Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: An Institute of Medicine Workshop

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The development and application of regulatory science - which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products - calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.

Publication information

118 pages · 6 x 9 · paperback
ISBN Paperback: 0-309-22214-1
ISBN Ebook: 0-309-22215-X
DOI: https://doi.org/10.17226/13283

Suggested citation

Institute of Medicine. 2012. Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: Workshop Summary. Washington, DC: The National Academies Press.

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Barry S. Coller

Barry S. Coller, M.D., is the David Rockefeller Professor of Medicine; Head, Laboratory of Blood and Vascular Biology; Physician-in-Chief of The Rockefeller University Hospital; and Vice President for Medical Affairs at The Rockefeller University. He also serves as the founding Director of the Rockefeller University Center for Clinical and Translational Science and the Principal Investigator of the University’s Clinical and Translational Science Award (CTSA) from the National Center for Research Resources of the National Institutes of Health. From 1993 to 2001, Dr. Coller was the Murray M. Rosenberg Professor of Medicine and Chairman of the Samuel Bronfman Department of Medicine at Mount Sinai School of Medicine in New York City. Dr. Coller received his B.A. degree, magna cum laude from Columbia College in 1966, and his M.D. from New York University School of Medicine in 1970. He completed his residency in internal medicine at Bellevue Hospital in New York City and advanced training in hematology and clinical pathology at the National Institutes of Health. He joined the faculty at Stony Brook in 1976 as an Assistant Professor of Medicine in the Division of Hematology. During his years at Stony Brook he was the Clinical Director and Head of the Hematology Division, and Associate Director for Biomedical Research of the Biotechnology Center for Advanced Technology. He was awarded the title of Distinguished Service Professor of Medicine and Pathology at Stony Brook in 1993. Dr. Coller is a member of Phi Beta Kappa, Alpha Omega Alpha, the American Society for Clinical Investigation, the Association of American Physicians, the Institute of Medicine of the National Academies, and the National Academy of Sciences. He is a Fellow of the New York Academy of Medicine, the American Association for the Advancement of Science, and the American Academy of Arts & Sciences, and a Master of the American College of Physicians. Dr. Coller served as President of the American Society of Hematology in 1997-1998, and as the founding President of the Society for Clinical and Translational Science from 2008-2010. He is a member of the Advisory Council of the National Heart, Lung and Blood Institute and the national Principal Investigators’ CTSA Consortium Steering Committee. Dr. Coller’s research interests have focused on hemostasis and thrombosis, in particular platelet physiology. He developed a monoclonal antibody that inhibits platelet function and a derivative of that antibody (abciximab; ReoPro?; Centocor/Eli Lilly) was approved for human use by the FDA in 1994. It is now in clinical use throughout the United States, Europe, Scandinavia, Australia, and portions of Asia, to prevent ischemic complications of percutaneous coronary interventions such as angioplasty and stent insertion. More than 4.0 million patients have been treated with abciximab. He also developed an assay to assess platelet function, and automated derivatives of that assay to monitor therapy with abciximab, aspirin, and clopidogrel (Plavix™) have been approved for human use by the FDA (VerifyNow; Accumetrics). Dr. Coller is the recipient or a co-recipient of fourteen U.S. patents.

Elaine K. Gallin

Elaine K. Gallin, Ph.D. is currently a partner at QE Philanthropic Advisors a consulting firm established in 2010 that serves non-profits specializing in biomedical research, science and math education, and international health. From 1999 through February 2010, Dr. Gallin served as the Doris Duke Charitable Foundation’s (DDCF) first Program Director for Medical Research. In that capacity, she led the creation and management of a portfolio of grant programs that committed more than $185 million to supporting clinical research. Dr. Gallin also designed and led DDCF’s $65 million African Health Initiative. Launched in September 2007, this initiative supports large-scale health services delivery projects designed to provide integrated primary health care linked to rigorous operations and implementation research in several sub-Saharan African communities. Before joining DDCF, Dr. Gallin spent two decades working for the U.S. government, first as a research physiologist and then as research administrator where she last served as the Deputy Director of the Office of International Health Programs in the U.S. Department of Energy overseeing health research programs in countries of the former Soviet Union. During this period, she also spent a sabbatical year working in the Science Committee of the U.S. House of Representatives as a Congressional Science Fellow. Dr. Gallin has participated in numerous professional committees and review panels including several for the Institute of Medicine and the National Institutes of Health. She was a founding member and the first Vice Chair of the Health Research Alliance (an alliance of not-for-profit, non-government research funders). Dr. Gallin is currently a member of the Sickle Cell Disease Advisory Committee at the National Heart Lung and Blood Institute, the Forum on Drug Discovery, Development, and Translation at the Institute of Medicine, the Scientific Advisory Board for the Avon Foundation, and the President’s Council of Cornell Women,. Dr. Gallin received her B.S. from Cornell University and her Ph.D. from the City University of New York, and completed postdoctoral fellowships in Physiology at Johns Hopkins University Medical School and Columbia University Medical School.

