TEX-VAL: Texas A&M Tissue Chip Validation Consortium

TEX-VAL：德克萨斯 A

• 批准号: 9788555
• 负责人: Ivan Rusyn
• 金额: $ 148.02万
• 依托单位: TEXAS A&M UNIVERSITY
• 依托单位国家: 美国
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-09-19 至 2022-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9788555
• 关键词: Academia; Address; Adoption; Analytical Chemistry; Animal Testing; Animals; Bacteria; Binding; Biological Assay; Biological Sciences; Biomedical Engineering; Bone neoplasms; Cells; Characteristics; Chemicals; Collaborations; Conflict of Interest; Contract Services; Data; Data Quality; Data Storage and Retrieval; Database Management Systems; Decision Making; Deposition; Development; Devices; Drug Screening; Economics; Educational workshop; Ensure; Europe; Evolution; Faculty; Fatty acid glycerol esters; Federal Government; Funding; Genomics; Geoscience; Goals; Government; Government Agencies; Guidelines; Heart; Human; Image; In Vitro; Industry; Infrastructure; Institute of Medicine (U.S.); Institutes; Interdisciplinary Study; International; Laboratories; Language; Legal; Liver; Measurement; Mediation; Medicine; Methods; Microfluidics; Modeling; National Toxicology Program; Neoplasms in Vascular Tissue; Organ; Performance; Pharmaceutical Preparations; Phase; Phenotype; Privatization; Procedures; Process; Production; Protocols documentation; Proximal Kidney Tubules; Quality Control; Records; Reproducibility; Research; Research Personnel; Risk Assessment; Safety; Scientist; Secure; Site; Skeletal Muscle; Skin; Standardization; State Government; System; Technology; Testing; Texas; Tissue Microarray; Tissue Model; Tissues; Toxicology; United States Food and Drug Administration; United States National Institutes of Health; Universities; Validation; Veterinary Medicine; Washington; Work; base; college; comparative; data sharing; drug development; drug efficacy; experience; experimental study; fitness; high standard; human tissue; in vivo evaluation; mathematical model; medication safety; member; microphysiology system; neurovascular unit; novel; novel therapeutics; operation; pharmacokinetic model; programs; public health relevance; public-private partnership; quality assurance; screening; sound; success

PROJECT SUMMARY 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.

项目概要 TEX-VAL：德克萨斯 A&M 组织芯片验证联盟 该提案旨在促进德克萨斯 A&M 大学组织芯片验证中心 (TEX- VAL) 纳入 TEX-VAL 联盟，用于验证微生理系统 (MPS)。 TEX-VAL联盟的目标 是通过创建“安全港”公众来促进行业和监管机构对组织芯片的使用 建立在 TEX-VAL 现有基础设施和专业知识基础上的私人合作伙伴关系，不存在潜在冲突 对组织芯片开发的兴趣。在不到两年的时间里，从2016年10月到2018年8月，TEX-VAL 完成了对其他 NIH 受资助者开发的 11 种组织芯片的测试。 TEX-VAL 既定功能， 适用于多种人体组织的组织芯片模型的可重复性、稳健性和可靠性。这些包括 华盛顿大学近端肾小管；范德比尔特大学神经血管单位；哥伦比亚 大学骨肿瘤和皮肤；约翰·霍普金斯/贝勒医学院肠肠；加州大学伯克利分校心脏、肝脏 和白色脂肪；加州大学尔湾分校血管化肿瘤；杜克大学骨骼肌；和匹兹堡大学 肝。每个组织芯片均使用标准化工作流程进行测试，包括材料转移（第 -1 层）、测试 流量和药物与设备的结合（第 0 层），复制开发人员进行的实验 （第 1 级），以及与 NIH、iQ Consortium 和 FDA 合作选择的新药测试（第 2 级）。启用 与标准体外系统进行比较分析，所有组织芯片实验均与 相关的二维文化。质量保证项目计划由一名教职人员制定和审核 适用指南的经验。所有实验方案和记录均遵循最高标准 基于经济合作与发展组织描述非指南的指南 体外方法，以及 FDA 和 FDA 对动物方法替代方案验证的适当指导 国家毒理学计划。所有数据和协议均与各自的开发人员共享并存入 匹兹堡大学微生理学系统数据库 (MPS-Db)。在下一阶段的融资中， TEX-VAL 联盟将利用德克萨斯农工大学现有的基础设施进行表型分析和成像 生物科学与技术研究所（德克萨斯州休斯顿）和兽医学院（大学站， 德克萨斯州），地球科学和环境研究小组（德克萨斯州大学城）的分析化学，以及 纳米生物系统实验室（德克萨斯州大学城）的微流体学。 TEX-VAL 中心已安全 NIH 资助的开发商承诺测试 19 种新的组织芯片。还有一些 iQ 联盟主要成员和政府机构承诺谈判从 美国国立卫生研究院 (NIH) 资助的组织芯片测试模型以公私合作伙伴关系的形式资助和管理。最后， TEX-VAL 与美国和欧洲的相关监管机构拥有广泛的合作伙伴网络， 它将继续作为与不同利益相关者沟通的重要渠道 所测试组织芯片的科学前景、技术稳健性以及任何局限性。