Area of Expertise:
Brian Mulhern, MS
Brian specializes in the nonclinical safety evaluation of drugs, biologics, and combination products. Brian offers strategic nonclinical development services to sponsors and has worked on products for a variety of indications, including oncology, cardiorenal, ophthalmic, gastrointestinal, vaccines, analgesics, and psychiatric disorders. Brian has extensive experience in nonclinical program management, outsourcing support, and study monitoring. Brian also provides nonclinical regulatory support through authorship and scientific review of nonclinical regulatory submissions including briefing packages to support FDA meetings, INDs, and NDAs, and participation in meetings with regulatory agencies. Brian holds a Master’s degree in Pharmacology and Toxicology from Michigan State University, is an active member of the American College of Toxicology (ACT) and Society of Toxicology (SOT), and continues his education and training through regular participation in toxicology workshops, classes, and meetings.