Brian Mulhern, MS

Brian specializes in the nonclinical safety evaluation of drugs and biologics. Brian manages nonclinical programs to meet the objectives and schedules of product development plans. As a study monitor, he participates in all aspects of outsourcing including preparing study outlines for pricing, identifying laboratories with expertise in areas specific to the product, preparing protocols, scheduling, and reviewing reports. He is experienced in monitoring genetic toxicology, general toxicology, carcinogenicity, developmental and reproductive toxicology, and juvenile animal studies in a variety of species and routes of administration. His experience provides a valuable perspective on best practices in the design, conduct, and reporting of nonclinical studies in the industry. Brian is responsible for the authorship and scientific review of nonclinical regulatory submissions including briefing packages to support FDA meetings, INDs, and NDAs. Brian is an active member of the American College of Toxicology and has an M.S. in Pharmacology and Toxicology from Michigan State University.