AMSTERDAM, Oct. 16, 2025 /PRNewswire/ -- Critical Path Institute® (C-Path) today announced the official launch of the Critical Path Disease Modeling Coalition (CP-DMC) on pediatric inflammatory bowel disease (pIBD). This is a multi-stakeholder, public-private initiative to develop regulatory-grade, quantitative disease progression and care models to accelerate and better inform drug development and evaluations for pediatric Crohn's disease and ulcerative colitis.
Launched with leading academics and clinicians from the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN), including Prof. Lissy de Ridder, M.D., Ph.D., Head of Department of Pediatrics, Leiden University Medical Center, based in Geneva, and supported by the Crohn's & Colitis Foundation, based in New York, the project brings together expertise and capabilities in medical practice, clinical and real-world data science, and regulatory science to build fit-for-purpose reference simulation models usable across programs and sponsors.
CP-DMC is being established with Quinten Health as the founding AI and disease modeling partner, working alongside both C-Path's Quantitative Medicine Program and Data Collaboration Center to integrate clinical trial and real-world data at scale for model development and application.
"The launch of the CP-DMC Pediatric IBD Project represents a pivotal step in how we develop medicines for children with chronic inflammatory diseases," said Cécile Ollivier, C-Path Vice President of Global Affairs and CP-DMC Lead. "Through this pre-competitive collaboration that unites regulators, clinicians, industry, and people living with the condition in a globally aligned framework, we can deliver tools that reflect real disease complexity and speed up innovation where it is most needed."
The models will transform integrated longitudinal datasets into actionable quantitative descriptions of disease trajectories, treatment response, and variability in pediatric populations. Designed to inform regulatory submissions and optimize trials, they will serve as reusable platforms that reduce patient burden and strengthen evidence generation across programs.
"This initiative is a major opportunity to align data, expertise, and regulatory science to close the gap in pediatric drug development for IBD," said Prof. de Ridder. "We are proud to support a project that puts children's needs at the center of scientific innovation."
The CP-DMC Pediatric IBD Project serves as a proof-of-concept for the broader disease modeling coalition platform. Following successful pilots, CP-DMC will expand to support multi-indication portfolios, with an evolving structure designed to ensure sustainability, regulatory impact, and patient relevance.
"The Foundation is excited to provide its expertise to this coalition, with the goal of accelerating approval of novel therapies for children with IBD worldwide," said Alan Moss, M.D., Chief Scientific Officer of the Crohn's & Colitis Foundation.
C-Path invites expressions of interest from industry partners and data owners to contribute datasets and join the initiative to shape the next phase of this work. To express interest, please reach out via developmentoffice@c-path.org.
About Critical Path Institute
Founded in 2005, as a public-private partnership in response to the FDA's Critical Path Initiative, Critical Path Institute® (C-Path) celebrates its 20th anniversary as a vital, independent, nonprofit. C-Path's mission is to lead collaborations that advance better treatments for people worldwide. Globally recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs and initiatives that currently include more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations and pharmaceutical and biotech companies. With dedicated team members located throughout the world, C-Path's global headquarters is located in Tucson, Arizona and C-Path's Europe subsidiary is headquartered in Amsterdam, Netherlands. For more information, visit c-path.org.
Media Contacts:
Roxan Triolo Olivas
C-Path
520.954.1634
rolivas@c-path.org
Kissy Black
C-Path
615.310.1894
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