Today pharmaceutical companies know that once proof of concept is demonstrated, drug candidates have a higher probability of regulatory approvals. However, sponsors always face massive hurdles while bringing new drug products to the patient population. The primary focus is identifying potential drug compounds that make it to the registration process, during development. Hence, identifying the best bioanalytical approaches that can help rapidly transit drug compounds through the development process is essential for clinical research. Biomarkers are one such tool that can help expedite the drug discovery and development process.
Generally, ideal biomarkers have demonstrated clinical relevance to a study endpoint. In fact, there are biomarkers that regulatory bodies have accepted as valid primary endpoints instead of hard clinical endpoints for the marketing authorization process. Besides, it is more economical to demonstrate the clinical utility of a drug product using these biomarkers as clinical endpoints. However, biomarker assay development and validation are necessary for generating reliable and accurate assay results. Let us understand more about biomarker development and how biomarker testing services such as NorthEast Biolabs achieve trial endpoints through testing biomarkers.
Achieving trial endpoints with biomarker discovery services
Biomarkers are generally considered surrogate biomarkers, so it is necessary to specify their relationship. It is defined in the International Harmonization Guideline that a surrogate endpoint and a hard clinical endpoint are related when certain conditions are met. These conditions include demonstrating biological plausibility, statistical relationship through epidemiological studies, and clinical evidence showing surrogates corresponding to clinical outcomes.
However, the dynamics of hard clinical endpoints and surrogate depends on the mode of action. This reliance means that regulatory agencies may accept a surrogate for one class of drug products but not the other.
Events such as myocardial infarction, stroke, and death are hard clinical endpoints of cardiovascular disease. These clinical endpoints require no validation. However, using them in early studies is not possible because they need testing a large number of subjects over a long period until they reach the event. Besides, death can usually never be an endpoint in human clinical studies.
Traditionally, the drug development process is conducted through a well-defined phase-based approach, where preclinical studies are followed by clinical trials in human participants. In today’s data-driven drug development process, these phases often overlap, and the next step is often deduced from the results of these overlapped phases. Besides, it is common today that unexpected results in the clinical stages may need conducting newer preclinical studies.
Biomarkers are particularly vital during Phase 2a of clinical studies. Phase 2a is termed as the section that provides evidence for supporting the claimed effects of a drug product. The drug effects can be relevant pharmacological action, surrogate endpoints, clinical outcomes, or changes in biomarkers.
In preclinical development, biomarker studies are necessary to optimize subsequent clinical research. These studies include several modern technologies such as proteomics, imaging, genomics, computational bioinformatics, multiplex biomarker assays, and humanized preclinical models. However, biomarker method validation will always be critical for reliable and accurate bioanalysis.
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