Accelerating the Development of Biomarkers for Drug Safety Workshop Summary (2009) / Chapter Skim
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Appendix B: Speaker Biographies
Appendix B: Speaker Biographies
Pages 71-84
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From page 71... ...
of the Food and Drug Administration (FDA) in 1999 as a medical officer in the Division of Gastrointestinal and Coagulation Drug Products, he developed a strong interest in drug-induced liver injury and the impact of pharmacogenomic analysis on evaluation of the risk associated with drug treatment.
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From page 72... ...
He joined Lilly Research Laboratories in 1989 as head, clinical pathology in the Toxicology Division, and in 1991 moved to the Medical Division, where he established the department of Clinical Laboratory Medicine, and later the departments of Experimental Medicine and Clinical Diagnostic Services. As distinguished medical fellow (executive director)
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From page 73... ...
Dr. Bloomfield is currently co-chair of the Cardiac Safety Research Consortium, a public–private partnership among the FDA, academia, and industry devoted to advancing scientific knowledge on cardiac safety for new and existing medical products by building a collaborative environment based on the principles of the FDA's Critical Path Initiative, as well as other public health priorities.
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From page 74... ...
Robert Califf, MD (Forum member) , is currently vice chancellor for clinical research, director of the Duke Translational Medicine Institute, and professor of medicine in the Division of Cardiology at the Duke University Medical Center in Durham, North Carolina.
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At Lilly he also led clinical development teams in the cardiovascular, critical care, and inflammation therapeutic areas as vice president, internal medicine, and in discovery as executive director of cardiovascular research and clinical investigation.
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From page 76... ...
In addition, he has extensive experience in global safety and risk management for drug development programs and post-marketing in multiple therapeutic classes. James Freston, MD, PhD, is professor of medicine emeritus and past Boehringer Ingelheim Chair of Clinical Pharmacology at the University of Connecticut Health Center.
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Dr. Hunt is vice president, GSK Clinical Safety Systems, building proactive safety systems to address the key toxicities affecting drug development.
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From page 78... ...
Public Health Service, and a Distinguished Investigator Award from the National Alliance for Research on Schizophrenia and Depression)
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From page 79... ...
Currently in the Liver Disease Research Branch of NIDDK, he helped design and oversee several large network studies, related mainly to viral hepatitis but also to the DILIN study. He has also coordinated several NIDDK meetings and workshops, including the Consensus Conference on Hepatitis C
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From page 80... ...
The department is responsible for genetic toxicology assessments and molecular carcinogenesis investigations; for bioanalytical toxicokinetic support; for the implementation of directed investigative toxicology research solutions and support for safety lead optimization; for the incorporation of new in vitro and in vivo model systems and technologies, including ion channel systems, genomics, proteomics, and metabonomics; and for the provision of clinical pathology, immunology, and biomarker development support to safety assessment.
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From page 81... ...
. He is currently immediate past president of the NKF and a founding member and member of the Executive Steering Committee of the Acute Kidney Injury Network.
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From page 82... ...
He serves as chair of both the steering committee for DILIN and the scientific advisory board for the Liver Toxicity Biomarker Study, an FDA Critical Path Initiative. He has served on multiple national advisory committees, including the FDA Clinical Pharmacology Advisory Committee.
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From page 83... ...
He previously served on the editorial boards of The British Journal of Clinical Pharmacology and Biopharmaceutics and Drug Disposition. He authored the chapter in Harrison's Principles of Internal Medicine on adverse drug reactions from the ninth through fifteenth editions.
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