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Dr. Cowlen joined Inspire in June 2000 as Senior Scientist Preclinical Programs. He held the position of Associate Director Drug Evaluation from January 2005 until his promotion to Director Toxicology in January 2008. Dr. Cowlen is responsible for regulatory toxicology at all stages of drug development for the respiratory and ophthalmic therapeutic areas. He is responsible for the design execution interpretation and reporting of toxicology and safety pharmacology studies required by international regulatory agencies and has supervised studies using ocular pulmonary intranasal oral and intravenous routes of administration. Dr. Cowlen has authored the toxicology and safety pharmacology sections of numerous regulatory filings with US European and Canadian agencies including pre-INDs INDs Investigator's Brochures End-of-Phase II packages and an NDA for the US Food and Drug Administration (FDA); Protocol Assistance briefing packages and an Orphan Drug Application for the European Medicines Agency (EMEA); and a Clinical Trial Application for Health Canada (HC). In addition he has participated in regulatory meetings at the FDA EMEA and HC in support of multiple clinical development programs. Prior to joining Inspire Dr. Cowlen held the position of Molecular Pathologist from 1996 to 2000 at Pathology Associates International in Frederick MD. He served on the Board of Directors of the Genetic Toxicology Association from 2005 to 2008 including two years as Secretary and one year as Chair. Dr. Cowlen received his Ph.D. in Pharmacology from the University of Missouri-Columbia was awarded a 2-year fellowship in Clinical Chemistry in the Department of Pathology and Laboratory Medicine University of North Carolina Hospitals UNC Chapel Hill and is certified as a Diplomate of the American Board of Toxicology. | 