Development of predictive biomarkers of disease progression and treatment response by using AI methodologies for chronic non-communicable diseases

The Horizon Europe grant opportunity titled "Development of predictive biomarkers of disease progression and treatment response by using AI methodologies for chronic non-communicable diseases" focuses on funding research that leverages artificial intelligence to enhance healthcare diagnostics. The grant is categorized as a HORIZON-RIA (Research and Innovation Actions) and offers substantial funding for collaborative projects.

Eligible applicants include research institutions, universities, hospitals, small and medium-sized enterprises (SMEs), large enterprises, and non-profit organizations based in EU member states, EFTA countries, Associated Countries, and the United States. A consortium is required, emphasizing multidisciplinary collaboration.

The funding amounts range from 6 million to 8 million EUR per project, with a total budget of approximately 44.2 million EUR for six expected grants. The application follows a two-stage submission procedure, with deadlines on April 13 and September 22, 2027. The initial stage involves evaluating proposals based on excellence and impact, while the second stage assesses implementation quality.

The target sector is health, specifically focusing on personalized medicine and AI applications in the development of predictive biomarkers for chronic diseases, excluding cancer. Projects are expected to include comprehensive clinical validation and demonstration phases, supporting multidisciplinary collaborations that engage clinical researchers, AI experts, healthcare professionals, and regulatory bodies.

The two-stage evaluation process aims to filter high-quality proposals, with estimated success rates hovering around 10-20%. Although there is no mandatory co-funding requirement, leveraging additional resources is encouraged. This opportunity highlights the importance of ethical considerations and data privacy in AI tools while aiming to improve clinical outcomes through the validation of innovative biomarker-based approaches in healthcare.

The EU Funding and Tenders Portal presents a Horizon Europe (HORIZON) call, specifically under Cluster 1 Health (Two stage 2027) (HORIZON HLTH 2027 02 two stage). The call focuses on the "Development of predictive biomarkers of disease progression and treatment response by using AI methodologies for chronic non communicable diseases," with the topic ID HORIZON HLTH 2027 02 TOOL 01 two stage. This is a HORIZON RIA Research and Innovation Action with a HORIZON Action Grant Budget Based [HORIZON AG] Multi annual Grant Agreement. The deadline model is two stage. The planned opening date is 10 February 2027, with deadlines on 13 April 2027 and 22 September 2027, both at 17:00:00 Brussels time.

The expected outcome of this topic is to support activities that enable or contribute to the impacts of "Developing and using new tools, technologies and digital solutions for a healthy society". The intended results are: clinical researchers and developers gaining access to novel predictive biomarkers for assessing disease progression and treatment response; clinicians and healthcare professionals using validated biomarkers for personalized medicine; stakeholders accessing trustworthy AI tools for developing multimodal predictive biomarkers; and citizens benefiting from improved health outcomes through better clinical guidelines and biomarker guided healthcare.

The scope of the call addresses the limitations of current biomarkers in addressing chronic, progressive, and multifactorial diseases. It focuses on the clinical development of predictive biomarkers for chronic non communicable diseases (excluding cancer), using established AI methodologies to combine data from clinically used and candidate biomarkers with data from clinical studies, longitudinal data, and Real World Data (RWD). The goal is to support collaborative projects that innovate personalized medicine and enable timely therapeutic interventions.

The research and innovation activities to be addressed include:

