The U.S. Food and Drug Administration’s 2025 roadmap to reduce reliance on animal testing has accelerated the adoption of New Approach Methodologies (NAMs) that are robust, human‑relevant, and fit for regulatory decision‑making. Central to this transition is the need for qualified microphysiological systems (MPS) with clearly defined contexts of use and demonstrated predictive performance.
In collaboration with the 3Rs Collaborative, FDA‑CDER, and NIH‑NIEHS, CN Bio is actively contributing to a cross‑platform regulatory evaluation of commercial liver MPS that has subsequently been accepted into the FDA’s ISTAND program. This blinded, multi‑platform study included eight liver MPS testing eight matched hepatotoxic and non‑hepatotoxic compounds dosed across clinically relevant exposure ranges. In the PhysioMimix system, continuously perfused, primary human liver microtissue system were assessed for liver injury, function, and metabolic competence over extended dosing, with all raw data independently analyzed by the central project team to support transparent, standardized comparison. This initiative provides a critical framework for building regulatory confidence and advancing MPS qualification for drug‑induced liver injury (DILI) risk assessment.
Building on this regulatory foundation, CN Bio is also addressing a key unmet need highlighted in the FDA roadmap: the assessment of immune‑mediated toxicity associated with new modalities such as monoclonal antibodies. By integrating immune cells into liver and lung MPS assays, immune‑competent platforms are being developed to capture human‑specific inflammatory and toxicity mechanisms that are poorly predicted by animal models. Proof‑of‑concept studies with clinically relevant antibodies demonstrate detection of immune‑mediated hepatotoxicity alongside cytokine‑driven responses aligned with clinical observations.
This session will discuss how these efforts support the FDA’s post‑roadmap vision—delivering mechanistically informative, non‑animal data to enable safer drug development, reduce attrition, and accelerate regulatory acceptance of NAMs for both small and large molecule toxicity assessment.
Speaker | Emily Richardson, PhD
Dr. Emily Richardson is a Biology Group Leader at CN Bio, where she oversees the development and validation of microphysiological systems (MPS) for toxicology and safety assessment. She joined CN Bio in 2020 as a Senior Scientist and played a central role in creating the company’s Lung and Lung/Liver MPS models, advancing their use in infectious disease research and the evaluation of inhaled therapeutics.
Throughout her time at CN Bio, Dr Richardson has led multiple collaborative and grant funded programmes and acts as a key liaison across academic partners, pharmaceutical organisations, contract research organisations, regulatory bodies, and standardisation groups.
Her expertise sits at the intersection of complex cell biology and real world drug discovery, informed by industry experience in cellular therapeutics and specialism in complex in vitro modelling. She received her degree in Biochemistry and Molecular Medicine from the University of Nottingham and PhD from the University of Leicester, where she used 3D cell culture to uncover molecular mechanisms driving highly metastatic lung cancers – expertise that continues to shape her approach to developing more predictive and robust human relevant models today.