https://ntp.niehs.nih.gov/go/n545376

NIH Standardized Organoid Modeling Center

Organoids are small, lab-grown models that mimic the structure and function of human organs and are transforming how researchers study disease and evaluate treatments. To date, most organoid models have been created through trial and error, making them difficult to reproduce across laboratories and slowing their adoption in both research and industry.

In 2025, NIH announced the establishment of the Standardized Organoid Modeling (SOM) Center, an integrated platform dedicated to developing standardized organoid-based NAMs. The initiative was launched by the NIH Division of Program Coordination, Planning, and Strategic Initiatives, in collaboration with other NIH institutes, centers, and offices including NCI and NCATS. The center will initially focus on organoid models of the liver, lung, heart, and intestine, with plans to expand to the brain, thymus, and other disease-specific models. The SOM Center will serve scientists and researchers, regulatory agencies, and clinicians and precision medicine experts. 

To ensure consistency, transparency, and broad scientific benefit, the following policies will guide SOM Center access and use:

  • Open Science Policy: All protocols, data, and models will be openly shared via FAIR principles to maximize community benefit and reuse.
  • Affordable Access: Physical organoids and digital resources will be made available at minimal cost to NIH-funded and other qualified investigators.
  • Regulatory Alignment: All models and data will be developed in alignment with standards recognized by agencies such as FDA, OECD, and ICCVAM to facilitate potential use in regulatory contexts.
  • Performance Qualification Framework: All organoid systems will undergo predefined benchmarking against structural, molecular, and functional criteria to establish reproducibility and comparability across sites.
  • Ethical and Inclusive Use: The SOM Center prioritizes heterogeneity in human cell lines (age, sex, ancestry), community engagement, and bioethical oversight to ensure models are representative and equitable.
  • Training and Use Compliance: Users must complete relevant training modules and adhere to standard operating procedures to ensure reproducibility and ethical use.
  • Data Contribution Encouraged: Collaborating researchers are encouraged to contribute their results (including negative data) to enhance collective learning and protocol refinement.