Complex In Vitro Model Characterization for Context of Use in Toxicologic Pathology: Use Cases by Collaborative Teams...

Area of Science:

• Toxicologic Pathology
• Preclinical Drug Development
• In Vitro Models

Background:

• Complex in vitro models (CIVMs) show promise for improving preclinical efficacy and toxicity assessments.
• CIVMs can potentially decrease the need for animal testing in drug development.
• Pathologists' expertise in comparative medicine is crucial for bridging animal models and human disease mechanisms.

Purpose of the Study:

• To highlight the essential role of pathologists in the development and application of CIVMs.
• To emphasize the collaborative development of CIVMs by diverse scientific teams.
• To advocate for the integration of morphological evaluations and translational biomarkers in CIVM assessment.

Main Methods:

• Reviewing the application of tissue technologies and analytics in CIVM development.
• Discussing the importance of robust histological techniques and image analysis.
• Correlating morphological evaluations with translational biomarkers for data interpretation.

Main Results:

• Pathologists' comparative medicine background aids in understanding disease mechanisms and validating CIVMs.
• Collaborative development involving engineers, biologists, and pathologists is ideal for novel CIVM characterization.
• Morphological evaluation, supported by tissue technologies and analytics, is essential for CIVM use.

Conclusions:

• CIVMs, when developed and validated with pathologist input, can increase clinical relevance in drug development.
• The scientific community should explore and adopt CIVM technologies for efficacy and safety evaluations.
• Engaging with health authorities on CIVM use in benefit-risk assessment is encouraged.