A New Liver Toxicity Prediction Assay for Use in the Biopharmaceutical Industry by NucroTechnics – A Partnership with One Million Solutions in Health

The Technology Evaluation Consortium^TM, managed by One Million Solutions in Health™, has a TEC Validation Project™ underway to evaluate and validate a new liver toxicity prediction assay (hepatotoxicity) to further inform scientists in the drug discovery process. In particular, the Technology Evaluation Consortium is running blinded tests to demonstrate the performance of the new liver toxicity prediction assay technology.

Hepatotoxicity is one of the most important reasons for the failure of drug candidates during the clinical phase of drug development. Therefore, the Technology Evaluation Consortium will be evaluating a new liver toxicity prediction assay that increases the accuracy of hepatotoxicity detection during the PRE-clinical phase. The concept behind the assay is that a panel of hepatotoxicity biomarkers, validated to collectively detect hepatotoxicity, is more predictive than several biomarkers used individually.

This liver toxicity prediction assay has the unique potential to analyze different toxicities with multiple endpoints, considering factors such as metabolism and pharmacokinetics. The assay is particularly appropriate for safety assessment in the pre-clinical phase as it also provides valuable mechanistic information to support the data needed for regulatory submission of these pre-clinical experiments.

The Technology Evaluation Consortium (TEC) will bring together a number of industry leaders from pharmaceutical and biotech companies to accomplish the following goals in the TEC Validation Project for this liver toxicity prediction assay:

1.    Close collaboration with the TEC members to advance the technical and non-technical aspects of the in vivo liver toxicity prediction assay to achieve a strong, mutually agreed upon proof-of-concept (POC)

2.    Gain the interest of the TEC members in participating in a 2nd follow-on project, a Phase II TEC Validation Project aimed at closing any technical and non-technical gaps that will be identified by the TEC members during the execution of the present TEC Validation Project (Phase I)

3.    Optimize the new assay for adoption by the TEC members and by the pharmaceutical drug development industry in general

“We look forward to evaluating this new hepatotoxicity assay. Once validated, this assay could be immensely useful to our partners in the pharmaceutical industry,” explained Dawn Van Dam, President and CEO of One Million Solutions in Health.

Each member of the Technology Evaluation Consortium will nominate one Subject Matter Expert to represent their company. These experts will meet virtually once every two to three weeks to formulate the project and then to discuss updates about the project, offer advice, and decide the next steps. In this manner, the technology will be validated by the top minds in the field, from across the globe.