Janifha Evangeline, Assistant Editor, India Pharma Outlook
The global biomarkers market size was estimated at USD 81.04 billion in 2023 and is expected to grow at a compound annual growth rate (CAGR) of 13.36% from 2024 to 2030.
A novel biomarker for alzheimer’s disease in its asymptomatic phase has been discovered in a study that was conducted by the Molecular and Cellular Neurobiotechnology group at the University of Barcelona & the Institute for Bioengineering of Catalonia. miR-519a-3p – the biomarker is a microRNA and this is closely associated with the PrPc’s regulation and this protein is known to be deregulated in patients or individuals who are afflicted with conditions that include the Alzheimer’s disease.
“Currently, tests to diagnose Alzheimer’s disease are usually carried out after the onset of symptoms, when there is already underlying cognitive impairment. We believe that the detection of this microRNA may help to establish additional criteria for a more accurate diagnosis in the early stages of the disease,” explains IBEC principal investigator José Antonio del Río, full professor at the Faculty of Biology and the Institute of Neurosciences of the University of Barcelona (UB) and co-leader of the study.
Biomarkers have emerged as one of the crucial elements in the drug discovery landscape and these have changed the way the pharmaceutical research as well as research is done. They have numerous uses and have made an impact in the stages of the drug development process by offering several benefits. These help in improving precision, efficiency, as well as success rates of finding out new therapeutics. In this article let us look at the important role biomarkers play in modern drug discovery.
Target Identification & Validation
The first stage of drug discovery process hinge on the validation & identification processes of the right biological targets. These are implicated in disease processes. Biomarkers play a huge role in this stage. They render insights about the molecular as well as cellular mechanisms underlying diseases. Advances in the proteomic as well as genomic technologies have led to the findings of biomarkers which display specific genetic mutations, protein alterations that are associated with numerous diseases.
Enhancing clinical trials
Clinical trials are pivotal part of any drug development and here biomarkers help in improving their execution, design, as well as outcomes remarkably. In the phase-1 safety biomarkers are used for monitoring the potential toxicities as well as tolerability of new drug candidates in healthy patients. Also, the pharmacodynamic biomarkers are implemented for rendering early evidence of biological activity. This offers a preliminary indication of the efficacy of the drug. This assessment in the early phase facilitates in finding whether to proceed with further development.
Most of the pharma giants are leveraging AI for streamlining patient selection for clinical trials & reduce the required participants and this leads to speeding up drug development & saving humongous financial resources. Companies like Bayer, Novartis & Amgen are using Artificial Intelligence for identifying potential trial patients. This is done by analyzing huge amounts of public health records, medical insurance claims,
internal data & prescription data. This approach has helped in cutting patient enrolment time in half in some of the cases.
According to Jeffrey Morgan, Managing Director at Deloitte, "AI integration has progressed beyond the experimental stage but hasn't yet permeated every aspect of drug development."
Regulatory Approval Processes
In the process of drug development the regulatory approval is crucial milestone and biomarkers are crucial to meet the stringent requirements of regulatory agencies which include the FDA & EMA. Biomarkers offer compelling evidence of a drug’s mechanism of action, safety as well as efficacy and these are imperative for regulatory evaluation. Biomarker data inclusion in the regulatory submissions facilitate in demonstrating that a drug precisely targets one of the intended biological pathways and leads to expected effects.
One of the significant impact of biomarkers on the regulatory process includes the accelerated approval pathways facilitation. Programs such as the FDA’s Breakthrough Therapy designation are designed for expediting the review & development of drugs either for life threatening or serious conditions. Furthermore, biomarker data can be imperative to qualify a drug for these programs by offering early & convincing evidence of significant improvements over the current therapies.
Personalized Medicine
The integration of biomarkers into the drug discovery and development has made the era of personalized medicine significantly advanced. Biomarkers help in customization of treatment regimens. These are done based on numerous factors which include unique genetic, molecular as well as clinical characteristics of every patient. Such kind of personalized approach make sure that patients get the most effective as well as appropriate therapies and thereby enhancing clinical outcomes as well as reducing the occurrence of adverse effects.
Personalized medicine is impactful in oncology and here biomarkers which include protein expressions, genetic mutations, as well as other molecular alterations help in guiding the selection of targeted therapies. For example, BRAF V600E mutations’ presence in melanoma patients helps in identifying those who are likely in benefiting from inhibitors of BRAF such as vemurafenib. Similarly, detecting PD-L1 expression in tumors facilitate in determining the suitability of immunotherapies. These include nivolumab & pembrolizumab. By customizing treatments to particular biomarker profiles of some patients, the personalized medicine not only improves the efficacy of interventions but it also decreases unnecessary exposure to harmful & ineffective therapies.
Biomarkers offer profound benefits across numerous phases of the process of drug development and they help in improving the efficiency & precision of target identification as well as validation process. These help in enhancing the design as well as outcomes of clinical trials significantly and further facilitate regulatory approval processes. As technological advancements continue to evolve, biomarkers are poised to expand further and these are supposed to herald a new era of personalized care as well as innovation in the pharma industry. Furthermore, the ongoing collaboration among clinicians, industry stakeholders, researchers, as well as regulatory agencies will be critical in addressing challenges & realizing the complete potential of biomarkers in the process of drug discovery as well as enhancing patient health outcomes.
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