Biomarker Development & Validation

Biomarker development and validation turn biological signals into measurements you can use for dose decisions, patient selection, pharmacodynamic confirmation, or safety monitoring. Early biomarker work fails when the biology is interesting but the assay cannot perform in the matrices and timelines of a real trial. Validation expectations scale with how hard you lean on the marker for decisions or claims, so context of use has to be stated before the validation plan balloons.

Viltis helps teams define biomarker context of use, assay feasibility, and a validation path that matches the decision the marker must support. We connect translational hypotheses to clinical sampling, analytical performance, and statistical analysis plans so biomarker data are interpretable at the end of the study. Work spans exploratory panels through more mature assays used for enrichment or response assessment, always with a clear statement of what the marker can and cannot claim. We also push for logistics realism: sample stability, site burden, and turnaround times that match decision points.

Multi-vendor biomarker programs fail when sample handling and analysis plans diverge site by site. We help standardize collection kits, shipping conditions, and chain-of-custody expectations, and we define how missing or delayed samples are handled in the analysis. Operational detail is part of scientific validity; a perfect assay cannot rescue a degraded sample set.

Biomarker activities we typically support

• Context-of-use and decision-link definition
• Assay feasibility and platform selection
• Analytical validation planning by intended use
• Clinical sampling and handling design input
• Data interpretation with clinical endpoints
• Vendor assay oversight and transfer support
• Regulatory discussion prep on biomarker role

Biomarkers earn their keep when they change a dose, a cohort, or a go/no-go call. We help programs invest in markers that can survive clinical logistics and scrutiny, and we push back when a panel adds cost without a decision attached. When markers migrate from exploratory to decision-driving use, we help update validation and documentation so the claim stays honest. If a biomarker is being asked to carry enrichment or response claims, we pressure-test assay readiness and context of use before the protocol language hardens.