Gail H. Cassell

Gail H. Cassell, Ph.D. is a Visiting Professor in the Department of Social Medicine, Harvard Medical School and Vice President of TB Drug Discovery of the not-for-profit Infectious Disease Research Institute in Seattle. Dr. Cassell has recently retired as Vice President, Scientific Affairs and Distinguished Lilly Research Scholar for Infectious Diseases, Eli Lilly and Company in 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 BS 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 PhD 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 Preparedness. 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.

Garret A. FitzGerald

Garret A. Fitzgerald, M.D. is Professor of Medicine and the Elmer Bobst Professor of Pharmacology, University of Pennsylvania, where he chairs the Department of Pharmacology and directs the Institute for Translational Medicine and Therapeutics. Previously, he was Professor and Chair of the Department of Medicine and Experimental Therapeutics, University College, Dublin, Ireland, as well as founding Director of the Center for Cardiovascular Science. Prior to that, he was William Stokes Professor of Experimental Therapeutics and Director of the Division of Clinical Pharmacology, Vanderbilt University School of Medicine, Nashville, Tennessee. Dr. FitzGerald holds membership in a number of learned societies in the United States and the United Kingdom, and has received numerous honors. He has authored 257 original articles in the fields of cardiovascular medicine and pharmacology. His work has contributed to the adoption of low-dose aspirin for cardiac prophylaxis, and he was the first to predict a cardiovascular hazard from selective inhibition of COX-2. He also pioneered the emergence of isoprostanes as biomarkers of oxidant stress. More recently, his group defined the role of peripheral clocks in vascular function and metabolism.

Jesse L. Goodman

Jesse L. Goodman, M.D., M.P.H., became Chief Scientist and Deputy Commissioner for Science and Public Health of the FDA in 2009. He has broad responsibility for and engagement in leadership and coordination of the Agency’s cross-cutting scientific and public health efforts. From 2003-2009, he was Director of FDA’s Center for Biologics Evaluation and Research (CBER), which oversees medical and public health activities critical to US and global preparedness concerning the development, evaluation, safety, quality and availability of biologics. A graduate of Harvard, he received his M.D. from the Albert Einstein College of Medicine and did residency and fellowship training at the Hospital of the University of Pennsylvania and at UCLA (where he was also Chief Medical Resident). Prior to joining FDA, he was Professor of Medicine and Chief of Infectious Diseases at the University of Minnesota, where he directed the multi-hospital Infectious Diseases research, training and clinical programs, and where his NIH funded laboratory first isolated and characterized Anaplasma phagocytophilum, the infectious agent causing a new tick borne disease, human granulocytic ehrlichiosis. He has authored numerous scientific papers and edited the book “Tick Borne Diseases of Humans” published by ASM Press in 2005. Dr. Goodman has been elected to the American Society for Clinical Investigation and to the Institute of Medicine of the National Academy of Sciences, where he is a longstanding member of the Forum on Emerging Threats. He is an active clinician and teacher who is Board Certified in Internal Medicine, Oncology and Infectious Diseases and is Staff Physician and Infectious Diseases Consultant at both the National Naval and Walter Reed Army Medical Centers, and is Adjunct Professor of Medicine at the University of Minnesota.

