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Updated: May 22, 2026
08:46
Implementation of In Vitro Drug Resistance Assays: Maximizing the Potential for Uncovering Clinically Relevant Resistance Mechanisms
Published on: December 9, 2015
Parallel anticancer drug development and molecular stratification to qualify predictive biomarkers: dealing with
Victor Moreno Garcia1, Philippe A Cassier, Johann de Bono
1Drug Development Unit, The Royal Marsden National Health Service Foundation Trust, Sutton, Surrey, United Kingdom.
Cancer Discovery
|May 16, 2012
Summary
Anticancer drug development is slow and costly. This study proposes a parallel process for predictive biomarker and drug development to improve efficiency and reduce risks in clinical trials.
Area of Science:
- Oncology
- Pharmacology
- Biomarker Discovery
Background:
- Current anticancer drug development models are inefficient, costly, and prone to late-stage failures.
- The traditional approach, developed decades ago for chemotherapy, struggles with modern targeted therapies.
- High attrition rates in late-stage clinical trials represent a significant financial and temporal burden.
Purpose of the Study:
- To address the inefficiencies and high risks in current anticancer drug development.
- To propose a novel, more efficient parallel process for developing predictive biomarkers and anticancer drugs concurrently.
- To overcome obstacles hindering progress in molecularly targeted drug development.
Main Methods:
- Incorporating a Pharmacologic Audit Trail with pharmacokinetic and pharmacodynamic data.
- Utilizing molecular biomarker-based patient selection in early clinical trials.
- Leveraging novel technologies like next-generation sequencing and circulating tumor-cell isolation.
Main Results:
- The proposed parallel process aims to accelerate the qualification of predictive biomarkers.
- It seeks to reduce the costs and time associated with developing certified clinical assays.
- This approach is designed to mitigate the risks of late drug attrition.
Conclusions:
- A parallel development process for predictive biomarkers and anticancer drugs is essential for modern oncology.
- This strategy can enhance the efficiency and success rate of bringing targeted therapies to patients.
- Addressing concerns about cost and time is critical for implementing biomarker-driven clinical trials.
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