Public-private collaboration to speed safer, better medicines
Official title: Critical Path Public Private Partnerships
Funded at Critical Path Institute · NIH-11421129 · Data updated 2026-11-12
A powerful public-private partnership aims to accelerate medical innovation by sharing data and expertise to create regulatory-ready tools for drug development.
Quick facts
| Grant type | NIH-funded research |
|---|---|
| Study type | NIH-funded research |
| Funding institution | Critical Path Institute NIH-funded |
| Lab location | 1 site (Tucson, United States) |
| Project start | September 5, 2014 |
| Project end | August 31, 2029 |
| Funding year | 2026 |
| Award (this year) | $15,254,636 |
| NIH project number | 5U18FD005320-13 |
| Project ID | NIH-11421129 on NIH RePORTER |
Who could benefit from this research
✓Could help
Any patient whose disease could benefit from improved drug development through better regulatory science and biomarkers.
✕Less likely to help
Patients not directly involved in drug development or those whose conditions are not addressed by the developed tools may see indirect benefits.
What this research studies
This grant funds the Critical Path Institute’s work with FDA and other partners to develop data, models, COAs, and regulatory science approaches that can speed safe and effective medicines to patients. The effort brings together industry, government, academia, and patient groups to build consensus-based solutions that address real drug-development unmet needs. The project emphasizes data management, analytics, COAs, biomarkers, and regulatory pathways to support endorsement of new tools. It also aims to training future regulatory scientists and advance neutral collaboration in drug development.
Why it matters
Potential benefit: If successful, patients could benefit from faster access to safer and more effective therapies guided by standardized regulatory science tools.
How similar studies have gone: Previous consortia efforts by C-Path have yielded regulatory-ready solutions and modeling approaches, with ongoing impact on drug development.
Where this research is happening
-
Critical Path Institute
Tucson, United States Active
Researchers
- Principal investigator: Romero, Klaus — Critical Path Institute
- Study coordinator: Romero, Klaus
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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.