Harry B. Greenberg

Harry Greenberg, M.D. received his BA 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 Hospital 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 respiratory tree. He has published over 400 articles, chapters and reviews during 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 trials of vaccine safety and efficacy. He has trained a large number of MD and PhD post-doctoral students who are now in independent careers in science and academic medicine. He has also carried out a variety of other administrative roles at Stanford including being the Chief of the GI division of the Department of Medicine, the acting Chairperson of the Department of Medicine (twice) and the ACOS for research at the Palo Alto VA. During a two-year leave of absence from Stanford Dr. Greenberg was the Chief Scientific Officer at a biotechnology company called Aviron (now MedImmune Vaccines) where he played a key role in bringing the live attenuated influenza vaccine to licensure.

Stephen Groft

Stephen Groft, Phamr.D., is the Director, Office of Rare Diseases at the National Institutes of Health. He started his career as a commissioned officer in the United States Public Health Service as a pharmacist in the Indian Health Service with assignments in South Dakota and Oklahoma. From 1982-1986, he served in the Office of Orphan Products Development at the Food and Drug Administration and from 1986-1989 with the Department of Health and Human Services as the Executive Director of the National Commission on Orphan Diseases. As the Director of NIH's Office of Rare Diseases, he has devoted particular attention to efforts to stimulate research with their diseases and develop information for the rare diseases community. The Office has co-sponsored approximately 725 scientific workshops and symposia with the NIH Research Institutes and Centers and patient support groups. Dr. Groft received both his Bachelor of Science in Pharmacy (1968) and Doctor of Pharmacy (1979) degrees from Duquesne University.

Sharon Hesterlee

Sharon Hesterlee, Ph.D., is Senior Director of Research and Advocacy with Parent Project Muscular Dystrophy (PPMD). Dr. Hesterlee joined PPMD in January of 2010 to lead its research efforts. She comes to PPMD after 11 years with the Muscular Dystrophy Association where she established MDA Venture Philanthropy (MVP), a wholly-controlled subsidiary exclusively focused on the discovery and commercialization of therapies for neuromuscular disease. Dr. Hesterlee has negotiated over $30 M in contracts with industry and nonprofit drug development groups, has been involved in the planning of numerous meetings to identify and remove barriers to therapy development for neuromuscular disease and she co-chairs the Working Group on Drug Development Funders for the Health Research Alliance. She is a past member of the Muscular Dystrophy Coordinating Committee and currently serves on the Council for the National Institutes of Neurological Disorders and Stroke. She also serves on the Board of Directors for the Health Research Alliance and the University of Arizona’s School of Mind, Brain and Behavior. She received her Ph.D. in neuroscience from the University of Arizona in 1999. As a graduate student she studied neural development, participated in the Marine Biological Laboratories 1997 course in embryology, and benefited from a departmental Flinn Foundation Training grant.

Petra Kaufmann

Petra Kaufmann, M.D., M.Sc. is the Director of the National Institute of Neurological Disorders and Stroke (NINDS) Office of Clinical Research. Petra is among the foremost experts in the design and management of clinical trials for neuromuscular disorders, including spinal muscular atrophy (SMA), amyotrophic lateral sclerosis (ALS), and mitochondrial diseases. Petra leads the Institute¹s efforts to increase the effectiveness of clinical studies by addressing issues such as optimal trial design, ethical safe conduct of trials, and challenges in patient enrollment. Petra has experience in all phases of clinical research, from conducting laboratory investigation and studies on disease mechanism to serving in key leadership positions on several major multicenter trials. Prior to her appointment at NINDS in 2009, Petra was co-director of the SMA Clinical Research Center and an associate professor of neurology at Columbia University¹s Neurological Institute, where she had been a faculty member since 2000. She was also director of Columbia¹s clinical trials unit within the Pediatric Neuromuscular Clinical Research Network for SMA. Throughout her career, Petra has implemented novel tools and techniques in clinical trials, including the development of Web-based data management systems, telephone-administered neurological scales, imaging tests in ALS, and magnetic resonance spectroscopy to measure a biomarker in mitochondrial disorders.

