Grants8 | The most comprehensive grants search on the web

Grant Analysis

Purpose & Target

This grant aims to accelerate cell therapy for Type 1 Diabetes (T1D) by developing standardised tools, methods, and foundational knowledge. The ultimate goal is to facilitate the widespread adoption and integration of these innovative therapies into European healthcare systems, improving patient outcomes and contributing to Europe's leadership in regenerative medicine. The grant is SECTOR-SPECIFIC, primarily targeting the healthcare, biotechnology, pharmaceutical, and medical research sectors. Target recipients are research consortia comprising academic researchers, industry (pharmaceutical, biotech, ICT), healthcare providers, regulatory bodies, and potentially patient organizations. While no specific organization size is mentioned, the consortium requirement implies larger, established entities or collaborations involving them. The geographic scope is Europe-focused, with funding eligibility primarily for entities established in EU Member States and Associated Countries. UK and Canada can participate but are not eligible for funding. Key filtering criteria for applicants include a strong focus on T1D cell therapy, a willingness to engage in European collaboration through a consortium, adherence to the Research and Innovation Action (RIA) scope (emphasizing foundational knowledge and tools over specific product development), and the ability to meet a significant industry contribution requirement. This grant is part of the recurring Horizon Europe / IHI JU Work Programme.

Financial Structure

Funding Details

Maximum Grant Amount: The maximum grant amount per project for this specific topic (HORIZON-JU-IHI-2025-11-04-two-stage) is 8,825,000.0 EUR.
Minimum Grant Amount: The minimum grant amount is also 8,825,000.0 EUR, meaning a fixed amount is allocated per selected project.
Currency: All financial amounts are specified in EUR.
Total Call Budget: The total indicative budget for the entire 'HORIZON-JU-IHI-2025-11-two-stage' call, which includes several topics, is 57,411,000.0 EUR.

Co-financing and Contribution Requirements

Industry Contribution: A crucial financial requirement is a mandatory 45% industry contribution from the consortium members. This contribution is a key eligibility criterion for funding and can be provided as in-kind contributions (e.g., staff, equipment, data) or direct financial contributions.

Cost Categories

Eligible and Ineligible Costs: Detailed information on eligible and ineligible costs is described in Annex G of the Horizon Europe Work Programme General Annexes. This document would specify what types of expenditures can be covered by the grant funding and what cannot.

Payment and Reporting

Payment Mechanisms: The grant operates on a 'HORIZON Action Grant Budget-Based' mechanism. Specific payment schedules and disbursement mechanisms are not detailed in the provided text but would follow standard Horizon Europe procedures.
Financial Reporting: Requirements for financial reporting are not explicitly detailed in the provided grant text but are a standard part of Horizon Europe grant agreements. Auditors may be required for larger grants.

Eligibility Requirements

Organizational Eligibility

Legal Entities: Any legal entity can participate in a consortium.
Funding Eligibility: Legal entities established in EU Member States and Associated Countries are eligible to receive funding. This includes countries such as Austria, Belgium, Bulgaria, Croatia, Cyprus, Czechia, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden. Specific associated countries are detailed in Annex B of the Work Programme General Annexes.
Exclusion from Funding: Legal entities established in the United Kingdom (UK) and Canada are not eligible to receive funding, although they may participate in consortia.
Consortium Requirement: The application must be submitted by a consortium, indicating that collaborative projects are expected.
Industry Contribution: Consortia must comply with IHI additional eligibility criteria, specifically demonstrating a 45% industry contribution. This contribution can be in-kind or financial and is a mandatory requirement for funding eligibility.
Project Scope Alignment: Proposals must strictly align with the scope of a Research and Innovation Action (RIA). This means the focus should be on generating foundational knowledge, technical standards, tools, and methodologies, rather than on the development of specific commercial products or therapeutic candidates intended for direct clinical use.

Application Process

Application Submission Timeline and Deadlines

This is a two-stage application process.
Stage 1 Submission Deadline: 2025-10-09
Stage 2 Submission Deadline: 2026-04-29 (This is the latest possible deadline for the full proposal).

Application Procedure and Materials All submissions must be made through the Funding & Tender Opportunities Portal's submission system. The required documentation includes specific templates:

For Stage 1 (Short Proposal):
- Part A: This section is automatically generated by the IT system within the submission environment. It requires applicants to input general proposal information (e.g., acronym), details on participating organizations, and the overall budget.
- Part B - Short Proposal: This is the core narrative of your proposal, with a strict limit of 20 pages. You must use the 'IHI JU Proposal template (RIA/SP) – Part B'.
- Compulsory Annex: 'Type of Participants': An Excel template that must be uploaded as a separate document, providing details on the types of organizations in your consortium. Instructions for this template are available.
For Stage 2 (Full Proposal):
- Part A: Also generated by the IT system, similar to Stage 1, for general information, participant details, and overall budget.
- Part B - Full Proposal: The comprehensive proposal narrative, with a limit of 50 pages. You must use the 'IHI JU Proposal template (RIA/FP) - Part B'.
- Compulsory Annex: 'Annex to the budget and type of participants': An Excel document that complements the budget figures in Part A, specifically guiding the consortium in detailing IHI-specific budget items and confirming compliance with the 45% industry contribution.
- Compulsory Annex: 'Declaration of in-kind contribution commitment': A Word document to formally commit to in-kind contributions.
- Compulsory Annex: 'Essential information for clinical studies': If your proposal includes clinical studies, this annex is mandatory. If not, a statement declaring no clinical studies must be uploaded.
- Optional Annex: 'In-kind contributions to additional activities (IKAA)': An Excel template if applicable.
- Optional Annex: 'Ethics': For proposals with several serious ethics issues, allowing for additional information beyond Part A's ethics section.

