Molecules that can be measured in bodily fluids including blood and other tissues comprise biomarkers. It signifies the interaction between the biological system and a chemical, physical and biological entity. The comparative proteomics and genomic study of healthy and diseased tissues help in biomarker discovery.
Biomarker discovery, selection, and validation have become preemptive in pharmacokinetics and pharmacodynamics (PK/PD).
What is the role of biomarker testing in drug discovery and development?
Pharmacokinetic studies utilize validated biomarkers to monitor the activity of new chemical entities (NCE). Biomarkers in toxicology and pharmacokinetic studies are critical in the establishment of absorption, distribution, metabolism, and excretion (ADME) of a new compound in a test system.
Every system has distinct biomarkers. Therefore preclinical study in animal systems and clinical trials in human systems have their set of biomarkers. Furthermore, the new technologies that aid the discovery and development of disease-related biomarkers for rare or complex diseases assist the process of drug development, dosage, dose route and alternate routes of therapy.
As the understanding of biomarkers in the different systems improves, effective and targeted therapies for various diseases are becoming available to the masses.
Does biomarker testing have any other significance?
Apart from drug development, biomarker discovery and testing play key roles in the diagnosis of diseases and the identification of treatment options. Currently, there are three broad categories of biomarkers– gene, chromosome, and biochemical markers. These can identify genetic, chromosomal and metabolic/biochemical causes of diseases.
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For example, PSA (prostate serum antigen) is a biochemical marker that is associated with prostate cancer and cholesterol is another biochemical marker that is a signifier of risk for heart diseases.
Why choose a renowned laboratory for biomarker testing?
Biomarker testing is an integral part of personalized medicine. These macromolecules are the biomarkers of exposure that determine the safe dosage, risk of toxicity, pharmacodynamics, target engagement, and the interactions of chemical compounds in a given system. Both preclinical study and clinical trial require biomarker testing during pharmacokinetic studies.
GLP-pharmacokinetics and biomarker testing can provide necessary data in accelerating the development or discontinuing a chemical compound. The result of FDA-approved biomarker testing determines the future of an NCE.
Modern laboratories that provide drug testing and analysis run PK and PD tests under the same roof. Laboratories like Covance, Charles River, PacificBio, NorthEast BioLab, and GVK Bio offer standardized biomarker testing for drug development and analysis.
How can the correct choice of biomarkers help drug development?
Working with laboratories that follow Good Laboratory Practices (GLP) during toxicology studies and use FDA approved biomarkers for testing can substantially accelerate the development process of a drug. Certain laboratories like NorthEast BioLab guarantee the use of standardized biomarker testing during drug discovery and preclinical study phases that can potentially help the marketing phase of an NCE.
The novel molecule you are working with can move to clinical trial phases quickly only if the laboratory you are working with ensures high-quality, reproducible, and genuine results in the initial phases of drug testing.