Jack D. Keene

Jack D. Keene, Ph.D. is James B. Duke Professor of Molecular Genetics and Microbiology at Duke University Medical Center, where he served as chairman of the Department of Microbiology and Director of Basic Science for the Duke Comprehensive Cancer Center for ten years. In 1999 he founded the Duke Center For RNA Biology and served as its first director. Dr. Keene is a graduate of the University of California, Riverside and received his doctorate in Microbiology and Immunology from the University of Washington in Seattle in 1974. After postdoctoral studies in molecular virology at the National Institutes of Health in Bethesda, Maryland, he joined the faculty at Duke University in 1979. Dr. Keene’s research concerns the functions of RNA-binding proteins in cells and viruses. In the early 1980’s, he derived the first genomic sequences of several RNA viruses, including rabies and Ebola; and discovered genetic mutations responsible for the formation of defective interfering RNA viruses. Beginning in 1983, Dr. Keene derived cDNA clones encoding human autoimmune proteins that are also RNA-binding proteins, including the La (SS-B), Ro (SS-A), U1-70K RNP, and other lupus autoantigens. These studies led to the discovery of the RNA Recognition Motif (RRM) family of RNA-binding proteins, one of the largest protein families in the human genome. His research has focused on the functions of RRM proteins in regulating gene expression in the nucleus and cytoplasm. Novel methods devised in his laboratory allowed Dr. Keene to propose an entirely new regulatory model of gene expression that is based upon the organization and dynamics of messenger RNA subpopulations in eukaryotic cells governed by RNA-binding proteins and microRNAs. Thus, Keene’s experimental mammalian cell models as well as experiments in other laboratories using S. cerevisiae have substantiated Keene’s theory of “Posttranscriptional RNA Regulons” that provides a novel mechanism for coordinated regulation of gene expression.

Freda C. Lewis-Hall

Freda C. Lewis-Hall, M.D. has been appointed as Chief Medical Officer and Senior Vice President, Pfizer Inc. Dr. Lewis-Hall will be the senior physician in the company, responsible for enterprise-wide medical, patient safety, regulatory affairs and quality assurance as well as outreach to doctors and other medical professionals. Dr. Lewis-Hall will report to Mr. Kindler and serve on Pfizer’s Executive Leadership Team, its most senior leadership group. She will shape Pfizer’s regulatory and medical policy during a time of fast-changing expectations for healthcare companies and a wave of new therapies in development, especially as information technologies change the ways companies develop medicines, clinicians prescribe them, and patients and payers value them. Prior to joining Pfizer, Dr. Lewis-Hall was Executive Vice President – Medicines Development of Vertex Pharmaceuticals where she was responsible for clinical and non-clinical development as well as both medical and regulatory; she also served as Senior Vice President of Medical Affairs at Bristol-Myers Squibb, Vice President of Research and Development at Pharmacia, and Product Team Leader at Eli Lilly and Company. Dr. Lewis-Hall is a Fellow of the American Academy of Psychiatry. She received her Bachelor of Arts and Sciences from The Johns Hopkins University and her Medical Doctorate from Howard University Hospital and College of Medicine.

