According to a recent article published on ScienceDirect by Donald E. Ingber, FDA and NIH initiatives to phase out animal testing have thrust human Organ Chips into the spotlight as a promising new approach methodology (NAM) for drug assessment.
These microfluidic systems, built with living human cells under dynamic flow, can replicate organ-level physiology more accurately than traditional animal models. Yet despite strong scientific promise, Organ Chips are not widely embedded in pharma pipelines. The main hurdles lie in regulatory qualification, reproducibility, cost, and the need to define narrow, context-specific uses accepted by regulators.
image: freepik
The FDA’s ISTAND program illustrates both the opportunity and difficulty: Organ Chips must meet strict standards for robustness, standardized manufacturing, and predictive performance against known human outcomes. Emulate’s Liver Chip, for example, showed dramatically improved prediction of drug-induced liver injury compared with animal models, but only after years of validation tied to a specific use case.
Looking ahead, Organ Chips could reshape drug development by reducing late-stage failures, enabling earlier human-relevant efficacy testing, supporting personalized medicine, and complementing – not instantly replacing – animal studies. The transition will be gradual, but the potential scientific, economic, and ethical gains are substantial.
Research article: Challenges and opportunities for human Organ Chips in FDA assessments and pharma pipelines
Lambda Biologics’ Oncology Solutions: Patient-derived cancer organoid-based drug evaluation service
Gastric Cancer Organoid | Breast Cancer Organoid | Hepatocarcinoma Cancer Organoid | Pancreatic Cancer Organoid
