TY - JOUR
AU - Donald E. Ingber
AB - 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.
BT - Cell Stem Cell
DA - 2026-01-20
DO - 10.1016/j.stem.2025.12.022
N2 - 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.
PY - 2026
T2 - Cell Stem Cell
TI - Challenges and opportunities for human Organ Chips in FDA assessments and pharma pipelines,
UR - https://www.sciencedirect.com/science/article/pii/S1934590925004564
Y2 - 2026-01-21
SN - 1934-5909
ER -