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).
Topics to be covered:
- Shifting regulatory frameworks and the accelerated acceptance of MPS for decision-making
- Benchmarking liver MPS performance using data from an FDA Innovative Science and Technology Approaches for New Drugs (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
Tuesday, May 26th 2026 | 10:00 AM – 11:00 AM Eastern Time
This webinar will be available to view live and on demand.
Speakers
Emily Richardson, PhD
Biology Group Leader
CN Bio
.jpg "Justina Then, PhD")
Justina Then, PhD
Senior Scientist
CN Bio
