center for Bioethics. He also serves as a consultant to Frazier Healthcare Ventures.

Clifford Lane, M.D., Clinical Director, National Institute of Allergy & Infectious Diseases, National Institutes of Health (NIH). H. Clifford Lane, a native of Detroit, Michigan, received his M.D. degree from the University of Michigan in 1976. He then completed an internship and residency at the University of Michigan Hospital, Ann Arbor, MI. In 1979, Dr. Lane came to NIH as a Clinical Associate in the Laboratory of Immunoregulation (LIR) at the National Institute of Allergy & Infectious Diseases (NIAID). In 1985, he was appointed Deputy Clinical Director, NIAID and in 1989, he became the Chief of the Clinical and Molecular Retrovirology Section (CMRS) of the LIR, a position he still holds. In 1991, Dr. Lane became Clinical Director of NIAID and in 2006, Director of the Division of Clinical Research and Deputy Director for Clinical Research and Special Projects.

Michael Lauer, M.D., FACC, FAHA, joined the National Heart, Lung, and Blood Institute (NHLBI) in July 2007 as Director of the Division of Prevention and Population Science; he now also serves as the Director of the Division of Cardiovascular Diseases. A board certified cardiologist, he received his M.D. from Albany Medical College in 1985 and underwent post-graduate training within the Harvard University system at Massachusetts General Hospital, Boston Beth Israel Hospital, the Harvard Graduate School of Education, and the Harvard School of Public Health. After completing specialized research training in cardiovascular epidemiology at the Framingham Heart Study, he joined the cardiovascular medicine staff of the Cleveland Clinic in 1993. During 14 years at the Clinic, he established a world-renowned clinical epidemiology research program with primary focus on diagnostic testing and comparative effectiveness. His research led to more than 200 publications in major medical journals (including the New England Journal of Medicine, JAMA, Lancet, and Annals of Internal Medicine), grant support from the American Heart Association and the National Institutes of Health, and election to the American Society of Clinical Investigation. Dr. Lauer has served as Contributing Editor for JAMA, Co-Director of the Cleveland Clinic Coronary Care Unit, Director of Cardiac Clinical Research, and as first Vice-Chair of the Cleveland Clinic IRB. He achieved distinction in medical education, leading the development of an award-winning clinical research curriculum at the newly founded Cleveland Clinic Lerner Medical College at Case Western Reserve University, where he was Professor of Medicine, Epidemiology, and Biostatistics. In November 2008, he was awarded the prestigious Ancel Keys lectureship at the annual meeting of the American Heart Association. In his current position at NHLBI, Dr. Lauer is leading a $1.5 billion per year research division that oversees major programs in cardiovascular biology, translation, clinical research, epidemiology, and prevention.

