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Grant Analysis

Purpose & Target

This grant aims to advance cell therapies by leveraging genomic techniques to design engineered cells with improved therapeutic features. The core objective is to overcome current limitations in cellular therapies and translate research into clinically viable solutions. - Target Recipient Type: Broad range of legal entities, including research institutions, universities, and businesses, with strong encouragement for SMEs. - Target Size: Not explicitly defined, but given the significant funding, implies entities with substantial research and development capacity. - Designation: SECTOR-SPECIFIC for Health, Biotechnology, and Medical Technologies. - Geographic Scope: Open to legal entities established in EU Member States and the United States of America. Other associated countries might also be eligible per general Horizon Europe rules. - Key Filtering Criteria: Focus on genomic engineering of human cells for allogeneic, 'off-the-shelf' cell therapeutics, targeting specific therapeutic areas. Requires strong research and development capabilities, and engagement with regulatory authorities. - Grant Frequency and Context: This is a single-stage call within the Horizon Europe Work Programme 2025, specifically under the 'Health' cluster, destination 'Developing and using new tools, technologies and digital solutions for a healthy society'.

Financial Structure

Funding is provided through HORIZON Research and Innovation Actions (RIA), typically covering 100.0% of eligible costs.
The total budget allocated for this topic ('HORIZON-HLTH-2025-01-TOOL-01') for the year 2025 is EUR 50,000,000.
The expected number of grants awarded for this topic is 5.
The minimum grant amount per project is EUR 8,000,000.
The maximum grant amount per project is EUR 10,000,000.
Currency: EUR.
Eligible costs are generally those necessary for the research and innovation activities, including personnel, equipment, travel, and other direct costs. Indirect costs are typically covered by a flat rate (specific percentage not detailed in the provided text, but standard for Horizon Europe).
Financial reporting and audit requirements are described in Annex G of the Work Programme General Annexes.

Eligibility Requirements

Organization Type and Legal Status

Any legal entity established in a Horizon Europe eligible country (EU Member States and Associated Countries).
Specifically, any legal entity established in the United States of America is eligible to receive Union funding.
SMEs (Small and Medium-sized Enterprises) are strongly encouraged to participate.
The Joint Research Centre (JRC) may participate as a member of the consortium.

Geographic Location

Organizations must be established in one of the following countries to receive funding:
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, Sweden, United States of America.
Eligibility for other non-EU/non-Associated Countries may exist if they have specific provisions for making funding available, as outlined in the Horizon Europe Programme Guide (not detailed here).

Organizational Capacity and Experience

Applicants must demonstrate sufficient financial and operational capacity as described in Annex C of the Work Programme General Annexes.
Track record in relevant biomedical research, genetic engineering, cell therapy development, and preclinical studies is implicitly required.
Experience with clinical studies is a significant asset, and a dedicated annex for clinical study details is required.

Partnership Requirements

Interdisciplinary Research and Innovation activities are expected, involving a broad spectrum of actors from different sectors, indicating a consortium is required or highly recommended.
Cross-sectoral cooperation among relevant stakeholders (e.g., healthcare providers, researchers, regulatory bodies) is encouraged.
Collaboration with relevant European research infrastructures and integration of findings from existing EU-supported research projects should be considered.

Exclusion Criteria

Entities assessed as 'high-risk suppliers' of mobile network communication equipment (and any entities they own or control) are not eligible to participate if the topic is identified as 'subject to restrictions for the protection of European communication networks'. This specific topic is not identified with such restrictions.

Application Process

Application Process Overview

Submission Model: Single-stage application process.
Application Platform: Electronic Submission Service via the Funding & Tenders Portal. Access is granted through EU Login or third-party sign-in services.

Application Timeline

Planned Opening Date: 2025-05-22.
Application Deadline: 2025-09-16 00:00:00+00 (Brussels time).

Required Documentation and Materials

Standard Application Form (HE RIA, IA): Available in the Submission System.
Dedicated Annex for Clinical Studies: Applicants are strongly encouraged to use the provided template in the submission system to detail their clinical studies, as proposals are expected to include them.
Proposal page limits and layout are described in Part B of the Application Form.

Evaluation Process

Evaluation and award criteria, scoring, and thresholds are described in Annex D of the Work Programme General Annexes.
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 are described in Annex F of the Work Programme General Annexes.

Support and Guidance

HE Programme Guide: Detailed guidance on Horizon Europe structure, budget, and political priorities.
Online Manual: Guide on procedures from proposal submission to grant management.
Funding & Tenders Portal FAQ: Answers to common questions.
Research Enquiry Service: For general questions on European research.
National Contact Points (NCPs): Guidance and assistance on participation in Horizon Europe, available in many countries.
Enterprise Europe Network: Advice for businesses, especially SMEs, on EU research funding.
IT Helpdesk: For technical issues with the Funding & Tenders Portal.
European IPR Helpdesk: Assistance on intellectual property issues.
CEN-CENELEC Research Helpdesk and ETSI Research Helpdesk: Advice on standardisation in project proposals.
Partner Search: Tool to find partner organizations for proposals.

Evaluation Criteria

Award Criteria and Scoring

Proposals will be evaluated based on three main criteria, each with a threshold of 4 points:
Excellence
Impact
Implementation
The cumulative threshold for all three criteria is 12 points.
Award criteria, scoring, and thresholds are detailed in Annex D of the Work Programme General Annexes.

