Appendix C

Participant Biographies

CO-CHAIRS

Martin Philbert, Ph.D., is professor of toxicology and dean of the University of Michigan School of Public Health. He earned his B.S. from the College of Arts and Technology at Cambridge, and his doctorate from the London University Royal Postgraduate Medical School. He was awarded a postdoctoral fellowship in the Neurotoxicology Laboratories at Rutgers University. Dr. Philbert served as a research assistant professor at Rutgers’ Neurotoxicology Laboratories until he joined the faculty at the University of Michigan School of Public Health as an assistant professor of toxicology. He was promoted to associate professor in 2000 and to professor in 2004. He served as associate chair for research and development in the Department of Environmental Health Sciences from 2000 to 2003. In 2004, Dr. Philbert was appointed senior associate dean for research of the School of Public Health, a position he held through 2010 when he was appointed as dean. He also served as interim director of the Center for Risk Science and Communication. Dr. Philbert has maintained a continuously federally funded portfolio of basic research activities throughout his career. His research focuses on the development of flexible polymer nanoplatforms for optical sensing of ions and small molecules and the early detection and treatment of brain tumors. Other research interests include the mitochondrial mechanisms of chemically induced neuropathic states. Most recently his work has been funded by the National Institutes of Health, the U.S. Department of the Air Force, and the National Cancer Institute. He is the author of more than 150 peer-reviewed scholarly manuscripts, abstracts,

and book chapters. Dr. Philbert is the chair of the newly formed U.S. Environmental Protection Agency (EPA) Chemical Assessment Advisory Committee, which provides peer review of risk assessments produced under the auspices of EPA’s Integrated Risk Information System and a standing member of the Agency’s Science Advisory Board. He also served a 4-year term on the National Advisory Environmental Health Sciences Council of the National Institute of Environmental Health Sciences and provides consultation to the federal agencies on a variety of issues surrounding emerging nanotechnologies, nanomedicine, health, and safety. Dr. Philbert is an elected member of the National Academy of Medicine, a Fellow of the Royal Society of Chemistry (UK), a Fellow of the Academy of Toxicological Sciences, and a member of the Division on Earth and Life Studies of the National Academies of Sciences, Engineering, and Medicine.

Alastair Wood, M.D., was professor of both medicine and pharmacology at Vanderbilt University Medical School and served as assistant vice chancellor for clinical research and associate dean, Vanderbilt Medical School, before being appointed Emeritus Professor of Medicine and Emeritus Professor of Pharmacology in 2006. His current academic appointments are professor of medicine and professor of pharmacology at Weill Cornell Medical College. He is a partner at Symphony Capital LLC, a private equity company investing in the clinical development of novel biopharmaceutical products. Dr. Wood is a member of many societies, including the National Academy of Medicine, American Association of Physicians, American Society for Clinical Investigation, Honorary Fellow, American Gynecological and Obstetrical Society, Fellowship of the American College of Physicians, Fellowship of the Royal College of Physicians of London, and Fellowship of the Royal College of Physicians of Edinburgh. He was the 2005 recipient of the Rawls-Palmer Award and in 2008 received the honorary degree of Doctor of Laws, honoris causa, from the University of Dundee. Dr. Wood has served on a number of editorial boards, including the New England Journal of Medicine Editorial Board and was the Drug Therapy Editor of the New England Journal of Medicine from 1985 to 2004. His research has resulted in more than 300 articles, reviews, and editorials.

PLANNING COMMITTEE

Russ Altman, M.D., Ph.D., is a professor of bioengineering, genetics, and medicine (and of computer science, by courtesy) and past chair of the Bioengineering Department at Stanford University. His primary research interests are in the application of computing and informatics technologies to problems relevant to medicine. He is particularly interested in methods for understanding drug action at molecular, cellular, organism, and population levels.

His lab studies how human genetic variation impacts drug response (e.g., http://www.pharmgkb.org). Other work focuses on the analysis of biological molecules to understand the action, interaction, and adverse events of drugs (http://features.stanford.edu). Dr. Altman holds an A.B. from Harvard College, an M.D. from Stanford Medical School, and a Ph.D. in Medical Information Sciences from Stanford. He received the U.S. Presidential Early Career Award for Scientists and Engineers and a National Science Foundation CAREER Award. He is a fellow of the American College of Physicians, American College of Medical Informatics, American Institute of Medical and Biological Engineering, and American Association for the Advancement of Science. He is a member of the National Academy of Medicine. He is a past president, founding board member, and a fellow of the International Society for Computational Biology, and a past president of the American Society for Clinical Pharmacology & Therapeutics. He has chaired the Science Board advising the U.S. Food and Drug Administration commissioner. He currently serves on the advisory committee to the National Institutes of Health director. Dr. Altman is board certified in internal medicine, and has recently been certified in the first class of diplomates in clinical informatics. He is an organizer of the annual Pacific Symposium on Biocomputing (http://psb.stanford.edu), and a founder of Personalis, Inc. He received the Stanford Medical School graduate teaching award in 2000 and the mentorship award in 2014.

Sharon Hesterlee, Ph.D., is the new chief science officer for the Myotonic Dystrophy Foundation. Previously, she has been the vice president of research for Parent Project Muscular Dystrophy (PPMD), where she oversaw research investments in Duchenne muscular dystrophy (DMD), began the DMD Research Round Table, and participated in the development of the first quantitative benefit-risk study in a rare disease and in the first patient organization–generated U.S. Food and Drug Administration draft guidance. Before PPMD, she spent 11 years with the Muscular Dystrophy Association (MDA), where as a senior vice president she established MDA Venture Philanthropy and MDA’s Translational Research program, brokering and managing more than $30M in drug development contracts with industry and other partners. She has also served as part-time scientific director for the Association for Frontotemporal Degeneration (FTD), where she managed the FTD Treatment Study Group. She has been involved in the planning of numerous meetings to identify and remove barriers to therapy development for rare disease and she has served on several advisory boards, such as the U.S. Department of Health and Human Services Federal Advisory Committee for muscular dystrophy and the NINDS (National Institute of Neurological Diseases and Stroke) Council. Dr. Hesterlee received her Ph.D. in Neuroscience from the University of Arizona in 1999. She currently serves on the board of directors of the Health Research Alliance and

the advisory board to the University of Arizona’s School of Mind, Brain and Behavior.

Rusty Kelley, Ph.D., joined the Burroughs Wellcome Fund (BWF) as a program officer in 2013 and directs the Fund’s Scientific Interfaces and Regulatory Science initiatives. Prior to his position at BWF, Dr. Kelley was the director of preclinical and translational medicine at Tengion, Inc., a regenerative and tissue engineering company originating from Boston Children’s Hospital and Wake Forest University. As a senior scientist and then as a director at Tengion, Dr. Kelley was responsible for stewarding a broad-based intellectual property (IP) portfolio, designing and executing good laboratory practice (GLP) efficacy and safety studies, authoring the pharm-tox and risk-benefit analysis sections of U.S. and European regulatory filings, and developing early-phase clinical trials for the renal and bladder franchises. Prior to Tengion, Dr. Kelley was a postdoctoral fellow at the University of North Carolina at Chapel Hill, where he was awarded an American Heart Association fellowship under Dr. Cam Patterson, a BWF Translational Science awardee. In Patterson’s translational genomics group, Dr. Kelley published in vascular biology using genetic BMP and VEGF mouse models of cardiovascular disease that included a faculty of 1,000 Journal of Cell Biology (JCB) manuscript describing a novel endocytic mechanism for regulating BMP signaling. Prior to his postdoc, Dr. Kelley was awarded a Stanley Scott Cancer Center graduate fellowship at Louisiana State University’s (LSU’s) Health Sciences Center, where he studied and published in Phase I, Cyp450-mediated drug metabolism. Before attending graduate school, Dr. Kelley worked in clinical development at PPD, Inc., of Wilmington, North Carolina, where he helped oversee multiple Phase I-III clinical trials (including for then Glaxo-Wellcome) in the United States and overseas in the divisions of General Medicine, National Institutes of Health (NIH)-sponsored trials, and Infectious Disease. Prior to joining PPD, Inc. in 1995, he worked for AAIPharma, also of Wilmington, North Carolina, in the formulation and development group of their Pharmaceutics Division following a wet chemistry bench position in their Analytical Division. He received a bachelor’s degree in chemistry from the University of North Carolina at Chapel Hill and earned his Ph.D. from LSU in pharmacology and experimental therapeutics.

