NextGen Tissue Chip Testing Centers: Validating Microphysiological Systems (U24 Clinical Trial Not Allowed)

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This Funding Opportunity Announcement (FOA) invites applications for NextGen Tissue Chip Testing Center(s) (NextGen TCTC) that will provide resources and infrastructure for the validation of tissue chips being developed as part of the NIH Tissue Chip (TC) for Drug Screening Program or NIH Microphysiological Systems (MPS) Program. The MPS program supports a consortium of investigators developing accurate cellular and organ microsystems representative of human physiology for the evaluation of drug efficacy and toxicity (RFA-RM-11-022; RFA-TR-16-017; RFA-TR-16-019). The developed in vitro MPS platforms are representative of major organs and tissues in the human body, and need to be validated for their predictive capabilities of the assessment of biomarkers, and the bioavailability, efficacy, and toxicity of therapeutic agents prior to entry into clinical trials. Validation of the tissue chips is currently being conducted through Tissue Chip Testing Centers. These are responsible for testing a select group of compounds using predefined assays and biomarkers, according to pharmaceutical industry standards, and the integration of the data into a public database. NextGen TCTC(s) will aim to accelerate the transition of NIH-supported research innovations and technologies toward a self-sustaining model to continue the validation of various MPS platforms. NextGen TCTC(s) will develop services that promote the use of MPS by industry, regulatory bodies, and biotech sectors, and create significant value and economic stimulus or, advance the research in MPS technology in a way that could stimulate future growth and investments, and advance drug discovery and development. This U24is intended to support research and development (R and D) specifically targeted at activities that can help address the funding gap between promising R and D and transitioning to the market, often called the Valley of Death by contributing the critical funding needed by applicants to pursue the next appropria

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