This proposal seeks to build on the mobile application (app) functionality delivered through the original WEB-RADR project to expand access to the platform and the reach of the information contained within it. It will achieve this by making the functionality available through application programming interfaces (APIs), meaning that third party organisations will be able to embed WEB-RADR platform functionality into their own systems, applications and websites. An important component to this will be a terminology/classification mapping activity involving the three core healthcare terminology owners; MedDRA MSSO, SNOMED International and WHO. The mapping will facilitate communication between regulatory and healthcare databases by establishing mapping protocols and delivering an initial mapping between a subset of key pharmacovigilance terms. The project has established use cases and adopters for the proposed functionality through the networks established through the original WEB-RADR delivery, and has a diverse range of partners keen to utilise different aspects of the proposed solutions including regulatory authorities, health charities and system providers.

The European Patients' Academy on Therapeutic Innovation (EUPATI) IMI project resulted in a number of key outputs for the field of patient engagement. The core activities continue running until 2019 under a PPP consortium under an EPF programme focusing on the Patient Expert Training Course, the multilingual public Toolbox, and the EUPATI National Platforms Network. It is imperative that these pillars that support the patient engagement landscape exist in the medium- and long-term to address the growing field of patient engagement. Further investment is needed to develop sustainable models of collaboration to ensure this, and put into place the infrastructure required for these to work, building on those already established under IMI-EUPATI.

Advancing personalized approaches in cancer therapy, aiding identification and adaptation of multi-modal treatment strategies for improved outcomes depends on clinical implementation of novel diagnostic technologies. For most cancer types the risk-features used to select individuals for post-operative adjuvant multimodal therapy are suboptimal, where many patients are overtreated and others undertreated. Liquid biopsy has opened a new diagnostic avenue to detect and monitor minimal residual disease (MRD) in individual cancer patients, especially for selecting patients for multi-modal therapies post-operatively. However, despite many circulating tumor DNA (ctDNA) diagnostics being developed there is a lack of standardization, harmonization, and robust data to demonstrate clinical validity. GUIDE.MRD is a consortium of leading academics, technology companies, pharmaceutical companies, and experts in multi-stakeholder engagements. Together, we will tackle the critical questions by developing reference standards for ctDNA diagnostics, clinically validate promising ctDNA diagnostics and develop data to guide the use of multi-modal therapies with a non-invasive diagnostic test. With robust engagement with regulatory authorities, payers and importantly patients themselves, we will develop recommendations and guidelines based on objective data to use ctDNA diagnostics to guide multi-modal therapy selection to improve patient outcomes.