Robust biomarkers improve the diagnosis of diseases and the monitoring of therapeutic responses. Hence, clinical biomarkers in drug discovery and development are crucial to bringing safe and effective drugs to the patient population. Although several reliable biomarkers have had a massive impact on the drug discovery and development process, identifying and validating biomarkers remains quite challenging. Recent advances in multi-omics research combined with biostatistics and bioinformatics have helped accelerate the development of novel biomarkers for specific chronic diseases.

However, further advances in biomarker assay platforms will only help in decision-making throughout different processes of drug development. Besides, getting preclinical biomarkers into clinical use will assist researchers to bring personalized medicine across complex medical areas. Hence, the current article focuses on clinical biomarker research and assay validation in the drug discovery and development processes.

Clinical biomarker research in drug discovery and development

Biomarker Services use biomarkers from early discovery studies to late clinical trials in drug development. Biomarker research data guide scientists to evaluate animal models, link animal and human experimental responses, and evaluate drug safety in animal and human studies. Besides, each phase of drug development may have unique biomarkers applicable only to that specific stage.

To have any clinical significance, biomarkers should be robust enough to deliver reproducible results. Besides, they should be specific and sensitive enough to distinguish true positive from false-negative data. Most importantly, biomarker discovery and analysis should be clinically relevant and benefit the concerned patient population.

During late Drug Development, biomarker experts can use data to evaluate the drug dose-response, determine safety and toxicity response, and design optimal regimens to achieve the desired pharmacological effect. Once a biomarker is identified and validated, researchers can use them to determine safe doses for phase II and III clinical trials from PK/PD data. Additionally, biomarkers can also differentiate potentially valuable compounds from other drug compounds. Besides, biomarker PK/PD data help determine whether drug mechanism translates to clinical trials.

Biomarker assay validation in drug discovery and development

Biomarker assay validation evaluates the analytical method and its performance characteristics. It also determines the conditions that will produce accurate and reproducible data. Validation of biomarker assays is crucial as it ensures the delivery of accurate data for the analysis of biological activity. Validation parameters for biomarker assay platforms include:

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• Understanding the research goal that the biomarker is designed for
• The certainty required to answer the research goal
• The assumptions made about the changes between clinical endpoints and the biomarker.

A successful biomarker assay validation requires a complete understanding of the working and desired outcome of a bioanalytical method. Once researchers have this knowledge, they can design experiments to test and prove the validity of the intended assay. Although the industry knows the importance of biomarker assay validation, the regulatory bodies have yet to draft official guidelines for biomarker validation. And therefore, there is a growing debate around biomarker assay validation. Hence, the fit-for-purpose approach emerged to solve the complexity of biomarker validation. This approach recommends that the validation criteria must be intended to meet the required research goal. Such strategies ensure that novel biomarkers can smoothly transit into clinical practice.