Janice Lansita

Dr. Janice Lansita is a board-certified toxicologist with over 16 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 as well as biologic therapies, including monoclonal antibodies, bispecifics, fusion proteins, cytokines, cell and gene therapies, peptides, enzyme replacement therapies, and DNA/RNA based 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 (>30), Investigator Brochures, annual reports, BLAs/NDAs, and package inserts/product labels for biopharmaceuticals. She has specialized expertise in the nonclinical development of biologic therapeutics, including pharmacologically relevant species selection, immunogenicity, immune-mediated toxicity (e.g., complement activation, anti-drug antibodies, autoimmunity, cytokine-release), surrogate animal models, immunotoxicology endpoints, study design and setting the FIH starting dose (MABEL, HNSTD, NOAEL).