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

项目描述 德克萨斯A&M组织芯片验证中心 该提案是在德克萨斯A&M大学（TEX-VAL）建立一个组织芯片验证中心， 对NIH受资助者开发的微生理系统进行测试。我们的目标是提供 用于建立功能性、再现性、稳健性和可靠性的资源、人员和基础设施 8-12个组织芯片模型，将代表广泛的人体器官和组织系统。实现这一 目标我们组建了一支由7名杰出研究人员组成的团队，他们专门研究毒理学、体外和体内 测试、显微镜、基因组学、药代动力学建模、生物工程、分析化学和风险 考核这些调查员将密切监督一个由高素质工作人员组成的小组， 与组织芯片开发人员合作，将进行验证实验，分析数据，生成详细的 报告，并确保数据可通过可访问的 数据库质量管理计划和质量保证项目计划将由 对这些程序和适用条例有经验的工作人员。所有实验方案和 数据记录将遵循基于现有经济合作组织的最高标准 描述非指导性体外试验方法的OECD指南，以及适当的 美国食品药品监督管理局和 国家毒理学计划。TEX-VAL中心将利用德克萨斯A&M大学现有的广泛的 研究所的中高通量体外筛选和高内容成像基础设施， 生物科学和技术（德克萨斯州休斯顿）和兽医和生物医学科学学院 （学院站，得克萨斯州），分析化学在地球科学和环境研究小组（学院 Station，TX），以及NanoBio Systems Laboratory（学院站，TX）的生物工程和微流体。 TEX-VAL中心将与NIH组织芯片受赠者和IQ联盟以及其他 制药和化学工业、政府机构和学术界的专家， 组织芯片验证问题，体外与体内一致性，非靶向代谢组学分析， 选择适当的细胞类型、实验方案或选择适当的测试化合物，以及 阳性和阴性对照。参与TEX-VAL的实验室和研究人员有几十年的经验， 通过多学科研究合作，具有数据的严谨性、可重复性和可复制性的经验 以及与工业、州和联邦政府以及学术合作者的服务合同。此外，本发明还提供了一种方法， TEX-VAL已经与美国和欧洲的监管机构建立了广泛的合作关系网络， 地方，这将成为与不同利益攸关方接触的重要渠道， 所测试的组织芯片的科学前景和技术稳健性，以及任何重要的局限性。

PROJECT DESCRIPTION TEX-VAL: Texas A&M Tissue Chip Validation Center This proposal is to establish a Tissue Chip Validation Center at Texas A&M University (TEX-VAL) which will conduct testing of the microphysiological systems developed by NIH grantees. Our goal is to provide resources, personnel and infrastructure for establishing functionality, reproducibility, robustness and reliability of 8-12 tissue chip models that will represent a wide array of human organ and tissue systems. To achieve this goal we have assembled a team of 7 outstanding investigators who specialize in toxicology, in vitro and in vivo testing, microscopy, genomics, pharmacokinetic modeling, bioengineering, analytical chemistry and risk assessment. These investigators will closely oversee a team of highly qualified staff members who, in collaboration with tissue chip developers, will conduct validation experiments, analyze data, generate detailed reports and ensure that the data are available to the NIH Tissue Chip Program through an accessible database. Quality management plan and quality assurance project plans will be developed and overseen by a staff member with experience in these procedures and applicable regulations. All experimental protocols and data records will adhere to the highest standards based on the existing Organization for Economic Cooperation and Development (OECD) guidance for describing non-guideline in vitro test methods, as well as appropriate guidance on validation of alternatives to animal methods from the Food and Drug Administration and the National Toxicology Program. The TEX-VAL Center will utilize Texas A&M University's existing extensive infrastructure for medium- and high-throughput in vitro screening and high-content imaging at the Institute for Biosciences and Technology (Houston, TX) and College of Veterinary Medicine and Biomedical Sciences (College Station, TX), analytical chemistry at the Geosciences and Environmental Research Group (College Station, TX), and bioengineering and microfluidics at the NanoBio Systems Laboratory (College Station, TX). TEX-VAL Center will engage with the NIH tissue chip grantees and the IQ Consortium, as well as additional experts in the pharmaceutical and chemical industry, government agencies and academia to address questions on tissue chip validation, in vitro to in vivo concordance, untargeted metabolomics analyses, selection of appropriate cell types, experimental protocols, or selection of appropriate test compounds and positive and negative controls. The laboratories and investigators involved in the TEX-VAL have decades of experience with rigor, reproducibility and replication of data through multi-disciplinary research collaborations and service contracts with industry, state and federal government, and academic collaborators. In addition, TEX-VAL has an extensive network of partnerships with regulatory agencies in the USA and Europe already in place, which will serve as an important channel for engagement with diverse stakeholders to communicate the scientific promise and technical robustness, as well as any important limitations, of the tested tissue chips.