Testing and Qualification of the Microphysiological Systems Through an Academia-Industry-Government Collaboration

The rapid explosion of the offerings in microphysiological systems space and persistent publicity have placed high expectations on both the industry and regulatory agencies to adopt these models in safety and efficacy evaluations. Some end-users became early adopters, whereas others have taken a more cautious approach because of the high cost and uncertainties of the value that microphysiological systems may have. The TEX-VAL Consortium was established through competitive funding from NIH-NCATS to assist academic developers of tissue chips to understand whether their technology is ready to be transferred to the end-users. After 4 years of NIH support, it evolved into a public-private collaboration focused on testing and qualification of various promising platforms before they would find their way into member organization’s laboratories. By pooling the resources, several drug and consumer health companies, government agencies, and a trade association are defining potential contexts of use, designing focused experiments, and evaluating the data to determine whether each technology is “ready” to be relied upon in their own decision-making workflows. This presentation will describe how this Consortium operates and the outcomes from 7+ years of testing over 30 diverse models and the practical aspects of using microphysiological systems in the context of their potential application to decision-making.