biomarker assays

What are Biomarkers and how are they useful in Drug Development?

The 21st century has seen a meteoric rise in the use of biomarkers in medicine and their use for drug development. The 21st Century Cures Act was approved in the USA in December 2016. Amongst other developments, this act adopts a process developed by the FDA for using Biomarkers as drug development tools. The act presents a formal legal seal of approval, though biomarker research has been yielding excellent results for several decades.

Understanding Biomarkers

Biomarkers, as used in medicine, are an indicator of the presence or severity of some disease state. These indicators should be objectively measurable. Several indicators can be used as biomarkers. For example, specific cells, antibodies, genes, enzymes, hormones, or other indicators may be employed. 

Body temperature is a biomarker as well. In that light, you may notice that though the term is relatively new, medicine has employed Biomarkers for quite some time. Modern use biomarkers tend to be more sophisticated and specific. 

Potentially, biomarkers can lend themselves towards measuring the progress (or even the possibility) of a disease, the impact of medicine, a more customized medical regimen, and proper evaluation. Now that sounds promising and futuristic, which is why biomarker research is making waves these days.

Biomarkers in Drug Development

As can be surmised given the potential of biomarkers, it should be no surprise that their use in drug development has expectations of being a game-changer. A major problem that plagues drug development is the failure rate. Even with thorough research and assays, less than 1 in 10 drugs make it to the market.

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Adding biomarkers to the mix can bring in more favorable results and accelerate the availability of new therapeutics. Of course, the larger process remains the same, but the expectation remains that with the more fine-tuned approach of biomarkers, greater success is possible.

Biomarkers may be used for diagnosis, monitoring or stratification of patients. This makes it possible to have a more nuanced approach. The use of biomarker assays and new approaches in bioinformatics and assay platforms makes it possible to study disparate datasets simultaneously.

Validation of small molecule bioanalysis with biomarkers has been another encouraging step. Generally speaking, small molecules are pharmaceutical substances that may regulate a specific biological process.

Common areas for small molecule bioanalytical studies include pharmacokinetic studies, pharmacodynamic studies, and biomarker assays. Determining and validating biomarker analysis with the study of small molecules may make the process of a proposed drug reaching predetermined characteristics faster. 

Even with all these possibilities, it is worth noting that the biomarker development is a multistep and iterative process. Discovery may start with disease and non-disease samples, followed by analytical validation to confirm the presence and use of a biomarker.

Overall, the customized approach possible with biomarkers can make drug development more successful and faster. Additionally, the possibility of using a drug with the presence and severity of the disease can push biomarker research and help create better models of therapeutic intervention.

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