Barbara Stewart has over 25 years of experience in the pharmaceutical industry and life sciences, with over 16 years focusing primarily on nonclinical safety. Barbara’s technical expertise is in design and execution of nonclinical development plans from discovery through IND, NDA, and global registration. She has in-depth experience in designing, monitoring and reviewing GLP studies in general toxicology, safety pharmacology, genetic toxicity, in silico evaluations, developmental/reproductive toxicity and carcinogenicity, and in preparing the pharmacology/toxicology sections for INDs, NDAs and rest of world regulatory submissions. Barbara has participated in many meetings and discussions with the FDA.
Barbara is owner and founder of Nonclinical Consulting LLC. Previously, she was the Vice President and Head of Nonclinical Safety at Pharmacyclics/AbbVie. Barbara previously held management positions at Alexza Pharmaceuticals, Alza Corporation/Johnson & Johnson, and SRI International.
Barbara earned her Bachelor of Arts degree in Human Biology from Stanford University and her Doctorate of Philosophy degree from the University of California, Davis. Barbara is affiliated with Society of Toxicology (SOT), and NorCal SOT, Environmental Mutagen Society (EMS), Genetic and Environmental Toxicology Association of Northern California (GETA, and the Teratology Society and is an author on numerous publications.