Abstract
Expert guidance in managing discovery and development of disease-related
biomarkers
This report focuses on disease-related biomarkers, those related to disease
screening, prognosis, and stratification-more specifically, disease-related
molecular biomarkers. Aspects covered include:
- Historical and contextual information
- Strategies and technologies currently used for biomarker discovery and
development
- Progress in biomarker discovery and development in several disease areas
- Current and future roles of consortia in disease-related biomarker
discovery and development
- Market-related considerations, including the role of various sectors,
competitive activity, deal activity, and regulatory factors
- Two separate surveys of individuals in (1) the pharma and biopharma
sectors, and (2) biomarker discovery and diagnostic sectors. Both surveys
capture attitudes, intentions, and current practices of individuals at the
forefront of disease-related biomarker discovery and development.
- Profiles of 44 companies active in disease-related biomarkers
- In-depth interviews with 7 disease-related biomarker experts
Biomarker discovery has grown dramatically during the past decade, driven by:
- The availability of powerful new "omics" technologies
- The increasing utilization of new and untested targets in pharma
- The opportunity to replace suboptimal in vitro diagnostic assays with
improved biomarkers
Disease-related biomarkers are not a new phenomenon. Early examples include
blood glucose for diabetes diagnosis and management and cholesterol for
cardiovascular risk. However, introduction of DNA microarrays in the mid-1990s
enabled a revolution in transcriptomics and triggered a major paradigm shift
in the way life scientists approached research. Subsequently, metabolomics and
metabonomics, applied mainly to safety-related biomarkers originally, began to
turn to disease-related biomarkers.
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