Translational Considerations and Challenges: An Overview

Biologics are one of the fastest growing subsets of pharmaceuticals today. In 2016, ten monoclonal antibodies were approved by the FDA for diverse conditions such as psoriasis and cancer. This high number of approvals followed the previous record number of approvals of ten monoclonal antibodies in 2015. Such high approval rate for biologics is a testament to advances in antibody technology and the unique advantage that this class of therapeutics offers. In addition to monoclonal antibodies, other biologics such as antibody-drug conjugates, multi-specific constructs, and antibody-derived modalities are also being considered as viable drug candidates for development. With so many players in the market, it becomes imperative to have an efficient and effective translational approach early on in the drug development process. Clarity on patient-related variables, construct manufacturing considerations, underlying pharmacology and pathophysiology, as well as integration of key translational considerations can accelerate drug development processes, ultimately benefiting patients in need of such therapies. In the previous edition of this book (First Edition), translational considerations for development of antibody-based therapeutics were discussed. This publication deals with topics related to novel and more complex modalities.