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

Global Pediatric IBD Initiative by C-Path

The Critical Path Institute® (C-Path) has officially launched the Critical Path Disease Modeling Coalition (CP-DMC) focusing on pediatric inflammatory bowel disease (IBD). This pivotal program aims to accelerate the development of quantitative disease progression models which will enhance drug development and regulatory evaluations for conditions like pediatric Crohn's disease and ulcerative colitis.

Collaboration with Leading Experts

The CP-DMC project is formed in collaboration with respected academics and clinicians from the European Society for Paediatric Gastroenterology Hepatology and Nutrition (ESPGHAN). Notable contributions come from Prof. Lissy de Ridder, M.D., Ph.D., Head of Pediatrics at Leiden University Medical Center. This effort also benefits from the support of the Crohn's Colitis Foundation, which is based in New York.

By connecting expertise in clinical practice, real-world data science, and regulatory standards, CP-DMC aspires to establish simulation models that can be effectively used across various programs and sponsors. This integration promises a more tailored approach to understanding and addressing the complexities of pediatric IBD.

Launching the Coalition with AI Support

Quinten Health has joined as the founding AI and disease modeling partner. Their collaboration with C-Path's Quantitative Medicine Program aims to merge clinical trial data with real-world data for assembling accurate disease models quickly. This initiative seeks to redefine how medicines for chronic inflammatory diseases are developed specifically for children.

Cécile Ollivier, C-Path's Vice President of Global Affairs and CP-DMC Lead, emphasizes the importance of this collaboration. She states, "The launch represents a pivotal step in developing medicines for children dealing with chronic inflammatory diseases. Uniting the expertise of regulators, clinicians, industry players, and patients creates a solid framework for quicker and more effective innovations."

Transforming Real-World Data into Actionable Insights

The coalition aims to utilize integrated longitudinal datasets to create actionable models that describe disease trajectories, treatment responses, and variability among pediatric populations. These models are designed to streamline regulatory submissions and optimize clinical trials, serving as reusable platforms that both enhance evidence generation and minimize patient burden.

Prof. de Ridder remarked, "This project showcases a significant chance to align our data, expertise, and regulatory science, ultimately bridging the gap in pediatric drug development for IBD." The focus remains solidly on the needs of children, placing them at the forefront of scientific advances.

Future Expansion and Sustainability

The CP-DMC Pediatric IBD Project is not only a proof-of-concept but a doorway to expanding the disease modeling coalition. After successful testing phases, CP-DMC plans to broaden its scope to support multiple indications, ensuring sustainability and relevance in patient care.

Alan Moss, M.D., the Chief Scientific Officer at the Crohn's Colitis Foundation, highlighted their excitement in collaborating. They aim to leverage their expertise to accelerate the approval of novel therapies for children worldwide facing IBD.

Invitation to Industry Partners

As the coalition progresses, C-Path encourages industry partners and data owners to engage and contribute datasets for this initiative. Interested parties can reach out via email to express their interest.

About Critical Path Institute

Founded in 2005 as a public-private partnership in response to FDA initiatives, C-Path has become a prominent entity in improving drug development processes. With over 1,600 scientists and representatives from various sectors, C-Path’s mission is to advance global health by leading collaborations that foster innovative treatments. The organization is based in Tucson, Arizona, with a European subsidiary located in Amsterdam.

For further insights and updates, visit c-path.org.