Advancing the Discipline of Regulatory Science for Medical Product Development An Update on Progress and a Forward-Looking Agenda: Workshop Summary (2016) / Chapter Skim
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Appendix C: Participant Biographies
Appendix C: Participant Biographies
Pages 61-88
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From page 61... ...
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.
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, 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.
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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.
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as a program officer in 2013 and directs the Fund's Scientific Interfaces and Regulatory Science initiatives. Prior to his position at BWF, Dr.
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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.
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From page 66... ...
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.
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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)
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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.
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Prior to joining FDA, he served as chief science officer at United States Pharmacopeial Convention (USP)
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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.
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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)
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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.
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Previously, Dr. Califf served as the FDA's Deputy Commissioner for Medical Products and Tobacco from February 2015 until his appointment as commissioner.
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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.
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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.
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, 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.
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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.
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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.
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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
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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.
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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.
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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.
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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.
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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.
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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.
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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.
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Most recently, Dr. Ward has extended her practice to rare disease foundations engaged in sponsorship and venture investment in drugfocused 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.
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