Administrative Core

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.