Emma Meagher, M.D., serves as associate professor of medicine and pharmacology at the Perelman School of Medicine at the University of Pennsylvania in Philadelphia. Dr. Meagher graduated cum laude with her M.D. from the Royal College of Surgeons in Dublin, Ireland, and completed postgraduate training in internal medicine, cardiology, and pharmacology. In her role as senior associate dean and chief clinical research officer,

Dr. Meagher is responsible for the institution’s clinical research infrastructure and its portfolio. Dr. Meagher’s research interest is the development of novel therapeutics for dyslipidemia. Her educational interests are in the fields of translational research methodology and career development for clinical and translational scientists and novel modalities for education in pharmacology to undergraduate medical students. She currently serves on the Association for Clinical and Translational Science board of directors and chairs its education committee.

Robert Meyer, M.D., is the inaugural director of the Virginia Center for Translational and Regulatory Sciences at the University of Virginia’s (UVA’s) School of Medicine, as well as being an associate professor of public health sciences. In this position, he is heading a group that will develop a regulatory science educational track, as well as provide regulatory and translational knowledge resources to university and external entities who seek to move basic science discoveries to the bedside. He is a member of the U.S. Pharmacopeia Expert Panel revising the Medicare Model Guidelines and on the Benefit–Risk Advisory Council for FasterCures. Prior to joining the faculty at UVA, Dr. Meyer was vice president and head, Global Regulatory Strategy, Policy and Safety at Merck Research Laboratories, where he was responsible for leading an organization of more than 1,000 individuals in the oversight of all regulatory strategy and operations, global regulatory policy and intelligence, and global product safety and pharmacovigilance. At Merck, Dr. Meyer served on the Early and Late Stage Development Review Committees and the Safety Review Committee and chaired the Development Policy Committee. Externally, Dr. Meyer chaired the Regulatory Affairs Coordinating Committee for Pharmaceutical Research and Manufacturers of America (PhRMA) from 2012 to 2013, and served as a key PhRMA negotiator on PDUFA V. Prior to Merck, Dr. Meyer worked for the U.S. Food and Drug Administration (FDA) from 1994 to 2007. In his final 5 years at FDA, Dr. Meyer was the director for the Office of Drug Evaluation II within the Center for Drug Evaluation and Research (CDER), with responsibilities for pulmonary and allergy, metabolic and endocrine, and analgesics, anesthetics and rheumatologic drug products. Dr. Meyer was involved in several CDER initiatives, amongst them chairing the development of the Pre-Market Risk Assessment guidance. Additionally, he participated with the FDA negotiation team for PDUFA III and IV. While at FDA, Dr. Meyer served as a technical expert to the Medical Aerosols Technical Options Committee to the Montreal Protocol on the Protection of the Ozone Layer, work for which he was recognized by both the United Nations Environmental Programme and the U.S. Environmental Protection Agency. He also served on the third expert panel for the National Heart, Lung, and Blood Institute’s National Asthma Education and Prevention

Program (NAEPP EPR3). Prior to joining FDA, Dr. Meyer was a practicing pulmonologist and critical care specialist on the faculty of the Oregon Health & Science University, where he helped create the medical service for the Lung/Heart-Lung Transplantation service. Dr. Meyer received his M.D. from the University of Connecticut School of Medicine and his bachelor’s degree in Natural Science from Lehigh University.

Stephen Ostroff, M.D., served as acting commissioner of the U.S. Food and Drug Administration (FDA) from April 2015 to February 2016. Previously, he was FDA’s chief scientist, responsible for leading and coordinating FDA’s crosscutting scientific and public health efforts. The Office of the Chief Scientist works closely with FDA’s product centers, providing strategic leadership and support for FDA’s regulatory science and innovation initiatives. Dr. Ostroff joined FDA in 2013 as chief medical officer in the Center for Food Safety and Applied Nutrition and senior public health advisor to FDA’s Office of Foods and Veterinary Medicine. Prior to that, he served as deputy director of the National Center for Infectious Diseases at the Centers for Disease Control and Prevention (CDC). He retired from the Commissioned Corps of the U.S. Public Health Service at the rank of Rear Admiral (Assistant Surgeon General). Dr. Ostroff was the director of the Bureau of Epidemiology and acting physician general for the Commonwealth of Pennsylvania and has consulted for the World Bank on public health projects in South Asia and Latin America. Dr. Ostroff graduated from the University of Pennsylvania School of Medicine and completed residencies in internal medicine at the University of Colorado Health Sciences Center and Preventive Medicine at CDC. He is a fellow of the Infectious Diseases Society of America and the American College of Physicians. Prior to assuming the role of FDA’s acting commissioner, he chaired the Public Health Committee of the American Society for Microbiology’s Public and Scientific Affairs Board.

Paul Seligman, M.D., M.P.H., is executive director for global regulatory policy at Amgen. Prior to joining Amgen in 2012, he had a public health career of nearly 30 years in the federal government. At the U.S. Food and Drug Administration (FDA), he served as the director of FDA’s Latin America Regional Office, as associate director for safety policy and communication in the Center for Drug Evaluation and Research (CDER), and as the director of the Office of Pharmacoepidemiology and Statistical Science. Before joining FDA in 2001, Dr. Seligman served for 7 years as the deputy assistant secretary for health studies at the Department of Energy. He began his Public Health Service (PHS) career in 1983 at the Centers for Disease Control and Prevention (CDC) as an Epidemic Intelligence Service officer. He completed a primary care internal medicine residency at The Cambridge Hospital in Cambridge, Massachusetts, prior to join-

ing CDC. From 1974 to 1976, he was a Peace Corps volunteer in Kenya. Dr. Seligman holds an M.D. from the University of California, Davis; an M.P.H. in industrial health from the University of Michigan; and a B.S. in Chemistry from Yale University. He is board certified in internal medicine, occupational medicine, and public health and general preventive medicine. He is a retired commissioned Oofficer from the PHS, having attained the rank of Rear Admiral.

Brian Strom, M.D., M.P.H., is the recently appointed inaugural chancellor of Rutgers Biomedical and Health Sciences (RBHS) and the executive vice president for Health Affairs at Rutgers University. RBHS has nine schools and five centers/institutes, and includes academic, patient care, and research facilities. Dr. Strom was formerly the executive vice dean of institutional affairs, founding chair of the Department of Biostatistics and Epidemiology, founding director of the Center for Clinical Epidemiology and Biostatistics, and founding director of the Graduate Program in Epidemiology and Biostatistics, all at the Perelman School of Medicine of the University of Pennsylvania (Penn). Dr. Strom earned a B.S. in molecular biophysics and biochemistry from Yale University in 1971, and then an M.D. from the Johns Hopkins University School of Medicine in 1975. From 1975 to 1978, he was an intern and resident in internal medicine, and from 1978 to 1980, he was a National Institutes of Health (NIH) fellow in clinical pharmacology at the University of California, San Francisco. He simultaneously earned an M.P.H. in epidemiology at the University of California, Berkeley. He has been on the faculty of the University of Pennsylvania School of Medicine since 1980. The Center for Clinical Epidemiology and Biostatistics (CCEB) that he created at Penn includes more than 550 faculty, research and support staff, and trainees. At the time Dr. Strom stepped down, CCEB research received nearly $49 million/year in extramural support. Its total budget was approximately $67 million. Although Dr. Strom’s interests span many areas of clinical epidemiology, his major research interest is in the field of pharmacoepidemiology, that is, the application of epidemiologic methods to the study of drug use and effects. He is recognized as a founder of this field and for his pioneer work in using large automated databases for research. He is editor of the field’s major text and editor-in-chief of Pharmacoepidemiology and Drug Safety, the official journal of the International Society for Pharmacoepidemiology. In addition to writing more than 580 papers and 14 books, he has been principal investigator (PI) for more than 275 grants, including more than $115 million in direct costs alone. Dr. Strom has been invited to give more than 400 talks outside his local area, including presentations as the keynote speaker for numerous international meetings. He has been a consultant to NIH, the U.S. Food and Drug Administration (FDA), Centers for Disease

