Ene I. Ette, Ph.D., FCP, FCCP, president and chief executive officer of Anoixis Corporation based in Natick, MA, has a broad experience in academia, drug evaluation and regulation, and the pharmaceutical industry. He is a prolific author of several original articles in peer-reviewed journals, book chapters, numerous conference presentations and proceedings, and sits on the editorial board of clinical pharmacology / pharmacy journals. He also serves as a referee for many biomedical journals. He is 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. He is the 2006 recipient of the American College of Clinical Pharmacy's Therapeutic Frontier Lecture Award for distinguished scientists. He was a consultant to FDA from 1998 to 2001. In 1999 he was the recipient of the American College of Clinical Pharmacy's prestigious Russell Miller Award for outstanding contributions to the clinical pharmacy literature; and in 1996 the recipient of Excellence in Review Science Award in CDER (FDA). At the FDA he was the major author of the Guidance for Industry: Population Pharmacokinetics. Dr. Ette is an adjunct professor of applied pharmaceutical sciences at the University of Rhode Island's College of Pharmacy, the University of the Pacific's School of Pharmacy, Stockston, California, and the primary editor of the book, Pharmacometrics: the Science of Quantitative Pharmacology. Until recently, he was the Senior Director/Head, Clinical Pharmacology, Vertex Pharmaceuticals, Cambridge, MA. where he introduced and championed efforts in the integration of knowledge-based (pharmacometric modeling and simulation) principles into drug development. Before taking up appointment at Vertex he was a leading pharmocometrician/clinical pharmacologist in the Office of Clinical Pharmacology, Center for Drug Evaluation and Research (CDER) at the Food and Drug Administration (FDA). He has broad experience in the development and evaluation of drugs.