Musa Mayer is a 20-year survivor, advocate, and author of three books on breast cancer, including Advanced Breast Cancer: A Guide to Living with Metastatic Disease. Her articles on breast cancer and advocacy frequently appear in magazines, newsletters, websites, and scientific journals, and she serves on a number of advisory and editorial boards, as well as steering committees for several clinical trials and registries. She frequently speaks and consults on advocacy and survivorship issues, and on advanced and metastatic breast cancer. As a teacher, Ms. Mayer has served as a faculty member and mentor in the National Breast Cancer Coalition’s science training program, Project LEAD, as well as on the planning committee of the joint NCI-AACR-FDA-Duke University workshop, Accelerating Anti-Cancer Agent Development. As an independent advocate, she has worked with national and local breast cancer organizations, and has been a frequent keynote and plenary speaker at many conferences. Providing daily information and support online for women with advanced (metastatic) breast cancer on the largest Internet mailing list of its kind at www.bcmets.org has informed Ms. Mayer’s work as a Patient Representative and Consultant for the FDA’s Cancer Drug Development Program, enabling her to represent the patient perspective on a number of advisory committees at the FDA. She is currently serving as a member of the FDA’s new Risk Communication Advisory Committee. In 2007, she completed work on “Understanding Evidence-Based Healthcare: A Foundation for Action,” a six-module Web training course for advocates, developed with Dr. Kay Dickersin, Director of the U.S. Cochrane Center at Johns Hopkins, available free at www.cochrane.us. To date, over one thousand advocates and healthcare professionals from around the world have enrolled in this course. Ms. Mayer works as an advocate on a Department of Defense Center of Excellence grant on breast cancer and brain metastases, and in December 2007 launched a website for patients with brain metastases and their families at www.BrainMetsBC.org. In March 2008, Ms. Mayer offered a U.S. perspective at the first Africa Breast Cancer Conference, in Abuja, Nigeria, and has presented the global findings of a global survey of 900 meta-static breast cancer patients at the 2009 conference in Cairo, Egypt. Other projects include a needs assessment survey of women with advanced breast cancer for Living Beyond Breast Cancer, presented at the 2005 San Antonio Breast Cancer Symposium, at the American Psychosocial Oncology Society 2007 conference, and at the 2008 New Strategies in Breast Cancer Conference. Ms. Mayer also serves on the Institute of Medicine Forum on Drug Discovery, Development, and Translation. Her Web resource for women with advanced breast cancer can be found at www.AdvancedBC.org.

Jim McNulty is Vice President of Peer Support for the Depression and Bipolar Support Alliance (DBSA). McNulty collaborates with federal agencies and other organizations to develop recovery-oriented programs and to coordinate DBSA’s federal policy initiatives. In Rhode Island, he serves as the President of DBSA MDDA-RI/Providence, where he has attended support group meetings for more than 20 years, and also as a board member of Mental Health Consumer Advocates of RI. Other positions that McNulty holds are Chair of the SAMHSA/CMHS National Advisory Council’s Subcommittee on Consumer/Survivor Issues and board member of the American Association of Human Research Protection Programs (an accrediting body for research organizations). In addition, McNulty is a member of the APA’s Task Force for the 5th edition of the Diagnostic and Statistical Manual of Mental Disorders. McNulty’s past positions include Director of the Office of Consumer Affairs for Rhode Island’s Division of Behavioral Health as well as Director of Consumer & Recovery Services at Magellan Health Services. He has also served as President of the National Alliance on Mental Illness (NAMI) and as a member of the National Advisory Mental Health Council for the National Institute of Mental Health (NIMH).

Margaret M. Mooney, M.D., is the Chief of the Clinical Investigations Branch in the Cancer Therapy Evaluation Program (CTEP), Division of Cancer Treatment and Diagnosis, at the U.S. National Cancer Institute (NCI), National Institutes of Health (NIH). She was formerly the Interim Director of the Office of Evidence-Based Surgery at the American College of Surgeons in Chicago, Illinois. She received her medical degree from the University of Chicago Pritzker School of Medicine and her general surgical training at the Dartmouth-Hitchcock Medical Center in Lebanon, New Hampshire. She received board certification in surgery in 1997. She completed her surgical oncology fellowship training at the Roswell Park Cancer Institute in Buffalo, New York, where she was also a research fellow in the Department of Cancer Control and Epidemiology. Dr. Mooney also holds an M.S. degree in management from the Massachusetts Institute of Technology in Cambridge, Massachusetts. Dr. Mooney joined the U.S. National Cancer Institute in 2002 as Head of Gastrointestinal and Neuroendocrine Cancer Therapeutics in the Clinical Investigations Branch and was appointed Chief of the Clinical Investigations Branch in May 2009. As Chief of the Clinical Investigations Branch, she is responsible for the direction of the NIH Clinical Trials Cooperative Group Program. This program performs nearly all the phase III cancer treatment trials sponsored by NCI and is a primary vehicle for conducting large, definitive, practice-changing clinical trials. As branch chief, Dr. Mooney supervises a staff that collectively oversees, reviews, and coordinates more than 100 active phase III treatment trials in various cancer types.

