Executive Committee

  Professor Paul Herrling, Ph.D. (Chairman, The Biomarkers Consortium)
Chairman of the Board of the Novartis Institute for Tropical Diseases (retired) and Member of the Board, Foundation for the National Institutes of Health

Dr. Paul Herrling is Chairman of the Board of the Novartis Institute for Tropical Diseases, a long-term endeavour to advance medical research in tropical infectious diseases, which historically have received little drug-research funding. He is also a consultant to Novartis Pharma AG since January 2012 after his official retirement.


Prior to his current position, he was Head of Novartis Institutes for Developing World Medical Research (NIDWMR) in Novartis Institutes for Biomedical Research (NIBR), a position he assumed in February 2010.


Before that Dr. Herrling was Head of Corporate Research in Novartis supervising 4 institutes, Head of Global Research of Novartis Pharma and a member of the Pharma Executive Committee (PEC). In this capacity, he directed the integration of the research organizations of Sandoz and Ciba-Geigy following their merger in 1996 to form Novartis.


Dr. Herrling joined Sandoz Pharma in 1975 and held various positions in research at both Sandoz in Basel, Switzerland and Wander in Bern, Switzerland. In 1985, he became Head of the Sandoz Research Institute in Bern and Head of the Preclinical CNS Research Department at Sandoz Pharma in Basel. In 1992, he was made Head of Preclinical Research Basel for Sandoz Pharma and, in 1994, Head of Pharma Corporate Research.


He is also a Professor of Drug Discovery Science at the University of Basel, Switzerland. In addition to scientific editing activities, he serves on several boards, most notably, University Council of the University of Basel , Board of Trustees of the Foundation for NIH and the Scientific Advisory Committee of the Drugs for Neglected Diseases Initiative (DNDi). Since January 2008 he is also the Vice-President of the ETH Board (Swiss Federal Institutes of Technology).


Dr. Herrling obtained his Ph.D. in 1975 from the University of Zurich, Switzerland and was a post-doctorate fellow at the Neuropsychiatric Institute at the University of California, Los Angeles (UCLA) in the USA.

  Christopher P. Austin, M.D.
Director, National Center for Advancing Translational Sciences, National Institutes of Health

Christopher Austin is Director of the National Center for Advancing Translational Sciences (NCATS) at the U.S. National Institutes of Health. NCATS’ mission is to catalyze the generation of innovative methods and technologies that will enhance the development, testing and implementation of diagnostics and therapeutics across a wide range of human diseases and conditions. Before becoming NCATS Director in September 2012, he was Director of the NCATS Division of Preclinical Innovation, which focuses on translating basic science discoveries into new treatments, particularly for rare and neglected diseases, and developing new technologies and paradigms to improve the efficiency of therapeutic and diagnostic development. In this role, he founded and directed numerous initiatives including the NIH Chemical Genomics Center (NCGC), the Therapeutics for Rare and Neglected Diseases (TRND) program, and the Toxicology in the 21st Century (Tox21) program. Before joining NIH in 2002, Dr. Austin directed research programs genomics-based target discovery, pharmacogenomics, and neuropsychiatric drug development at Merck, with a particular focus on schizophrenia. Austin earned an A.B. in biology from Princeton University and an M.D. from Harvard Medical School. He completed clinical training in internal medicine and neurology at Massachusetts General Hospital, and a research fellowship in genetics at Harvard.

  Diana W. Bianchi, M.D.
Director, Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Diana W. Bianchi is the Director of the Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) at the National Institutes of Health (NIH) in Bethesda, Maryland. She is also an investigator in the National Human Genome Research Institute. Formerly, she was the Executive Director of the Mother Infant Research Institute at Tufts Medical Center and the Natalie V. Zucker Professor of Pediatrics, Obstetrics and Gynecology at Tufts University School of Medicine. She was also Vice Chair for Pediatric Research at the Floating Hospital for Children, Boston.


