The FDA ICH S1B (R1) guidance introduces a Weight of Evidence (WoE) approach for assessing human carcinogenic risk in drug development, aiming to replace traditional two-year rat carcinogenicity studies. This innovative framework integrates data from diverse sources, including in vitro, animal, and clinical studies, while focusing on six key WoE factors: target biology, secondary pharmacology, chronic histopathology, hormonal perturbation, genotoxicity, and immune modulation. Together, these factors offer a comprehensive and interconnected perspective on carcinogenic risk.
In this webinar, discover how Eurofins Discovery has developed a comprehensive WoE platform using advanced in vitro methods. Key innovations include molecular target evaluations to detect non-genotoxic carcinogens, nuclear hormone receptor panels for assessing hormonal perturbation, and genotoxicity assays such as ames and micronucleus tests. Plus, find out how cutting-edge BioMAP technology provides insights into immune and hormonal safety profiles, while an AI-driven cell transformation assay (CTA) evaluates carcinogen-induced malignant phenotypes with precision.
Results demonstrate that the carcinogenicity risk assessment panel effectively identifies diverse carcinogens and their mechanisms. AI-enhanced image analysis in the Bhas 42 CTA boosts efficiency and objectivity. This approach enables early detection of carcinogenic liabilities, aligns with ICH S1B(R1) guidelines, and offers a humane, streamlined alternative to traditional two-year rat studies.
Key learning points:
- Understand the Weight of Evidence (WoE) approach and its role in modern carcinogenicity risk assessment.
- Explore the six critical WoE factors that provide comprehensive insights into carcinogenic risks.
- Discover innovative in vitro alternatives to animal testing for ethical and efficient drug development.
- Learn about AI-assisted Cell Transformation Assays (CTA).
- Gain insights into identifying carcinogenic mechanisms.
- Adopt a cost-effective and ethical strategy that aligns with regulatory guidelines while advancing drug safety.
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