In pharmaceutical R&D since 2001: Preclinical development and safety teams in North America and EU. Before that, drug efficacy/resistance in academic veterinary research since 1989. Worked on compounds in multiple therapeutic areas: CNS, oncology, diabetes, endocrinology, pain, sleep, hematology, ophthalmology, urinary, vaccines, medical devices (coronary stents), and new drug forms. Conducted almost 100 GLP and non-GLP preclinical studies, outsourced and monitored a number of studies at CROs. Designed preclinical safety programs, worked as a scientific liaison to preclinical efficacy teams and clinical teams. Worked in clinical project teams, FIH strategies, co-authored regulatory documents: pre-IND, IND, IMPD, IB, end of Phase II, etc. Leading and mentoring a group of Study Directors, adivising in preclinical safety testing strategy and study designs.
Drug Development,Clinical development,toxicology,good laboratory practices,regulatory affairs,Good Clinical practices