Launching the Critical Path Disease Modeling Coalition for Pediatric IBD: A Global Initiative

The Launch of the Critical Path Disease Modeling Coalition for Pediatric IBD

On October 16, 2025, the Critical Path Institute® (C-Path) officially unveiled its latest initiative, the Critical Path Disease Modeling Coalition (CP-DMC), dedicated to addressing pediatric inflammatory bowel disease (IBD). This innovative project represents a major collaboration between public and private sectors, uniting experts and stakeholders with the goal of creating quantitative models that explain disease progression and care at a regulatory level. By doing so, the coalition aims to not only accelerate drug development but also improve assessment criteria for conditions like Crohn’s disease and ulcerative colitis among children.

The CP-DMC was conceived by leading academics and clinical professionals associated with the European Society for Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). Notable figures such as Prof. Lissy de Ridder, M.D., Ph.D., head of the pediatric department at Leiden University Medical Center in Geneva, play essential roles in this coalition, alongside support from the Crohn's Colitis Foundation located in New York. The coalition’s formation allows for a fusion of clinical expertise, data science, and regulatory knowledge, focusing on developing appropriate simulation models that can be leveraged across various programs and sponsors.

A key partner, Quinten Health, will support the initiative through advanced AI and modeling capabilities, working alongside C-Path’s Quantitative Medicine Program and Data Collaboration Center. The goal is to blend clinical trial data with extensive real-world evidence to create models that precisely depict disease progression, treatment responses, and variability among pediatric populations.

Cécile Ollivier, C-Path's Vice President for Global Affairs and CP-DMC lead, emphasized the importance of this launch, stating, "The initiation of the CP-DMC project for pediatric IBD is a crucial step in developing therapies for children suffering from chronic inflammatory diseases. This pre-competitive collaboration unites regulators, healthcare providers, industry stakeholders, and patients within a globally aligned framework, allowing us to develop tools that account for the real complexities of these diseases and expedite innovations where they are most desperately needed."

Through robust modeling techniques, this coalition will transform integrated longitudinal datasets into actionable quantitative insights regarding the disease's progression. These insights not only guide regulatory bodies but also optimize study designs, providing platforms that lessen patient burden and enhance evidence generation across programs.

Prof. de Ridder added, "This initiative offers a significant opportunity to align data, clinical expertise, and regulatory science to bridge the gap in developing pediatric medications for IBD. We take pride in supporting a project that centers the needs of children in the heart of scientific innovations."

The CP-DMC initiative for pediatric IBD serves as a proof of concept for a broader coalition platform aimed at disease modeling. Following a successful pilot, the CP-DMC will expand its support to encompass multiple indications, ensuring sustainability, regulatory impact, and relevancy to patient needs.

Alan Moss, M.D., Chief Scientific Officer at the Crohn's Colitis Foundation, expressed enthusiasm about the coalition, stating, "The Foundation is excited to lend its expertise in speeding up the approval of new therapies for children with IBD worldwide."

C-Path invites industry partners and data owners to express interest, contribute datasets, and engage in shaping the next phase of this vital work. Interested parties can reach out via [email protected]

About the Critical Path Institute

Founded in 2005 as a public-private partnership in response to the FDA's Critical Path Initiative, C-Path celebrates its 20th anniversary as a vital and independent non-profit entity. C-Path’s mission is to lead collaborations that enhance treatments for individuals globally. Recognized as a pioneer in accelerating drug development, C-Path has established numerous international consortia, programs, and initiatives, currently involving more than 1,600 scientists and representatives from government and regulatory agencies, academia, patient organizations, disease foundations, and pharmaceutical and biotechnology firms. C-Path's global headquarters is located in Tucson, Arizona, with its European office in Amsterdam, Netherlands. For more information, visit c-path.org.