Challenges and opportunities for human Organ Chips in FDA assessments and pharma pipelines.

The Food and Drug Administration recently announced a plan to phase out animal-testing requirements for drug assessments based on advances in new approach methodologies, including human organ-on-a-chip (Organ Chip) microfluidic culture technology. Although Organ Chips are being explored in many pharmaceutical laboratories, they have not yet been integrated into drug-development pipelines. Here, I review challenges that must be overcome to bridge this gap and new opportunities that will emerge. I also discuss additional work that will be required for Organ Chips to reduce animal use, lower drug costs, meet regulatory goals, and improve clinical success in the future.