Cancer remains the leading cause of disease-related death in children. For the ~25% of children who experience relapses of their malignant solid tumors, usually after very intensive first-line therapy, curative treatment options are scarce. Preclinical drug testing to identify promising treatment options that match the molecular make-up of the tumor is hampered by the facts that i) molecular genetic data on pediatric solid tumors from relapsed patients and thus our understanding of tumor evolution and therapy resistance are very limited to date and ii) for many of the high-risk entities no appropriate and molecularly well characterized patient-derived models and/or genetic mouse models are currently available. Thus, quality-assured upfront preclinical testing of novel molecularly targeted compounds in a (saturated) repertoire of well-characterized models will establish the basis to increase therapeutic successes of these drugs in children with solid malignancies. Since these tumors are overall genetically much less complex than their adult counterparts, it is anticipated that it will be easier to identify powerful predictive biomarkers to allow for accurate matching of targets and drugs. To address this high, as yet unmet clinical need, we have formed the ITCC-P4 consortium consisting of academic and commercial partners from 8 European countries and covering the full spectrum of qualifications needed for quality-assured preclinical drug development including expertise in patient derived models, histopathology, in vivo pharmacology, bioinformatics and data management, centralized testing capabilities, medical expertise regarding the entities in question, regulatory knowledge, and project management of large consortia. With this consortium in a public-private partnership with the participating pharma companies we strongly believe to be ideally positioned to greatly expedite the development of more precise and efficacious drugs for children with malignant solid tumors

Over 200,000 children and adolescents are diagnosed with cancer each year globally, 50,000 in Europe and North America. While there has been improvement in survival since the 1970s, the decrease in mortality has reached a plateau – for children with poor-prognosis cancers resistant or refractory to conventional treatment, the survival is less than 25%. Therefore, there is an urgent need for new medicines to cure aggressive tumors, and to reduce the toxicity and sequelae of the treatments. Developing new drugs for children with cancer is a complicated multi-step process with many involved actors (academic researchers, pharmaceutical industry, patient advocates, regulatory authorities, …). There is a need to improve the efficiency of this process and fulfil the unmet needs of children with cancer. To achieve optimal progress, multi-stakeholder collaboration is mandatory. A lack of knowledge and understanding of regulatory processes is a major roadblock to children and adolescents accessing new and beneficial drugs.The aim of this project is to build an innovative, multi-stakeholder and structured framework with an educational program tailored to the needs of the different actors, that is sustainable in the long-term and takes advantage of the expertise and work already initiated by the ACCELERATE platform. The global objectives of the educational program are:1) To build an educational structure for strategy and regulatory science in pediatric oncology drug development that is sustainable and long-lasting, for future generations of experts to come;2) To foster and disseminate expertise and to overcome stakeholder’s working in silos and strengthen true multi-stakeholder collaboration.The educational program will be based on four pillars: P1: Course on Strategic/Regulatory Science in Paediatric Oncology Drug Development; P2: 360º Multi-stakeholder rotation; P3: ACCELERATE Research Fellowship; and P4: Online Educational Training Program.