# Critical Path Public Private Partnerships

> **NIH FDA U18** · CRITICAL PATH INSTITUTE · 2024 · $2,100,000

## Abstract

PROJECT SUMMARY
The Critical Path Institute (C-Path) was established in 2005 as a public-private partnership with FDA under the
auspices of the Agency’s Critical Path Initiative, with a mission to be a catalyst in the development of new
approaches to advance medical innovation and regulatory science. This mission is realized by leading teams
of stakeholders from industry, government, academia, and patient advocacy organizations that share data,
knowledge, and expertise, resulting in sound, consensus-based regulatory science solutions and advances to
address unmet needs in drug development. Developing such solutions and advances require C-Path
competencies in data management and science, quantitative modeling and analytics, development of clinical
outcome assessments (COAs) and biomarkers as well as knowledge of the appropriate regulatory pathways
for the review and potential endorsement of such solutions. C-Path has established core competencies in
these areas that allow our collaborations to achieve meaningful impact on unmet drug development needs.
C-Path’s core competencies also function to further their respective fields (e.g., refine data management
practices, develop new analytic and modeling techniques, develop specific COAs, or train future regulatory
scientists) and to create a neutral collaborative environment for experts and stakeholders to address specific
needs in drug development. Over the past 5 years, C-Path has launched new consortia and two extensive
programs in rare and orphan diseases, as well as supporting the qualification of COAs, the fit-for-purpose
endorsement of disease progression models and clinical trial simulation tools, the generation of new data
standards and databases, the creation of a new data and analytics platform, and educational initiatives that
advance regulatory science and model informed drug development. These accomplishments can decrease the
time, resources, and number of patients needed to develop and approve medical products and thus de-risk
and expedite the medical product development process. This proposal aims to maintain and expand on C-
Path’s core competencies and continue to support the FDA to modernize drug development and potentially
support future projects in real-world evidence/real-world data, artificial intelligence and machine learning, digital
health technologies, and to establish new consortia in areas of critical unmet need. Altogether, these efforts
support the FDA in its mission to promote public health and ensure the safety, efficacy, and efficiency of
medical product development.

## Key facts

- **NIH application ID:** 11048623
- **Project number:** 2U18FD005320-11
- **Recipient organization:** CRITICAL PATH INSTITUTE
- **Principal Investigator:** Klaus Romero
- **Activity code:** U18 (R01, R21, SBIR, etc.)
- **Funding institute:** FDA
- **Fiscal year:** 2024
- **Award amount:** $2,100,000
- **Award type:** 2
- **Project period:** 2014-09-05 → 2029-08-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/11048623

## Citation

> US National Institutes of Health, RePORTER application 11048623, Critical Path Public Private Partnerships (2U18FD005320-11). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/11048623. Licensed CC0.

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