FDA guides on streamlined nonclinical monoclonal antibody safety studies

The FDA has proposed industry guidance to assist sponsors in implementing streamlined approaches for nonclinical safety assessments of monoclonal antibodies that recognize a single molecular target, referred to as monospecific antibodies. “Most antibodies are pharmacologically active in nonhuman primates only, and this guidance is intended to facilitate drug development for monospecific antibodies while avoiding unnecessary use of animals, particularly NHPs, consistent with the 3R principles of reducing, refining, and replacing animal testing. By reducing animal testing and incorporating an integrated knowledge-based risk assessment, this guidance is anticipated to facilitate greater efficiencies in product development,” the draft guidance document posted by the FDA stated. Analysts at Craig Hallum have noted that Certara (CERT), Schrodinger (SDGR) and Simulations Plus (SLP) offer simulation/modeling platforms that will help pharmaceutical companies meet the proposed changes.