Control and Prevention (CDC), United States Pharmacopeial Convention (USP), Association of American Medical Colleges (AAMC), Joint Commission on Accreditation of Healthcare Organizations (JCAHO), foreign governments, most major pharmaceutical manufacturers, and many law firms. Dr. Strom is also a nationally recognized leader in clinical research training. At the Perelman School of Medicine, Dr. Strom developed graduate training programs in epidemiology and biostatistics. Dr. Strom was PI or Co-PI of 11 different NIH-funded training grants, each of which supported clinical epidemiology trainees in funded training grants and in different specialties and subspecialties, and has been the primary mentor for more than 40 former and current clinical research trainees and numerous junior faculty members. Internationally, Dr. Strom was a key contributor to the conceptualization and planning that led to the development of the International Clinical Epidemiology Network (INCLEN), created in 1979 with support provided by the Rockefeller Foundation to provide clinical research training to clinicians from selected developing country sites. Dr. Strom was a member of the board of regents of the American College of Physicians, the board of directors of the American Society for Clinical Pharmacology and Therapeutics, and the board of directors for the American College of Epidemiology, and is currently a member of the board of directors for the Association for Patient-Oriented Research. He was previously president of the International Society for Pharmacoepidemiology and the Association for Clinical Research Training. Dr. Strom was on the Drug Utilization Review Committee and the Gerontology Committee of USP, served on the Drug Safety and Risk Management Advisory Committee for FDA, and chaired or was a member of a number of Institute of Medicine committees. He is an elected member of the National Academy of Medicine. Dr. Strom is a member of the American Epidemiology Society, and is one of a handful of clinical epidemiologists ever elected to the American Society of Clinical Investigation and American Association of Physicians. He has been awarded a multitude of awards, including the John Phillips Memorial Award for Outstanding Work in Clinical Medicine, an award from the American College of Physicians that is considered to be one of the highest awards in internal medicine. Dr. Strom also received the 2013 Association for Clinical and Translational Science/American Federation for Medical Research National Award for Career Achievement and Contribution to Clinical and Translational Science for translation from clinical use into public benefit and policy. Penn awards that Dr. Strom received include the Class of 1992 Class Teaching Award and the Samuel Martin Health Evaluation Sciences Research Award. Dr. Strom received the 2004 Christian R. and Mary F. Lindback Award, the University’s most prestigious teaching award, in recognition of the contribution he has made in his career to clinical research teaching.

SPEAKERS/PANELISTS

Darrell Abernethy, M.D., Ph.D., is the lead for the biosimilars program in the Office of Clinical Pharmacology. In addition, he is responsible for leading the development of a pharmacological mechanism–based safety program in the Office of Clinical Pharmacology to work in synergy with efforts in the Office of Surveillance and Epidemiology and other offices and centers at the U.S. Food and Drug Administration (FDA). Dr. Abernethy brings more than 25 years of experience in medicine and pharmacology, including positions in academia, practice, and research. Prior to joining FDA, he served as chief science officer at United States Pharmacopeial Convention (USP). Dr. Abernethy earned his M.D. and Ph.D. from the University of Kansas School of Medicine. In addition to his work at FDA, he is currently a professor of medicine (geriatrics) and of pharmacology and molecular science (part-time) at the Johns Hopkins University School of Medicine. Dr. Abernethy’s training in internal medicine was at the University of Miami/ Jackson Memorial Hospital, and postdoctoral training in clinical pharmacology at Massachusetts General Hospital followed this. He is board certified in internal medicine and clinical pharmacology. He joined the faculty at Tufts–New England Medical Center as an assistant professor. Following this he was at Baylor College of Medicine, where he became associate professor of medicine. Dr. Abernethy then moved to Brown University School of Medicine as chief of the Division of Clinical Pharmacology and became a professor of medicine at that institution. He then moved to Georgetown University School of Medicine as Francis Cabell Brown Professor of Medicine and Pharmacology and director of the Division of Clinical Pharmacology. Dr. Abernethy then joined the National Institute of Aging as chief of the Laboratory of Clinical Investigation in the intramural research program. Following that he served as chief science officer at USP. Dr. Abernethy’s studies of mechanisms of peripheral distribution of drugs and drug disposition and effect in obesity and pharmacokinetic/pharmacodynamic relationships of cardiovascular drugs in aging have been well received and led to his being named to the Institute for Scientific Information’s Most Highly Cited Researchers in Pharmacology. He has received the Rawls-Palmer Award from the American Society for Clinical Pharmacology and Therapeutics, the Nathaniel Kwit Award from the American College of Clinical Pharmacology, and the Abrams Award in Geriatric Clinical Pharmacology from the American Society for Clinical Pharmacology and Therapeutics. As an educator, he has served on the National Board of Medical Examiners (NBME) Pharmacology Test Committee (1992–1996; chair 2009–present), chair of the NBME (now called the United States Medical Licensing Examination [USMLE]) Applied Pharmacology Committee (1997–2000), the USMLE biostatistics task force and Step 1 Test Committee (2000–2006),

the USMLE International Foundations of Medicine Task Force (2010–2012), and the Evidence-Based Medicine Committee (2013–present). As an extramural investigator, he served on the National Institute of General Medical Sciences Pharmacological Sciences study section (1988–1992), the FDA generic drugs (1990–1992) and cardiorenal (1992–1996) advisory committees, and as chair of the U.S. Department of Veterans Affairs merit review geriatrics subcommittee (1998–2000). Dr. Abernethy’s professional affiliations include serving as president of the American Society of Clinical Pharmacology and Therapeutics (1991–1992). In addition, he has served as a member of the editorial boards of the Journal of the American Geriatrics Society, Biopharmaceutics and Drug Disposition, and Molecular Interventions, and as editor-in-chief of Pharmacological Reviews. He is currently on the editorial boards of Clinical Pharmacology and Therapeutics, the Journal of Clinical Psychopharmacology, Drugs, and Drugs and Therapy Perspectives; is associate editor of the Journal of Pharmacology and Experimental Therapeutics; and is deputy editor of Pharmacology Research & Perspectives.

Brian Alexander, M.D., M.P.H., is a radiation oncologist specializing in research and clinical care for patients with tumors of the central nervous system. He is the disease center leader for radiation oncology at the Center for Neuro-Oncology, Dana-Farber Cancer Institute. His research interests include the characterization of the radiation responsiveness of glioma stem cells, preclinical evaluation of novel therapeutics, and innovative designs for early-phase clinical trials. Dr. Alexander’s work has been pioneering in the area of biomarker-based and Bayesian clinical trial designs in neurooncology. Dr. Alexander previously served as a White House fellow and special assistant to the Secretary of Veterans Affairs. Under Secretary Peake, he helped prepare the U.S. Department of Veterans Affairs (VA) for the transition of administrations and worked to develop a public reporting system for quality performance indicators that formed the foundation for VA ASPIRE. During the transition and the early part of the Obama administration, Dr. Alexander served as a health policy advisor to Secretary Shinseki. In addition to advising on daily operations, he led the department’s effort to organize the International Roundtable on Clinical Quality and Patient Safety, coordinated the VA’s preparation for the Obama administration’s Health Care Summit, and organized the stand-up and directed the activities of the VA’s Coordinating Council on National Health Reform. Dr. Alexander was a member of the Institute of Medicine’s Committee on the Governance and Financing of Graduate Medical Education. He is a graduate of Kalamazoo College, the University of Michigan Medical School, and the Harvard School of Public Health.