William Z. Potter, M.D., Ph.D., Vice President, Translational Neuroscience, Merck Research Labs. Dr. Potter earned his B.A., M.S., M.D., and Ph.D. at Indiana University, after which he held positions of increasing responsibility and seniority over the next 25 years at the National Institutes of Health (NIH) focused on translational neuroscience. While at the NIH, Dr. Potter was widely published and appointed to many societies, committees, and boards; a role which enabled him to develop a wide reputation as an expert in psychopharmacological sciences and champion the development of novel treatments for central nervous system (CNS) disorders. Dr. Potter left the NIH in 1996 to accept a position as Executive Director and Research Fellow at Lilly Research Labs, specializing in the neuroscience therapeutic area and in 2004 joined Merck Research Labs as Vice President of Clinical Neuroscience, then the newly created position of Translational Neuroscience in 2006. His experience at Lilly and MRL in identifying, expanding, and developing methods of evaluating CNS effects of compounds in human brain cover state-of-the-art approaches across multiple modalities. These include brain imaging and cerebrospinal fluid proteomics (plus metabolomics) as well as development of more sensitive clinical, psychophysiological, and performance measures allowing a range of novel targets to be tested in a manner that actually addresses the underlying hypotheses. He has become a widely recognized champion for the position that more disciplined hypothesis testing of targets in humans is the best near term approach to moving CNS drug development forward.

Marc S. Sabatine M.D., M.P.H., is an Investigator in the Thrombolysis in Myocardial Infarction (TIMI) Study Group, an Associate Physician in Cardiovascular Medicine at Brigham and Women’s Hospital, and an Assistant Professor of Medicine at Harvard Medical School. Dr. Sabatine graduated magna cum laude in biochemical sciences from Harvard College and received his medical degree magna cum laude from Harvard Medical School. He did his internal medicine residency and cardiology clinical fellowship at the Massachusetts General Hospital and his research fellowship at TIMI. He received an M.P.H. degree from the Harvard School of Public Health. Dr. Sabatine is an NIH R01-funded investigator whose research focuses on optimizing the treatment of patients with acute coronary syndromes through (1) clinical trials of novel pharmacotherapies, (2) application of proteomics and metabolomics for discovery of biomarkers for risk stratification, and (3) tailoring of therapy using pharmacogenetics. Dr. Sabatine has published extensively in these fields and has authored 100 original research articles. He has been awarded the American College of Cardiology Zipes Distinguished Young Scientist Award.

Jay S. Skyler, M.D., MACP, is currently a Professor of Medicine, Pediatrics, & Psychology, in the Division of Endocrinology, Diabetes, & Metabolism, Department of Medicine, University of Miami Miller School of Medicine, Miami, Florida. He served as Director of that Division from 2000 to 2004. He is Associate Director for Academic Programs, and Area Leader for Immunomodulation and Tolerance, at the Diabetes Research Institute, University of Miami. He was also Program Director of the University’s General Clinical Research Center from 2001 to 2006. He is also an Adjunct Professor of Pediatrics at the Barbara Davis Center for Childhood Diabetes, University of Colorado at Denver. He is Chairman of the National Institutes of Health (National Institute of Diabetes and Digestive and Kidney Diseases)-sponsored Type 1 Diabetes TrialNet, an international network conducting clinical trials to prevent type 1 diabetes or interdict the type 1 diabetes disease process. His research interests are in clinical aspects of diabetes, particularly improving the care of type 1 diabetes through meticulous glycemic control, psychosocial and behavioral support, and immune intervention. He is widely acclaimed for developing “algorithms” for patient adjustment of insulin doses. He is a past President of the American Diabetes Association, the International Diabetes Immunotherapy Group, and the Southern Society for Clinical Investigation, and was a Vice-President of the International Diabetes Federation. He served as a member of the Endocrinology, Diabetes, and Metabolism Subspecialty Examining Board of the American Board of Internal Medicine, as Chairman of the Council of Subspecialty Societies of the American College of Physicians (ACP), and a member of the ACP Board of Regents. He was founding Editor-in-Chief of Diabetes Care, and currently is Scientific Editor of International Diabetes Monitor and Associate Editor of Diabetes Technology & Therapeutics.

