Clinical validation of biomarkers for diagnosis, monitoring disease progression and treatment response
Programme Category
Programme Name
Programme Description
IHI JU is based on the idea that interdisciplinary and cross-sector collaboration will enable perspective and breakthrough innovations in healthcare, including the pharmaceutical industry but also new fields such as biopharmaceuticals, medical technologies and biotechnologies.
Identifier Code
Call
Summary
Technology development or improvements to existing technologies may be required to progress these biomarkers to clinical validation. For example, there are many novel and highly innovative technologies in development (e.g. imaging, artificial intelligence (AI), omics markers, phage-based diagnostics in multiple formats among others) and their further development and validation would be a necessary element for validating their detected biomarkers in the clinic.
Furthermore, different healthcare actors (e.g. academics, clinicians, patients, health technology developers and regulators) may have different definitions and expectations on the utilities of biomarkers, and there is a need for an aligned methodological framework for scaling up the clinical validation of candidate biomarkers.
Detailed Call Description
To address the above mentioned challenge, this topic aims:
- to progress candidate biomarkers towards clinical validation and, when relevant, to regulatory acceptance;
and/or
- to progress towards clinical validation innovative technologies necessary for making biomarker(s) accessible for clinical use. In proposals focusing uniquely on these technologies, applicants should justify how such progress will enable the validation of the biomarker(s) for use in a clinical context.
Projects funded under this topic should:
- Assemble a cross-sectoral public-private partnership to align and develop a methodological framework and roadmap for progressing selected candidate biomarker(s) and/or linked technologies enabling the clinical use of the biomarker(s) (or a combination thereof) to rigorous clinical validation
- Provide a justification and clearly demonstrate why the proposal area responds to an unmet public health need1.
- Progress biomarker(s) and/or technologies towards clinical and analytical validation in one or more of these areas: diagnosing disease, early treatment path selection, monitoring disease progression, or treatment response assessment:
- All types of biomarkers including digital, combinations of biomarkers and multimodal biomarkers are in scope. Proposals addressing biomarker(s) intended for specific populations such as the elderly or children are very welcome.
- The candidate biomarkers can be combined with existing biomarkers for more personalised decision making.
- All types of technologies for progressing biomarkers to a stage closer to clinical validation, including innovative and novel approaches, are in scope. Some examples could be technologies for the effective collection, preparation, measurement and analysis of samples and biomarkers, or diagnostic equipment, methods, or systems.
- In their proposal, applicants must clearly identify the candidate biomarker(s) and/or linked technology(ies) and the proposed application in research and development (R&D) and/or clinical practice.
- Applicants should provide in their proposal sufficient preliminary evidence, including relevant methodology(ies) and high-quality data to demonstrate that the biomarker(s) and/or technology(ies) can be progressed towards clinical validation and, when relevant, to regulatory acceptance.
- As relevant, applicants must ensure effective collection, preparation, measurement, and analysis of biomarker samples to allow validation in the clinical setting.
- Build on existing solutions to develop a collaborative platform to integrate, analyse and share data (historical or generated de novo) gathered for the validation of biomarker(s) and/or linked technologies during the project, as well as to support future biomarker validation beyond the project duration. Applicants should plan to ensure the future scalability and sustainability of the platform and future data sharing and ensure adherence to FAIR (findable, accessible, interoperable, reusable) principles.
- Develop a regulatory strategy and interaction plan for evidence generation to support the regulatory qualification of the biomarker/s and/or technologies and engage with regulators in a timely manner (e.g. national competent authorities, European Medicines Agency (EMA) Innovation Task Force, qualification advice). Applicants should reserve resources to support these interactions.
- Elaborate a plan for interacting with all the relevant actors in the learning healthcare system (for example clinicians, academic researchers, healthcare professionals, health technology developers, regulators, policy makers, and others as relevant) to align on utilities of the candidate biomarker(s) and/or technologies for clinical use and guide the roadmap.
- Disseminate the results of the project to ensure uptake by relevant stakeholders, including healthcare systems and technology developers.
Call Total Budget
Financing percentage by EU or other bodies / Level of Subsidy or Loan
Expected contribution per project: €15.000.000
Thematic Categories
- Education and training
- Health
- Research, Technological Development and Innovation
Eligibility for Participation
- Central Government
- Educational Institutions
- Large Enterprises
- Legal Entities
- Other Beneficiaries
- Private Bodies
- Researchers/Research Centers/Institutions
- State-owned Enterprises
Eligibility For Participation Notes
Different healthcare actors (e.g. academics, clinicians, patients, health technology developers and regulators) may have different definitions and expectations on the utilities of biomarkers.
ENTITIES ELIGIBLE FOR FUNDING
The following provisions shall apply:
- Legal entities identified in the topic text of the call for proposals shall not be eligible for funding from IHI JU. Nevertheless:
- These entities will be entitled to provide contributions as IHI JU members other than Union or contributing partners or as constituent or affiliated entities of either.
- Legal entities participating in indirect actions selected under this type of calls for proposals shall not be eligible for funding where:
(a) they are for-profit legal entities with an annual turnover of EUR 500 million or more;
(b) they are under the direct or indirect control of a legal entity described in point (a), or under the
same direct or indirect control as a legal entity described in point (a);
(c) they are directly or indirectly controlling a legal entity referred to in point (a).
The following additional condition applies:
- The applicants which are IHI JU members other than the Union, or their constituent entities and
- affiliated entities, and contributing partners and that are pre-identified in the topics – under the section ‘Industry consortium’ – of a call for proposals shall not apply at the first stage of the call. The applicant consortium selected at the first stage shall, in preparation for the proposal submission at the second stage, merge with the pre-identified industry consortium.
In addition, in line with Articles 11 and 119(1) and (3) of the Council Regulation (EU) 2021/2085, legal entities providing in-kind contributions as constituent entities or affiliated entities of IHI JU private members or as contributing partners that are:
- Not eligible for funding in two-stage calls for proposals; or
- Not established in a country generally eligible for funding in accordance with Part B of the General Annexes to the Horizon Europe Work Programme 2023 – 2024, may exceptionally sign the grant agreement.
This is subject to the following conditions:
- Their participation is considered essential for implementing the action by the granting authority; and
- They participate without requesting any funding.
The essentiality of non-EU legal entities for implementing the action shall be ascertained by the granting authority.
Call Opening Date
Call Closing Date
EU Contact Point
All the questions pertaining to the IHI JU Calls are to be addressed to infodesk@ihi.europa.eu.