Erin Nissen Castelloe, M.D.
Pharmaceutical Medicine Consultant
Dr. Castelloe specializes in early-phase clinical drug development and pharmacovigilance. She has monitored clinical research as an Institutional Review Board (IRB) member, a Data and Safety Monitoring Board (DSMB) member/chair, a Medical Monitor, a Safety Review Committee (SRC) 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, analyses of similar events, regulatory briefing books, and standard operating procedures; clinical trial preparation and management; safety surveillance and signal detection; and comprehensive risk-benefit analysis and management. She has worked on an array of compounds (small molecules and biologics) with various delivery routes (inhaled, intramuscular, intranasal, intrathecal, intravenous, oral, subcutaneous) in numerous therapeutic areas (allergy/asthma, bioterrorism, endocrinology, hepatology, nephrology, neurology, oncology, psychiatry, radiation injury prevention/treatment).