Dr. Bianchi is a magna cum laude graduate of the University of Pennsylvania. She received her M.D. from Stanford University School of Medicine and her postgraduate training in Pediatrics, Medical Genetics and Neonatal-Perinatal Medicine at Boston Children’s Hospital and Harvard Medical School. She is board-certified in all three specialties. Her clinical expertise is in prenatal and neonatal genetics and genomics.


Dr. Bianchi’s research focuses on noninvasive prenatal diagnosis using fetal and placental DNA sequencing and using information from fetal gene expression to develop novel fetal therapies for genetic disorders such as Down syndrome. Dr. Bianchi has published over 300 peer-reviewed articles and is one of four authors of the book Fetology: Diagnosis and Management of the Fetal Patient, which won the Association of American Publishers award for best textbook in clinical medicine in 2000. She is also Editor-in-Chief of the International Society for Prenatal Diagnosis’ (ISPD) official journal, Prenatal Diagnosis.


She has held multiple leadership positions in professional societies, including President of the ISPD and the Perinatal Research Society, council membership in the Society for Pediatric Research and the American Pediatric Society, and as a Director in the American Society for Human Genetics. Dr. Bianchi has received multiple awards, including the Christopher Columbus Spirit of Discovery Award and the Distinguished Faculty Award, both from Tufts University, the 2015 Neonatal Landmark Award from the American Academy of Pediatrics, the 2016 Maureen Andrew Award for Mentorship from the Society for Pediatric Research, and the 2017 Colonel Harland Sanders Award for lifetime achievement in Medical Genetics from the March of Dimes. In 2013 she was elected to the Institute of Medicine (now National Academy of Medicine). She is a past member of the National Advisory Council of the NICHD.

  Linda S. Birnbaum, Ph.D., D.A.B.T., A.T.S.
Director, National Institute of Environmental Health Services and Director of the National Toxicology Program

Linda S. Birnbaum, Ph.D., D.A.B.T., A.T.S., is the Director of the National Institute of Environmental Health Sciences (NIEHS) of the National Institutes of Health (NIH), and Director of the National Toxicology Program.


A board certified toxicologist, Birnbaum has served as a federal scientist for over 35 years. Dr. Birnbaum has received many awards and recognitions, including the Women in Toxicology Elsevier Mentoring Award, the Society of Toxicology Public Communications Award, EPA’s Health Science Achievement Award and Diversity Leadership Award, the National Center for Women’s 2012 Health Policy Hero Award, Breast Cancer Fund Heroes Award, and 14 Science and Technology Achievement Awards, which reflect the recommendations of EPA’s external Science Advisory Board, for specific publications. Dr. Birnbaum was also elected to the Institute of Medicine of the National Academies, and received an honorary degree from Ben-Gurion University in Israel.


Dr. Birnbaum is a former president of the Society of Toxicology, the largest professional organization of toxicologists in the world; former chair of the Division of Toxicology at the American Society of Pharmacology and Therapeutics; and former vice president of the American Aging Association. She is the author of more than 700 peer-reviewed publications, book chapters, and reports. She is also an adjunct professor at several universities, including the University of North Carolina at Chapel Hill and Duke University.


A native of New Jersey, Dr. Birnbaum received her M.S. and Ph.D. in microbiology from the University of Illinois at Urbana-Champaign.

  Peter K. Honig, M.D., M.P.H
Senior Vice President, Worldwide Regulatory Affairs, Pfizer Worldwide Research and Development

Dr. Peter K. Honig is currently Senior Vice President, Worldwide Regulatory Affairs, Pfizer Worldwide Research and Development. Dr. Honig received his baccalaureate, medical and public health degrees from Columbia University in New York. He has postgraduate training and is board-certified in internal medicine and clinical pharmacology and has authored numerous peer reviewed publications and book chapters. He has held senior leadership positions at US Food and Drug administration and Merck Research Laboratories. He is and has been the PhRMA representative to the International Conference on Harmonization (ICH) Steering Committee since 2002 and the current co-chair of the ICH Global Cooperation Group (GCG) whose mission it is to promote regulatory harmonization in non-ICH countries and regions. Dr. Honig has a faculty appointment at the Uniformed Services University of the Health Sciences and is an Associate Editor of Nature Clinical Pharmacology and Therapeutics.

