PredictCan Biotechnologies has contributed to a new collaborative publication describing a harmonized framework for the evaluation of commercially available liver microphysiological systems (MPS) for Drug-Induced Liver Injury (DILI) assessment.
The work brings together FDA CDER, the 3Rs Collaborative, commercial MPS developers, industry end-users, and academic partners around a shared challenge: how to generate robust and comparable evidence supporting the use of emerging liver MPS technologies in drug safety assessment.
PredictCan participated as one of the commercial liver MPS providers contributing to this collaborative effort.
A Common Framework Without Requiring a Common Model
Liver MPS platforms can differ substantially in their biological composition, architecture, experimental workflows, and intended applications. Rather than attempting to determine which platform is universally “best,” the initiative establishes a framework through which different technologies can be systematically evaluated within a defined regulatory Context of Use.
Commercially available liver MPS platforms are evaluated using harmonized experimental conditions and common reference compounds, allowing their performance to be examined within a shared framework while preserving the technological diversity of each system.
This approach is particularly important for technologies such as MPS, where different platforms may provide value for different applications and stages of drug development.
Generating Evidence for Regulatory Confidence
The initiative focuses on generating the type of evidence required to understand how reliably these technologies perform for a specific application.
Key considerations include reproducibility, cross-platform performance, and the ability to detect clinically relevant liver toxicity. By generating evidence prospectively across independent technologies, the collaboration aims to establish greater confidence in how liver MPS can be evaluated and interpreted for drug safety applications.
For PredictCan, this represents an important opportunity to benchmark its individual-centric liver platform within a broader ecosystem of commercially available MPS technologies and contribute to the development of shared standards for the field.
Collaboration as a Path Toward MPS Adoption
Moving New Approach Methodologies from promising scientific tools toward broader industrial and regulatory use requires more than demonstrating the performance of individual platforms.
It requires transparent benchmarking, harmonized methodologies, collaboration between technology developers and end-users, and early engagement with regulatory scientists.
This publication illustrates how precompetitive collaboration across the MPS ecosystem can help build the evidence base necessary for more consistent evaluation and, ultimately, greater confidence in human-relevant approaches to drug safety.
PredictCan Contributing to the Future of Regulatory Toxicology
PredictCan’s participation in this work aligns with its broader strategy of developing human-relevant preclinical technologies while contributing to the scientific and regulatory frameworks necessary for their adoption.
Alongside its work on human biological diversity and individual susceptibility to DILI, participation in cross-platform initiatives allows PredictCan to demonstrate its technology within standardized evaluation frameworks and contribute to collective efforts toward robust, reproducible, and regulatory-relevant approaches to predictive toxicology.
