Ceramedix, Inc., a privately-held biotherapeutics company developing proprietary anti-ceramide antibodies designed to treat diseases driven by microvascular injury, today announced that it has engaged Dr. Janice Lansita, PhD, DABT, founder of ToxAlliance LLC, a specialized toxicology consulting firm, as a consultant in toxicology and safety. She and her firm will advise on the company’s nonclinical development strategy. Dr. Lansita will join Ceramedix’s advisory team of experts in regulatory affairs, CMC, radiation research, ophthalmology, and clinical development to provide integrated guidance across the company’s diabetic retinal disease and radiation medical countermeasures programs.

Dr. Lansita is a regulatory toxicology consultant and board-certified toxicologist with more than 20 years of experience spanning the biopharmaceutical industry and the U.S. Food and Drug Administration. She has developed therapeutics across a broad range of indications, with specialized expertise in ocular toxicology and the nonclinical development of biologics, including monoclonal antibodies. She brings extensive experience in the design, monitoring, and interpretation of GLP and non-GLP toxicology studies, setting the first-in-human starting dose, and guiding overall nonclinical development strategy.  Dr. Lansita has authored the nonclinical section of numerous regulatory submissions, including more than 60 INDs/CTAs, and has represented clients in regulatory authority meetings.