The development of biomarkers to reduce attrition rate in drug discovery focused on oncology and central nervous system

ABSTRACT

Introduction: The task of discovery and development of novel therapeutic agents remains an expensive, uncertain, time-consuming, competitive, and inefficient enterprise. Due to a steady increase in the cost and time of drug development and the considerable amount of resources required, a predictive tool is needed for assessing the safety and efficacy of a new chemical entity.

Areas covered: This study is focused on the high attrition rate in discovery and development of oncology and central nervous system (CNS) medicines, because the failure rate of these medicines is higher than others. Some approaches valuable in reducing attrition rates are proposed and the judicious use of biomarkers is discussed.

Expert opinion: Unlike the significant progress made in identifying and characterizing novel mechanisms of disease processes and targeted therapies, the process of novel drug development is associated with an unacceptably high attrition rate. The application of clinically qualified predictive biomarkers holds great promise for further development of therapeutic targets, improved survival, and ultimately personalized medicine sets for patients. Decisions such as candidate selection, development risks, dose ranging, early proof of concept/principle, and patient stratification are based on the measurements of biologically and/or clinically validated biomarkers.

KEYWORDS:

• Attrition
• biomarkers
• drug discovery
• expert review
• oncology and central nervous system

Article Highlights

• The current model of drug development has a high failure rate, suggesting that initial candidate selection processes are not optimal.

• The attrition rate for development of oncology and CNS drugs is high relative to other therapeutic areas.

• Biomarkers play an increasingly important role in many aspects of drug development and medical practice.

• Biomarkers with ideal sensitivity, specificity, and predictive value should be discovered and validated.

• ‘Omics’ technology, a combination of genomics, proteomics, and metabolomics, are applied in drug discovery and play a major role in developing personalized medicine.

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Acknowledgments

This manuscript has been language edited by Radan English Edit of Iran.

Declaration of interest

The authors has no relevant affiliations or financial involvement with any organization or entity with a financial interest in or financial conflict with the subject matter or materials discussed in the manuscript. This includes employment, consultancies, honoraria, stock ownership or options, expert testimony, grants or patents received or pending, or royalties.

Additional information

Funding

This manuscript has not been funded.