#USA #Amsterdam #Crohn's Disease #Pediatric IBD #Critical Path

A New Hope for Pediatric Patients

On October 16, 2025, the Critical Path Institute (C-Path) announced the official launch of the Critical Path Disease Modeling Coalition (CP-DMC), a groundbreaking initiative aimed at addressing inflammatory bowel diseases (IBD) in children. This coalition emerges as a significant milestone in creating quantitative models that illustrate disease progression and treatment impacts, specifically for conditions like Crohn's disease and ulcerative colitis.

Collaborative Framework

The CP-DMC is a multifaceted public-private cooperation that gathers expertise from leading scientists and clinicians associated with the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN). Pioneering figures such as Professor Lissy de Ridder, M.D., Ph.D., who leads the pediatrics department at Leiden University Medical Center in Geneva, are instrumental in guiding this initiative. With the support of the Crohn's Colitis Foundation from New York, the coalition aims to integrate clinical practices, real-world data analysis, and regulatory science to craft benchmark modeling simulations suitable for numerous sponsors and programs.

Innovative Partnership with Quinten Health

To enhance its capabilities, the CP-DMC collaborates with Quinten Health, a leader in disease modeling and artificial intelligence applications. This partnership will synchronize efforts with C-Path’s quantitative medicine program and data collaboration center, allowing for the integration of clinical trial data and real-world data to streamline model development and application.

A Step Forward in Drug Development

Cécile Ollivier, Vice President of C-Path and chief of the CP-DMC, remarked on the importance of this initiative, emphasizing that it represents a critical step towards accelerating the development of medications tailored for children with chronic inflammatory diseases. By fostering this pre-competitive collaboration that bridges regulatory bodies, health professionals, industry representatives, and patients, the coalition hopes to create tools that accurately reflect the disease's complexities and stimulate innovation where it is most necessary.

Transformative Data Models

The models generated by the CP-DMC will convert longitudinal integrated data sets into actionable quantitative descriptions, outlining disease trajectories, treatment responses, and variability within pediatric populations. By informing regulatory agencies and optimizing clinical trials, these models will serve as reusable platforms, alleviating patient burdens and enhancing evidence generation across various programs.

Closing Gaps in Treatment Development

Professor de Ridder highlighted the coalition’s mission, stating that this initiative offers a vital opportunity to align data, expertise, and regulatory science to close existing gaps in drug development targeted at children with IBD. The CP-DMC initiative positions children's needs at the forefront of scientific innovation, providing hope for improved treatment pathways.

Future of the Coalition

The CP-DMC's pediatric IBD initiative serves as a proof of concept for a broader disease modeling coalition platform. After initial pilot project successes, the CP-DMC intends to expand its scope to accommodate portfolios across multiple indications, establishing an adaptive structure designed to ensure sustainability, regulatory impact, and relevance for patients.

Commitment from the Crohn's Colitis Foundation

Alan Moss, M.D., chief academic officer of the Crohn's Colitis Foundation, expressed the organization’s commitment to supporting this coalition, aiming to accelerate the approval of new therapies for children with IBD on a global scale.

Invitation for Collaborative Engagement

C-Path invites industry collaborators and data owners to participate in this pioneering initiative, emphasizing the importance of collective efforts in the realm of pediatric IBD treatment development. Interested parties can reach out through the provided contact channels to express their interest and contribute to shaping the next phase of this vital work.

About Critical Path Institute

Founded in 2005 as a public-private partnership in response to the FDA's Critical Path Initiative, C-Path has been a cornerstone in the promotion of innovative treatment methods worldwide. Celebrating its 20th anniversary, C-Path remains a pivotal, independent non-profit organization, committed to leading collaborative efforts to advance drug development strategies that serve the needs of patients globally. With over 1,600 members from diverse sectors united in their mission, C-Path continues to make significant strides in the field. Its headquarters are in Tucson, Arizona, with an additional branch located in Amsterdam, Netherlands.

For more information about C-Path’s initiatives and to get involved, visit c-path.org.