Advancing drug development and approval for paediatric and orphan diseases
Funded by Horizon Europe and launched in January 2024, the ERAMET (“Ecosystem for Rapid Adoption of Modelling and Simulation Methods to Address Regulatory Needs in the Development of Orphan and Paediatric Medicines”) project aims to revolutionize the decision-making process by creating an integrated ecosystem that addresses key critical and scientific questions to enhance and accelerate drug development for paediatric and orphan diseases.
The project is managed by a multidisciplinary consortium of 17 partners located in Belgium, Norway, United Kingdom, Italy, Spain, France and the Netherlands, including our member, CVBF which is directly involved in the tasks of advancing drug development platform models, alongside the enhancement of experimental protocol designs, development plans and regulatory submission packages.
The first-year achievements of the project include the creation of a regulatory question repository, the development of model credibility frameworks, and pioneering work on paediatric extrapolation use-cases. Furthermore, advanced cohort selection strategies using simulation scenarios, and a cloud-based secure platform for research teams were also developed within the project.