Brian Mulhern, MS, DABT

Senior Principal Consultant

Brian is a board-certified toxicologist and general regulatory affairs professional with more than 12 years of experience in the pharmaceutical consulting industry.  He 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, endocrine/metabolism, cardio-renal, ophthalmic, gastrointestinal, vaccines, analgesics, and psychiatric disorders.  Brian has experience with novel pharmaceutical and biologic products including small molecule and gene, cell, and immune therapies.  His experience includes working with products delivered by standard and nontraditional routes of administration including inhalation, intravitreal injection, and intravesical instillation.  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, Investigational New Drug Applications (INDs), and New Drug Applications (NDAs), and participation in meetings with regulatory agencies.  Brian has a B.S. in Biology from Colorado College, an M.S. in Pharmacology & Toxicology from Michigan State University, and he is a certified Diplomate of the American Board of Toxicology (DABT).