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Grant Analysis

Purpose & Target

This grant, 'Towards precision medicine: platform for transdiagnostic stratification of brain dysfunction', aims to revolutionize how brain disorders are diagnosed and treated. Its core objective is to develop a sustainable, large-scale data platform to identify new biological markers for brain dysfunctions, specifically focusing on Reward/Motivation & Impulsivity (RM&I) symptoms that cut across conditions like Alzheimer's, major depressive disorder, and obesity. The goal is to move towards more personalized healthcare by understanding the shared biological underpinnings of these symptoms. This is a SECTOR-SPECIFIC grant primarily targeting the Healthcare and Technology sectors, specifically focusing on neuroscience, digital health, and public health. It seeks significant research organizations, universities, and industry partners capable of undertaking large-scale research and innovation projects. Legal entities from EU Member States, the UK, and Canada are eligible to receive funding. The ultimate impact is expected to benefit patients and healthcare systems across Europe and beyond. Key filtering criteria for potential applicants include a focus on brain dysfunction research (specifically RM&I symptoms), the ability to integrate and leverage existing data platforms (not build new ones from scratch), a track record in significant research, and a willingness to form a consortium with a mandatory 45% industry financial contribution for the second stage of the application. This grant is part of the Innovative Health Initiative Joint Undertaking's (IHI JU) annual call (Call 11) under the broader Horizon Europe program, indicating a recurring funding opportunity with a focus on public-private partnerships.

Financial Structure

The financial structure for this specific grant topic is clearly defined:

Funding Amount: The grant provides a fixed amount per project. For 'HORIZON-JU-IHI-2025-11-01-two-stage', the grant amount is €20,202,000. Both the minimum and maximum grant amounts for this topic are set at this figure, indicating an expected scale of project.
Currency: All financial amounts are in Euros (EUR).
Co-financing and Matching Funds: This is a critical aspect. For eligible second-stage proposals, a compulsory 45% financial contribution from industry partners is required. This means that if industry partners are involved, the grant will cover up to 55% of their eligible costs. For non-industry participants (e.g., research organizations, universities), the typical Horizon Europe Research and Innovation Action (RIA) funding rate is 100% of eligible costs, but this should be confirmed in the full Work Programme General Annexes (Annex G).
Eligible and Ineligible Costs: Specifics regarding eligible and ineligible costs are detailed in 'Annex G' of the Work Programme General Annexes. The grant also references 'IHI-specific budget items' (e.g., IKOP, IKAA, FC PAID, FC RECEIVED) that must be accounted for and reported. An 'In-kind contributions to additional activities (IKAA)' annex is optional.
Payment Schedule and Mechanisms: The grant is an 'HORIZON Action Grant Budget-Based'. Details on specific payment schedules and disbursement mechanisms are not provided in the topic description but would be outlined in the Model Grant Agreement (MGA).
Financial Reporting Requirements: Financial reporting is required and detailed in Annex C and G of the Work Programme General Annexes. Compulsory annexes for financial reporting, such as the 'Annex to the budget and type of participants' and the 'Declaration of in-kind contribution commitment', must be submitted with second-stage proposals.

Eligibility Requirements

To be considered for this grant, your organization must meet several strict, non-negotiable criteria:

Organization Type: Eligible applicants are 'legal entities'. This broadly includes research organizations, universities, public bodies, and private industry (companies). The grant emphasizes the formation of a 'public-private partnership' (PPP) and requires a significant industry contribution, indicating a preference for consortia that include both public and private sector entities.
Geographic Eligibility: Legal entities established in any EU Member State are eligible. Additionally, legal entities established in the United Kingdom (UK) and Canada are specifically eligible to receive funding under this topic. The project's impact is expected to extend broadly across Europe.
Consortium Requirement: A consortium is mandatory for this application. You cannot apply as a single entity. The consortium must be a public-private partnership, and should include People with Lived Experience (LE) as active and meaningful participants throughout the initiative and within the consortium's governance.
Financial Contribution (Industry): For proposals that reach the second stage, there is a compulsory 45% financial contribution from industry partners. This is a critical eligibility criterion for industry participants in the consortium.
Existing Infrastructure Requirement: A fundamental requirement is to adapt and extend an existing federated data platform. Proposals aiming to build a new data platform or biorepository from scratch are explicitly out of scope and will be deemed ineligible. You must leverage and build upon existing infrastructures like the 'AD Workbench' and 'EPND hub'.
Data Contribution: Applicants must commit to bringing and making accessible their own datasets and samples to the entire public-private partnership consortium from the very start of the project.
Proposal Page Limits: Adherence to strict page limits is required:
- Stage 1 (Short Proposals): Maximum 20 pages.
- Stage 2 (Full Proposals): Maximum 50 pages.
Ethical Review: An ethics self-assessment must be included in Part A of the proposal. If serious ethical issues are anticipated, additional information may be required in an annex to Part B.