1.  Establishing a multidisciplinary collaboration to map and evaluate available information and data on biomarkers used in clinical settings and candidate biomarkers from clinical studies. This includes stratification by biological sex and integration of gender related variables and sociodemographic determinants.
2.  Adapting and applying established AI methods to deliver novel predictive biomarkers of disease progression and treatment response. This involves integrating data from current and candidate biomarkers with data from longitudinal and clinical studies, including RWD. Applicants should demonstrate the availability of high quality clinical data for AI optimization. Biomarkers should be multimodal, covering molecular, cellular, physiological, imaging, behavioral, and digital markers.
3.  Using AI and other data integration methods to describe relationships among biomarkers and prioritize predictive biomarkers tailored to patient characteristics, disease stage, and treatment response. Proposals should emphasize AI trustworthiness and develop performance metrics to assess accuracy, reliability, and reproducibility, including bias assessment. AI and datasets should comply with privacy legislation, and proposals should develop user friendly visualization and decision support tools for clinicians.
4.  Establishing a biomarker validation platform to assess the clinical utility of identified predictive biomarkers. This involves implementing clinical validation studies in independent disease cohorts, RWD, and exploratory clinical studies to demonstrate their clinical value compared to established clinical practice. Prospective clinical studies are expected to be led by entities in the EU/EFTA and/or Associated Countries.
5.  Developing a comprehensive exploitation plan for research outputs and a regulatory strategy to support alignment with regulatory requirements for biomarker and AI tool qualification. Applicants should prioritize exploitation of research results in the EU, and participation of SMEs is encouraged.

Proposals should apply good practices for GDPR compliance. They are also encouraged to use available data services, expertise, and digital tools from European research infrastructures and data infrastructures funded under the Digital Europe Programme. All selected proposals are strongly encouraged to participate in networking and joint activities, allocating sufficient budget for these activities. Applicants should provide details of their clinical studies in a dedicated annex.

The general conditions cover admissibility conditions, proposal page limits and layout, eligible countries (described in Annex B of the Work Programme General Annexes), other eligibility conditions (including the eligibility of US based entities and the use of Copernicus and Galileo/EGNOS for projects using satellite data), financial and operational capacity and exclusion, evaluation and award criteria (described in Annex D of the Work Programme General Annexes), submission and evaluation processes (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), and legal and financial set up of the grants (described in Annex G of the Work Programme General Annexes).

The application and evaluation forms include standard application forms for HE RIA IA Stage 1 BLIND and HE RIA, IA, as well as standard evaluation forms for HE RIA, IA and CSA Stage 1 BLIND and HE RIA, IA. Guidance documents include the HE Programme Guide and the Model Grant Agreement (MGA). Call specific instructions and information on clinical studies are also provided. Additional documents include the HE Main Work Programme 2026 2027, the HE Framework Programme 2021/695, the HE Specific Programme Decision 2021/764, the EU Financial Regulation 2024/2509, decisions authorising lump sum contributions, rules for legal entity validation, and the EU Grants AGA Annotated Model Grant Agreement.

The budget overview lists several topics: HORIZON HLTH 2027 02 DISEASE 01 two stage (63,800,000 EUR, contributions of 7,000,000 to 8,000,000 EUR, 8 grants), HORIZON HLTH 2027 02 DISEASE 14 two stage (39,300,000 EUR, contributions around 10,000,000 EUR, 4 grants), HORIZON HLTH 2027 02 IND 02 two stage (39,300,000 EUR, contributions of 5,000,000 to 7,000,000 EUR, 6 grants), and HORIZON HLTH 2027 02 TOOL 01 two stage (44,200,000 EUR, contributions of 6,000,000 to 8,000,000 EUR, 6 grants). All topics follow a two stage submission process, with opening on 2027 02 10, and deadlines on 2027 04 13 and 2027 09 22.

There is a partner search announcement section, and the submission system is planned to open on the date stated on the topic header. A general FAQ and support section provides links to online manuals, programme guides, FAQs, research enquiry services, national contact points, enterprise Europe network, IT helpdesks, and IPR helpdesks.

In summary, this Horizon Europe call aims to advance personalized medicine by developing and validating AI driven predictive biomarkers for chronic non communicable diseases. It encourages multidisciplinary collaboration, the use of established AI methodologies, and the exploitation of European research and data infrastructures. The call emphasizes ethical considerations, data privacy, and the trustworthiness of AI tools. Successful projects are expected to contribute to improved clinical guidelines, better patient health outcomes, and the strengthening of the European health innovation ecosystem.

