Dr. Janice A. Lansita serves as a Preclinical Safety and Toxicology Consultant at Ceramedix, Inc. A board-certified toxicologist with deep expertise in biologics and regulatory toxicology, she provides strategic guidance on the design, execution, and interpretation of nonclinical safety studies from IND through all stages of clinical development.
With over 20 years of experience across the biopharmaceutical industry and the U.S. Food and Drug Administration, Dr. Lansita has led nonclinical development programs for biologics and small molecules, with a strong focus on monoclonal antibodies and ophthalmology. As Founder and Principal Toxicologist at ToxAlliance LLC, she advises biotechnology and pharmaceutical companies on regulatory toxicology strategy and interactions with regulatory authorities in the U.S. and internationally. Previously, she served as Principal Scientist and Biopharmaceuticals/Pharmaceuticals Practice Director at ToxStrategies, Inc., where she led toxicology programs across a broad range of therapeutic modalities and disease areas. Earlier, she served as a Pharmacologist/Toxicologist at the FDA’s Center for Drug Evaluation and Research (CDER), where she conducted regulatory review of INDs and marketing applications and contributed to FDA guidance development. Prior to the FDA, she held roles at Biogen supporting IND and CTA submissions and advancing biologic therapeutics into the clinic. She has extensive experience in the design, monitoring, and interpretation of nonclinical toxicology studies (GLP and non-GLP), has authored the nonclinical sections of various regulatory documents, including >60 INDs/CTAs, and has represented numerous clients in regulatory authority meetings (U.S. and ex-U.S.).
Dr. Lansita earned a PhD in toxicology from the Massachusetts Institute of Technology and a BA in biochemistry from Barnard College, Columbia University.