# MPS Qualification Section

> **NIH NIH U2C** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2024 · $1,148,044

## Abstract

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.

## Key facts

- **NIH application ID:** 10815366
- **Project number:** 1U2CTR004863-01
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Mark E Schurdak
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $1,148,044
- **Award type:** 1
- **Project period:** 2024-01-01 → 2028-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10815366

## Citation

> US National Institutes of Health, RePORTER application 10815366, MPS Qualification Section (1U2CTR004863-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10815366. Licensed CC0.

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