TEX-VAL: Texas A&M Tissue Chip Validation Consortium This proposal is to facilitate the evolution of the Tissue Chip Validation Center at Texas A&M University (TEX- VAL) into TEX-VAL Consortium for validation of microphysiological systems (MPS). TEX-VAL Consortium's goal is to promote the use of tissue chips by the industry and regulatory bodies by creating a ?safe harbor? public- private partnership that builds on an existing infrastructure and expertise of TEX-VAL, free of potential conflicts of interests in tissue chip development. In less than 2 years, between October 2016 and August 2018, TEX-VAL completed testing of 11 tissue chips developed by other NIH grantees. TEX-VAL established functionality, reproducibility, robustness and reliability of tissue chip models for a wide array of human tissues. These included the University of Washington proximal kidney tubule; Vanderbilt University neuro-vascular unit; Columbia University bone-tumor and skin; Johns Hopkins/Baylor College of Medicine gut enteroid; UC-Berkeley heart, liver and white fat; UC-Irvine vascularized tumor; Duke University skeletal muscle; and the University of Pittsburgh liver. Each tissue chip was tested using a standardized workflow consisting of material transfer (Tier -1), testing of the flow and drug binding to the devices (Tier 0), replication of the experiments performed by the developers (Tier 1), and testing of new drugs selected in partnership with NIH, iQ Consortium, and FDA (Tier 2). To enable comparative analyses with standard in vitro systems, all tissue chip experiments were conducted in parallel with relevant 2D cultures. Quality assurance project plans were developed and audited by a faculty member with experience in applicable guidelines. All experimental protocols and records adhered to the highest standards based on the Organisation for Economic Cooperation and Development guidance for describing non-guideline in vitro methods, and appropriate guidance on validation of alternatives to animal methods from the FDA and the National Toxicology Program. All data and protocols were shared with respective developers and deposited into the University of Pittsburgh Microphysiology Systems Database (MPS-Db). In the next phase of funding, the TEX-VAL Consortium will utilize Texas A&M University's existing infrastructure for phenotyping and imaging at the Institute of Biosciences and Technology (Houston, TX) and College of Veterinary Medicine (College Station, TX), analytical chemistry at the Geosciences and Environmental Research Group (College Station, TX), and microfluidics at the NanoBio Systems Laboratory (College Station, TX). TEX-VAL Center already secured commitments for testing of 19 new tissue chips from NIH-funded developers. There are also a number of commitments from key members of the iQ Consortium and government agencies to negotiate transition from NIH-funded model for tissue chip testing to one funded and administered as a public-private partnership. Finally, TEX-VAL has an extensive network of partnerships with relevant regulatory agencies in the USA and Europe, which will continue to serve as an important channel for engagement with diverse stakeholders to communicate the scientific promise, technical robustness, as well as any limitations of the tested tissue chips.
TEX-VAL is a Tissue Chip Validation Center at Texas A&M University that was established with a goal to testing a number of microphysiological systems developed by other academic investigators. TEX-VAL will use reference chemicals to establish whether performance of tissue chips is reproducible and whether the data that can be obtained from them can be used by companies and regulatory agencies to make decisions about safety and efficacy of the chemicals. In addition TEX-VAL will establish a public-private Consortium to facilitate transition of tissue chips from development to use in drug development.