Clinical pharmacogenomics: applications in pharmaceutical R&D

Area of Science:

• Pharmaceutical Science
• Genetics
• Drug Development

Background:

• Clinical pharmacogenomics offers significant advantages in pharmaceutical research and development.
• Current applications focus on early-stage clinical drug development, particularly Phase I trials, for population stratification based on drug metabolism phenotypes.

Purpose of the Study:

• To provide an overview of the driving forces behind pharmacogenomic strategy development in the pharmaceutical industry.
• To highlight the significance of polymorphisms in drug metabolizing enzymes (DMEs) and target proteins.

Main Methods:

• Review of current practices in clinical pharmacogenomics within the pharmaceutical industry.
• Discussion of the role of prospective genotyping and retrospective genetic material analysis.

Main Results:

• Pharmacogenomics enhances drug response marker discovery and reduces clinical trial size and expense.
• Prospective genotyping in Phase I trials is common for ensuring representative subject populations.
• Retrospective analysis of genetic material from later-stage trials is increasing but not yet standard.

Conclusions:

• Clinical pharmacogenomics is a valuable tool for addressing regulatory approval issues and optimizing drug development.
• The strategic development and application of pharmacogenomics are crucial for the pharmaceutical industry's future.
• Understanding polymorphisms in DMEs and target proteins is key to leveraging pharmacogenomic benefits.