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A Strategy for Sensitive, Large Scale Quantitative Metabolomics
Published on: May 27, 2014
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Mass spectrometry-based biomarkers in drug development
Ronald A Miller1, Daniel S Spellman
1Molecular Biomarkers Department, Merck Research Laboratories, 770 Sumneytown Pike, West Point, PA, 19486, USA.
Advances in Experimental Medicine and Biology
|June 22, 2014
Summary
Mass spectrometry advances enable biomarker discovery and development for pharmaceuticals. These tools improve drug development efficiency by measuring therapeutic impact and target engagement.
Area of Science:
- Biochemistry and Proteomics
- Analytical Chemistry
- Pharmacology and Drug Development
Background:
- Significant advancements in mass spectrometry, proteomics, and bioanalytical techniques have accelerated biomarker discovery and development.
- Progress in defining guidelines for analytical validation, acceptance, and qualification of biomarkers has been made over the last decade.
- Decreased pharmaceutical R&D ROI necessitates improved early decision-making tools in drug development.
Purpose of the Study:
- To describe biomarker classes relevant to drug development.
- To review mass spectrometry-based, protein-centric approaches for biomarker discovery.
- To discuss the development of targeted assays for precise biomarker measurement.
Main Methods:
- Leveraging mass spectrometry for high-throughput proteomic analysis.
- Applying advanced bioanalytical techniques for protein quantification.
- Developing and validating targeted assays for specific biomarker measurement.
Main Results:
- Biomarkers enhance understanding of drug mechanisms and facilitate preclinical to clinical translation.
- Biomarkers enable early proof of concept, dose selection, and improved decision-making.
- Mass spectrometry-based approaches offer selective and precise measurement of protein biomarkers.
Conclusions:
- Mass spectrometry-based biomarker discovery and development are crucial for efficient, data-driven drug development.
- Implementing appropriate biomarkers improves the understanding of therapeutic interventions and drug efficacy.
- Targeted assays ensure analytical precision for reliable biomarker assessment in clinical settings.
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