ExpectedOutcome:Research and innovation (R&I) actions to be supported under this topic must contribute to at least three of the following outcomes:
Patients will benefit from increased treatment efficacy, reduction of time-to-treat, fewer side effects, and reduced duration of hospitalisation.Healthcare professionals benefit from education, training on theranostic treatment approaches, recommendations, and clinical guidelines on the most appropriate use of theranostic solutions.European healthcare systems benefit from a broader spectrum of theranostic treatments and improved cost-effectiveness and affordability of theranostic solutions due to scale effects and more robust European supply chains.Technology developers, healthcare professionals and patients benefit from increased information on the sensitivity, quantification, stratification and staging of diseases.
Scope:Multi-modal theranostic solutions, currently dominated by radionuclide-based therapy and companion diagnostics, are emerging as safe, personalised, and effective approaches for the treatment of several diseases. However, the use of such therapies is limited to a few specialised centres with...
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ExpectedOutcome:Research and innovation (R&I) actions to be supported under this topic must contribute to at least three of the following outcomes:
Patients will benefit from increased treatment efficacy, reduction of time-to-treat, fewer side effects, and reduced duration of hospitalisation.Healthcare professionals benefit from education, training on theranostic treatment approaches, recommendations, and clinical guidelines on the most appropriate use of theranostic solutions.European healthcare systems benefit from a broader spectrum of theranostic treatments and improved cost-effectiveness and affordability of theranostic solutions due to scale effects and more robust European supply chains.Technology developers, healthcare professionals and patients benefit from increased information on the sensitivity, quantification, stratification and staging of diseases.
Scope:Multi-modal theranostic solutions, currently dominated by radionuclide-based therapy and companion diagnostics, are emerging as safe, personalised, and effective approaches for the treatment of several diseases. However, the use of such therapies is limited to a few specialised centres with the need to increase clinical treatment capacities, and to widen the arsenal of theranostics, possibly including novel non‑nuclear approaches, e.g. enabled by nanotechnologies.
To address this challenge, project(s) funded under this topic should aim at developing new, or innovative combinations of existing multi-modal theranostic solutions including radiopharmaceuticals and/or non- radioactive theranostic solutions. Applicants should clearly identify a disease(s) of unmet public health need, (e.g., oncology, neurology and/or advanced multi-disease conditions) and explain their choice with relevant evidence where possible.
In particular, for the selected disease(s), the project(s) funded under this topic are expected to address all the following objectives:
develop innovative theranostic solutions and consider conducting early phase clinical trial(s) as proof of concept(s) to demonstrate the added value of the proposed theranostic solutions for patients;develop tools for the quantification of the chosen disease(s) through the development of novel modalities to ensure proper planning and monitoring of patient care, which may include imaging, artificial intelligence and pathology models;facilitate the development of tools to increase European theranostic manufacturing capabilities and treatment capacities, including guidance on quality assurance and improving logistics of supply at the EU level;develop education and training materials on the deployment of multi-modal theranostic solutions and their integration in clinical settings including recommendations for the organisation and composition of disease-specific medical expert boards. In addition, applicants are expected to consider the potential regulatory impact of the results and if relevant develop a strategy/plan for generating appropriate evidence as well as engaging with regulators in a timely manner (e.g., through the EMA Innovation Task Force, qualification/scientific advice).
Expected Impact:Improved availability of effective treatments for patients based on multi-modal theranostic1 solutions.Stronger resilience and improved strategic autonomy of Europe’s health systems, for example, by implementing new manufacturing capabilities for medical radioisotopes and radiopharmaceuticals (in accordance with the EU SAMIRA2 action plan).Depending on the disease area of the application, contributing to the objectives of Europe's Beating Cancer Plan and the Horizon Europe Mission on Cancer. 1 Theranostics refers to the pairing of diagnostic biomarkers with therapeutic agents that share a specific target in diseased cells or tissues.
2 The SAMIRA action plan is the EU’s first comprehensive plan for action to support a safe, high quality and reliable use of radiological and nuclear technology in healthcare.
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