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Updated: Feb 16, 2026

Evaluating the Effectiveness of Cancer Drug Sensitization In Vitro and In Vivo
Published on: February 6, 2015
Modernizing Human Cancer Risk Assessment of Therapeutics
Mark R Fielden1, Lucas D Ward1, Sheroy Minocherhomji1
1Amgen, One Amgen Center Drive, Thousand Oaks, CA, USA.
Traditional rodent models for cancer risk assessment in therapeutics show poor translatability. New human-based models and biomarkers are needed to accurately evaluate therapeutic cancer risk.
Area of Science:
- Oncology
- Toxicology
- Genetics
Background:
- Rodent models for evaluating therapeutic cancer risk have limitations in translatability to human outcomes.
- Understanding cancer mechanisms and human genetic variations is crucial for accurate risk assessment.
Purpose of the Study:
- To review and highlight new approaches for assessing the carcinogenic risk of therapeutics.
- To explore the development of human-based in vitro models and biomarkers for cancer risk evaluation.
Main Methods:
- Review of current literature on carcinogenesis and therapeutic risk assessment.
- Discussion of advancements in understanding human genome variation's role in cancer.
- Exploration of novel human-based in vitro models and biomarker strategies.
Main Results:
- Identified limitations in current rodent-based cancer risk assessment models.
- Highlighted the importance of human-specific data and models.
- Proposed a shift towards human-based in vitro systems and biomarkers.
Conclusions:
- New human-based in vitro models and biomarkers offer improved accuracy for therapeutic cancer risk assessment.
- Integrating knowledge of carcinogenesis mechanisms and human genetics is key.
- This approach promises more reliable evaluation of novel therapeutics' safety.
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