@article{6926, author = {Donald E. Ingber}, title = {Challenges and opportunities for human Organ Chips in FDA assessments and pharma pipelines,}, abstract = {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.}, year = {2026}, journal = {Cell Stem Cell}, month = {2026-01-20}, issn = {1934-5909}, url = {https://www.sciencedirect.com/science/article/pii/S1934590925004564}, doi = {10.1016/j.stem.2025.12.022}, }