December 2, 2022

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Critical Application And Impact Of Clinical Biomarker Testing On Drug Development

A biomarker is an informational biological substance such as cellular, biochemical, genetic, molecular, and others that can act as an indicator to measure and evaluate biological processes. A biomarker establishes the role of personalized medicine in the present time. 

Clinical biomarker testing services help to measure various physiological, pathogenic, and other characteristics in the body. In the drug development process, biomarker assays are employed to diagnose medical conditions. It helps to gain various information about the biological reactions to the novel drug discovered. 

The application of biomarker refers to the fact that all crucial phases of clinical drug development use clinical biomarker services in determining pharmacodynamics properties and measure responses that approves the drug for further clinical trials. 

Application of Clinical Biomarker Testing on Drug Development

Biomarkers have been impactful in the process of drug development over the years. Multi omics like genomics, proteomics, metabolomics in combination with bioinformatics and statistics facilitate the possibility of discovering biomarkers in the treatment of complex, acute, and chronic diseases. Biomarkers transfer information in the form of human genes, RNA measurement, metabolites, etc. The evaluation of biomarkers is performed on biological samples like blood, serum, urine and with the support of various profiling techniques like mapping, epigenomics, and many others. 

Extensive application of biomarkers in drug development include

  • The role of biomarkers from pre-clinical to clinical transformation will aid in implementing personalized modes of therapies for the treatment and benefit of patients, healthcare providers, and the pharmaceutical or drug industry.
  • Clinical trials expedite and reduce development costs in the biomarker lab where biomarker analysis takes place.
  • Attention to targeted therapies and development in the therapeutic response has led to patients getting treated with biomarker validation.
  • Due to the pharmacogenetic heterogeneity among individuals, biomarkers assists in safety and improves the efficacy of the drug. 
  • Patient satisfaction is achieved as predictive biomarkers help in analyzing the occurrence of molecular and phenotypic alteration after administration of the drug. 
  • The application of using cytokine testing is as a predictive biomarker. Cytokines activate innate immune effector cells and act as an indicator, especially the role of biomarkers in clinical testing.

Impact of Clinical Biomarkers in Drug Development

The role of biomarkers as indicators of biological functions has numerous pharmaceutical applications as seen above. They provide information for the diagnosis, testing, prognosis, and the effect the drug has on an individual. It also encompasses data of side effects anticipated in the individual after drug administration. 

Biomarkers also screen toxic compounds in the pre-clinical trials and provide insights on whether to manufacture that drug or not. 


Rapid development in biomarker assay and its application in a clinical trial can only be achieved with the rigorous scientific approach, methods in bioanalytics, and standardized data collection. Regulatory bodies ensure and validate the use of biomarkers in a clinical trial, and hence early interaction with them can enhance the performance and readability of the biomarker.

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