Characterizing and Communicating Uncertainty in the Assessment of Benefits and Risks of Pharmaceutical Products Workshop Summary (2014) / Chapter Skim
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Appendix D: Participant Biographies
Appendix D: Participant Biographies
Pages 113-134
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From page 113... ...
A second objective of his research is to develop and test decision support tools that can be used by people to improve decision quality across a wide range of environmental, social, and economic contexts; these include energy transitions, climate change, international development, space exploration, food security, health promotion, business and finance, and the protection of ecosystem services.
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From page 114... ...
Ms. Barton joined Health Canada in 2002 with the Marketed Pharmaceuticals and Medical Devices Bureau of the Marketed Health Products Directorate (MHPD)
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From page 115... ...
Dr. Fox serves as a member of various advisory and review committees for the National MS Society and NIH, the General Advisory Council for the Cleveland Clinic Clinical Research Unit, and the Editorial Board of Neurology and Multiple Sclerosis Journal, and as a consultant to the pharmaceutical industry.
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From page 116... ...
in CDER. In 2000, he joined the Divisions of Neurology and Psychiatry Drug Products in CDER as a drug safety Medical Reviewer and served as an active member of a multidisciplinary team that had overall responsibility for pre- and postmarketing safety evaluation of neurology and psychiatry drugs in the Divisions.
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From page 117... ...
Dr. Hughes joined FDA 11 years ago as a Medical Officer Safety Reviewer and subsequently was the leader of the division's safety group prior to assuming her current position.
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From page 118... ...
Dr. Huntley-Fenner's research employs a range of tools, including literature reviews, incident database analyses, statistics, experimental design, hazard and risk analyses, and specific human behavioral research methods such as surveys and human subjects testing.
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From page 119... ...
Dr. Jenkins joined FDA as a Medical Officer in the Division of Oncology and Pulmonary Drug Products in 1992.
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From page 120... ...
Joyce Korvick, M.D., M.P.H., is currently the Deputy Director for Safety in the Division of Gastroenterology and Inborn Error Products, Office of Drug Evaluation III, CDER, FDA. In addition, she has extensive experience as a primary medical reviewer evaluating benefit–risk, having worked in several Divisions within CDER over the past 20 years.
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From page 121... ...
Lim was a Health Canada clinical and non-clinical safety and effectiveness reviewer (with the Therapeutic Products Directorate, since 1996) and assessed drug submissions across product lifecycle (clinical trial applications, pre- and postmarket drug submissions)
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From page 122... ...
In 2012, Dr. Lim also received an honor from the editors of the Journal of Pharmacoepidemiology and Drug Safety for best peer reviewer performance.
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From page 123... ...
She has participated in every opportunity organized by FDA to shape its Patient-Focused Drug Development Initiative (PFDDI) , including a range of consultations leading up the first of the 20 PFDDI workshops focused on chronic fatigue syndrome and myalgic encephalopathy held in April 2013.
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From page 124... ...
In 2008, he was appointed to the NAS Committee on the Human Dimensions of Global Change. He served as the Decision Sciences area editor of the journal Risk Analysis for 8 years, and is a Fellow of the Society for Risk Analysis.
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From page 125... ...
She joined FDA as a Medical Officer in 1998 in the Division of Metabolism and Endocrinology Products, where she served as Division Director from 2006 through 2013. Francesco Pignatti, M.D., is Head of Oncology, Hematology, Diagnostics Section, Scientific and Regulatory Management Department, Human Medicines Evaluation Division, EMA.
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From page 126... ...
Robert E Ratner, M.D., FACP, FACE, is Chief Scientific and Medical Officer for the American Diabetes Association, where he provides leadership and oversight of scientific and medical activities, including research, clinical affairs, program recognition and certification, medical information, and professional education.
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From page 127... ...
He is voting consultant to the FDA Drug Safety and Risk Management Advisory Committee and member of the Methods Committee of the Patient-Centered Outcomes Research Institute. He received his medical training at the University of Munich Medical School and his doctoral degree in Pharmacoepidemiology from Harvard University.
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From page 128... ...
At FDA he served as the Director of FDA's Latin America Regional Office, as Associate Director for Safety Policy and Communication in CDER, and as the Director of the Office of Pharmacoepidemiology and Statistical Science. Before joining FDA in July 2001, Dr.
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From page 129... ...
He is editor of the field's major text (now in its fifth edition) and editor in chief for Pharmacoepidemiology and Drug Safety, the official journal of the International Society for Pharmacoepidemiology.
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From page 130... ...
Pharmacopoeia, served on the Drug Safety and Risk Management Advisory Committee for FDA, chaired the IOM Committee to Assess the Safety and Efficacy of the Anthrax Vaccine, chaired the IOM Committee on Smallpox Vaccine Program Implementation, chaired the IOM Committee to Review NIOSH's Traumatic Injury Program, chaired the IOM Committee on the Consequences of Reducing Sodium in the Population, was a member of the IOM Committee to Review the CDC Anthrax Vaccine Safety and Efficacy Research Program, and was a member of the IOM Committee on Standards for Developing Trustworthy Clinical Practice Guidelines.
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From page 131... ...
He also has a longstanding interest in hepatotoxicity of drugs, having participated in the first detailed FDA–NIH-outside discussion of the subject in 1978. Steven Woloshin, M.D., M.S., is Professor, Departments of Medicine and Community & Family Medicine, Dartmouth Medical School, and CoDirector, Center for Medicine and the Media, at The Dartmouth Institute for Health Policy and Clinical Practice.
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From page 132... ...
From 2004 to 2008, Dr. Woodcock provided support to FDA's Commissioner, serving as Deputy Commissioner for Operations and Chief Medical Officer.
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From page 133... ...
As Acting Deputy Commissioner for Operations, in 2004, Dr. Woodcock led the Critical Path Initiative, which continues to encourage and foster the development of new and better tools to support medical product research so that drug, device, and biologics development is more predictable and more informative.
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From page 134... ...
She completed a clinical decision-making fellowship, a pediatric internship, and is Board Certified in General Psychiatry, as well as in Child and Adolescent Psychiatry.
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