Clinical biomarkers in drug discovery and development

Abstract

Biomarkers enable the characterization of patient populations and quantitation of the extent to which new drugs reach intended targets, alter proposed pathophysiological mechanisms and achieve clinical outcomes. In genomics, the biomarker challenge is to identify unique molecular signatures in complex biological mixtures that can be unambiguously correlated to biological events in order to validate novel drug targets and predict drug response. Biomarkers can stratify patient populations or quantify drug benefit in primary prevention or disease-modification studies in poorly served areas such as neurodegeneration and cancer. Clinically useful biomarkers are required to inform regulatory and therapeutic decision making regarding candidate drugs and their indications in order to help bring new medicines to the right patients faster than they are today.

Discovery of Protein Biomarkers for Renal Diseases

“…Biomarkers and surrogate end point markers have many uses in laboratory and clinical investigations and in drug discovery (Table 2, Figure 1) (6,12). Biomarkers are useful for diagnosing, classifying, or grading the severity of disease in both laboratory and clinical settings.…”

Informatics Platform for Global Proteomic Profiling and Biomarker Discovery Using Liquid Chromatography-Tandem Mass Spectrometry

“…Despite these advances, the treatment of many diseases, such as cancer and cardiovascular disease, still suffers from the fact that most patients present at late stages of illness. Earlier detection of pathology is highly beneficial to patient outcomes (5), yet there are few effective diagnostic tools for recognizing early stage disease or prognostic tools for identifying those at high risk of dying or being nonresponsiveness to therapy (6). Development of satisfactory therapeutics is also hampered by a lack of informative bioassays (6).…”

Emotional memory in pregnant women at risk for postpartum depression

“…Additionally, salivary cortisol and alpha-amylase levels may serve as a reliable biological marker to diagnose or predict PPD in longitudinal experimental designs with larger sample sizes than the current study. Identifying biomarkers for psychiatric disorder is an area of heavy research in psychiatry (Frank & Hargreaves, 2003). In the context of PPD, elevated placental corticotropin-releasing hormone (pCRH) as a potential biomarker of those at risk for perinatal or puerperal depression has been an area of recent interest.…”