Application Process

Applying for this grant involves a two-stage submission process:

Application Timeline and Deadlines:
- Call Opening: June 17, 2025
- Stage 1 Deadline (Short Proposal): October 9, 2025, 00:00:00 UTC (Brussels time). Only successful proposals from Stage 1 will be invited to submit a full proposal.
- Stage 2 Deadline (Full Proposal): April 29, 2026, 00:00:00 UTC (Brussels time).
Required Documentation and Materials:
- For Stage 1 (Short Proposal):
  - Part A of the proposal: Generated by the IT system in the submission environment, containing general information, participant details, and overall budget.
  - Part B - Short proposal: A detailed narrative limited to 20 pages.
  - 'Type of Participants' Annex: A compulsory Excel template that must be uploaded as a separate document.
- For Stage 2 (Full Proposal):
  - Part A of the proposal: As in Stage 1, generated by the system.
  - Part B - Full proposal: A comprehensive narrative limited to 50 pages.
  - 'Annex to the budget and type of participants': A compulsory Excel document complementing budget figures in Part A, guiding the consortium on IHI-specific budget items and confirming compliance with additional eligibility criteria (e.g., 45% industry contribution).
  - 'Declaration of in-kind contribution commitment': A compulsory Word document template.
  - 'Essential information for clinical studies': A compulsory annex. If your proposal does not include clinical studies, you must upload a statement declaring this.
  - Optional Annexes include 'In-kind contributions to additional activities (IKAA)' and an 'Ethics' annex if substantial ethical issues require more space than Part A allows.
Application Procedure and Submission: Applications must be submitted electronically through the Funding & Tenders Portal. The process is detailed in the Online Manual.
Types of Support Offered: The primary support offered is funding as an 'HORIZON Action Grant Budget-Based'. Beyond monetary support, various resources are available to assist applicants:
- Online Manual: Provides guidance on procedures from submission to grant management.
- National Contact Points (NCPs): Offer practical information and assistance.
- Enterprise Europe Network (EEN): Provides advice to businesses, especially SMEs.
- IT Helpdesk: For technical issues with the submission system.
- European IPR Helpdesk: For intellectual property matters.
- Partner Search Tool: To help find suitable partners for your consortium.
Project Implementation Timeline: The project should include an initial pilot clinical case study within its first year and a systematic literature review within the first six months.
Reporting Obligations: Reporting requirements will be specified in the grant agreement and are generally outlined in Annex G of the Work Programme General Annexes, along with specific IHI budget annexes.

Evaluation Criteria

The evaluation of proposals for this grant will be based on specific criteria that assess the quality, impact, and implementation of your proposed project. While the full details are described in Annex D of the Horizon Europe Work Programme General Annexes and the IHI JU Work Programme, the grant topic description highlights key aspects:

Innovation and Scientific Excellence: Proposals are expected to demonstrate strong scientific merit, leading to the identification of novel transdiagnostic candidate markers and endpoints. This includes the innovative application of 'advanced computational analytics', such as Artificial Intelligence (AI) and Machine Learning (ML), to analyze multimodal data and generate new insights into the biological basis of brain dysfunction. The development of new diagnostic and treatment frameworks is a key objective.
Impact and Contribution to Precision Medicine: The proposed action should clearly contribute to the grant's expected impacts, including:
- Developing a 'comprehensive, sustainable data-driven health platform' for precision medicine.
- Advancing the 'mechanistic understanding' of CNS transdiagnostic symptoms.
- Significantly improving 'patient outcomes' and reducing stigma through more integrated and personalized care.
- Enhancing 'efficiency in the healthcare system' through precision treatments and cost reduction.
- Boosting 'European competitiveness' and aligning with key EU policies like the European Health Data Space Regulation (EHDS) and the EU Artificial Intelligence Act.
Societal Relevance and SDG Alignment: Although not explicitly numbered, the grant strongly aligns with several UN Sustainable Development Goals (SDGs):
- SDG3: Good Health and Well-being: Through improving patient outcomes, providing personalized care, and reducing the burden of brain disorders.
- SDG9: Industry, Innovation, and Infrastructure: By fostering innovation in healthcare, building robust data infrastructure, and strengthening European industry's competitiveness.
- SDG17: Partnerships for the Goals: Emphasizing public-private partnerships, stakeholder collaboration, and shared data resources.
Competitive Advantage Factors: Successful proposals will likely demonstrate:
- A strong and balanced consortium with diverse, relevant expertise (e.g., clinicians, researchers, data scientists, industry, regulators, patient advocates).
- Access to, and a clear strategy for effectively integrating, high-quality, multimodal existing datasets.
- A well-defined regulatory strategy and interaction plan for engaging with bodies like EMA and HTA bodies early on.
- A robust commitment to inclusive and equitable practices, particularly concerning data representation (gender, ethnicity, age) and the active, meaningful involvement of People with Lived Experience (LE).
- A credible and detailed plan for the long-term sustainability of the developed data platform beyond the project's duration.

Compliance & Special Requirements

Compliance and special requirements for this grant are rigorous, reflecting the sensitive nature of health data and research:

Regulatory Compliance: Projects must adhere to 'Council Regulation (EU) 2021/2085' establishing the Joint Undertakings under Horizon Europe. Applicants are expected to proactively engage with regulators (e.g., European Medicines Agency (EMA) and national competent authorities) to define a strategic approach to evidence collection and develop a regulatory strategy for their results, especially concerning new markers and endpoints.
Data Protection and Privacy: Strict adherence to data protection regulations, specifically the General Data Protection Regulation (GDPR), is mandatory. Proposals must ensure the 'robust protection of data volunteers' rights' and explain how they will develop consensus on data sharing principles, including model interpretability, data provenance, and traceability of AI decision-making processes.
Ethical Standards: An ethics self-assessment is a required part of the proposal (Part A). If significant ethical concerns are identified, additional information may be requested in an annex to Part B of the proposal. The project must implement fair and transparent governance for data- and sample-sharing.
Intellectual Property (IP) Policies: The Innovative Health Initiative Joint Undertaking (IHI JU) reserves the 'right to object to transfer/exclusive licensing'. Proposals must comply with intellectual property rights (IPR) regulations.
Technology Specifications: The grant mandates the adaptation and extension of existing federated data platforms (e.g., AD Workbench, EPND hub). Building new platforms from scratch is not permitted. The platform must be scalable, adaptable, and support advanced computational analysis, including Artificial Intelligence (AI) and Machine Learning (ML) technologies, ensuring interoperability with other global data platforms.
Risk Management: Applicants are expected to outline their approach to inclusive and equitable practices throughout the initiative, potentially including a 'risk register and appropriate mitigations'.
Unique Aspects and Challenges:
- Transdiagnostic Approach: The unique focus on 'transdiagnostic stratification of brain dysfunction' requires a multidisciplinary approach that transcends traditional diagnostic categories.
- Leveraging Existing Infrastructure: The requirement to adapt and extend existing data platforms means applicants must have the technical capability and relationships to integrate with these established systems.
- Mandatory Industry Contribution: The compulsory 45% financial contribution from industry partners for the second stage is a significant requirement, demanding strong commitment and investment from the private sector.
- Involvement of People with Lived Experience (LE): The grant places strong emphasis on the 'active and meaningful participation of people with LE' (patients, carers, advocacy organizations) within the consortium's governance and activities. This ensures that research is patient-centered and relevant.
Strategic Opportunities: This grant offers a significant opportunity to contribute to EU political priorities in health, including the European Health Data Space, the EU AI Act, and broader mental health and non-communicable disease initiatives. It also allows for long-term impact by ensuring the developed platform remains 'open access for ongoing research and validation' post-project.

Grant Details