Portfolio Balancing

To ensure a balanced project portfolio across different therapeutic areas, grants will not be awarded solely based on ranking.
Priority will be given to the highest ranked proposals across different therapeutic areas (as specified in the scope: Cancer and oncology, Nervous and sensory system, Cardiovascular and circulatory system, Endocrinology and metabolic system, Musculoskeletal system, Digestive system, Infectious diseases, Respiratory system, Dermatology, Immune system and auto-immune diseases, Other), provided they meet all cumulative and individual thresholds.

Specific Project Quality and Innovation Factors

Scientific Quality: Demonstrated rigor in the design of engineered cells, use of new genomic techniques, synthetic biology, and gene control systems.
Technical Soundness: Application of state-of-the-art tools (e.g., Computer-Aided Design - CAD) for efficient construction and acceleration of design-build-test cycles.
Testing and Validation: Use of suitable in-vitro and ex-vivo systems, and appropriate preclinical models for testing and demonstrating function, performance, safety, and efficacy.
Clinical Relevance: Clear pathway to clinically viable solutions. The demonstration of feasibility in first-in-human studies is considered an asset.

Impact Expectations

Contribution to the expected impacts of the destination 'Developing and using new tools, technologies and digital solutions for a healthy society'.
Enhancement of Europe's scientific and technological expertise and innovation capabilities in health technologies.
Improved patient outcomes and wellbeing through safer, more sustainable, efficient, cost-effective, and affordable tools for personalized disease prevention, diagnosis, treatment, and monitoring.
Increased EU visibility and leadership in health technology development, including through international cooperation.
Reduction of disease burden globally through innovative diagnostic and therapeutic approaches.
Improved productivity of health Research and Innovation and quality of healthcare via health data and AI tools, ensuring security and ethical considerations.
Fostering public trust and support for innovative healthcare technologies.

Implementation Quality

Project Plan: Comprehensive plan covering all required elements of the scope, from engineering synthetic genetic circuits to preclinical validation.
Team Composition: Demonstration of required technical expertise and qualifications within the project team.
Risk Management: Implicit requirement for robust risk management, particularly regarding safety and efficacy of engineered cells.
Regulatory Engagement: Explicitly required engagement and interaction with regulatory authorities to qualify developed cell-based therapies.
Consideration of Sex Differences: Integration of sex differences in the parent cells and targeted therapeutic application.

Cross-Cutting Themes Impact on Scoring

Proposals demonstrating consideration of ethical, legal, and regulatory aspects, safety, effectiveness, accessibility, and fiscal sustainability are likely to score higher. Consideration of sex differences is also a scoring factor.

Compliance & Special Requirements

Regulatory Compliance and Standards

Engagement with Regulatory Authorities: Essential for qualification of the developed cell-based therapy and for conducting clinical studies. Collaboration with regulatory bodies should be established during the project.
Ethical, Legal, and Regulatory Aspects: Proposals must address issues of ethical, legal, and regulatory nature, ensuring inclusive, ethically sound, and secure delivery and deployment of solutions.
Data Protection and Privacy: Solutions should ensure secure and ethical handling of health data, respecting individual integrity.

Technical Specifications and Quality

Human-Derived Cells: Engineered cells must be derived from human cells.
Allogeneic Origin: Preference for cells of allogeneic origin to enable 'off-the-shelf' cell therapeutics.
Therapeutic Mechanism: The therapeutic action must be based on the endogenous capabilities of the cells; exogenous loading of cells with drugs (using cells as drug carriers) is explicitly not in scope.
Technology Use: Mandates the use of genetic engineering, specifically gene editing tools, as a key element. Synthetic biology introducing transgenes or artificial genes is also permitted. Use of gene control systems (transcriptional, translational, post-translational) and 'sense-and-respond' mechanisms is encouraged.
Digital Tools: Utilization of state-of-the-art digital tools (e.g., Computer-Aided Design - CAD) for design-build-test cycles is expected.

Intellectual Property Policies

Legal and financial set-up of grants, including IP policies, are described in Annex G of the Work Programme General Annexes.

Risk Management

While not explicitly detailed, the focus on 'safe and efficient application' and 'patient safety' implies robust risk management and safety assessments throughout the project, particularly in preclinical and potential first-in-human studies.

Special Opportunities and Considerations

SME Participation: Strongly encouraged to foster innovation and commercialization.
JRC Collaboration: The European Commission's Joint Research Centre (JRC) may collaborate with successful proposals, particularly as an interface between research and pre-normative regulatory science.
Synergies with Other Projects: Cooperation between EU-funded projects (networking, workshops, knowledge exchange, best practices) is welcomed to increase impact.
Consideration of Sex Differences: Required both for the parent cells and for the targeted therapeutic application.
Focus on Unmet Needs: Actions are driven by the need to address diseases with insufficient therapeutic strategies, aligning with the EU Biotechnology and Biomanufacturing Strategy and Artificial Intelligence Strategy.
Contribution to STEP: Support for the Strategic Technologies for Europe Platform (STEP) objectives, boosting investments in critical technologies.
Broad Definition of Clinical Studies: Applicants should thoroughly review the broad definition of clinical studies provided in the work programme introduction.

Grant Details