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Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary
Epidemiology. He is currently a member of CDER’s Drug Safety Oversight Board.
Melanie Blank, MD, is a nephrologist in the Division of Cardiovascular and Renal Products at the FDA. She is a member of the Biomarker Qualification Review Team. Prior to joining her current division, Dr. Blank was a medical officer in the Division of Medical Imaging. She performed her internal medicine residency at Lenox Hill Hospital in New York City and her nephrology fellowship at George Washington University Hospital. She was in private practice for 14 years prior to joining the FDA 4 years ago.
John C. Bloom, PhD, holds a BS degree in biology from the University of Pittsburgh and doctorates in veterinary medicine and experimental hematology from the University of Pennsylvania. He completed his postdoctoral training at Lankenau Hospital (Jefferson Medical College) in hematology/oncology and served on the faculty of the University of Pennsylvania School of Veterinary Medicine as chief, clinical laboratory medicine before joining Smith Kline & French Laboratories in 1981 as associate director of pathology. Dr. Bloom is a past president of the American Society for Veterinary Clinical Pathology and has been active in the fields of hematotoxicology, hepatotoxicology, and immunotoxicology within the pharmaceutical industry. He has authored several manuscripts, chapters, and reviews on these topics; edited texts on toxicology and clinical biomarkers in drug development; and served on several committees sponsored by the National Academy of Sciences, the Institute of Medicine (IOM), the Society of Toxicologic Pathology, and PhRMA. 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), diagnostic and experimental medicine, he is now responsible for routine laboratory, electrocardiogram (ECG), imaging, and specimen banking support for global clinical development, and novel clinical biomarker discovery, validation, and application in the Division of Translational Medicine and Pharmacogenomics. Dr. Bloom holds adjunct academic appointments at the University of Pennsylvania and Purdue University.
Daniel M. Bloomfield, MD, MPhil, FACC, currently works at Merck Research Laboratories as an executive director in clinical cardiovascular research and is responsible for drug development for hypertension, arrhythmias, and heart failure. After receiving a BA in chemistry at Haverford College, he studied social anthropology at Oxford University as a Rhodes Scholar. Upon returning to the United States, he attended Harvard Medical School, and then received