Accelerating the approval of new therapies for complex diseases using advanced liver models
Official title: Administrative Core
Funded at University of Pittsburgh at Pittsburgh · NIH-11003750 · Data updated 2026-11-12
This study is testing new tools that mimic how the human liver works to help speed up the approval of safe and effective treatments for conditions like non-alcoholic fatty liver disease, so patients can get access to better therapies more quickly.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | University of Pittsburgh at Pittsburgh NIH-funded |
| Lab location | 1 site (Pittsburgh, United States) |
| Project start | January 1, 2024 |
| Project end | December 31, 2028 |
| Funding year | 2025 |
| Award (this year) | $173,896 |
| NIH project number | 5U2CTR004863-02 |
| Project ID | NIH-11003750 on NIH RePORTER |
Who could benefit from this research
✓Could help
Ideal candidates for this research are patients suffering from complex heterogeneous diseases, particularly non-alcoholic fatty liver disease.
✕Less likely to help
Patients with conditions unrelated to liver function or those not involved in clinical trials may not benefit from this research.
What this research studies
This research focuses on qualifying innovative drug development tools, specifically human liver biomimetic microphysiology systems, to support FDA decisions. By using these advanced models, the project aims to improve the approval process for new therapies targeting complex diseases like non-alcoholic fatty liver disease. The approach includes assessing liver toxicity, drug safety, and efficacy, as well as optimizing clinical trial cohorts. Patients may benefit from faster access to new treatments that are proven to be safe and effective.
Why it matters
Potential benefit: If successful, this research could lead to quicker approvals of novel therapies, providing patients with more effective treatment options for complex diseases.
How similar studies have gone: Other research has shown success in using biomimetic systems for drug development, indicating a promising approach for this project.
Where this research is happening
-
University of Pittsburgh at Pittsburgh
Pittsburgh, United States Active
Researchers
- Principal investigator: Soto-Gutierrez, Alejandro — University of Pittsburgh at Pittsburgh
- Study coordinator: Soto-Gutierrez, Alejandro
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About this research
- This is an active NIH-funded research project — typically early-stage science, not a clinical trial accepting patient enrollment.
- Some NIH-funded labs run parallel clinical studies or seek volunteers for related work. To check, contact the principal investigator or institution listed above.
- For full project details, budget, and progress reports, visit the official NIH RePORTER page.