Sandy Allerheiligen, Ph.D., is vice president of quantitative pharmacology and pharmacometrics, Merck Research Laboratories, and previously led the modeling and simulation department at Merck. Prior to joining Merck in 2010, she held positions at Eli Lilly & Company, including global senior director of Pharmacokinetics, Pharmacodynamics (PK/PD) & Trial Simulation; senior director, Drug Disposition; and distinguished fellow and chief scientific officer of Quantitative Pharmacology. Her research focuses on study design and application of mathematical methods to enable quantitative decisions for nonclinical and clinical development. She has applied PK/PD modeling to oncolytic and endocrine agents. Her recent work is on the integration of biomarkers, PK/PD modeling, and trial simulation in nonclinical and clinical drug development, drug disease models, and use of quantitative and systems pharmacology approaches. Dr. Allerheiligen received a doctorate in PK/PD from the University of Texas, Austin; completed postdoctoral fellowships at the University of Texas Health Center, San Antonio; and was a clinical assistant professor of Clinical Pharmacology. Through her involvement in American Association of Pharmaceutical Scientists, American Association of Clinical Pharmacology and Therapeutics, International Society of Pharmacometrics, and National Institutes of Health working groups, she has worked to expand the use of PK/PD modeling and quantitative and systems pharmacology methodologies in academia, regulatory agencies, and across the industry. She is a fellow of the American Association of Pharmaceutical Sciences and frequently lectures on modeling and simulation topics.

Shashi Amur, Ph.D., is currently the scientific lead for the Biomarker Qualification Program housed in the Office of Translational Sciences (OTS) in the Center for Drug Evaluation and Research (CDER), U.S. Food and Drug Administration. She received her Ph.D. in biochemistry from the Indian Institute of Science, India, and completed postdoctoral fellowships at Temple University and at the University of California, Los Angeles. She then gained experience in diagnostic and biotech sectors (Specialty Laboratories in Santa Monica, California; Applied Biosystems in Foster City, California; and Neotropix, Inc., in Pennsylvania) before joining CDER as a senior genomics reviewer in the Office of Clinical Pharmacology (OCP). Dr. Amur has been an invited speaker at national and international conferences and is the author of several scientific publications. Her current research interest areas include pharmacogenomics, human leukocyte antigen–associated adverse events, and biomarkers in autoimmune diseases and in Alzheimer’s disease. Dr. Amur has served as chair of the Pharmacogenomics Science Interest Group and chair of the OCP Science Day Committee, and has organized seminars and workshops at CDER. She is currently the chair of

the Pharmacogenomics Focus Group at American Association of Pharmaceutical Scientists.

Ariana Anderson, Ph.D., is an assistant research statistician at the University of California, Los Angeles (UCLA), a recent recipient of the Burroughs Wellcome Fund 2014 Career Award at the Scientific Interface, and a trainee of Dr. Robert M. Bilder. She received her B.S in mathematics and her Ph.D. in statistics from UCLA, followed by a postdoctoral fellowship in neuroimaging with Dr. Mark S. Cohen. She was a featured speaker at the Institute for Pure and Applied Mathematics’ Multimodal Neuroimaging conference, the Neuroimaging Training Program, and worked with Dr. Karl Friston at University College London on approaches to relaxing Bayesian priors in dynamic causal models. Dr. Anderson’s research focuses on measuring the impact of pharmaceutical interventions in neuropsychiatric and related disorders. This includes measuring how the placebo effect changes brain activity measured through functional magnetic resonance imaging, and how best to measure psychiatric disorders for which no objective laboratory test exists.

Derek Angus, M.D., M.P.H., FRCP, is a physician and researcher focusing on optimal care of the critically ill. He currently holds the title of Distinguished Professor and Chair of the Department of Critical Care Medicine at the University of Pittsburgh, where he is also the founder and director of the CRISMA (Clinical Research, Investigation, and Systems Modeling of Acute Illness) Center. CRISMA is a large, National Institutes of Health–funded multidisciplinary research center with a broad portfolio of clinical, translational, and health services research studies of sepsis, trauma, and acute respiratory failure. Dr. Angus has published several hundred papers, is the section editor for “Caring for the Critically Ill” at JAMA, and is the recipient of numerous national and international awards and honors in his field.

Enrique Avilés, joined the Critical Path Institute in 2010 as director of data standards, management, and technology. In 2012, Mr. Avilés was appointed chief technology officer. He has more than 30 years of experience in information technology (IT) product development, data storage, and program management, and has led numerous projects to support large IT clients with a special focus on health care and banking IT systems. Since 2001, Mr. Avilés served as an executive at IBM in roles such as data storage product program management, storage product development, client technical support, and marketing. His executive experience also includes a 2-year assignment working as the IBM technical advocate for a major health care provider in the United States in support of its electronic health record (EHR) system, one of the largest deployments of an EHR system.

In this role, his responsibility was to ensure that IBM hardware, software, and services used for the client’s EHR system operated reliably on a 24/7 basis. Additionally, Mr. Avilés was the IBM executive data storage advocate for one of the largest banks in Japan, traveling there multiple times each year to review product quality and new product development status with senior bank executives. Mr. Avilés received his Bachelor of Science degree in Mechanical Engineering from the Georgia Institute of Technology. He also received graduate certificates from the University of Arizona for an executive M.B.A. program and from George Washington University for Project Management.

John Brownstein, Ph.D., is an associate professor at Harvard Medical School and is the chief innovation officer of Boston Children’s Hospital. He also directs the Computational Epidemiology Group at the Children’s Hospital Informatics Program in Boston. He was trained as an epidemiologist at Yale University. Overall, his research agenda aims to have translation impact on the surveillance, control, and prevention of disease. He has been at the forefront of the development and application of public health surveillance, including HealthMap.org, an Internet-based global infectious disease intelligence system. The system is in use by millions each year, including the Centers for Disease Control and Prevention, World Health Organization (WHO), U.S. Department of Homeland Security, U.S. Department of Defense, U.S. Department of Health and Human Services (HHS), and European Union, and has been recognized by the National Library of Congress and the Smithsonian. Dr. Brownstein has advised WHO, the Institute of Medicine, HHS, and the White House on real-time public health surveillance. He was awarded the Presidential Early Career Award for Scientists and Engineers, the highest honor bestowed by the U.S. government to outstanding scientists and engineers. Dr. Brownstein is also co-founder of UberHEALTH, a collaboration between the Vaccine Finder project, also co-founded by Dr. Brownstein, and logistics company Uber. He has authored more than 150 peer-reviewed articles on epidemiology and public health. This work has been widely reported in media outlets, including the New England Journal of Medicine, Science, Nature, The New York Times, The Wall Street Journal, CNN, National Public Radio, and the BBC.

Robert Califf, M.D., MACC, was confirmed as commissioner of the U.S. Food and Drug Administration (FDA) in February 2016. Previously, Dr. Califf served as the FDA’s Deputy Commissioner for Medical Products and Tobacco from February 2015 until his appointment as commissioner. In that capacity, Dr. Califf provided executive leadership to the Center for Drug Evaluation and Research, the Center for Biologics Evaluation and Research, the Center for Devices and Radiological Health, and the Cen-

ter for Tobacco Products. He also oversaw the Office of Special Medical Programs and provided direction for crosscutting clinical, scientific, and regulatory initiatives, including precision medicine, combination products, orphan drugs, pediatric therapeutics, and the advisory committee system. Prior to joining FDA, Dr. Califf was a professor of medicine and vice chancellor for clinical and translational research at Duke University. He also served as director of the Duke Translational Medicine Institute and founding director of the Duke Clinical Research Institute. A nationally and internationally recognized expert in cardiovascular medicine, health outcomes research, health care quality, and clinical research, Dr. Califf has led many landmark clinical trials and is one of the most frequently cited authors in biomedical science, with more than 1,200 publications in the peer-reviewed literature. Dr. Califf served on the Institute of Medicine (IOM) committees that recommended Medicare coverage of clinical trials and the removal of ephedra from the market, as well as on the IOM Committee on Identifying and Preventing Medication Errors and the National Academies of Sciences, Engineering, and Medicine’s Health Sciences Policy Board. He has served as a member of the FDA Cardiorenal Advisory Panel and the FDA Science Board’s Subcommittee on Science and Technology. Dr. Califf has also served on the Board of Scientific Counselors for the National Institutes of Health and the National Library of Medicine, as well as on advisory committees for the National Cancer Institute; the National Heart, Lung, and Blood Institute; the National Institute of Environmental Health Sciences; and the Council of the National Institute on Aging. While at Duke, Dr. Califf led major initiatives aimed at improving methods and infrastructure for clinical research, including the Clinical Trials Transformation Initiative, a public–private partnership co-founded by FDA and Duke. He also served as the principal investigator for Duke’s Clinical and Translational Science Award and the NIH (National Institutes of Health) Health Care Systems Research Collaboratory coordinating center. Dr. Califf is a graduate of Duke University School of Medicine. He completed a residency in internal medicine at the University of California, San Francisco, and a fellowship in cardiology at Duke.

