Accelerating the approval of new therapies for complex diseases using advanced liver models
Administrative Core
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 ID | NIH-11003750 on NIH RePORTER |
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.
Who could benefit from this research
Good fit: Ideal candidates for this research are patients suffering from complex heterogeneous diseases, particularly non-alcoholic fatty liver disease.
Not a fit: Patients with conditions unrelated to liver function or those not involved in clinical trials may not benefit from this research.
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 performed: Other research has shown success in using biomimetic systems for drug development, indicating a promising approach for this project.
Where this research is happening
Pittsburgh, United States
- 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
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 below.