C-Path's New Coalition Enters Global Pediatric IBD Research Arena

Significant Initiative Launched

On October 16, 2025, the Critical Path Institute® (C-Path) announced the official initiation of the Critical Path Disease Modeling Coalition (CP-DMC), which aims to enhance research in pediatric inflammatory bowel diseases (pIBD). This initiative represents a collaborative effort between public and private sectors, engaging multiple stakeholders. Its primary goal is to develop quantitative models for disease progression and regulatory-level care, aiming to expedite and improve the development and assessment of medications for pediatric Crohn's disease and ulcerative colitis.

The project kicked off with contributions from leading researchers and clinical practitioners from the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). Notable figures, including Professor Lissa de Ridder, M.D., Ph.D., from Leiden University Medical Center, participated in the launch, supported by the Crohn's and Colitis Foundation based in New York. This coalition combines expertise from clinical practice, real-world data, and regulatory science to create tailored reference simulation models that can be utilized across various programs and sponsors.

A Collaborative Approach

Collaborating with Quinten Health as a founding partner in artificial intelligence and disease modeling, this coalition aims to integrate clinical studies with real-world data at scale for the advancement and application of disease models.

Cécile Ollivier, Vice President for Global Affairs at C-Path and head of CP-DMC, remarked, "The launch of the CP-DMC Pediatric IBD project marks a pivotal milestone in how we develop drugs for children with chronic inflammatory diseases. By fostering this collaboration before commercial competition, we can provide tools that reflect the real complexities of the illness and accelerate innovation where it is most needed."

Transformative Models

The models will convert integrated longitudinal data sets into usable quantitative descriptions of disease progression, treatment responses, and variability within the pediatric population. They are designed to inform regulatory applications and optimize clinical trials, serving as reusable platforms that reduce patient burden and strengthen evidence generation within programs.

Professor de Ridder emphasized the significance of this initiative by stating, "This represents a critical opportunity to unify data, expertise, and regulatory science to bridge the gap in developing pediatric medications for IBD. We are proud to support a project that prioritizes children's needs in scientific innovation."

As a proof of concept, the CP-DMC for pediatric IBD aims to pave the way for a broader platform within the coalition for disease modeling. Following successful pilot projects, CP-DMC plans to expand its support portfolio with multiple indications, structuring itself to ensure sustainability, regulatory impact, and patient relevance.

Community Support and Invitation

Alan Moss, M.D., Chief Scientific Officer of the Crohn's and Colitis Foundation, stated, "The Foundation is excited to lend its expertise to this coalition in order to expedite the approval of new therapies for children with IBD globally."

C-Path encourages industry partners and data owners to express their interest in providing data sets and joining this initiative to shape the next phase of this work. Interested parties can apply via [email protected].

About Critical Path Institute

Founded in 2005 as a partnership between public and private sectors in response to the U.S. Food and Drug Administration's Critical Path Initiative, C-Path celebrates its 20th anniversary this year as a leading independent nonprofit organization. C-Path's mission is to lead collaboration that enhances the treatment possibilities for people globally. Recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs, and initiatives currently involving over 1,600 scientists and representatives from government and regulatory agencies, the scientific community, patient organizations, disease foundations, and pharmaceutical and biotechnology companies. With dedicated team members worldwide, C-Path's global headquarters is located in Tucson, Arizona, with its European branch situated in Amsterdam, Netherlands. For more information, visit c-path.org.