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Preparation of Peripheral Blood Mononuclear Cell Pellets and Plasma from a Single Blood Draw at Clinical Trial Sites for Biomarker Analysis
Published on: March 20, 2021
Biomarkers in drug discovery and development
1Wyeth Pharma, Arcola Road, Collegeville, PA 19401, United States. ray_bakhtiar@merck.com
Journal of Pharmacological and Toxicological Methods
|November 21, 2007
Summary
Biomarkers aid pharmaceutical research and development. However, a lack of validated biomarkers hinders drug development, despite technological advances.
Area of Science:
- Biomarker research in pharmaceutical drug discovery and development.
Background:
- Biomarkers are crucial for pharmaceutical R&D, aiding decisions on safety and efficacy.
- Technological advancements like gene arrays and high-resolution mass spectrometry enhance biomarker utility.
- Despite progress, a significant scarcity of robust, validated biomarkers impedes drug development.
Purpose of the Study:
- To provide an overview of biomarker definitions and categories.
- To discuss challenges in biological and analytical validation of biomarkers.
- To present clinical examples illustrating biomarker applications.
Main Methods:
- Literature review of current biomarker definitions and classifications.
- Discussion of validation challenges in biomarker research.
- Presentation of case studies and clinical examples.
Main Results:
- Biomarkers offer significant potential across pharmaceutical R&D stages.
- Advanced technologies improve confidence in safety and efficacy assessments.
- The need for validated biomarkers remains a critical bottleneck.
Conclusions:
- Validated biomarkers are essential to accelerate drug development from pre-clinical to clinical stages.
- Addressing validation challenges is key to realizing the full potential of biomarkers.
- Further research and development of robust biomarkers are necessary.
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