Support and Guidance The following resources are available to assist applicants: * Online Manual: Provides guidance on procedures from proposal submission to grant management. * Horizon Europe Programme Guide: Offers detailed guidance on the structure, budget, and political priorities of Horizon Europe. * Funding & Tenders Portal FAQ: Answers to frequently asked questions on submission, evaluation, and grant management. * Research Enquiry Service: For general questions about European research and EU Research Framework Programmes. * National Contact Points (NCPs): Provide guidance, practical information, and assistance in participating in Horizon Europe. * Enterprise Europe Network (EEN): Offers advice to businesses, particularly SMEs, including guidance on EU research funding. * IT Helpdesk: For technical issues with the Funding & Tenders Portal. * European IPR Helpdesk: Assists with intellectual property issues. * CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk: Advise on standardization in project proposals. * European Charter for Researchers and Code of Conduct: General principles for researchers, employers, and funders. * Partner Search: A tool to help find partner organizations for your proposal. Project Implementation and Reporting Applicants are expected to consider a sustainability plan for maintaining, updating, and validating the project's results beyond the grant's duration to ensure long-term impact. Specific reporting schedules are not detailed but are standard for Horizon Europe grants.

Evaluation Criteria

Evaluation criteria for this grant are primarily detailed in Annex D of the Horizon Europe Work Programme General Annexes and the 'Conditions of the Calls for proposals and Call management rules' section of the IHI JU Work Programme (WP). While the full scoring system is not provided here, the grant document highlights several key areas that will likely be crucial for assessment: Core Assessment Areas

Innovation Requirements: Proposals should demonstrate significant advancements in various fields, including manufacturing techniques (e.g., cryopreservation, scalable processes), preclinical models, AI-driven predictive tools, and the identification of novel biomarkers. The focus is on groundbreaking therapies and innovative approaches to accelerate cell therapy development.
Social Impact Expectations: A high-scoring proposal will clearly articulate its expected impact on improving healthcare quality, accessibility, and sustainability. This includes reducing the burden of Type 1 Diabetes, improving patient outcomes, and enhancing long-term health. The project is explicitly expected to contribute to UN Sustainable Development Goal (SDG) 3: Good Health & Well-being, particularly by reducing the impact of non-communicable diseases like T1D.
Competitive Advantage Factors: Projects that strengthen Europe's position as a leader in beta-cell therapy, foster the creation of European innovation hubs, and significantly boost European industrial competitiveness in regenerative medicine will be highly regarded. This includes driving innovation in cell-based therapies and enhancing Europe's global leadership.
Quality Thresholds and Excellence Benchmarks: Emphasis is placed on developing standardised criteria, analytical methods, quality control frameworks, and consistent methodologies. This suggests that the scientific and technical excellence of the proposed research, its robustness, and its potential for broad applicability will be critically assessed.
Cross-cutting Themes: The evaluation will consider how proposals address important cross-cutting issues. This includes adherence to ethical standards, robust data privacy frameworks (especially for personal health data and biobanks), and ensuring transparency requirements for AI decision-making processes (such as model interoperability, data provenance, and traceability). Proposals should also consider a sustainability plan for the project's results beyond its duration.

Compliance & Special Requirements

Regulatory Compliance

Engagement with Regulators: Proposers are encouraged to engage with the European Medicines Agency (EMA) to ensure regulatory relevance and potential adoption of methodologies. A regulatory strategy and interaction plan for generating appropriate evidence is expected.
EU Policy Alignment: Projects must contribute to and comply with relevant EU policies and initiatives, including the European Health Data Space Regulation (EHDS) and the EU Artificial Intelligence Act.

Data Protection and Privacy

Adherence to strict ethical standards and robust data privacy frameworks is required, especially concerning the use of personal health data and biobanks.
For AI-driven tools, there are specific transparency requirements, including ensuring model interoperability, data provenance, and traceability of AI decision-making processes.

Intellectual Property (IP) Policies

The IHI Joint Undertaking (JU) reserves the right to object to transfer/exclusive licensing of project results.
A key specific condition relates to background assets: if a project result is a direct improvement to a beneficiary's pre-existing background asset, the ownership of that specific result will need to be transferred back to the beneficiary who contributed the background asset. This arrangement and its conditions must be explicitly specified in the project's consortium agreement.

Risk Management

While not explicitly detailed, the grant's focus on standardized criteria, quality control, and safety in developing therapies implies robust risk management practices will be expected, especially concerning product development within a research context.

Unique Aspects and Strategic Opportunities

Focus on Foundational Knowledge: This grant is distinct as it emphasizes the generation of foundational knowledge, technical standards, and reference systems, rather than the development of specific commercial products or therapeutic candidates for immediate clinical use. The outputs are intended to support the field at large.
Mandatory Industry Contribution: The requirement for a 45% industry contribution is a unique and significant financial commitment for participating consortia.
Non-Funded Participation: Entities from the UK and Canada can participate in consortia but are explicitly not eligible to receive funding from this grant.
Emphasis on Collaboration: Strong encouragement for synergies with complementary initiatives (e.g., NHPIG, Vanguard-project, Islet-project, JOIN4ATMP, EPITR, Horizon 2020/Europe projects) and the establishment of European innovation hubs to foster knowledge sharing and harmonized regulatory approaches.
Sustainability Expectation: Applicants are required to provide a sustainability plan for the long-term maintenance, update, and validation of the project's results beyond the grant's duration, ensuring lasting impact.

Grant Details