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Building regulatory confidence with immune-competent MPS
Discover how human liver models are building regulatory confidence in DILI risk assessment. How a continuously perfused, primary human Liver model, with immune-competent capabilities, can be leveraged to address a critical unmet need — capturing immune mediated toxicities associated with new drug modalities such as monoclonal antibodies (mAbs).
The US FDA’s 2025 roadmap to reduce reliance on animal testing has accelerated the adoption of human‑relevant new approach methodologies (NAMs), including microphysiological systems (MPS). Central to this transition is the requirement for qualified models with defined contexts of use and demonstrated predictive performance.
In this webinar, Emily Richardson and Justina Then will discuss how cross‑platform evaluations support the regulatory acceptance of non‑animal data, highlighting how immune‑competent liver MPS models capture immune‑mediated toxicities associated with new drug modalities, such as monoclonal antibodies (mAbs).
Key Learning on how to build regulatory confidence with immune-competent MPS
- Shifting regulatory frameworks and the accelerated acceptance of MPS for decision-making
- Benchmarking liver MPS performance using data from an FDA-ISTAND –accepted cross-platform evaluation project
- Achieving long-term in vitro safety insights with continuously perfused human liver microtissue systems
- Utilizing immune-competent liver and lung platforms to capture human-specific toxicities that are poorly predicted by animal models
About the Presenter:
Dr. Emily Richardson
Biology Group Leader
Her work bridges complex cell biology and real-world drug discovery, informed by a PhD from the University of Leicester in 3D cell culture for metastatic lung cancer and a BSc in Biochemistry and Molecular Medicine degree from the University of Nottingham.
Dr. Justina Then
Senior Scientist
With nine years in academia and three years in industry, she brings a wealth of expertise to advancing biological research and practical applications.