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Development and proof of principle of new clinical applications of theranostics solutions

European Comission

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Summary
27 July 2023
16 January 2024
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For profit
Individuals
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Public sector
R&D and Higher Education
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Research, Development and Innovation Medical and Health Sciences
Overview

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.

Eligibility

General conditions

  1. Admissibility conditions: described in Annex A and Annex E of the Horizon Europe Work Programme General Annexes

Proposal page limits and layout: described in Part B of the Application Form available in the Submission System

  • for a single-stage Call, the limit for RIA full proposals is 50 pages
  1. Eligible countries: described in Annex B of the Work Programme General Annexes

A number of non-EU/non-Associated Countries that are not automatically eligible for funding have made specific provisions for making funding available for their participants in Horizon Europe projects. See the information in the Horizon Europe Programme Guide .

  1. Other eligibility conditions: described in Annex B of the Work Programme General Annexes and in the ''Conditions of the Calls for proposals and Calls management rules'' section of the IHI JU Work Programme (WP)

  2. Financial and operational capacity and exclusion: described in Annex C of the Work Programme General Annexes

  3. Evaluation and award:

  • Award criteria, scoring and thresholds are described in Annex D of the Work Programme General Annexes and in the ''Conditions of the Calls for proposals and Calls management rules'' section of the IHI JU Work Programme (WP)

  • Submission and evaluation processes are described in Annex F of the Work Programme General Annexes and the Online Manual

  • Indicative timeline for evaluation and grant agreement: described in Annex F of the Work Programme General Annexes

  1. Legal and financial set-up of the grants: described in Annex G of the Work Programme General Annexes

Specific conditions

  1. Specific conditions: described in the ''Conditions of the Calls for proposals and Calls management rules'' section of the IHI JU Work Programme (WP)
  • specific conditions on Availability, Accessibility and Affordability (3A) apply to this topic
  • JU's right to object to transfer/exclusive licensing

Documents

Call documents:

The IHI JU 5th Call for proposals full topics text is available here

Evaluation form (single and two-stage Calls)

Proposal Templates Part A and Part B (Research and Innovation Actions – single-stage and second stage of two-stage procedure)

  • Proposal template - Part A of the proposal is generated by the IT system in the submission environment (for more information see the HE Part A template here ). In Part A of the proposal applicants insert general information on their proposal (e.g. proposal acronym), details on the participants, on the budget, information on Ethics and Security, as well as other type of questions (e.g. information on clinical studies). Please note that only Part A of this template is applicable for this call. For Part B, see point below.

  • IHI JU Proposal template (RIA/FP) - Part B

Proposal Annexes

  • Annex: Type of Participants

The “ type of participants” is an IHI specific annex. The excel template can be found here and the instructions on how to fill in this template can be found here .

This is a compulsory annex and it must be uploaded as a separate document in the submission system.

This annex is applicable to single-stage and two-stage Calls.

  • Annex: Declaration of in-kind contribution commitment

The “ Declaration of in-kind contribution commitment” is an IHI specific annex.

The word document template can be found here .

This is a is a compulsory annex and it must be uploaded as a separate document in the submission system.

This annex is applicable to all single-stage Calls.

  • Annex: In-kind contributions to additional activities (IKAA)

The ‘ ’In-kind contributions to additional activities (IKAA)’’ is an IHI specific annex. The excel template can be found here and the instructions on how to fill in this template can be found here .

This is an optional annex and it is applicable to all single-stages Calls and the second stage of two-stage Calls.

  • Annex: Essential information for clinical studies

The information on clinical studies is a Horizon Europe annex.

This is a is a compulsory annex and it must be uploaded as a separate document in the submission system.

If your proposal does not include clinical studies, please upload a statement declaring your proposal does not include clinical studies.

The information on clinical studies annex can be found here :

The annex is applicable only for single-stage Calls and the second stage of two-stage Calls .

  • Annex: Ethics

This is a HE annex. Ethics self-assessment should be included in proposal part A. However, in Calls where several serious ethics issues are expected, the characters limit in this section of proposal part A may not be sufficient for participants to give all necessary information. In those cases, participants may include additional information in an annex to proposal part B.

This is an optional annex and it is applicable to all single-stage Calls and the second stage of two-stage Calls.

  • Annex to the budget for the Full Proposal

This is a compulsory annex , which complements the budget figures already included in the proposal budget in PART A. Its purpose is to correctly guide the consortium in providing IHI-specific budget items (e.g. IKOP, IKAA, FC PAID, FC RECEIVED, etc.) and to comply with IHI additional eligibility criteria (e.g. 45% industry contribution).

Model Grant Agreement (MGA)

[

](https://www.ihi.europa.eu/sites/default/files/uploads/Documents/Calls/IHI_Call5_CallText.pdf)

Additional documents:

Horizon Europe Reference Documents

Learn more or apply
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16 January 2024