Biomarkers Seen as Key to Drug Development Success

Biomarkers help clinicians and drug developers study which patients may or may not respond to a specific therapy, advance a disease, or have some safety issue generated because of therapy. All of that info can be important to tease out who is best suited for a treatment, which helps reduce the number of individuals needed for clinical trials and increases trial success rates.

Learn how biomarkers can increase the success rate of drug development efforts

As pharmaceutical companies fight to improve the success rate and cost-effectiveness of the drug development process, biomarkers have developed as a valuable tool. Researches synthesize and review the latest efforts to identify, develop, and integrate biomarkers as a key strategy in translational medicine and the drug development process. The research determines how biomarkers can develop drug development timelines, lower costs, help better compound selection, decrease late-stage erosion, and open the door to personalized medicine.
Biomarkers use as drug development tools: discovery, validation, qualification, and use
Few Important Points:
A biomarker is distinguishing that is objectively measured and evaluated as a sign of a normal biological process, a pathological process or a biological response to a therapeutic involvement.

• Biomarkers raise the success rate of drug development programmes and thereby accelerate the availability of new therapeutics.
• Biomarker development is a multistep and iterative process beginning with biomarker discovery in disease and non-disease samples.
• The analytical validation phase of biomarker development is considered by analysis of the performance metrics of the biomarker to confirm that the test is reliable, reproducible and of acceptable sensitivity and specificity.
• Qualification is a sorted evidentiary process that links a biomarker with biological and clinical endpoints.
• Consumption of biomarkers for clinical applications is dependent on their clinical utility for disease diagnosis, disease performance, and treatment selection.

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