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Mass Spectrometry-Based Biomarkers in Drug Development
Michelle R Robinson1, Ronald A Miller2, Daniel S Spellman3
1Pharmacokinetics, Pharmacodynamics and Drug Metabolism, Merck Research Laboratories, West Point, PA, USA.
Advances in Experimental Medicine and Biology
|July 27, 2019
Summary
Mass spectrometry advances protein biomarker discovery and development for pharmaceuticals. This enhances drug development efficiency by improving decision-making and understanding therapeutic impact.
Area of Science:
- Biochemistry
- Proteomics
- Analytical Chemistry
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.
- 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:
- Review of mass spectrometry-based proteomics and bioanalytical approaches.
- Analysis of established guidelines for biomarker validation and qualification.
- Description of protein-centric strategies for biomarker discovery and assay development.
Main Results:
- Biomarker implementation enhances understanding of drug mechanisms and facilitates preclinical to clinical translation.
- Biomarkers enable early proof of concept, dose selection, and increase drug development efficiency.
- Mass spectrometry provides selective and analytically precise methods for biomarker measurement.
Conclusions:
- Mass spectrometry-based biomarker discovery and development are crucial for efficient, data-driven drug development.
- Well-defined biomarkers improve decision-making throughout the pharmaceutical R&D pipeline.
- Targeted protein assays are essential for measuring therapeutic intervention impact and pharmacodynamic effects.
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