Eileen Cannon, B.S., is president of the PhRMA Foundation, which provides competitive grants and fellowships—funded by pharmaceutical company contributions—to young scientists beginning careers in research and teaching related to drug discovery. PhRMA currently provides more than $3.4 million annually in awards. They have supported more than 2,200 scientists through more than $80 million in the past 50 years. Its programs are geared toward young scientists to help them build connections that have encouraged them to dedicate their careers to research that benefits the lives of patients globally. Ms. Cannon is responsible for program develop-

ment, fund raising, review committee meeting planning, budgeting and financial operations, and the administration of the Foundation programs. Ms. Cannon joined the PhRMA Foundation in 1999 as the director of development and became executive director of the Foundation in 2005. In 2015 she was promoted to the position of president. Previously, she spent several years at PhRMA in Washington, DC, in the Meetings and Conference Department as a meeting planner and hotel specialist. In her years prior to PhRMA/PhRMA Foundation, she held positions as director of sales and sales manager for Wyndham Hotel and Resorts in Washington, DC, and Annapolis, Maryland. She received a B.S. in human resources and education from the University of Delaware. She is a member of the American Association of Pharmaceutical Scientists and the Association Foundation Group in Washington, DC.

Brian Corrigan, Ph.D., received his B.Sc. in pharmacy from the University of Alberta, Canada, and Ph.D. in pharmacokinetics from the University of Alberta. He is currently an executive director within Clinical Pharmacology at Pfizer, in Groton, Connecticut. Dr. Corrigan’s work has focused on application of clinical pharmacology and pharmacometric approaches to facilitate decision making in all stages of drug development for compounds in the neuroscience and pain therapeutic areas. Dr. Corrigan is an advocate for the discipline of pharmacometrics. He served as treasurer of the Midwest Users Forum for Population Approaches in Data Analysis (MUFPADA), and was a co-organizer of multiple MUFPADA meetings. He served on the editorial advisory board for the Journal of Pharmacokinetics and Pharmacodynamics. He was programming chair for the American Conference on Pharmacometrics in 2013. He served as a member on the American Society for Clinical Pharmacology and Therapeutics Pharmacometrics Task Force. He is the current president of the International Society of Pharmacometrics.

Owen Fields, Ph.D., received a B.S. in Biochemistry with a minor in Mathematics from Wichita State University. He earned his Ph.D. from the Department of Molecular and Cellular Biology at the University of California, Berkeley. He then served in the Policy Development Branch, Center for Food Safety, U.S. Food and Drug Administration (FDA), where he helped develop the initial U.S. policy on agricultural biotechnology, led the team that developed the review procedure that applies to such products, and served as the lead reviewer for three of the first seven products FDA approved. He then moved to Regulatory Affairs at Wyeth, where he worked on both late- and early-stage products, worked on the initial and supplemental approvals of Rapamune and BMP2, and worked extensively in inflammation and tissue growth and repair. At the time of the merger with Pfizer he became vice president of regulatory strategy for the Biothera-

peutics Research Unit. Subsequently Dr. Fields assumed the same title for the consolidated Pfizer Research and Development.

Garret FitzGerald, M.D., is the McNeil Professor in Translational Medicine and Therapeutics at the University of Pennsylvania in Philadelphia, where he chairs the Department of Pharmacology and directs the Institute for Translational Medicine and Therapeutics. Dr. FitzGerald’s research has been characterized by an integrative approach to elucidating the mechanisms of drug action, drawing on work in cells, model organisms, and humans. His work contributed substantially to the development of low-dose aspirin for cardioprotection. Dr. FitzGerald’s group was the first to predict and then mechanistically explain the cardiovascular hazard from nonsteroidal anti-inflammatory drugs. He has also discovered many products of lipid peroxidation and established their utility as indexes of oxidant stress in vivo. His laboratory was the first to discover a molecular clock in the cardiovascular system and has studied the importance of peripheral clocks in the regulation of cardiovascular and metabolic function. Dr. FitzGerald has received the Boyle, Coakley, Harvey, and St. Patrick’s Day medals; the Lucian, Scheele, and Hunter Awards; and the Cameron, Taylor, Herz, Lefoulon-Delalande, and Schottstein Prizes. He is a member of the National Academy of Medicine and a fellow of the American Academy of the Arts and Sciences and of the Royal Society.

John H. Holmes, Ph.D., is a professor of medical informatics in epidemiology at the University of Pennsylvania Perelman School of Medicine. He is the interim director of the Penn Institute for Biomedical Informatics and is chair of the Graduate Group in Epidemiology and Biostatistics at Penn. He has been recognized nationally and internationally for his work on developing and applying new approaches to mining epidemiologic surveillance data, as well as his efforts at furthering educational initiatives in biomedical informatics. Dr. Holmes’s research interests are focused on several areas in medical informatics, including evolutionary computation and machine learning approaches to knowledge discovery in clinical databases (data mining), interoperable information systems infrastructures for epidemiologic surveillance, regulatory science as it applies to health information and information systems, clinical decision support systems, semantic analysis, shared decision making and patient–physician communication, and information systems user behavior. Dr. Holmes is a principal or co-investigator on projects funded by the National Cancer Institute, the National Library of Medicine, and the Agency for Healthcare Research and Quality, and he is the Penn Principal Investigator of the National Institutes of Health-funded Penn Center of Excellence in Prostate Cancer Disparities. Dr. Holmes is engaged with the Botswana–UPenn Partnership, assisting in building infor-

matics education and clinical research capacity in Botswana. Dr. Holmes sits on the board of directors of the American Medical Informatics Association (AMIA), and is chair of the International Affairs Committee of AMIA and the AMIA representative to the International Medical Informatics Association (IMIA). Internationally, he serves as vice president of IMIA for North America, and in the past was vice chair of the IMIA Working Group on Data Mining and Big Data Analytics and on the board of directors of the Artificial Intelligence in Medicine Society (Europe). Dr. Holmes is an elected fellow of the American College of Medical Informatics and the American College of Epidemiology.

Peter Honig, M.D., M.P.H., is senior vice president and head of Worldwide Safety and Regulatory at Pfizer. In this role, Dr. Honig leads Pfizer’s commitment to patient safety by working across the organization to ensure regulatory efficiency, quality control, and compliance throughout all stages of product development and once marketed.

Eric Horvitz, M.D., Ph.D., is a technical fellow at Microsoft and director of the Microsoft Research lab at Redmond. His contributions in biomedical informatics include efforts to build and field predictive models of clinical outcomes from electronic health record data and the use of anonymized logs of online behavioral data for public health, including projects in pharmacovigilance, mental health, and health care use. Dr. Horvitz has been elected a fellow of the National Academy of Engineering, the Association for Computing Machinery, the Association for the Advancement of Artificial Intelligence (AAAI), the American Association for the Advancement of Science, and the American Academy of Arts and Sciences. He was recently awarded the AAAI Feigenbaum Prize for his contributions to advances in artificial intelligence. He has served on the National Library Working Group Advisory Committee to the National Institutes of Health Director, on the National Science Foundation Computer and Information Science and Engineering Advisory Board, and as president of AAAI. He received his Ph.D. and M.D. at Stanford University.

