Nonclinical toxicological evaluation for non-natural peptide therapeutics

Abstract

The number of peptide drugs approved in the USA as well as Japan has increased significantly despite inherent challenges of rising cost of manufacturing, peptide instability, and patient-friendly delivery. Disparities in interpretations and application of existing International Council for Harmonization (ICH) guidance ICH M3(R2) and ICH S6 to non-natural synthetic and conjugated peptide therapeutic products will be explored. The presentation will discuss the gaps in current regulatory guidance and provide the working group’s opinion on specific case examples.