How Does Biomarkers Assay Development, Validation, And Analysis Benefit Drug Approval?

Biomarkers are measured as an indicator of a healthy biological response to a therapeutic intervention. Biomarker development is an iterative and multistep process beginning with biomarker discovery in disease and non-disease samples. It is responsible for improving the success rate of drug development programs and pace-up the availability of new therapeutics.

Biomarker Assay Development involves examining the biomarker in a suitable analysis platform and surveying proteins, buffers, diluents, antibody pairs, reagents, etc. This is followed by biomarker validation with calibrated standards and quality controls for analysis of the sample. As preliminary testing is attained, biomarker labs perform validation of biomarkers to demonstrate method reliability for the intended use. Analytical validation is characterised by analysis of performance metrics of biomarkers, ensuring the reproducibility, sensitivity, and effectiveness of tests.

Biomarker assays play an essential role in drug development and approval. The selection of correct biomarker and identification of optimal biomarker assays accelerates drug development. Early and accurate biomarker validation enhances the decision-making at every step of drug development.

Pre-clinical biomarkers assay validation by pharmacokinetics and pharmacodynamicmodels validates the drug dose's efficacy at clinical trials. The biomarkers are used in animal studies for understanding the effect and duration of exposure to the drug compound. These biomarker validations also measure the compound's plasma concentration and its targeted activity at the site of action.

At clinical trials, these are used to specify the inclusion criteria for human volunteers. It is the most critical step for measuring the efficacy and safety of the drug for approval. It facilitates regulatory decisions and benefits drug approval.

The clinical trials are done in three phases- first, healthy volunteer study and second & third, studies in the patient population. In phase 1, the drug is tested in healthy volunteers for safety, absorption, metabolic effects, elimination effects, and side effects on the body.

In the second and third phases, the drug is tested on patients to analyse optimal dose, medication labelling, and instruction of proper use. The drug then proceeds for FDA approval. The drug regulatory approval timeline can vary, and the FDA decides whether to grant approval or not.

The clinical application of biomarkers is dependent on its utility for disease staging, diagnosis, and treatment. Some of the examples of biomarker services currently used in everyday life are tracking BP or glucose levels. The bioanalysis evaluates molecular pathways leading to disease and identifies the mechanism of action. It is the evidentiary process linking a biomarker with biological and clinical endpoints and directing drug discovery & development as well as approval.

Strong evidence of the positive impact on clinical endpoints and the benefits of the drug provides help in its approval. However, toxicity, efficacy, bioavailability, or inadequate drug performance can result in drug failure.

We can conclude that the biomarker analysis, its development and validation, and analysis when furthered can result directly in the approval or rejection of the drug. Each step of the process adds relevancy and helps test the interest drug’s efficacy and utility, thereby resulting in its approval.