Charles Jaffe, M.D., Ph.D., is the chief executive officer of Health Level Seven International. He completed his medical training at Johns Hopkins and Duke Universities and postdoctoral training at the National Institutes of Health and the Lombardi Cancer Center at Georgetown University. He has served in various academic positions in the Departments of Medicine and Pathology as well as in the School of Engineering.

Martin Landray, Ph.D., FRCP, FBPhS, is a professor of medicine and epidemiology within the Nuffield Department of Population Health and

deputy director of Oxford’s Big Data Institute within the Li Ka Shing Centre for Health Information and Discovery at the University of Oxford. His work seeks to further understanding of the determinants of common life-threatening and disabling diseases through the design, conduct, and analysis of efficient, large-scale epidemiological studies (including clinical trials) and the widespread dissemination of both the results and the scientific methods used to generate them. His previous and ongoing international trials have enrolled more than 65,000 individuals with cardiovascular or kidney disease from 18 countries across four continents. The results of completed studies have changed regulatory drug approvals, influenced clinical guidelines, and changed prescribing practice to the benefit of patients. He also oversees the development of systems for recruitment, data collection (including integrated measurement devices and record linkage), analysis, and data sharing for U.K. Biobank, a prospective cohort study of 500,000 middle-aged men and women. In addition to leading his own research, he is heavily involved in efforts to streamline clinical trials, working with national and international organizations (including the U.S. Food and Drug Administration [FDA], European Medicines Agency, Medicines & Healthcare products Regulatory Agency [MHRA], and Medical Research Council [MRC]) to ensure high-quality research is efficient in providing robust information for health care decision making. He is a member of the Steering Committee of the Clinical Trial Transformation Initiative (CTTI, an FDA initiative, coordinated by Duke University) and a leader of the CTTI Monitoring and Quality by Design Projects. He was previously an advisor to the U.S. FDA initiative to develop standardized definitions for cardiovascular endpoints in clinical trials, a member of the National Institute for Health Research Commissioning Board, and a member of a U.K. Department of Health/MRC/MHRA project to promote risk-based monitoring of clinical trials. Dr. Landray completed medical training at University of Birmingham (UK) and specialist training in Clinical Pharmacology and Therapeutics and General Internal Medicine at the University of Birmingham. He continues to practice clinical medicine as an Honorary Consultant Physician in the Cardiology, Cardiac and Thoracic Surgery Directorate at Oxford University Hospitals National Health Service Trust. He is a fellow of the Royal College of Physicians of London, the Higher Education Academy, the American Society of Nephrology, and the British Pharmacological Society.

Gabriela Lavezzari, Ph.D., M.B.A., joined PhRMA in 2012 as assistant vice president, Science and Regulatory Advocacy. In this role, Dr. Lavezzari is the primary staff lead for a variety of strategic initiatives aimed at establishing PhRMA as a valuable source of scientific expertise in innovative biopharmaceutical research and development within the Scientific and Regulatory Affairs division of PhRMA. Dr. Lavezzari brings to PhRMA

more than 10 years of combined research experience in the government and industry, with multidisciplinary expertise in Personalized Medicine and Regulatory Science. Prior to joining PhRMA, Dr. Lavezzari served as director of extramural development at the Medco Research Institute, a subsidiary of Medco Health Solutions, where she led clinical utility and cost-effectiveness research to create value-based reimbursement decisions for a variety of diagnostics products across different therapeutic areas. Prior to Medco, Dr. Lavezzari spent 2 years at Theranostics Health, a proteomicbased diagnostics company, where she led the laboratory operations and the oncology product development. Prior to Theranostics, Dr. Lavezzari worked at Social Scientific Systems, where she provided scientific support to and managed multiple Adult Clinical Trial Groups (HIV/AIDS) and laboratory science, laboratory technical, and specialty laboratory committees, subcommittees, and working groups. In addition to her experience in the industry, Dr. Lavezzari performed research at the National Institutes of Health, National Institute of Neurological Disorders and Stroke, and Georgetown University, where she completed her postdoctoral training in neuroscience. Dr. Lavezzari received her Ph.D. in biological sciences from the University of Milano (Italy) and her M.B.A. from the New York Institute of Technology.

Danica Marinac-Dabic, M.D., Ph.D., is director of the Division of Epidemiology at the U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). She has more than 20 years of experience in obstetrics, gynecology, perinatal epidemiology, and regulatory science and surveillance settings. A physician and an epidemiologist by training, Dr. Marinac-Dabic is in charge of scientific oversight of all device postmarket studies mandated by FDA either as a condition of approval or anytime postmarket. Dr. Marinac-Dabic also oversees CDRH’s Epidemiologic Regulatory Science Program, charged with advancing the methodologies and infrastructure for evidence development and appraisal with application to medical device regulatory science. Under Dr. Marinac-Dabic’s leadership, in 2010 FDA launched its Medical Device Epidemiology Network (MDEpiNet) Initiative to develop national/international infrastructure and innovative methodological approaches for conducting robust studies and surveillance to improve medical device safety and effectiveness understanding throughout the device lifecycle through public-private partnerships with academia and other stakeholders. Dr. Marinac-Dabic also leads FDA’s International Consortium of Orthopedic Registries Initiative (launched in 2011) focusing on innovative approaches to regulatory science and surveillance for orthopedic medical devices/procedures through through a distributed model of more than 30 national and international orthopedic registries capturing information on more than 3.5 million ortho-

pedic procedures worldwide. Under her leadership, in 2013 FDA launched its International Consortium of Cardiac Registries and in 2014 International Consortium of Vascular Registries Initiatives designed to expand collaborative work among international cardiovascular registries and integrate it into medical device regulatory science, active surveillance, and comparative effectiveness and safety research. Dr. Marinac-Dabic served as a chair of the Medical Device Special Interest Group at the International Society for Pharmacoepidemiology and Therapeutic Risk Management. She also serves as the FDA principal and member of the executive committee of the MDEpiNet Public–Partnership, member of the Steering Committee of the STS/ACC Transcatheher Valve Therapies Registry, TJ FORCE Registry, National Breast Implants Registry, and Oxford-based IDEAL Collaborative. Dr. Marinac-Dabic authored several book chapters, several dozens of manuscripts, and invited presentations on various topics in the fields of medical device epidemiology and surveillance, registry development and use for medical device research, innovative methods for evidence synthesis, and comparative effectiveness and safety research. Prior to coming to FDA, Dr. Marinac-Dabic garnered experience in obstetrics, gynecology, and epidemiology in the academic and hospital settings as well as teaching experience in the academic environment.

Kyle J. Myers, Ph.D., received bachelor’s degrees in mathematics and physics from Occidental College and a Ph.D. in optical sciences from the University of Arizona. Following a postdoc at the University of Arizona, she worked in the research labs of Corning Inc. Since 1987 she has worked for the Center for Devices and Radiological Health (CDRH) of the U.S. Food and Drug Administration (FDA), where she is currently director of the Division of Imaging, Diagnostics, and Software Reliability in CDRH’s Office of Science and Engineering Laboratories. In this capacity she serves as the director for CDRH research programs in medical imaging systems and software tools, including 3D breast imaging systems and computerized tomography devices, digital pathology systems, medical display devices, computer-aided diagnostics, biomarkers (measures of disease state, risk, prognosis, etc., from images as well as other assays and array technologies), and assessment strategies for imaging and other high-dimensional dataset medical devices. She holds adjunct faculty positions at the University of Arizona and Georgetown University. Dr. Myers is a fellow of the Optical Society (OSA), SPIE, and the American Institute for Medical and Biological and a member of the National Academy of Engineering. Along with Harrison H. Barrett, she is the co-author of Foundations of Image Science, published by John Wiley and Sons in 2004 and winner of the First Biennial J. W. Goodman Book Writing Award from OSA and SPIE. She is the FDA principal investigator on the Medical Device Innovation Consortium

Computer Modeling and Simulation Project. She is an associate editor for the Journal of Medical Imaging and Medical Physics.

