#None #Amsterdam #Critical Path Institute #Pediatric IBD #Disease Modeling Coalition

C-Path Launches Initiative for Pediatric IBD

On October 16, 2025, the Critical Path Institute (C-Path) officially launched the Critical Path Disease Modeling Coalition (CP-DMC) focused on pediatric inflammatory bowel diseases (pIBD). This innovative public-private partnership is dedicated to creating quantitative models that describe disease progression and quality care regulations. The goal is to accelerate and enhance the development of medications for conditions like Crohn's disease and ulcerative colitis in children.

Founded with the support of leading academics and clinicians, particularly from the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN) based in Geneva, the initiative collaborates with experts like Professor Lissy de Ridder, the head of the pediatrics department at Leiden University Medical Center. This partnership brings together knowledge in medical practice, clinical and real-world data science, and regulatory science to develop adaptable benchmark simulation models that are applicable across various programs and stakeholders.

C-Path has initiated this project in collaboration with Quinten Health, a founding partner specializing in AI disease modeling. Together, they work alongside C-Path’s quantitative medicine program and data collaboration center to integrate large-scale clinical and real-world datasets into model development and implementation.

Cécile Ollivier, Vice President of Global Affairs at C-Path and head of CP-DMC, emphasized, “The launch of the CP-DMC Pediatric IBD project is a critical milestone in advancing pediatric drug development for chronic inflammatory diseases. By uniting regulators, clinicians, industry stakeholders, and patients in a collaborative, international framework, we can provide tools that reflect the real complexities of these conditions and expedite innovation where it is most needed.”

The models being created aim to transform integrated longitudinal datasets into actionable quantitative descriptions of disease trajectories, treatment responses, and variability among pediatric populations. Designed to support regulatory submissions and optimize clinical trials, these models will create reusable platforms that will ease patient burdens and enhance the generation of evidence in all programs.

Professor de Ridder expressed her excitement about the project, stating, “This initiative is a significant opportunity to align data, expertise, and regulatory science to close the gap in pediatric drug development for inflammatory bowel diseases. We are proud to support a project that places children's needs at the forefront of scientific innovation.”

The CP-DMC Pediatric IBD project serves as a proof of concept for a broader disease modeling coalition platform. Following the success of its pilot initiatives, CP-DMC plans to expand to address multi-indication portfolios while developing a scalable structure that guarantees sustainability, regulatory impact, and patient relevance.

Alan Moss, M.D., Chief Scientific Officer of the Crohn's Colitis Foundation, noted, “The Foundation is eager to contribute our expertise to this coalition aimed at accelerating the approval of new therapies for children with IBD around the world.”

C-Path invites industry partners and data owners to express their interest in contributing datasets and joining this initiative to shape the next phase of this endeavor. Interested parties can reach out via email at [email protected].

About Critical Path Institute

Founded in 2005 in response to the FDA's Critical Path Initiative, the Critical Path Institute (C-Path) celebrates its 20th anniversary as a vital and independent nonprofit organization. C-Path's mission is to facilitate collaborations that enhance global treatment options. Renowned for its pioneering work in expediting drug development, C-Path has established numerous consortiums, programs, and international initiatives that currently unite over 1,600 scientists and representatives from various sectors, including government and regulatory agencies, universities, patient organizations, disease foundations, and pharmaceutical and biotechnology companies. With dedicated team members around the globe, C-Path’s headquarters are located in Tucson, Arizona, with its European branch based in Amsterdam, Netherlands. For more information, visit c-path.org.