Biomarkers in drug discovery and development

1 November 2010  •  Author(s): Attila A. Seyhan.Translational Immunology, Inflammation and Immunology, Pfizer

Robust and validated biomarkers are needed to improve diagnosis, monitor drug activity and therapeutic response and guide the development of safer and targeted therapies for various chronic diseases. While different types of biomarkers have been impactful in the field of drug discovery and development, the process of identifying and validating disease specific biomarkers has been quite challenging. Recent advances in multiple ‘omics’ (multi-omics) approaches (e.g., genomics, transcriptomics, proteomics, metabolomics, cytometry and imaging) in combination with bioinformatics and biostatistics have made it possible to accelerate the discovery and development of specific biomarkers for complex chronic diseases. Although many challenges still need to be addressed, current efforts for the discovery and development of disease-related biomarkers will assist in optimal decision-making throughout the course of drug development and improve our understanding of the disease processes. Furthermore, effective translation of the preclinical biomarkers into the clinic will pave the way towards effective execution of personalised therapies across complex disease areas for the benefit of patients, healthcare providers and the bio-pharmaceutical industry.

Advances in biomedical research over the years have raised expectations that safer and more effective therapies will be available. However, the drug industry’s ability to effectively translate biomedical research into marketed new therapies has met serious limitations2, with a discouragingly high attrition rate in clinical trials of greater than 90 per cent3. In another words, the chances for success of candidate drugs or biologics entering the phase I trial is estimated at approximately eight per cent3,4.

The low probability of success from first-in-human (FIH) to new drug application (NDA) may be explained by one or more reasons including pharmacogenetic heterogeneity of individuals to treatments and drug response3, lack of robust biomarkers, lack of safety and efficacy of drugs, and narrow therapeutic window. The goal of any drug discovery activity is to achieve maximal efficacy with minimal effects with a broader therapeutic window, and when side effects are inevitable, an early detection during clinical trials is essential. Additionally, the goal is to develop precision medicine and stratify patients by disease type or response to treatment for targeted therapies.

For the successful treatment of complex chronic diseases, including autoimmune, inflammatory, metabolic diseases and cancer, as well as to develop precision medicine and targeted therapies, it is essential to monitor the molecular basis of disease initiation and progression before, during and after the therapeutic intervention5. Therefore, a better understanding of the factors affecting response to drugs has resulted in an increased demand for additional efficacy, specificity and safety testing of drugs during new drug development. There is also public pressure for drugs to be more extensively tested for safety before approval6.

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