New approach methods on the bench side to accelerate clinical trials during pregnancy.

Abstract

Introduction: Pregnant women are therapeutic orphans as they are excluded from clinical drug development and therapeutic trials. We identify limitations in conducting clinical trials and propose two 'New Approach Methods'(NAMs) to overcome them.

Areas covered: NAMs have proven invaluable tools in basic and clinical research to understand human health and disease better, elucidate mechanisms, and study the efficacy and toxicity of therapeutics that have not been possible through animal-based methodologies. The lack of humanized experimental models of FMi and drugs that can safely and effectively cross FMi to reduce the risk of adverse pregnancy has hindered progress in the field of reproductive pharmacology. This report discusses two technological advancements in perinatal research and medicine to accelerate clinical trials during pregnancy. (1) We have developed a humanized microphysiologic system, an Organ-on-a-chip (OOC) platform, to study FMi and their utility in pharmacological studies, and (2) use of extracellular vesicles (EVs) as drug delivery vehicles that are immunologically inert and can cross the fetomaternal barriers.

Expert opinion: We provide an overview of NAMs that can accelerate preclinical trials and develop drugs to cross the feto-maternal barriers to reduce the risk of adverse pregnancy outcomes like preterm birth.