Integrating Pharmacoproteomics into Early-Phase Clinical Development: State-of-the-Art, Challenges, and
1Novartis Pharmaceuticals Corporation, One Health Plaza, East Hanover, NJ 07936, USA. savita.nandal@novartis.com.
International Journal of Molecular Sciences
|February 21, 2017
Summary
Pharmacoproteomics, the study of drug effects on proteins, is advancing rapidly but underutilized in early drug development. Integrating this powerful tool, especially in oncology, could significantly improve clinical trial outcomes.
Area of Science:
- Pharmacoproteomics
- Proteomics
- Clinical Pharmacology
Background:
- Pharmacoproteomics analyzes drug-induced changes in proteins to understand efficacy and toxicity.
- Advancements in analytical technologies are driving the evolution of pharmacoproteomics.
- Despite its potential, pharmacoproteomics is minimally applied in early-phase clinical development.
Purpose of the Study:
- To review the current state of pharmacoproteomics in early-phase drug development.
- To identify challenges and opportunities for its integration.
- To provide recommendations for incorporating pharmacoproteomics into clinical trials.
Main Methods:
- Analysis of clinicaltrials.gov and PubMed databases.
- Review of historical development, technologies, and current usage.
- Assessment of limitations and future potential.
Main Results:
- Pharmacoproteomics application is limited, predominantly in oncology.
- Significant potential exists for broader application in early drug development.
- Challenges include technological integration and data interpretation.
Conclusions:
- Pharmacoproteomics offers valuable insights into drug effects.
- Increased adoption in early-phase trials, particularly oncology, is recommended.
- Strategic integration can enhance drug development and patient safety.
Keywords:
Omicsbiomarkerclinical developmentclinical researchdrug developmentdrug toxicityearly phase developmentfirst-in-human (FIH) studiespharmacodynamics (PD)pharmacogenomicspharmacokinetics (PK)pharmacometabolomicsphase 0phase 1phase 2proof-of-conceptproof-of-mechanismproof-of-principleproteomeproteomicsMore Related Videos
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