Pathologists and toxicology in CROs.

Abstract

In recent years, nonclinical safety studies, particularly GLP complied studies, of pharmaceuticals, chemical substances, and agrochemicals has become common to primarily conducted by the CROs. However, for example of pharmaceuticals, as drug discovery modalities have diversified from low molecular weight compounds to antibody drugs, nucleic acid drugs, gene therapy, and regenerative medical products. As a result, their safety evaluation has become increasingly challenging, and the level of demand for toxicologic pathologists as well as study directors has also been increasing. The level of demand for pathologists in charge of pathology evaluation as well as study directors is increasing. Under such circumstances, I will discuss the current status and challenges of toxicologic pathologists in CROs, including pathological evaluation, training and education, and the measures to new technologies/tools such as whole mount imaging (WSI) and digital pathology.