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Ingrid Holst-Laubjerg

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Review Open access Aug 2026

Operationalizing Precision Medicine in Drug Development: Predictive Biomarkers, Companion Diagnostics, and Regulatory Pathways

A pragmatic operational framework to guide the incorporation of precision medicine into drug development across therapeutic areas is presented and opportunities to extend precision medicine beyond predictive biomarkers to diagnostic, prognostic, and safety biomarkers, as well as digitally derived signatures are discussed.

Ingrid Holst-Laubjerg, J. Moreira · 0 citations

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