The FDA is moving away from its traditional reliance on animal testing for preclinical safety evaluation. The agency is encouraging drug developers to incorporate New Approach Methodologies, such as AI-based modeling, organoids, and in vitro assays, along with relevant international real-world safety data, to support faster and more human-relevant progression of therapies into clinical trials.
Two recent open-access review articles that may be useful for those interested in this area.
Microfluidic chips for decoding cancer-immune crosstalk in immunotherapy https://doi.org/10.3389/fimmu.2026.1825593
This review discusses the limited predictability of conventional immuno-oncology models, which often do not capture key features of the tumor microenvironment, including immune-cell trafficking, vascular flow, and stromal barriers. It highlights immunocompetent tumor-on-chip systems as human-relevant platforms for studying cancer and immune interactions, evaluating CAR-T and checkpoint therapies, screening combination treatments, and supporting precision oncology. The authors also note ongoing challenges related to standardization and clinical validation.
Advanced in vitro cardiac models for drug evaluation https://doi.org/10.1038/s41378-026-01249-6
This review discusses the limitations of animal models, hERG assays, and 2D cultures in predicting human cardiotoxicity, arrhythmia risk, and drug efficacy. It summarizes advanced cardiac platforms, including hiPSC-derived cardiomyocytes, engineered heart tissues, organoids, ventricular constructs, and heart-on-chip systems, as more predictive tools for safety pharmacology and efficacy testing. The article also highlights remaining challenges related to maturation, reproducibility, scalability, and regulatory validation.
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Sudip Das, MPharm, PhD
Distinguished Faculty, Butler University
Professor of Pharmaceutics & Drug Delivery
4600 Sunset Avenue, Indianapolis, IN 46208-3485
E-mail:
[email protected]Webpage:
https://research.butler.edu/nanomedicine/LinkedIn:
http://www.linkedin.com/in/sudipkdasDisclaimer: Opinions expressed are solely my own and do not express the views or opinions of my employer.
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