Dr. Janice Lansita

Dr. Janice Lansita
Toxicology Lead

Dr. Janice Lansita is a board-certified toxicologist with over 17 years of experience, both in the biopharmaceutical industry and with the Food and Drug Administration (FDA). As a regulatory toxicologist, she has developed small molecule (NME and 505(b)(2)) and biologic therapies for a broad range of indications (e.g., rare disease, oncology, neurology, pain, ophthalmology, and immunology). Dr. Lansita has extensive experience in the design, monitoring, and interpretation of nonclinical toxicology studies (GLP and non-GLP) and has authored the nonclinical sections of various regulatory documents, including pre-INDs, INDs/CTAs (>40), Investigator Brochures, BLAs/NDAs, and package inserts/product labels for biopharmaceuticals.