Sharing Clinical Research Data Workshop Summary (2013) / Chapter Skim
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Appendix C: Participant Biographies
Appendix C: Participant Biographies
Pages 105-134
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From page 105... ...
She is the author of more than 90 peer-reviewed articles. In her focus at the forefront of consumer participation in genetics research, services, and policy, she serves in a leadership role on many of the major international and national organizations, including the Institute of Medicine (IOM)
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From page 106... ...
He served on an Institute of Medicine committee that developed recently released recommendations for the use of systematic reviews in clinical effectiveness research. He currently serves on the Scientific Advisory Committee to the Observational Medical Outcomes Partnership, a public-private partnership aimed at understanding methodology for assessing drug safety in large administrative databases.
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From page 107... ...
Dr. Califf attended Duke University, graduating summa cum laude and Phi Beta Kappa.
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From page 108... ...
As founder and a decade-long director of the DCRI, Dr. Califf led many landmark clinical trials and health services research projects, and remains actively involved in designing, leading, and conducting multinational clinical trials.
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From page 109... ...
Cantor was the chief medical information officer for the South Manhattan Healthcare Network of the New York City Health and Hospitals Corporation, based at Bellevue Hospital in Manhattan. His work there focused on developing the network's EMR system to improve patient safety and on using the network's clinical data warehouse for research.
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From page 110... ...
Dr. Compton has held many national and international leadership positions in pathology and cancer-related professional organizations.
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From page 111... ...
de Crescenzo held a number of leadership positions during his decade at IBM Corporation, working with health care and life sciences clients throughout the world. Prior to entering the IT industry, he held leadership positions in health care operations at multiple medical centers and a major health insurer.
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From page 112... ...
She is a current member of the UW Graduate School Committee on Interdisciplinary Education. Hans-Georg Eichler, M.D., M.Sc., is the senior medical officer at the European Medicines Agency (EMA)
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From page 113... ...
Dr. Fitzmartin has been a frequent presenter at many industry meetings and has authored numerous articles in areas such as informatics, pharmacovigilance, clinical data management, regulatory compliance, and R&D strategy.
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From page 114... ...
Dr. Goodman was appointed by the Government Accountability Office to serve on the Methodology Committee of the Patient Centered Outcomes Research Institute and is a scientific advisor to the Medical Advisory Panel of the National Blue Cross/Blue Shield Technology Evaluation Center.
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From page 115... ...
He was an intern, resident, and the chief medical resident in internal medicine at the University of Massachusetts Medical Center. He was a fellow in cardiology at Duke University Medical Center, where he received training in interventional cardiology and research training in the Duke Databank for Cardiovascular Diseases.
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From page 116... ...
He has previously served as vice president and head, Oncology Medical Affairs, North America, for Sanofi-Aventis; vice president of brand management and vice president of medical affairs at Enzon Pharmaceuticals; executive director, Medical Affairs, at Schering AG/ Berlex/Bayer-Schering; director of medical affairs for Schering AG, Global Business Unit; senior medical advisor for Schering AG, United Kingdom; and specialist registrar at Hammersmith Hospital, United Kingdom.
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From page 117... ...
He has served as president of the Society for Research Synthesis Methodology, as a member of the editorial board of 27 leading international journals (including PLoS Medicine, Lancet, Annals of Internal Medicine, Journal of the National Cancer Institute, Science Translational Medicine, Molecular and Cellular Proteomics, AIDS, International Journal of Epidemiology, Journal of Clinical Epidemiology, Clinical Trials, Cancer Treatment Reviews, Open Medicine, and PLoS ONE) , and as editor in chief of the European Journal of Clinical Investigation from 2010 to 2014.
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From page 118... ...
At ONC, Dr. Jain worked with David Blumenthal to implement the Health Information Technology for Economic and Clinical Health provisions of the American Recovery and Reinvestment Act that provide incentives for physicians and hospitals to become meaningful users of health information technology.
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From page 119... ...
He worked with DaVita-Bridge of Life to bring charity dialysis care to rural Rajasthan, India, and Medical Missions for Children to bring cleft lip and palate surgery to that region. He maintained a faculty appointment at Harvard Business School's Institute for Strategy and Competitiveness and worked with Strategy Professor Michael Porter on a new case literature on health care delivery innovation.
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From page 120... ...
Harlan Krumholz, M.D., is the Harold H Hines, Jr., Professor of Medicine and director of the Robert Wood Johnson Clinical Scholars Program at Yale University School of Medicine, and director of the YaleNew Haven Hospital Center for Outcomes Research and Evaluation.
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From page 121... ...
Kush, Ph.D., is founder, president, and CEO of the Clinical Data Interchange Standards Consortium (CDISC)
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From page 122... ...
Dr. Kush served on the appointed Planning Committee for the Department of Health and Human Services Office of the National Coordinator for Health Information Technology sponsored Workshop Series on the "Digital Infrastructure for the Learning Health System" for the Institute of Medicine.
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From page 123... ...
She also served on two key workgroups of the American Health Information Community, the federal advisory body established by HHS to develop recommendations on how to facilitate use of health IT to improve health. Specifically, she cochaired the Confidentiality, Privacy and Security Workgroup and was a member of the Personalized Health Care Workgroup.
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From page 124... ...
, chair of the SCDM Good Clinical Data Management Practices (GCDMP) Committee, chair of the Clinical Data Interchange Standards Consortium Industry Advisory Board, and the data management content expert for the National Institutes of Health (NIH)
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From page 125... ...
Ms. Okun is a member of the Institute of Medicine Clinical Effectiveness Research Innovation Collaborative, the Evidence Communication Innovation Collaborative, and the Best Practices Innovation Collaborative.
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From page 126... ...
Perakslis also held the posts of vice president R&D informatics, vice president and chief information officer, director of research information technology as well as assistant director and director of drug discovery research prior to his current role. Before joining J&J, he was the group leader of Scientific Computing at ArQule Inc.
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From page 127... ...
In 2004 he joined Merck Research Labs (MRL) as vice president of clinical neuroscience, and in 2006, he took on the newly created position of vice president of Translational Neuroscience, from which he retired in 2012.
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From page 128... ...
He is a past chair of the board of directors of the Clinical Data Interchange Standards Consortium and a member of the National Library of Medicine Advisory Group for ClinicalTrials.Gov. He is past president, Society for Clinical Trials; past chair, Pharmaceutical Research and Manufacturers Association (PhRMA)
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From page 129... ...
with honors in biology from Washington and Lee University and earned a doctorate in cell biology from Baylor College of Medicine. Michael Rosenblatt, M.D., is executive vice president and chief medical officer of Merck & Co., Inc.
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From page 130... ...
He received his undergraduate degree summa cum laude from Columbia University and his M.D. magna cum laude from Harvard.
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From page 131... ...
She also served as director of the Office of Innovative Scientific Research Technologies at the National Institute of Allergy and Infectious Diseases at the National Institutes of Health, where she worked to integrate emerging technologies into existing immunology and infectious disease programs.
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From page 132... ...
Dr. Vickers' clinical research falls into three broad areas: randomized trials, surgical outcomes research, and molecular marker studies.
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From page 133... ...
Dr. Woodcock held various leadership positions within the Office of the Commissioner, FDA, including deputy commissioner and chief medical officer, deputy commissioner for operations, and chief operating officer and director,
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From page 134... ...
Zarin oversees the development and operation of an international registry of clinical trials. Previous positions include director of the Agency for Healthcare Research and Quality Technology Assessment Program and director of the American Psychiatric Association Practice Guidelines program.
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