Perry Nisen, M.D., Ph.D., is a physician scientist whose expertise spans fundamental research, clinical practice, and drug discovery and development. He was appointed as CEO of Sanford Burnham Prebys Medical Discovery Institute in August 2014, and holds the Donald Bren Chief Executive Chair. He oversees execution of the Institute’s strategic vision to accelerate the translation of basic research discoveries into innovative therapeutics that have a tangible impact on people’s lives. Before joining Sanford Burnham Prebys, Dr. Nisen was senior vice president of science and innovation at GlaxoSmithKline (GSK). In that role, he facilitated innovation and integration of research and development across GSK’s global organization; facilitated the discovery, development, and commercialization of a large portfolio of medicines; and was a champion for clinical trial data transparency. Earlier in his career at GSK, he held various key positions, including interim chief medical officer, senior vice president and oncology therapy area head, senior vice president of cancer research, and senior vice president of clinical pharmacology and discovery medicine. Previously, Dr. Nisen was divisional vice president of cancer research and oncology development at Abbott Laboratories, where he helped build a Cancer Discovery organization and created a pipeline of clinical candidates. Dr. Nisen holds a B.S. from Stanford University and an M.D. and a Ph.D. from the Albert Einstein College of Medicine. Formerly, he was the Lowe Foundation Professor of Neuro-Oncology at the University of Texas Southwestern Medical Center.

Richard Platt, M.D., is professor and chair of the Harvard Medical School Department of Population Medicine at the Harvard Pilgrim Health Care Institute. He is principal investigator of the U.S. Food and Drug Administration Sentinel System, which performs postmarketing safety surveillance using electronic health data from more than 175 million people. Dr. Platt is also principal investigator of the Patient-Centered Outcomes Research Institute’s PCORnet coordinating center, a consortium of 34 networks that will use electronic health data to conduct comparative effectiveness research. He co-leads the coordinating center of the National Institutes of Health Care System Research Collaboratory and leads a Centers for Disease Control Prevention Epicenter. He co-chairs the Clinical Effectiveness Research Innovation Collaborative of the National Academy of Medicine’s Leadership Consortium for Value & Science-Driven Health Care, and is a member of the Association of American Medical Colleges Advisory Panel on Research.

Mark C. Rogers, M.D., M.B.A., was trained at Harvard and Duke in pediatrics, cardiology, anesthesiology, and critical care medicine, then arrived at Johns Hopkins to become the first director of the Pediatric Intensive Care Unit. He was later named professor and chair of the Department of Anesthesiology and Critical Care Medicine. For 14 years, Dr. Rogers led both the Department and the Pediatric Intensive Care Unit to leadership positions in medicine, both nationally and internationally. During this time, he was awarded a Fulbright and was elected to the National Academy of Medicine. He was author of 125 publications and author or senior editor of 12 books translated into many languages. His Textbook of Pediatric Intensive Care, now named for him in its fifth edition, is the international standard in the field. He became associate dean at Hopkins and also received an M.B.A. from the Wharton School of the University of Pennsylvania during his tenure at Hopkins. When Dr. Rogers left Hopkins, the Medical School named the Endowed Professorship for the Chair of the Department after him. Beginning in 1992, Dr. Rogers served as CEO of Duke Hospital and Health Network and vice chancellor for health affairs at Duke University. The work he did was highlighted in The New York Times, in a case study at Harvard Business and Public Health Schools, and in a featured article on him in The Wall Street Journal. He next became the senior vice president for the New York Stock Exchange company that sequenced the human genome. From there, he became president of a major biotech investment bank in what was then the new field of biotechnology. In that role and subsequently on his own, he has been the founder of multiple biopharmaceutical companies, including several that have gone public on NASDAQ and on the Toronto Stock exchange. In addition, he has significant roles in the public service sector and is presently chair of the Reagan-Udall Foundation, which was set up by the U.S. Congress as the civilians advisory group for the U.S. Food and Drug Administration.

Klaus Romero, M.D., is a clinical pharmacologist and epidemiologist by training with 15 years of combined experience in academic clinical research. He is a fellow of the American College of Clinical Pharmacology and the American Society for Clinical Pharmacology and Therapeutics. He has conducted research on endemic channels for non-steroidal anti-inflammatory drug-related gastropathy, antibiotic-related dysglycemia, drug-induced QT prolongation, pharmaco-epidemiology, and patient education. Dr. Romero has been with Critical Path since 2008. He has helped to lead clinical pharmacology, pharmacoepidemiology, and modeling and simulation projects for the Coalition Against Major Diseases, the Polycystic Kidney Disease Outcomes Consortium, and the Critical Path to Tuberculosis Drug Regimens Consortium, achieving major milestones such as the first regulatory endorsement by the U.S. Food and Drug Administration and Euro-

pean Medicines Agency of a clinical trial simulation tool for mild and moderate Alzheimer’s disease. He is fluent in English, Spanish, German, and Portuguese, and has published in the areas of clinical pharmacology, pharmacometrics, cardiovascular drug safety, and pharmacoepidemiology.

Marc Salit, Ph.D., and his team in the Material Measurement Lab at the National Institute of Standards and Technology (NIST) are dedicated to technology development and measurement infrastructure supporting biology and biotechnology, including standards, reference data, predictive models, genome-scale measurement methods, and the engineering of living matter. He has worked extensively in measurement science in chemistry and physics, with emphasis on precision measurements, lab automation, algorithm development, measurement uncertainty, traceability, and standards development. His research is now focused on bringing experience from the chemical metrology community to the emerging biometrology community. Most recently, Dr. Salit’s team is best known for convening and hosting the Genome in a Bottle Consortium, and development of the first whole human genome reference materials to support regulated applications of NextGen DNA sequencing. Earlier work led to the development of standards from the External RNA Control Consortium, the widely used External RNA Controls Consortium spike-in RNA controls. Dr. Salit now leads the NIST team in Palo Alto, California, embedded full-time on the Stanford main campus. He is working together with faculty from the School of Engineering and School of Medicine to build a new Joint Initiative for Metrology in Biology, a public-private-academic collaboration platform to develop the critical measurement science and standards for the 21st century of biology.

John-Michael Sauer, Ph.D., is the executive director of the Predictive Safety Testing Consortium at the Critical Path Institute (C-Path) and an adjunct professor in the Department of Pharmacology at the University of Arizona College of Medicine. He received his undergraduate and master’s degrees in biomedical science at Western Michigan University and his doctorate degree in pharmacology and toxicology from the University of Arizona. Dr. Sauer is a toxicologist by training with more than 15 years of experience in drug discovery and development. He has been responsible for leading multiple functional areas across several pharmaceutical companies. He is dedicated to bringing quantitative translational science approaches to safety assessment, as well as transforming the way we use nonclinical safety data to drive clinical study design and data interpretation. Prior to joining C-Path in 2013, Dr. Sauer had the opportunity to play an individual contributor role at Eli Lilly in the toxicology and ADME (absorption, distribution, metabolism, and excretion) department, where he participated in the devel-

opment, registration, and commercialization of the drug Strattera for the treatment of attention deficit hyperactivity disorder in children and adults. In addition, he supported many other discovery and development teams across multiple therapeutic areas. He also played a pivotal leadership role in the transformation of Elan Pharmaceutical’s discovery and development strategies, including the incorporation of several translational science approaches. Dr. Sauer gained operational and management experience in the Contract Research Organization environment as the Site Scientific Head for Covance Chandler in Arizona. Dr. Sauer has more than 100 scientific publications in the areas of toxicology, drug metabolism, clinical pharmacology, pharmacokinetics, and pharmacology.

