2018 - 2020
PROJECT SUMMARYTEX-VAL: Texas A&M Tissue Chip Validation ConsortiumThis 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 goalis to promote the use of tissue chips by the industry and regulatory bodies by creating a â€œsafe harborâ€ public-private partnership that builds on an existing infrastructure and expertise of TEX-VAL, free of potential conflictsof interests in tissue chip development. In less than 2 years, between October 2016 and August 2018, TEX-VALcompleted 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 includedthe University of Washington proximal kidney tubule; Vanderbilt University neuro-vascular unit; ColumbiaUniversity bone-tumor and skin; Johns Hopkins/Baylor College of Medicine gut enteroid; UC-Berkeley heart, liverand white fat; UC-Irvine vascularized tumor; Duke University skeletal muscle; and the University of Pittsburghliver. Each tissue chip was tested using a standardized workflow consisting of material transfer (Tier -1), testingof 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 enablecomparative analyses with standard in vitro systems, all tissue chip experiments were conducted in parallel withrelevant 2D cultures. Quality assurance project plans were developed and audited by a faculty member withexperience in applicable guidelines. All experimental protocols and records adhered to the highest standardsbased on the Organisation for Economic Cooperation and Development guidance for describing non-guidelinein vitro methods, and appropriate guidance on validation of alternatives to animal methods from the FDA and theNational Toxicology Program. All data and protocols were shared with respective developers and deposited intothe University of Pittsburgh Microphysiology Systems Database (MPS-Db). In the next phase of funding, theTEX-VAL Consortium will utilize Texas A&M University''s existing infrastructure for phenotyping and imaging atthe 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), andmicrofluidics at the NanoBio Systems Laboratory (College Station, TX). TEX-VAL Center already securedcommitments for testing of 19 new tissue chips from NIH-funded developers. There are also a number ofcommitments from key members of the iQ Consortium and government agencies to negotiate transition fromNIH-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 communicatethe scientific promise, technical robustness, as well as any limitations of the tested tissue chips.