Translational advances require qualified non-animal models.

Supporting consortia, NIH Complement-ARIE performers, and translational researchers to replace animal testing through defensible Context of Use specifications and qualification dossiers.

Microphysiological Organ-on-Chip Barrier

Microphysiological System

Shear Stress Endothelial Barrier Model · OECD GD 34

Methodological Foundations

Meeting the FDA Modernization Act 2.0 and NIH standards.

NIH Complement-ARIE Alignment

Methodological support within the NAMs Reduction to Practice Challenge to establish empirical validation criteria for organ-on-chips and in vitro models.

✓ Active federal program performer

DDT Qualification Dossiers

Authoring Drug Development Tool (DDT) qualification packages under FDA CBER/CDER guidelines for regulatory acceptance as surrogate endpoints.

✓ Defined Context-of-Use protocols

OECD GD 34 Harmonization

Harmonizing experimental repeatability, biological relevance, and inter-laboratory transferability across international validation bodies.

✓ Multi-lab reproducibility verification