Eligible Applicant Types: The opportunity is open to a wide range of legal entities including but not limited to: clinical researchers, developers, healthcare professionals, small and medium-sized enterprises (SMEs), and other relevant stakeholders in the EU, EFTA, Associated Countries, and the United States of America. The emphasis is on collaborative projects, suggesting that consortia are encouraged.

Funding Type: The primary funding type is a grant, specifically a HORIZON Action Grant Budget-Based [HORIZON-AG] under the HORIZON Research and Innovation Actions (HORIZON-RIA) and HORIZON Innovation Actions (HORIZON-IA).

Consortium Requirement: The opportunity explicitly mentions the need for multidisciplinary collaboration and supports collaborative projects, indicating that a consortium is strongly preferred, if not required.

Beneficiary Scope (Geographic Eligibility): Eligible applicants are those established in EU member states, EFTA countries, Horizon Europe Associated Countries, and the United States of America.

Target Sector: The target sector is health, with a focus on developing new tools, technologies, and digital solutions for a healthy society. Specifically, it targets the clinical development of predictive biomarkers for chronic non-communicable diseases (excluding cancer) using AI methodologies. The program also touches on personalized medicine, artificial intelligence, and digital health.

Mentioned Countries: European Union (EU), EFTA countries, Horizon Europe Associated Countries, United States of America.

Project Stage: The project stage is clinical development, validation, and implementation. The focus is on adapting and applying established AI methods to deliver novel predictive biomarkers, validating these biomarkers in clinical studies, and developing a comprehensive exploitation plan for the research outputs.

Funding Amount: The funding amounts vary depending on the specific topic within the call:
 HORIZON-HLTH-2027-02-DISEASE-01-two-stage: EUR 7,000,000 to 8,000,000
 HORIZON-HLTH-2027-02-DISEASE-14-two-stage: around EUR 10,000,000
 HORIZON-HLTH-2027-02-IND-02-two-stage: EUR 5,000,000 to 7,000,000
 HORIZON-HLTH-2027-02-TOOL-01-two-stage: EUR 6,000,000 to 8,000,000

Application Type: The application type is a two-stage open call.

Nature of Support: Beneficiaries will receive money in the form of a grant to support their research and innovation activities.

Application Stages: The application process involves two stages. In the first stage, proposals are evaluated blindly based on Excellence and Impact. In the second stage, proposals are evaluated based on Excellence, Impact, and Implementation.

Success Rates: The success rates are not explicitly mentioned, but the evaluation process indicates that the total requested budget of proposals admitted to stage 2 should be as close as possible to four times the available budget, and not less than three and a half times the available budget. This suggests that only a fraction of initial proposals will make it to the second stage.

Co-funding Requirement: The text does not explicitly state a co-funding requirement.

Summary: This Horizon Europe call focuses on the clinical development of predictive biomarkers for chronic non-communicable diseases (excluding cancer) using AI methodologies. The goal is to improve patient outcomes, guide treatment decisions, and accelerate personalized medicine. The call encourages collaborative projects that bring together multidisciplinary teams to map and evaluate existing biomarkers, adapt and apply AI methods to develop novel predictive biomarkers, validate these biomarkers in clinical studies, and develop exploitation plans for the research outputs. The call is structured as a two-stage process, with the first stage focusing on Excellence and Impact, and the second stage adding Implementation as an evaluation criterion. Funding amounts vary depending on the specific topic, ranging from EUR 5 million to EUR 10 million per project. Eligible applicants include a wide range of legal entities from the EU, EFTA, Associated Countries, and the USA, with a strong emphasis on collaborative projects involving SMEs. The call aims to support activities that contribute to the development of new tools, technologies, and digital solutions for a healthy society, ultimately benefiting citizens through improved clinical guidelines and personalized healthcare.