DYNAMARK-CKM

DYNAMARK-CKM aims to develop and clinically validate dynamic, multimodal AI-based predictive biomarkers to improve the assessment of disease progression and treatment response in patients with interconnected chronic non-communicable diseases.

The project focuses on cardio-kidney-metabolic (CKM) multimorbidity, particularly type 2 diabetes, chronic kidney disease and cardiovascular conditions, including heart failure.

By integrating existing clinical biomarkers, molecular and physiological measurements, medical imaging, longitudinal patient data and Real-World Data (RWD), DYNAMARK-CKM will apply established, trustworthy AI methodologies to generate interpretable predictive biomarker signatures.

The objective is to move beyond isolated risk indicators towards personalised, evidence-based assessment of disease trajectories and treatment-response patterns.

Target Groups and Expected Benefits

The primary target population comprises adults with CKM multimorbidity, particularly patients with type 2 diabetes and chronic kidney disease, with or without cardiovascular complications. The project also addresses clinicians, hospitals, biomedical researchers, healthcare technology developers and regulatory stakeholders. Expected benefits include improved patient stratification, clinically validated predictive evidence, better-informed clinical decision-making and more reliable integration of AI-based biomarkers into healthcare research and practice.

Innovation and Expected Results

The project's central innovation is the DYNAMARK Response Signature (DRS), a multimodal predictive biomarker profile combining disease-progression and treatment-response information. The project will develop:

• AI-based predictive biomarker signatures validated in independent clinical cohorts.

• A secure, interoperable multimodal health-data environment.

• A Biomarker Evidence Passport documenting data provenance, AI model versions, validation evidence and traceability.

• A reusable biomarker validation framework.

• Clinician-facing decision-support visualisation tools.

• A regulatory qualification and European exploitation roadmap.

NEWCO S.A. (Greece) is positioned as a specialised technology partner, potentially leading or co-leading the trusted data infrastructure, provenance, cybersecurity and clinical integration activities. Its proposed contributions include:

• Designing secure, GDPR-compliant health-data integration architectures and interoperable APIs.

• Developing the Biomarker Evidence Passport through cryptographic provenance and verifiable audit mechanisms.

• Implementing cybersecurity, access-control and secure data-exchange solutions.

• Supporting trustworthy AI through model traceability, monitoring and explainability interfaces.

• Integrating validated biomarker outputs into clinician-facing demonstrators.

• Contributing to technology exploitation, scalability and European market uptake.

Partners Sought

We are building a multidisciplinary European consortium and are particularly seeking:

• Clinical/Scientific Coordinator: University hospital or medical university with CKM expertise and established longitudinal cohorts.

• Clinical Research Centres: Nephrology, cardiology, endocrinology and diabetes specialists with existing patient and treatment-response data.

• Independent Validation Hospitals: Organisations capable of external clinical validation.

• AI/Bioinformatics Institutes: Expertise in predictive modelling, biostatistics and multimodal biomarker analysis.

• Health Data/RWD Partners: Patient registries, longitudinal datasets, epidemiology and data harmonisation.

• Biobanks and Omics Institutes: Existing molecular biomarker data and research infrastructure.

• Regulatory/HTA Experts: Biomarker qualification, regulatory strategy and clinical adoption.

• Patient Organisations: Patient engagement, usability and dissemination.

Priority will be given to partners contributing existing, high-quality clinical datasets, relevant biomarkers, scientific expertise and independent validation capabilities.

Strategic Collaboration Opportunities

Beyond DYNAMARK-CKM, NEWCO S.A. welcomes long-term, reciprocal European R&I collaborations with universities, research organisations, hospitals, SMEs and experienced Horizon Europe coordinators.

We are interested in joining complementary EU-funded proposals as a specialised technology partner, particularly in AI-enabled healthcare, secure health-data ecosystems, trustworthy AI, interoperability and cybersecurity.

Our objective is to develop mutually beneficial partnerships, exchange expertise and explore reciprocal inclusion in future Horizon Europe and other EU research and innovation consortia.

NEWCO S.A. – Greece
Website: www.newcotech.io