(TOOL-01) Real-world NCD data and clinical validation for AI-biomarker development

ELPEN Pharmaceutical (Greece) offers the readily-available high-quality clinical data and validation capability that HORIZON-HLTH-2027-02-TOOL-01 requires.

As a Marketing Authorisation Holder in cardiometabolic and respiratory disease, ELPEN provides real-world Phase IV data, baseline plus post-treatment outcomes, in chronic-NCD cohorts (asthma/COPD; cardiovascular), directly supporting the treatment-response dimension and the demonstration of unmet clinical need. ELPEN also supports the required regulatory-qualification strategy and the EU exploitation/valorisation plan.

Via Athens LifeTech Park, the group contributes biomarker measurement and bioanalysis (LC-MS/MS, ligand-binding, qPCR/protein analysis) and can run the required clinical validation studies in independent cohorts and exploratory studies through its early-phase CRO (Phase 0–II, EU sites), noting that prospective clinical studies must be EU/EFTA/AC-led, which ALTP satisfies.

ELPEN/ALTP contributes the clinical data, biomarker measurement and validation side; ALTP's incubator can bring qualifying digital-health/biomarker SMEs.