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

Introduction

The Critical Path Institute (C-Path) has officially inaugurated the Critical Path Disease Modeling Coalition (CP-DMC) to advance research specifically focused on pediatric Inflammatory Bowel Disease (IBD). This coalition, established in a public-private partnership, aims to enhance drug development processes for children suffering from chronic inflammatory conditions like Crohn's disease and ulcerative colitis.

Collaboration and Leadership

The CP-DMC has brought together leading scientists and clinicians, particularly from the European Society of Pediatric Gastroenterology, Hepatology and Nutrition (ESPGHAN). Influential members such as Professor Lissy de Ridder from the University Medical Center in Leiden are integral to this initiative, which is based in Geneva and supported by the Crohn's & Colitis Foundation from New York.

This collaboration is focused on developing regulatory-compliant, quantitative models of disease progression and management, designed to accelerate the drug development timeline while ensuring that therapies are better tailored to meet patient needs.

Innovative Approach to Data Integration

Partnering with Quinten Health, a pioneer in AI and disease modeling, the coalition plans to leverage both clinical trial data and real-world evidence on a large scale. The goal is to integrate this data to forge robust models that can navigate various drug development programs, thus optimizing the research landscape for IBD therapies.

Cécile Ollivier, C-Path’s Vice President, emphasized the coalition's significance, stating that it represents a pivotal step towards improving drug development for children with chronic inflammatory diseases. By harmonizing efforts across regulatory bodies, clinicians, the pharmaceutical industry, and patients, the coalition hopes to innovate effectively within this critical healthcare space.

Expected Outcomes of the Coalition's Efforts

The data-driven models developed by CP-DMC will transform long-term observational data into actionable, quantitative insights concerning disease progression, treatment responses, and variability among pediatric populations. These models are not only expected to streamline regulatory processes but also enhance clinical trials by providing multi-use platforms that minimize patient burden and strengthen evidence acquisition across various research initiatives.

Aim to Bridge the Drug Development Gap

“This initiative is a vast opportunity to merge data, expertise, and regulatory insights to close the gap in drug development for children with IBD,” noted Professor de Ridder. She expressed pride in supporting a project that centralizes children's needs in scientific innovation endeavors.

The CP-DMC pilot on pediatric IBD serves as proof-of-concept for a broader disease modeling coalition platform. Upon successful pilot projects, the coalition is set to expand its portfolio to include multiple indications—as part of a growing structure designed for longevity, regulatory impact, and patient relevance.

The Crohn's & Colitis Foundation is looking forward to applying its expertise to expedite the approval of new therapies for children suffering from IBD worldwide, as stated by Dr. Alan Moss, the Foundation’s scientific director.

Call for Collaboration

C-Path invites industry partners and data holders to express interest in collaborating, sharing data sets, and being part of this groundbreaking initiative to shape the next phase of research efforts. Those interested in collaboration are encouraged to contact C-Path to assist in advancing this crucial work further.

About Critical Path Institute

Founded in 2005 as a public-private partnership, the Critical Path Institute (C-Path) responds to the FDA's Critical Path Initiative, dedicating itself to improving drug development methods globally for over 20 years. Recognized as a pioneer in accelerating drug development processes, C-Path has created numerous international consortia and programs involving over 1,600 scientists, regulatory representatives, academic allies, patient organizations, disease foundations, and both pharmaceutical and biotechnology companies. C-Path’s headquarters is located in Tucson, Arizona, while C-Path Europe operates from Amsterdam with local offices worldwide. For more information, please visit c-path.org.