  Christopher Leptak, M.D., Ph.D.
Acting Director, OND Regulatory Science Program and Co-Director of the Biomarker Qualification Program, Office of New Drugs, Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration (FDA)

Chris Leptak, MD, PhD, completed his MD and PhD in microbiology/immunology at UCSF. After residency in Emergency Medicine at Harvard’s combined Mass General and Brigham program, he joined FDA in 2007 as a primary reviewer in OND’s division of gastroenterology products, focusing on immunomodulators for inflammatory bowel diseases. In 2010, he joined OND’s Guidance and Policy Team and became OND’s Biomarker and Companion Diagnostics Lead. His focus is on biomarker and diagnostic device utility in clinical trials and drug development, both for drug-specific programs as well as serving as the Co-Director for the Biomarker Qualification Program.

  Shari M. Ling, M.D.
Deputy Chief Medical Officer, Centers for Medicare and Medicaid Services
Dr. Shari M. Ling currently serves as the Deputy Chief Medical Officer for the Centers for Medicare and Medicaid Services (CMS), and Medical Officer in the Center for Clinical Standards and Quality (CCSQ).  She assists the CMS Chief Medical Officer in the Agency’s pursuit of: empowering patients and doctors to make decisions about their health care, ushering in a new era of state flexibility and local leadership, supports innovative approaches to improve quality, accessibility and affordability and improving the CMS customer experience. Dr. Ling’s committed focus is on the achievement of meaningful health outcomes for patients and families through the delivery of high quality, person-centered care, across all care settings.  Her leadership of the Agency’s clinician engagement efforts as part of this.  Her clinical focus and scientific interest is in the care of persons with dementia, multiple chronic conditions, and functional limitations.  
Dr. Ling represents CMS on several Health and Human Services (HHS) efforts.  She leads the Clinical Services federal workgroup for the National Alzheimer’s Project Plan, and represents CMS on the workgroups to eliminate and prevent Healthcare Associated Infections (HAIs), the National Strategy to Combat Antimicrobial Resistance, and previously Vice President Biden’s Cancer Moonshot Initiative.    
Dr. Ling earned a Master’s in Gerontology in Direct Service at the Leonard Davis School of Gerontology, an MD degree at Georgetown University School of Medicine, completed a rheumatology fellowship at Georgetown University Hospital followed by a Geriatric Medicine fellowship at Johns Hopkins University School of Medicine.  
  Douglas Lowy, M.D.
Deputy Director (Acting Director), National Cancer Institute

Dr. Douglas R. Lowy received his M.D. from New York University School of Medicine in 1968. Between 1970 and 1973, he was a research associate in the Laboratory of Viral Diseases, National Institute of Allergy and Infectious Diseases, NIH. He trained in Internal Medicine at Stanford University and Dermatology at Yale University, and started his laboratory at the National Cancer Institute (NCI) in 1975. In addition to his role as chief of the NCI Laboratory of Cellular Oncology, Dr. Lowy is also chief of the Basic Research Laboratory and serves as a deputy director for the Center for Cancer Research. He has received the Wallace Rowe Award for Virus Research and has been a member of many scientific advisory boards, grants committees, and editorial boards. As of April 1, 2015, Dr. Lowy has been named Acting Director of the NCI.

