Integrated OMICS and IT Supportive Strategies for Biomarker-Driven Drug Development and Application in Personalized and Precision Healthcare Services

Abstract

Drug development continues to move in the direction of the development of clinical practice as applicable to Personalized and Precision Medicine (PPM), - where ideally the most effective therapy or treatment is determined by the genetic makeup of the patient. The area of PPM as an upgraded model of the healthcare services and thus an area of daily clinical practice, that involves the use of measuring biomarkers in clinical samples, is an area of high clinical interest. Tremendous efforts have been made to date to discover biomarkers of the next step generation for use in clinical practice, but, unfortunately, a rate of implementing of biomarkers into clinical practice is still rather low. PPM thus has the potential to offer improved medication selection and targeted therapy being biomarker-based, reduce adverse effects, increase patient compliance, shift the goal of medicine from reaction to prevention, and increase patient confidence post-marketing by approving novel biomarker-based and driven therapeutic strategies and altering the perception of medicine in the healthcare system. By utilizing the power of biomarkers, PPM offers the potential to revolutionize patient care across a wide range of therapeutic areas. One of the key applications of biomarker technology is in disease diagnosis, prediction and risk assessment. Biomarkers serve as sensitive and specific indicators of underlying physiological or pathological processes, allowing for earlier detection and precise prognostication of diseases. Biomarkers can help to define subpopulations of patients who profit or do not profit from therapy. Relevant markers may differ between the various types of targeted therapy and are under continuous development. Any biomarker used as a basis for patient selection must be validated and demonstrate excellent sensitivity and specificity as the risk of not treating patients who might benefit would otherwise be unacceptably high. The involvement of biomarkers in clinical practices will be more and more common in the next 5–10 years because of the development in medical-related biological and transdisciplinary research, as well as in Biodesign-inspired and biotech-driven translational applications. Meanwhile, a principally new generation of biomarkers is required that define all aspects of the variability of unified system indicators.