# Administrative Core

> **NIH NIH U2C** · UNIVERSITY OF PITTSBURGH AT PITTSBURGH · 2024 · $253,605

## Abstract

Qualifying drug development tools (DDTs), such as human liver biomimetic microphysiology systems (MPS), to
support FDA decisions will accelerate the approval of novel and innovative therapies for complex heterogeneous
diseases (e.g., Non-alcoholic fatty liver disease). The University of Pittsburgh Translational Center for
Microphysiology Systems (Pitt-TraCe) will qualify DDTs for the following contexts of use (CoUs): 1) quantifying
hepatic clearance and identifying major metabolites; 2) quantifying liver toxicity; 3) drug testing for safety and
efficacy; and 4) selecting clinical trial cohorts. The Pitt-TraCe is built upon the multiple institutional and historical
strengths of the University of Pittsburgh, a renowned leader in research, discovery, education, and innovation
and the University of Pittsburgh Medical Center, a pioneer in innovative healthcare delivery. The University of
Pittsburgh Drug Discovery Institute has an established, robust, and dynamic infrastructure with a strong
organizational and administrative framework, which will serve as the foundation for the Pitt-TraCe
Administrative Section. The Administrative Section brings together a very strong group of multi-PIs, scientists,
clinicians, commercial partners, and subject-matter experts engaged in drug development, MPS, basic and
regulatory science, translational research and in clinical care. The Pitt-TraCe Administrative Section is a critical
component that will integrate the entire Center through optimal organization, coordination, communication, and
implementation of the MPS Resources Section and Qualification Section in addition to maintaining
communication with NCATS and FDA. The success of the Pitt-Trace depends on an administrative structure that
ensures effective daily operations while working toward the mission of our center. Our organizational approach
includes soliciting input and guidance from both the External Advisory Board and the Internal Advisory Board
and empowers the multi-PIs to make decisions regarding the qualification of our DDTs. The Administrative
Section, which includes seasoned managers and administrators, will manage the interactions of the Pitt-TraCe
through regularly scheduled meetings to optimize the flow of information internally and externally, fostering a
highly productive environment. The Administrative Section will ensure impactful science, qualification of our
DDTs and their commercialization, leading to improved clinical care and the long-term sustainability of the Pitt-
TraCe.

## Key facts

- **NIH application ID:** 10815364
- **Project number:** 1U2CTR004863-01
- **Recipient organization:** UNIVERSITY OF PITTSBURGH AT PITTSBURGH
- **Principal Investigator:** Alejandro Soto-Gutierrez
- **Activity code:** U2C (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2024
- **Award amount:** $253,605
- **Award type:** 1
- **Project period:** 2024-01-01 → 2028-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10815364

## Citation

> US National Institutes of Health, RePORTER application 10815364, Administrative Core (1U2CTR004863-01). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/10815364. Licensed CC0.

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