Erin Nissen Castelloe, M.D.
Pharmaceutical Medicine Consultant
Dr. Castelloe has been responsible for pharmacovigilance and clinical- and safety-related regulatory submissions for a variety of small and mid-sized firms. In addition, she has monitored clinical research as an Institutional Review Board (IRB) member, a Data and Safety Monitoring Board (DSMB) member/chair and an Independent Research Monitor (IRM). Her experience includes first-in-human dose selection; drafting protocols, investigator brochures, informed consents, serious adverse event narratives and analyses of similar events; clinical trial preparation and management (Phases I-3); medical monitoring; and comprehensive risk assessment and management. She has worked on an array of compounds with various delivery routes (inhaled, intranasal, intrathecal, intravenous, oral, subcutaneous) in numerous therapeutic areas (allergy/asthma, bioterrorism, endocrinology, hepatology, neurology, nephrology, oncology, radiation injury prevention/treatment).