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Dr. Ene I. Ette has broad experience in academia, regulatory agency and the pharmaceutical industry. He has interest in pharmacometrics, and he was an expert scientist in the Pharmacometrics Staff Unit, Office of Clinical Pharmacology and Biopharmaceutics, Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). He has a Ph.D. in clinical pharmacology, and he is author of several original articles in peer-reviewed journals, book chapters, numerous conference presentations and proceedings. In addition, he is on the editorial board of many clinical pharmacology/pharmacy journals, as well as referee for many biomedical journals. He has been an invited speaker at many international clinical pharmacology/pharmacy, pharmaceutical science and statistical meetings.
Dr. Ette is a fellow of the American Colleges of Clinical Pharmacology and Clinical Pharmacy, and the 1999 winner of the American College of Clinical Pharmacy's prestigious Russell Miller Award for outstanding contributions to clinical pharmacy literature. In 1996 he was the recipient of the Excellence in Review Science Award in CDER (FDA). He was a consultant to the FDA from 1998 to 2001. At the FDA, he was the chairman of the Population PK Working Group and was the major author of Population Pharmacokinetics Guidance for Industry.
He is an adjunct professor at the University of Rhode Island College of Pharmacy. Dr. Ette currently is the senior director and head of Clinical Pharmacology at Vertex Pharmaceuticals, Cambridge, Massachusetts, where he leads efforts in rational drug development through clinical trial modeling and simulation, development of novel study designs, development and implementation of advanced PK/PD methods, and has filed several patents.
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