Importance of Biomarkers in Drug Development

A transformation towards personalized medicine in healthcare has increased biomarker development, and a corresponding accelerates in the complexities and hurdles in biomarker research.

FREMONT, CA: Biomarkers as indicators of biological and pathogenic operations have been leveraged for decades to diagnose patients and prescribe treatment. In the past few years, they’ve substantially transformed drug development practices. The demand for analyzing biomarkers in drug development has risen significantly with the innovation of precision medicine. In drug development, biomarkers that indicate the mechanism of action, target engagement, and clinical results have been deployed to assess both the safety and efficacy of an intervention. More specifically, biomarkers have been leveraged to choose patients for clinical trials, make decisions, help register and label claims, or treat patients.

The number of platforms at disposal to assay biomarkers continues to widen to address different testing hurdles and priorities. It is difficult to select the right platform for the biomarker assay. Among the most common bioanalytical platforms for gauging biomarkers today are ligand-binding assays, flow cytometry, immune histochemistry, and genomics assays. 

Ultimately, several factors go into deciding which methodology to leverage, and researchers must understand both the biological question at hand and the advantages and limitations of each platform.

A good essay requires balancing sensitivity and selectivity. This is specifically true for large molecules in biologic matrices. However, till now, there is no harmonized global biomarker specific analysis/validation guidance. The C-Path White Paper offered the consensus document on best practice methods. However, it only addressed biomarker assay validation for singleplex LBA and immunometric assays, mass spectrometry, and enzyme-based assays. The qualification or validation parameters and acceptance criteria may differ based on the platforms and specific technology, and some may not apply to the qualitative assays.

Given that there is a major increase in biomarkers used to help drug development, best regulatory practices in the laboratories for analyzing biomarkers are forecasted to follow. Outsourcing biomarker research comes with several hurdles, and selecting the right research partner is vital to the success of a complex biomarker project.