James L. Hinson

Vice President, Regulatory Affairs - Myriad Pharmaceuticals, Inc.

James L. Hinson is a senior drug industry professional specializing in drug product development and regulatory affairs.  During his career, he has directed and significantly contributed to the successful preparation, submission and approval of numerous INDs, ANDAs and NDAs.  He has 25 years experience in the drug industry including hands-on experiences in leading product development teams; regulatory affairs; planning, conducting and analyzing clinical trials; statistics and SAS programming; and laboratory assays. He has a strong background in pharmacokinetics, bioequivalence and clinical pharmacology.  Currently, he is part of the executive management (Vice President, Regulatory Affairs) at Myriad Pharmaceuticals, Inc. providing leadership to development and commercial teams.  He was formerly Director of Regulatory Affairs at PPD, Inc. where he oversaw a diverse group of regulatory professionals, information scientists and two ethics committees.  Prior to joining PPD, he independently consulted for national and international clients on matters of drug development and regulatory affairs.  He also served as Manager, Pharmacokinetics and Bioequivalence at Boots Pharmaceuticals, Inc. where he planned, managed and reported clinical pharmacology studies for submission to US and international regulatory agencies along with integrating US pharmacokinetic programs into international development plans.