  Husseini K. Manji, M.D., F.R.C.P.C.
Global Therapeutic Head for Neuroscience, Janssen Research & Development, LLC
Husseini K. Manji, MD, FRCPC is Global Therapeutic Head for Neuroscience at Janssen Research & Development, LLC, one of the Pharmaceutical Companies of Johnson & Johnson. He is also Visiting Professor at Duke University. Dr. Manji was previously Chief of the Laboratory of Molecular Pathophysiology & Experimental Therapeutics at the National Institutes of Health (NIH) and Director of the NIH Mood and Anxiety Disorders Program, the largest program of its kind in the world. 
The major focus of Dr. Manji’s research is the investigation of disease- and treatment-induced changes in gene and protein networks that regulate synaptic and neural plasticity in neuropsychiatric disorders. His work has helped to conceptualize these illnesses as genetically-influenced disorders of synaptic and neural plasticity and has led to the investigation of novel therapeutics for refractory patients. Dr. Manji has also been actively involved in developing biomarkers to help refine these multifactoral diseases.
Dr. Manji has received a number of prestigious awards, including the NIMH Director's Career Award for Significant Scientific Achievement, the A. E. Bennett Award for Neuropsychiatric Research, the Ziskind-Somerfeld Award for Neuropsychiatric Research, the NARSAD Mood Disorders Prize, the Mogens Schou Distinguished Research Award, the ACNP’s Joel Elkes Award for Distinguished Research, the DBSA Klerman Senior Distinguished Researcher Award, the Briggs Pharmacology Lectureship Award, the American Federation for Aging Research Award of Distinction, and the Global Health & the Arts Award of Recognition. He has received PhRMA’s Research & Hope Award for Excellence in Biopharmaceutical Research, 2017. He has also recently been recognized as one of 14 inaugural “Health Heroes” by Oprah magazine. 
Dr. Manji has been inducted into the National Academy of Sciences’ Institute of Medicine (IOM), and has held numerous leadership positions within the IOM, the FNIH Biomarkers Consortium Executive Committee, the ACNP, and the Society of Biological Psychiatry.
Throughout his career, Dr. Manji has also been committed to undertakings related to medical and neuroscience education and has worked with the National Board of Medical Examiners (NMBE), the Howard Hughes Medical Institute Research Scholars Program, and numerous national curriculum committees. He founded and co-directed the NIH Foundation for the Advanced Education in the Sciences Graduate Course in the Neurobiology of Neuropsychiatric Illness, and has received several teaching and mentoring awards. 
Dr. Manji has published extensively on the molecular and cellular neurobiology of severe neuropsychiatric disorders and development of novel therapeutics, with over 300 publications in peer-reviewed journals, including Science, Science Transl Med, Nature Neurosci, Nature Rev Neurosci, NEJM, J Clin Investigation, PNAS, J Neurosci, JAMA Psychiatry, Molecular Psychiatry, and Nature Reviews Drug Discovery.  In addition to serving on the editorial board of numerous journals, Dr. Manji has been Editor of Neuropsychopharmacology Reviews, Deputy Editor of Biological Psychiatry, and Associate Editor of Bipolar Disorders
  Richard (Rich) A. Moscicki, M.D.
Executive Vice President for Science and Regulatory Advocacy and Chief Medical Officer, Pharmaceutical Research and Manufacturers of America (PhRMA)
Richard (Rich) A. Moscicki (Mo-shis-ke), M.D., is the Executive Vice President for Science and Regulatory Advocacy and the Chief Medical Officer at Pharmaceutical Research and Manufacturers of America (PhRMA). 
Dr. Moscicki came to PhRMA in 2017 after serving as the Deputy Center Director for Science Operations for the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) since 2013. While at FDA, Dr. Moscicki brought executive direction of Center operations and leadership in overseeing the development, implementation, and direction of CDER’s programs. Previous positions include serving as Chief Medical Officer at Genzyme Corporation from 1992 to 2011 where he was responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He served and a senior vice president and Head of Clinical Development at Sanofi-Genzyme from 2011-2013. 
Dr. Moscicki received his medical degree from Northwestern University Medical School. He is board certified in internal medicine, diagnostic and laboratory immunology, and allergy and immunology. He completed his residency in Internal Medicine, followed by a fellowship at Massachusetts General Hospital (MGH) in clinical immunology and immunopathology. He remained on staff at MGH and on the faculty of Harvard Medical School from 1979 until 2013.
  Vasum Peiris, M.D., MPH, FAAP, FACC, FASE
Chief Medical Officer for Pediatrics and Special Populations, Center for Devices and Radiological Health, U.S. Food and Drug Administration

