C-Path Launches Global Pediatric IBD Initiative to Enhance Drug Development

C-Path's New Initiative for Pediatric IBD

On October 16, 2025, the Critical Path Institute® (C-Path) officially unveiled its Critical Path Disease Modeling Coalition (CP-DMC) aimed at pediatric inflammatory bowel disease (pIBD). This initiative represents a collaborative effort among multiple stakeholders dedicated to developing regulatory-grade quantitative models that accurately represent the progression and management of conditions such as Crohn's disease and ulcerative colitis in children.

The Significance of CP-DMC

Launched with support from leading experts in pediatric gastroenterology, including Dr. Lissy de Ridder from the Leiden University Medical Center, the CP-DMC seeks to bridge a critical gap in pediatric drug development. The involvement of prominent organizations like the Crohn's & Colitis Foundation signifies the project's commitment to leveraging clinical and real-world data to create effective treatment protocols while addressing unique challenges faced by young patients.

Cécile Ollivier, the Vice President of Global Affairs at C-Path, emphasized, "The launch of the Pediatric IBD Project is a pivotal advancement in creating better treatments for children with chronic inflammatory diseases. Our collaboration fosters a united approach among regulators, healthcare professionals, and patients to innovate where it's most needed."

Collaborative Framework

Quinten Health, a founding partner specializing in AI and disease modeling, is working alongside C-Path's Quantitative Medicine Program and Data Collaboration Center to integrate both clinical trial data and real-world insights. This strategic partnership aims to enhance the quality and relevance of models being developed to inform drug approval submissions and optimize clinical trials, ultimately creating reusable platforms that ease patient burden while strengthening evidence generation across various programs.

The models being created will transform longitudinal datasets into practical, quantitative descriptions of disease trajectories, treatment responses, and variability within pediatric populations. They are designed not just for optimizing regulatory submissions but as versatile tools that can be adapted across multiple conditions and treatment pathways.

Bridging the Pediatric Drug Gap

Professor de Ridder remarked, "This initiative is an incredible opportunity to align data, expertise, and regulatory science crucial to closing the pediatric drug development gap for IBD. We are proud to support a project focused on children's needs in scientific innovation."

As the Pediatric IBD Project serves as a proof of concept for the broader disease modeling coalition, its success will facilitate the expansion of CP-DMC to support various indications within a collaborative structure designed for sustainability and regulatory impact.

Alan Moss, Chief Scientific Officer at the Crohn's & Colitis Foundation, noted, "We are excited to lend our expertise to this coalition to hasten the approval process for novel therapies aimed at children with IBD."

C-Path is inviting industry stakeholders and data owners to contribute their datasets and join this transformative initiative, encouraging interested parties to reach out for further collaboration.

About C-Path

Established in 2005 in response to the FDA's Critical Path Initiative, C-Path is celebrating two decades as an independent, nonprofit organization that leads collaborations fostering better treatments for patients worldwide. Recognized as a pioneer in drug development acceleration, C-Path convenes over 1,600 scientists and professionals from government agencies, academic institutions, patient organizations, and the biopharmaceutical industry. The organization operates globally, with its headquarters in Tucson, Arizona, and a European branch in Amsterdam, Netherlands. Visit c-path.org for more information.