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.

The Gravitate-Health mission is to equip and empower citizens with digital information tools that make them confident, active, and responsive in their patient journey, specifically encouraging safe use of medicines for better health outcomes and quality of life. It is our vision that engagement of citizens in their own health can only be achieved with access to actionable, understandable, relevant, reliable and evidence-based information that meets their specific needs, health context, and literacy level. This project's ambition is to provide a key piece to advance this vision: the Gravitate Lens (G-lens), which focuses (but does not conceal or filter) approved electronic product information (ePI) content, and offers a route for patients to access trustworthy, up-to-date information that better meet their individual needs. Gravitate-Health is an integrated digital health information project. The principle objective is to demonstrate how use of an integrated, digital, user-centric health information solution with two-way communication could enable tangible improvements in availability and understanding of health information from a set of trusted sources, starting with regulator-approved medicinal product information (e.g. package leaflet content) and EHR-IPS (International Patient Summary). The secondary objectives are to demonstrate that the improved availability and understanding of health information from trusted sources translate to higher levels of adherence to treatment, safer use of medication (Pharmacovigilance), better health outcomes and quality of life, and to develop new and deeper insights into how use of available health information can be optimized to act as effective risk minimization measures. The project allows for efficient and timely development of the G-lens, provides testing grounds for new services and an evaluation framework to test the efficiency, efficacy and safety of Gravitate-Health services. Our main outputs will be an open source digital platform supporting G-lens functionally, demonstrated in a number of testing scenarios, and a White Paper with recommendations on realistic strategies to strengthen access, understanding and future use of digital services like ePIs as a tool for Risk Minimization. The Gravitate-Health is a public – private partnership with 45 members from Europe and the US, co-led by University of Oslo (coordinator) and Pfizer (industry lead), funded by the Innovative Medicines Initiative (IMI) – a joint undertaking of the European Commission, the European Federation of Pharmaceutical Industries and Associations (EFPIA), IMI Associated Partners.

There are around 1900 active pharmaceutical ingredients (APIs) in use, yet the environmental risks of only a small proportion of these has been assessed. This calls for pragmatic science-based approaches for prioritising existing APIs in terms of their environmental risk. Such approaches could also be used pro-actively, i.e. to identify environmental concerns earlier in the drug development process, thereby contributing to a more sustainable future. The overall aim of PREMIER is to deliver an API information and assessment system for characterising the potential environmental risks of APIs, including relevant human metabolites and environmental transformation products, based on minimal testing. This system will be designed to screen and prioritise legacy APIs for tailored environmental assessment; identify potential environmental hazards associated with APIs in development; and to make the available environmental data more accessible for all stakeholders. The system will be optimized and validated using case studies on approximately 25 APIs. PRIME will realize its aim by combining world-leading research on the environmental risks of APIs with the principles of co-design and smart knowledge-based IT. Through this combination, we want to be more than a conventional research project. We want to ensure that the results of our ground-breaking research “work” address all the societal concerns about the potential risks posed by the presence of pharmaceuticals in the environment.