As Chief Medical Officer for Pediatrics and Special Populations at the U.S. Food and Drug Administration Center for Devices and Radiological Health, Dr. Peiris provides executive and clinical leadership. He serves as the Center’s senior clinical science and practice expert on pediatrics and pediatric medical device issues and provides executive leadership on Center policies and initiatives associated with medical devices intended for use in pediatric and special populations. As a systems architect, he leads the Center’s outreach for developing strategic initiatives which facilitate synergy among internal and external stakeholders and enhances the ability of the Agency and the medical device ecosystem to optimally serve the public health with respect to the needs of historically underserved populations at the FDA.


Prior to joining the FDA, Vasum was the Joon Park MD Endowed Chair in Medical Excellence, Associate Professor, and Chief of Pediatric and Adult Congenital Cardiology at Texas Tech University Health Sciences Center (TTUHSC) School of Medicine, the Graduate School of Biomedical Sciences, and University Medical Center (UMC), with appointments in both the Departments of Pediatrics and Internal Medicine. He served as the Medical Director of the Pediatric and Adult Congenital Imaging Laboratory and as Medical Director of the Pediatric and Adult Congenital Cardio-Respiratory Exercise Laboratory at TTUHSC/UMC. He provided senior leadership in the development of the TTUHSC Clinical Research Institute, promoting patient-oriented translational and outcomes research. Vasum helped develop the Department of Public Health from its inception, serving as inaugural faculty creating the curricula and program which offers a unique training that encompasses rural health.


Vasum is an accomplished researcher, author and speaker. He has been awarded First Prize-Young Investigator Award by the Section on Cardiology and Cardiac Surgery of the American Academy of Pediatrics. He has worked under grants from a number of major organizations including the Robert Wood Johnson Foundation, the American Federation for Aging Research, the Harvard Medical Scholars Program and has been awarded an Albert Schweitzer Fellowship. He is an author/editor of the FDA-NIH BEST (Biomarkers, EndpointS, and other Tools) Resource e-textbook and has been published in AIM journals. He has been an invited keynote speaker, served as the media lead speaker for FDA initiatives, and lectured as a visiting professor.


Vasum is triple-board certified in Pediatrics and Pediatric Cardiology by the American Board of Pediatrics and in Adult Congenital Cardiology by the American Board of Internal Medicine. He is a Fellow of the American Academy of Pediatrics, the American College of Cardiology, and the American Society of Echocardiography.


Vasum completed fellowship in Pediatric Cardiology and Cardiovascular Research at Harvard Medical School/Children’s Hospital Boston with senior fellowship training in Congenital Cardiovascular Magnetic Resonance Imaging at the Children’s Hospital and the Beth Israel Deaconess Medical Center at Harvard Medical School. He completed residency at the Yale School of Medicine/Yale-New Haven Hospital. Prior to achieving his Medical Doctorate at The University of Vermont College of Medicine, he earned his Master of Public Health ‘With Distinction’ at the Yale School of Medicine Department of Epidemiology and Public Health. Vasum earned his undergraduate degree in the honors major of Ethics, Politics and Economics at Yale University.

