PredictCan Biotechnologies is proud to contribute to a major collaborative initiative led by the 3Rs Collaborative (3RsC) and involving the U.S. Food and Drug Administration’s Center for Drug Evaluation and Research (FDA CDER), following acceptance of the project’s Letter of Intent into the FDA Innovative Science and Technology Approaches for New Drugs (ISTAND) Pilot Program.
The initiative brings together eight commercial liver microphysiological system (MPS) providers, alongside regulators, non-profit organizations, and industry end-users, to address a critical challenge in the adoption of New Approach Methodologies: generating robust and comparable evidence that can support confidence in their use for drug safety assessment.
Building Confidence in Liver MPS for DILI Assessment
Drug-induced liver injury (DILI) remains an important challenge in drug development and an area where more human-relevant preclinical approaches are needed.
As part of this collaborative study, commercially available liver MPS platforms are being evaluated using the same compounds and harmonized experimental protocols. The objective is to assess their ability to detect liver toxicity while examining key parameters including reproducibility, reliability, and comparability across platforms.
This coordinated framework provides an opportunity to generate evidence that goes beyond the performance of any single technology and contributes to a broader understanding of how liver MPS can be used reliably in drug development.
From Scientific Performance to Regulatory Confidence
For PredictCan, participation in this initiative reflects an important aspect of the company’s development strategy: ensuring that innovative human-relevant technologies are not only scientifically relevant, but also evaluated within frameworks that can ultimately support regulatory confidence and industrial adoption.
PredictCan contributes its individual-centric liver MPS technology alongside other commercial platforms, helping generate the shared evidence needed to better understand the performance and appropriate use of these models for DILI assessment.
The project will also contribute to the development of shared methodologies, scientific publications, and a potential future qualification plan within the FDA ISTAND framework.
Advancing the Next Generation of Preclinical Drug Safety
Acceptance into the ISTAND process represents an important milestone for the broader MPS community and reinforces the growing interest in human-relevant New Approach Methodologies (NAMs) for regulatory drug development.
For PredictCan, this collaboration complements its broader mission to bring human biological diversity into preclinical safety assessment while contributing to the collective effort required to move innovative MPS technologies from promising research tools toward trusted solutions for industrial and regulatory toxicology.