Michael E. Mendelsohn

Michael E. Mendelsohn, M.D., is Senior Vice President and Franchise Head, Atherosclerosis and Cardiovascular Diseases at Merck Research Laboratories (MRL). In this role, Dr. Mendelsohn has overall responsibility for scientific direction across drug discovery and development for cardiovascular research. He also works with the company’s Global Human Health division to closely align Merck's research and marketing functions. Prior to his time at Merck, Dr. Mendelsohn spent 17 years at Tufts Medical Center, where he served as the first-ever chief scientific officer and the founder and first executive director of Tufts Medical Center's Molecular Cardiology Research Institute. He was also the first recipient of the Elisa Kent Mendelsohn Professorship of Molecular Cardiology and Medicine at Tufts University School of Medicine. As a physician-scientist, Dr. Mendelsohn has investigated molecular and cellular signal transduction pathways regulating vascular tone and function. His laboratory at Tufts contributed importantly to deciphering the mechanisms of action of endogenous vascular protective molecules, including cyclic GMP and nuclear hormone receptor signaling pathways important in cardiovascular health and disease. Dr. Mendelsohn received his B.A. Magna Cum Laude in Chemistry and English from Amherst College in 1978 and his Medical Degree from Harvard Medical School in 1982. He completed his residency in internal medicine and fellowship in cardiovascular medicine at the Brigham and Women's Hospital (BWH). Dr. Mendelsohn was a member of the faculty of the BWH Cardiology Division from 1988 to 1993 and an assistant professor of medicine at Harvard Medical School. Dr. Mendelsohn then joined the Cardiology Division at Tufts Medical Center in 1993 as the Director of the Molecular Cardiology Research Center and an Associate Professor of Medicine, Tufts University School of Medicine. During his time at Harvard and Tufts, Dr. Mendelsohn was the Principal Investigator on numerous NIH awards, including a Specialized Center of Research (SCOR) in Ischemic Heart Disease and a Program Project Grant studying molecular mechanisms of vascular relaxation. He is the recipient of an Established Investigatorship from the American Heart Association, the Sir William Osler Young Investigator Award of the Interurban Clinical Club, and both the Distinguished Faculty Award and the Milton O. and Natalie V. Zucker Faculty Award for Outstanding Research from Tufts University School of Medicine. Dr. Mendelsohn has served on the editorial board of several publications and has published 150 peer-reviewed articles on numerous cardiovascular disease-related topics. He was an invited speaker at the Nobel Symposium, “Estrogen and Women’s Health” in Sweden in 1999 and the 2008 Nobel Conference, “Recent Advances in Understanding Estrogen Signaling.” He was the Chairman of the Experimental Cardiovascular Sciences Study Section of the NIH from 2000-2002. Dr. Mendelsohn’s awards also include election to the American Society of Clinical Investigation (ASCI), the Association of University Cardiologists (AUC) and the Association of American Physicians (AAP).

Amy Patterson

Amy Patterson, M.D., is the Acting Director of the Office of Science Policy at the National Institutes of Health, in the Department of Health and Human Services (DHHS). In this position, Dr. Patterson advises the NIH Director and the 27 NIH Institute and Center Directors. She provides national leadership on a myriad of science policy issues, including the ethical, legal, social, and economic implications of biomedical research, policy development for human subject protections, the privacy and confidentiality of research records, genetics, health, and society, and dual use research, among others. She is responsible for the NIH’s oversight of gene therapy research, including the activities of the Recombinant DNA Advisory Committee (RAC), as well as for the activities of the Secretary’s Advisory Committee on Genetics, Health and Society; the NIH Clinical Research Policy Analysis and Coordination Program (CRpac); and the National Science Advisory Board for Biosecurity (NSABB). The Office of Science Policy is also the catalyst for a variety of programmatic activities, such as the NIH Office of K-12 Science Education, the NIH Roadmap for Medical Research – an NIH-wide effort to determine and plan for the challenges facing biomedical research in the next decade, including the role of biomedical research in national competitiveness, the face of healthcare in the next three decades, the Trans-NIH Nanotechnology Task Force, and the NIH program on Public-Private Partnerships. Dr. Patterson also oversees NIH’s policy issues as they relate to other federal agencies, serving as the NIH liaison to the Food and Drug Administration (FDA) and the Office of Human Subjects Protections (OHRP), in addition to organizations such as the National Academy of Sciences. She also serves as the NIH liaison to the Foundation for the NIH (FNIH.)