  Ellen Sigal, Ph.D.
Founder and Chairperson, Friends of Cancer Research and Member of the Board, Foundation for the National Institutes of Health

Dr. Ellen Sigal is the founder and Chairperson of Friends of Cancer Research (“Friends”), a Washington, DC based non-profit organization. Friends is dedicated to accelerating the nation's progress toward prevention and treatment of cancer by mobilizing public support for cancer research funding and providing education on key public policy issues. Dr. Sigal serves on the National Cancer Institute Board of Scientific Advisors, the National Institutes of Health prestigious Director’s Council of Public Representatives, the Foundation for the National Institutes of Health (chairing its Public-Private Initiatives Committee), the American Society of Clinical Oncology Foundation Board, and the American Association for Cancer Research Foundation Board. Dr. Sigal holds leadership positions with a broad range of cancer advocacy and public policy organizations, and leadership positions with academic health centers including Duke University Comprehensive Cancer Center, the Johns Hopkins Cancer Center Advisory Council and the Howard University Cancer Center Board of Visitors. Dr. Sigal also serves on the C-Change (formerly the National Dialogue on Cancer Research) Research Committee. Most recently she was named to the Entertainment Industry Foundation Oversight Committee for the Biomarker Discovery Project.


During her more than twenty year commitment to advancing the war on cancer, Dr. Sigal has served in a number of critical public positions. She was a Presidential Appointee to the National Cancer Advisory Board from 1992-1998, where she chaired the Budget and Planning Committee that oversees the federal cancer budget. In 1998, Dr. Sigal was named Vice Chairman of the Board of The March, a national grassroots advocacy group that brought thousands of volunteers to Washington to liaise with Congress and to set a new advocacy agenda for cancer research and treatment. Dr. Sigal also has been instrumental in harnessing the energies of Hollywood on behalf of cancer research, serving as President of The Creative Community Task Force for Cancer Research.


For her efforts on behalf of cancer research advocacy, Dr. Sigal was awarded the Association of American Cancer Institutes’ 2004 Public Service Award and was honored by Washingtonian magazine as a 2004 Washingtonian of the Year. In 2004 she was also honored by Research!America, the George Washington University Cancer Institute, and the International Spirit of Life Foundation. Dr. Sigal was awarded the 2002 American Society of Clinical Oncology Special Recognition Award, the 1999 Sidney Kimmel Cancer Center National Leadership Award, and the 1998 American Association for Cancer Research National Leadership Award.


Dr. Sigal received her Ph.D. from Rutgers University in Russian History.

  John Wagner, M.D., Ph.D.
Senior Vice President and Head, Clinical and Transitional Sciences, Takeda

John A. Wagner, MD, PhD, FCP, FAAPS is currently Senior Vice President and Head of Clinical and Translational Sciences at Takeda Pharmaceuticals International Co. He is also currently Immediate Past-President, the American Society for Clinical Pharmacology and Therapeutics (ASCPT). Dr. Wagner has over 20 years of experience in pharmaceuticals, drug research and development, translational medicine, experimental medicine, clinical pharmacology, biomarkers and surrogate endpoints, modeling and simulation, precompetitive collaboration, project leadership and management, portfolio management and prioritization, and scientific strategy. Dr. Wagner received his M.D. from Stanford University School of Medicine and Ph.D. from the Johns Hopkins University School of Medicine. Postgraduate training included Internal Medicine Internship and Residency, as well as Molecular and Clinical Pharmacology Postdoctoral Fellowships at Stanford. He began his professional career in academic research on Cystic Fibrosis and has continued in the pharmaceutical industry, largely in the context of drug development as well as biomarkers. Previously, Dr. Wagner’s professional positions included Senior Consultant to the Institute of Medicine, Vice President and Head, Early Development Pipeline and Projects and Head, Global Project Management at Merck & Co., Inc., Vice President and Head, Clinical Pharmacology, at Merck & Co., Inc and Acting Modeling and Simulation Integrator, Strategically Integrated Modeling and Simulation at Merck & Co., Inc. He is the past chair of the PhRMA Clinical Pharmacology Technical Group, past chair of the adiponectin work group for the Biomarkers Consortium, past committee member of the National Academies Institute of Medicine Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease, and past member of the National Academies Institute of Medicine National Cancer Policy Forum. Over 200 peer-reviewed publications detail work across a variety of therapeutic areas and disciplines.

