How Biomarkers Impact Drug Discovery and Development

The advanced biomarkers are helping the healthcare sector to improve drug discovery and development. 

FREMONT, CA: Research in drug development drives the outlook of the biopharma industry. A breakthrough for drug development was the Precision Medicine initiative's achievement by the USFDA, which influenced the industry's growth. The framework formalizes the biomarker qualification and promotes the effectiveness of clinical trials by applying it to assess patient inclusion/exclusion and determine the biological responses of patients after therapeutic treatment.

In assessing the primary and secondary endpoints of clinical trials, analytical validation and certification of biomarkers are also related to usability. In the discovery, growth, and confirmation of drugs and novel therapies, biomarkers become widespread.

The transition from medications to orphan drugs for morbidities affecting millions is a significant change noticed recently (which treats diseases that affect minimal patient populations). Meanwhile, as initial competition increases, more excellent drug safety and effectiveness remain crucial to the clinical development cycles. As microarrays and nanosensing technologies perform critical roles in the clinical application and quantification of biomarkers like small molecules, electrolytes (Xsensio is a good example), and metabolites, manufacturers of biomedical sensors have also joined onto the frontline. Therefore, below are a few recent examples of applications with biomarkers.

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The growth of therapeutic agents for Alzheimer's disease

Alzheimer's disease, with numerous drug discovery setbacks to its account, remains a non-treatable disease. 

Biomarkers have enhanced understanding of the different forms of AD, its various types, its emerging mechanisms, and effectively target tau and amyloid while the clinical development of drugs to minimize its morbidity and address its symptoms is ongoing. To that purpose, the USFDA has also issued guidelines on biomarkers' function, including prodromal AD, in managing the disease.

The following biomarkers have been in use since 2019 in the ongoing clinical development for Alzheimer's disease:

• Amyloid and tau in cerebrospinal fluid (27 clinical trials)

• Fluorodeoxyglucose-PET (1 trial)

• Volumetric magnetic resonance imaging (10 trials)

• Amyloid PET (10 trials)

The most widely utilized biomarkers were amyloid-PET and CSF amyloid for disease staging and patient inclusion.

Predicting Disease Progression in Polycystic Kidney Disease

Numerous levels and types of toxicity, especially kidney diseases, are present in urinary disorders. Clinical trial designs integrate participation criteria based on baseline attributes and disease-specific biomarkers to minimize the number of cytotoxicities leading to medications or experimental therapies. In clinical trials, toxicity cases were as high as 43 percent, while the number of preclinical studies increased to 71 percent.

Genotypic biomarkers have been utilized to explain disease progression patterns and the risk factors related to end-stage kidney disease development. Qualitative evaluation of genotypic and inflammatory biomarkers (like an inhibitory factor for macrophage migration and MCP-1) will display tubular damage in polycystic kidney disease and determine patients' qualification for kidney replacement.