Biomarkers


Protein biomarker


With the biopharma industry under heavy pressure, transforming the scientific interchange between the laboratory and the clinic is exceedingly critical. Realising the costly toll of drug attrition in late-stage development, many companies are turning to translational medicine strategies to aid ‘go/no-go’ decisions in preclinical and clinical development. The incorporation of informative biomarkers as predictive tools in clinical trials is increasingly viewed as enabling not only smarter decisions and resource investment but also as potentially yielding new targeted medicines guided by companion diagnostics. Critical for the application of biomarkers is their ‘qualification’, ie the demonstration that they yield reliable and meaningful information. While early work has been strongly focused on nucleic acid-based biomarkers (DNA SNPs and mRNA expression profiles), recent experience suggests that the utility of these markers as clinically applicable decision tools may generally be limited. Protein biomarkers, which offer a significantly greater degree of differentiated information content, are likely to close this gap. Immunoassays continue to be the most sensitive, specific and selective technology to interrogate such markers. The development of innovative, suitable and fit-for-purpose protein- based assays represents a significant challenge both with regard to the technical aspects of antibody and assay development and the clinical validation of the analytes targeted. This article will focus on protein biomarkers and antibodies for immunoassay development as we coin the term ‘fit-for-purpose’ antibody.


P


ersonalised healthcare concepts – the role of biomarkers: Most significant advances in medicine have been characterised by an increasingly differentiated approach to patients’ treatment, based on a more sophisticated under- standing of disease causation. Thus, the advent of antibiotics allowed the specific treatment of those inflammatory disorders that are related to infec-


Drug Discovery World Winter 2010/11


tion, and the development of subclasses of antibi- otics the differentiated, and thus more effective, treatment of infections caused by different micro- organisms. Of late, the further refinement of med- ical intervention guided by an emerging deeper understanding of disease- and patient-heterogene- ity has been labelled ‘personalised medicine’, and biomarkers are heralded as the carriers of the


By Dr M. Walid Qoronfleh and Dr Klaus


Lindpaintner


immunoassays opportunities and challenges


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