Carl C. Peck

Carl C. Peck, M.D., obtained a B.A. in mathematics and chemistry from the University of Kansas in 1963 and the M.D. in 1968. Following training in internal medicine, he undertook a research fellowship in clinical pharmacology at the University of California San Francisco (1972-74). From 1974 to 1980, Dr. Peck was employed at the Letterman Army Institute of Research, San Francisco, CA, as Chief of the Army Blood Preservation Research Program. In 1980, Dr. Peck became Director of the Division of Clinical Pharmacology and, Professor, Departments of Medicine and Pharmacology, Uniformed Services University, Bethesda, Maryland. Dr. Peck joined the FDA as Director, Center for Drug Evaluation and Research, in October 1987. He was promoted to Assistant Surgeon General in the Public Health Service in October 1990. Retiring from FDA in late 1993, Dr. Peck was appointed “Boerhaave” Professor of Clinical Drug Research at Leiden University in The Netherlands. In 1994 Professor Peck joined the faculty of the Georgetown University Medical Center, as the founding Director of the Center for Drug Development Science. In 1999, Dr. Peck received the FDA Distinguished Alumnus Award. Sweden’s University of Uppsala conferred an honorary doctorate degree (Doctor Honoris Causa) to Dr. Peck in January 2002 in recognition of "outstanding contributions to the science of drug development". Dr. Peck founded NDA Partners LLC in 2003 and in 2004, CDDS moved to UCSF, located in the UC-Washington Center. Throughout his career, he has mentored more than 40 postdoctoral fellows and graduate students and co-founded the American (2007) and Chinese (2009) Courses in Drug Development and Regulatory Science (ACDRS, CCDRS). Dr. Peck’s research interests center on optimizing informativeness, efficiency, speed and economy of drug development and regulation using advanced concepts and techniques of clinical pharmacology, trial designs, and pharmacostatistical modeling and simulation to generate causal evidence of effectiveness and safety. He is an author of more than 150 original research papers, chapters and books.

Nancy S. Sung

Nancy S. Sung, Ph.D., is a Senior Program Officer with the Burroughs Wellcome Fund, having joined its staff in 1997. She oversees grantmaking of $13-15 million annually in the areas of Translational Research and Interfaces in Science. This portfolio includes programs ranging from individual bridging awards for postdoctoral fellows to mid-career awards for clinical investigators to institutional awards for interdisciplinary training programs that bridge the physical/mathematical and biological sciences. She has also shaped BWF's funding and activities in the area of clinical research policy and workforce development. Dr. Sung earned her undergraduate degree from the University of Pennsylvania and a Ph.D. in Microbiology and Immunology from the University of North Carolina at Chapel Hill. Prior to joining the Fund’s staff, Dr. Sung was a visiting fellow at the Chinese Academy of Preventive Medicine’s Institute of Virology in Beijing, with the support of the WHO and the NIH-NCI. Dr. Sung is founding chair of the Health Research Alliance, a growing consortium of private foundations and voluntary health agencies with a shared interest in fostering basic science discoveries and removing barriers that prevent them from being translated into clinical studies and then into better health. She has served as a member of several Institute of Medicine panels including the Clinical Research Roundtable.

Leslie Wheelock

Leslie D. Wheelock, M.S., R.N., is the Director of the Office of Scientific Professional Development (OSPD) in Office of the Chief Scientist at the Food and Drug Administration (FDA). The OSPD manages FDA-wide scientific training and professional development programs to include the Commissioner’s Fellowship Program, professional development activities, scientific exchanges, and scientific achievement award. Prior to her position as OSPD Director, she was the Director of the Division of Manufacturers Assistance and Training at the Center for Biologics Evaluation and Research (CBER), FDA for six years. Previously, Leslie worked for the FDA’s Center for Drug Evaluation and Research (CDER) where she was as an Associate Director for Safety Outreach and Communication co-leading FDA’s Mid-Progress Review for Healthy People 2010 Focus Area Chapter 17, Medical Product Safety. At CDER, she also worked as a Regulatory Health Education Specialist Team Leader serving as the Program Manager for CDER’s Competency Based Training Program which received the Federal Government’s 2000 W. Edward Deming Outstanding Training Award. Before joining the FDA in 1997, Leslie was Nurse Director of the Clinical Research Department at the Washington Cancer Institute, Washington Hospital Center, and she also worked as a Clinical Nurse Specialist and Clinical Nurse Educator at the National Institutes of Health Clinical Center supporting the National Cancer Institute’s Intramural Research Program. As an oncology nurse, she held certifications from the Oncology Nursing Society as an Oncology Certified Nurse (OCN) and Advanced Oncology Certified Nurse (AOCN). Leslie earned a B.A. in Biology from Hood College and M.S. in Nursing from the University of Maryland. She additionally has graduate education in Adult Learning and Human Resource Development from Virginia Polytechnic Institute and State University.

Janet Woodcock

Janet Woodcock, M.D., is the Director of the Center for Drug Evaluation and Research (CDER) at the 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 Officer, 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.

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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development: An Institute of Medicine Workshop

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