Sam Shekar, M.D., M.P.H., is the chief medical officer within Northrop Grumman’s Information Systems Sector. He provides strategic direction for the Health Division and serves as an adviser to health care and public health organizations, customers, and partners on technology and policy issues in the medical and public health fields. He also directs the Life Sciences Program and its bioinformatics, genomic analytics, and medical ontology programs within the Health Division.

Scott Steele, Ph.D., M.A., serves as the director of government and academic research alliances at the University of Rochester, where he facilitates strategic research and educational partnerships between the university and government agencies and laboratories, industry, and other academic institutions. He is an associate professor in the Department of Public Health Sciences, where his academic interests are focused on a range of science and technology policy issues, including translational research and regulatory science, public health preparedness, and national security. He also serves as the deputy director of the Goergen Institute for Data Science. He is actively involved in regulatory science educational programs at its Clinical and Translational Science Institute and coordinating national Clinical and Translational Science Award initiatives, including recently co-leading the development of a set of regulatory science competences to guide training and education in this area. Dr. Steele currently chairs a subcommittee of the U.S. Food and Drug Administration (FDA) Science Board evaluating the FDA Centers of Excellence in Regulatory Science and Innovation. Prior to joining the University of Rochester, Dr. Steele served in the White House Office of Science and Technology Policy (OSTP), initially as a policy analyst and later as the executive director of the President’s Council of Advisors on Science and Technology (PCAST). Dr. Steele coordinated PCAST studies addressing issues in personalized medicine, information technology, nanotechnology, energy technologies, and approaches to enhance university-private-sector research partnerships. At OSTP, he also led several programs

related to biosecurity, medical countermeasures development, biotechnology, and science education. Dr. Steele received his B.S. with honors in biology from Union College in Schenectady, New York. Following this, he performed research at the General Electric Center for Research and Development and was a fellow at the National Institutes of Health. Dr. Steele completed his M.A. and Ph.D. in molecular biology at Princeton University.

James L. Stevens, Ph.D., is a Distinguished Research Fellow at Lilly Research Laboratories. For more than four decades in the government, academic, and industry sectors, he has studied molecular and cellular responses to the metabolism and toxicity of drugs and xenobiotics. His current research focuses on application of systems biology to improving drug safety assessment and elucidating mechanisms of drug toxicity. Prior to joining Lilly Research Laboratory in 2000, Dr. Stevens held positions at the National Institutes of Health, the U.S. Food and Drug Administration, the University of Vermont, and the W. Alton Jones Cell Science Center, where he was executive director. He has served on a variety of national advisory committees, including the Health Education Systems Incorporated Board of Trustees, National Advisory General Medical Sciences, National Toxicology Program Board of Scientific Counselors, Environmental Protection Agency Board of Scientific Counselors Subcommittee on Chemical Safety for Sustainability, as well as the boards of directors for Argonex Pharmaceuticals, Inc., and Upstate Biotechnology, Inc. He has received the Achievement Award from the Society of Toxicology and was elected a fellow of the American Association for the Advancement of Science.

Katherine von Stackelberg, Sc.M., Sc.D., is a research scientist at the Harvard Center for Global Health and the Environment and an affiliate at the Harvard Center for Risk Analysis. She is also co-leader of the Biogeochemistry of Global Contaminants Group at Harvard University and a principal at NEK Associates Ltd. For the past several years, she has served as leader of the Research Translation Core of a Superfund Research Program grant at Harvard University. Dr. von Stackelberg has nearly 30 years’ experience designing and implementing human health and ecological risk assessments, focused on integrated, risk-based modeling approaches to support sustainable environmental decision making. She has published on the use of uncertainty analysis in decision making, bioaccumulation modeling, and the use of decision analytic approaches to integrate ecosystem services and risk assessment for more effective decision making. Dr. von Stackelberg is the area editor for ecological risk assessment for the journal Risk Analysis and serves on the editorial boards of Human and Ecological Risk Assessment and Risk Analysis. She is a frequent peer reviewer for several additional journals. Dr. von Stackelberg served on the Board of Scientific Counselors

at the U.S. Environmental Protection Agency (EPA) for 6 years and was chair for the past 3 years. She led the effort to explore the use of decision analytic tools and methods to support environmental decision making within the EPA Office of Research and Development. She is a member of the Scientific Advisors on Risk Assessment for the European Commission in Brussels, and serves on several technical committees of the Interstate Technology and Regulatory Council, including complex sites, contaminated sediments, and risk assessment. Dr. von Stackelberg was elected treasurer of the Society for Risk Analysis, and was recently elected to the board of directors for the Society for Environmental Toxicology and Chemistry, where she also serves on the Global Science Committee (chair from 2012 to 2015) and on the steering committee for the Ecosystem Services Advisory Group. She has served on several EPA funding and grant program peer review panels. She was an invited participant to a recent Society of Environmental Toxicology and Chemistry Pellston workshop on ecosystem services, and a National Institute for Mathematical and Biological Sciences workshop on population modeling in ecological risk assessment. Dr. von Stackelberg received an A.B. cum laude from Harvard College, and an Sc.M. and an Sc.D. from the Harvard School of Public Health in Environmental Science and Risk Management.

John Wagner, M.D., Ph.D., received his M.D. from Stanford University School of Medicine and Ph.D. from the Johns Hopkins University School of Medicine. Postgraduate training included an 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. Currently, Dr. Wagner is senior vice president and head, Clinical and Translational Sciences, Takeda Pharmaceutical International. He is also president of the American Society for Clinical Pharmacology and Therapeutics, a premier translational medicine and clinical pharmacology scientific association. Dr. Wagner is also on the adjunct faculty at Harvard–Massachusetts Institute of Technology. Previously, he was a senior consultant to the Institute of Medicine (IOM); vice president and head, Early Development Pipeline, and projects and head, Global Project Management at Merck & Co., Inc.; co-chair of Merck’s early development governance committee; vice president and head, Clinical Pharmacology, at Merck; and acting modeling and simulation integrator, Strategically Integrated Modeling and Simulation. 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 IOM Committee on Qualification of Biomarkers and Surrogate Endpoints in Chronic Disease; and current member

of the National Academies of Sciences, Engineering, and Medicine’s Forum on Drug Discovery, Development, and Translation. More than 200 peer-reviewed publications detail work across a variety of therapeutic areas and disciplines.

Susan Ward, Ph.D., is an experienced strategist, helping large and small companies transition technology into products. Dr. Ward earned her bachelor’s, master’s, and Ph.D. degrees in pharmacology from the University of Manchester, United Kingdom. She has more than 50 articles in peer-reviewed journals, holds 9 patents, and is a frequent invited speaker. Dr. Ward is the independent director for Provasculon Inc., is a mentor for M.B.A. students at Boston University, and recently completed 6 years as a trustee, treasurer, and executive committee member at the Cambridge School of Weston, a leader in progressive education. Dr. Ward has held prominent positions at Sterling Drug, Wyeth Research, and Millennium Pharmaceuticals. Since 2004, Dr. Ward has built a consulting practice crafting the initial research and development strategy for Alnlyam Pharmaceutical, establishing a global program that markedly enhanced quality of development candidates for Novartis Institutes for BioMedical Research (NIBR), and delivering value-based commercialization strategies for software companies focused on life sciences, including Definiens, Conformia (acquired by Oracle), and GNS Biotech. Most recently, Dr. Ward has extended her practice to rare disease foundations engaged in sponsorship and venture investment in drug-focused programs and biotechnology companies.

Frank Weichold, M.D., Ph.D., is director, Office of Critical Path and Regulatory Science Initiatives in the Office of the Chief Scientist at the U.S. Food and Drug Administration (FDA). He also chairs the FDA Senior Science Council and represents FDA at the Maryland Life Science Advisory Board. The expertise and leadership he brings to the regulatory agency build on his clinical, academic, and industrial medical product development experiences. With his team and in partnership with other stakeholders, he leverages creative ability to advance, coordinate, and integrate scientific innovation and resources for FDA to address mission-critical health science and regulatory responsibilities in a global environment.

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