Cancer immunotherapy represents a new and promising area of treatment of cancer. This is an exciting field and is overseen by the FDA CBER OCTGT division. A number of new drugs have been successfully approved. This class of drugs is presenting a wide spectrum of unusual and difficult clinical toxicities some of which are not predicted by traditional two species toxicity studies. For this reason, the FDA is working closely with sponsors in order to devise unique and science-driven investigational toxicology, pharmacology, and customized studies that are particularly relevant for each different molecule in addition to standard 2,4,12 week acute, subacute, and chronic toxicology studies.

Immunotherapeutic agents include small molecules, biologics, antibodies, immunoproducts, gene therapies, and vaccines. CBI has a wide range of experience in the toxicologic assessment of these products, as well as designing and interpreting special and mechanistic studies with these agents. CBI looks forward to working with our clients in this novel and cutting edge field of research.