The overall objective of the Qualification Section is to qualify our liver acinus MPS (LAMPS) as a drug development tool (DDT) for the following two contexts of use (CoUs): a) to predict candidate hepatic clearance and 2) to identify toxicity of drug candidates in patients with non-alcoholic fatty liver disease (NAFLD) to aid in the assessment of first-in-human (FIH) dosing for NAFLD clinical trials and provide supporting data showing acceptable toxicity in the human diseased liver for inclusion of the drug candidate NAFLD clinical trials. We will also qualify our vascularized LAMPS (vLAMPS) as a DDT for two CoUs: a) to predict efficacy of drug candidates for resolving NAFLD providing data to support advancement to clinical trials and assist in determining first-in- human dosing, and b) to predict the responsiveness of individual patients to drug candidates for their inclusion in clinical trials (clinical trial enrichment). We have outlined the plan for the qualification process, including working with a consultant experienced with FDA qualification and the FDA during the process. These DDTs used for these CoUs will address the following FDA regulatory science focus areas: a) Individualized therapies and precision medicine; b) Complex innovative trial design; c) Technologies to improve predictivity of non-clinical studies; d) Technologies to reduce reliance on animal testing; and e) Human relevancy of toxicity. In addition, these DDTs will address the clinical unmet needs for NAFLD of a) Identifying toxic drugs that should not be given to NAFLD patients; b) Identifying the most efficacious drugs to give to NAFLD patients; and c) Enrichment of NAFLD clinical trials. Additionally, the vLAMPS will be integrated with the Nortis Gen2 platform to create an Automated Biomimetic Analytic MPS (ABAMPS) platform. The ABAMPS platform creates a workflow through the integration of the BioSystics Analytics Platform (BioSystics-AP™) at the front end for study design, review of existing data, and recording of study protocols, and at the back end of the Nortis Gen2 automation platform for data capture, analysis and computational modeling. The Gen2 automation platform employs a new chip material that replaces the PDMS polymer, and a system that includes semi-automated chip handling, fluidic control, in- line imaging for temporal and spatial measurements. The ABAMPS platform will create a more efficient and reproducible platform that utilizes the vLAMPS DDT.