Our Biologics Toxicology group designs and executes nonclinical safety assessment strategies, producing quality, comprehensive non-clinical safety and toxicology data to guide the administration of Janssen biologics and biopharmaceutical products in patients.
Beginning early in the discovery process, the Toxicology, Investigational Pharmacology/Toxicology and Experimental Pathology/Immunotoxicology groups within Biologics Toxicology focus on generating early target-related safety information. This is done in partnership with Biologics Research and therapeutic area discovery scientists. It may also involve developing in vivo and in vitro models. As a result of extensive experience in this area, Biologics Toxicology has established relationships with and access to contract research labs to supplement internal laboratory efforts.
As projects progress to new molecular entity (NME; formal entry into early development) declaration and beyond, Biologics Toxicology designs the non-clinical safety assessment strategy, executes programs to support clinical dosing in patients and registration of products, interprets safety data, and interacts with global regulatory agencies to ensure that all studies are conducted to meet high standards of quality for patient safety.