Madhukar H. Trivedi, M.D., is currently a Professor and Chief of the Division of Mood Disorders in the Department of Psychiatry at the University of Texas Southwestern Medical Center at Dallas. He holds the Betty Jo Hay Distinguished Chair in Mental Health. Dr. Trivedi is an established efficacy and effectiveness researcher in the treatment of depression. Dr. Trivedi has focused his research on pharmacological, psychosocial, and other nonpharmacological treatments for depression. Dr. Trivedi has been a principal investigator in multiple clinical trials funded through the National Institute of Mental Health (NIMH) and the Texas Department of Mental Health. He has been involved with evidence-based depression guideline development since 1990, when he joined the Depression Guideline Panel of the Agency for Health Care Policy and Research (AHCPR). Dr. Trivedi has been the Director of the Depression Algorithm for the Texas Medical Algorithm Project (TMAP) since its inception. Dr. Trivedi has served as the chair of the Depression Work Group of the International Psychopharmacology Algorithm Project and as the scientific content expert for the San Antonio Cochrane Center’s evidence-based, AHCPR-funded efforts to update the Depression Guidelines. Dr. Trivedi spearheaded the rollout of best practices for the treatment of major depressive disorder (MDD) in various Mental Health and Mental Retardation (MHMR) centers across the state of Texas. Dr. Trivedi is also studying the effectiveness of treatments of depression in primary care. Dr. Trivedi is the Principal Investigator of the Depression Trials Network Combining Medications to Enhance Depression Outcomes (CO-MED) trial, which focuses on the use of specific antidepressant combinations to increase remission rates by treating a broader spectrum of depressed patients and by capitalizing on additive pharmacological effects. Dr. Trivedi is also Principal Investigator of three current NIMH grants titled CBASP Augmentation for Treatment of Chronic Depression (REVAMP), TReatment with Exercise Augmentation for Depression (TREAD), and Computerized Decision Support System for Depression (CDSS-D). Dr. Trivedi is also the Co-Principal Investigator of the Texas Node of the National Institute on Drug Abuse (NIDA)-funded Clinical Trials Network and was the Co-Principal Investigator of the NIMH-funded project titled Sequenced Treatment Alternatives to Relieve Depression (STAR*D). Dr. Trivedi has mentored multiple psychopharmacology post-doctoral fellows and research track residents over the past several years in Mood and Anxiety Disorders and is the Principal Investigator of an NIMH-funded post-doctoral T32 training program. Dr. Trivedi has received numerous awards including the Gerald L. Klerman Award from the National Depressive and Manic-Depressive Association Scientific Advisory Board-NDMDA and the Psychiatric Excellence Award from the Texas Society of Psychiatric Physicians-TSPP. Dr. Trivedi is or has been a member of several institutional review groups of the NIMH. Dr. Trivedi has published over 300 articles and book chapters related to the diagnosis and treatment of mood disorders.

Janet Woodcock, M.D., is the Director of the Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). She also served as CDER Director from 1994 to 2005. Dr. Woodcock has held various positions within the Office of the Commissioner, FDA from October 2003–April 1, 2008. Prior to her 2008 reappointment to CDER, she served as Deputy Commissioner for Operations and Chief Operating Of-ficer, where she was responsible for overseeing agency operations and cross-cutting regulatory and scientific processes. She previously served in other positions at the FDA, including Director, Office of Therapeutics Research and Review, and Acting Deputy Director, Center for Biologics Evaluation and Research. Dr. Woodcock received her M.D. from Northwestern Medical School, and completed further training and held teaching appointments at the Pennsylvania State University and the University of California, San Francisco. She joined the FDA in 1986.

Copyright © 2010, National Academy of Sciences.
Bookshelf ID: NBK50891

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