For Part 4 of Mastering the Clinical Investigation, several experts were interviewed. Their full biographies are as follows.

Virginia Perry is president of Perry D’Amico and Associates. She has 25 years of experience in the industry, having served at Nellcor, Baxter Health Care Corp., American Hospital Supply Corp., and Warner Lambert.

Michael Hamrell is president of Moriah Consultants. He is a former CDER employee and NIH researcher. Hamrell has more than 25 years of experience in drug and device development, clinical research, and regulatory affairs, including holding an adjunct professorship of molecular pharmacology and toxicology position at the University of Southern California, the Massachusetts College of Pharmacy, and the University of North Carolina, Wilmington. He also teaches regulatory affairs and clinical compliance courses at George Washington University. He is a founding editorial board member of Applied Clinical Trials and is currently the editor-in-chief of the Drug Information Journal.

Louise Peltier is a regulatory affairs consultant. She has 30 years of experience in the industry, having served at Guildford Pharmaceuticals, Northwest Biotherapeutics, and Centocor.

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