  Janet Woodcock, M.D.
Director, Center for Drug Evaluation and Research, U.S. Food and Drug Administration (FDA)

Dr. Janet Woodcock joined FDA in 1986 and has most recently held various positions within the Office of the Commissioner, FDA: from October 2003- April 1, 2008 as Deputy Commissioner and Chief Medical Officer, Deputy Commissioner for Operations and Chief Operating Officer and Director, Critical Path Programs. She oversaw scientific and medical regulatory operations for FDA. Dr. Woodcock served as Director, Center for Drug Evaluation and Research at FDA 1994-2005. She previously served in other positions at FDA including Director, Office of Therapeutics Research and Review and Acting Deputy Director, Center for Biologics Evaluation and Research.


Dr. Woodcock has close interactions with diverse constituencies, including the clinical and scientific communities, members of Congress and the Administration, national media, patient and consumer advocacy groups, the international drug regulatory community, the regulated industry, and representatives of the Federal and State agencies. She frequently appears in or is quoted by the national media and has testified repeatedly before Congress.


Dr. Woodcock has led many cross-Agency initiatives while at FDA. She introduced the concept of pharmaceutical risk management in 2000 as a new approach to drug safety. She has led the “Pharmaceutical Quality for the 21st Century Initiative” since 2002. This effort, to modernize pharmaceutical manufacturing and its regulation through the application of modern science and quality management techniques, has been highly successful in meeting its objectives. She has spearheaded an initiative on pharmacogenomics that has led to unprecedented agency-industry interactions on pharmacogenomics use in drug development. Over the last 18 months, she has been leading FDA’s “Critical Path” Initiative, which is designed to improve the scientific basis for medical product development.


Dr. Woodcock was director of the Center for Drug Evaluation and Research from 1994-2005. During this period, review times for new and generic drugs were cut in half, while the standards for quality, safety and effectiveness were improved. Dr. Woodcock also oversaw initiatives to automate submission and review of applications and adverse event reports. Now nearing completion, these initiatives will allow the Center to make much more drug information publicly available.


Under Dr. Woodcock’s leadership, CDER’s regulatory decision-making was made more open and transparent to the public. Changes included publishing CDER’s regulatory procedures and policies, developing over 100 technical “guidances” that describe regulatory standards, providing an unprecedented degree of participation of consumer and patient representatives in FDA processes, and creating an extensive Center web site which includes drug reviews and consumer information.


Prior to joining CDER, Dr. Woodcock was director of the Office of Therapeutics Research and Review, Center for Biologics Evaluation and Research (CBER). There she oversaw approval of the first biotechnology-based treatments for multiple sclerosis and cystic fibrosis. She also served as Acting Deputy Director of CBER for several years.


Dr. Woodcock has earned numerous FDA awards including six Commissioner’s Special Citations. She also received a Presidential Rank Meritorious Executive Award, the Nathan Davis Award from the American Medical Association (1999), the Roger W. Jones Award for Executive Leadership from American University (2000) the Public Health Leadership Award (2004) from the National Organization for Rare Disorders (NORD), the VIDA Award from The National Alliance for Hispanic Health (2005), The Leadership Award in Personalized Medicine from the Personalized Medicine Coalition, three HHS Secretary’s Distinguished Service Awards and the HHS Asian-Pacific Network achievement award (2001).


Dr. Woodcock received her M.D. from Northwestern University Medical School in 1977. She received her undergraduate degree from Bucknell University. She has held teaching appointments at Pennsylvania State University and the University of California at San Francisco. She lives in Maryland with her husband and is the mother of two daughters.