Building confidence for regulatory decision-making with immune competent models

Evolving regulatory expectations are shifting how drug safety is assessed, with increasing focus on validated, human-relevant approaches that can support decision-making, especially in areas of unmet need such as immune competent models.

This webinar explores how liver microphysiological systems (MPS) are being benchmarked through a cross-platform FDA-ISTAND –accepted study (led by the 3Rs Collaborative) to build regulatory confidence in drug-induced liver injury (DILI) assessment. It also introduces emerging immune-competent models designed to address a key gap in predicting immune-mediated toxicity for newer modality therapies as cited in the FDA’s roadmap to phase out animal testing. Attendees will gain insight into how these advances are shaping regulatory acceptance and enabling more predictive, mechanism-driven safety evaluation.

Key Learnings

Discover how to build regulatory confidence with microphysiological system (MPS)-based immune competent models through:

• 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 PhysioMimix® human liver microtissue systems
• Utilizing PhysioMimix® immune-competent liver and lung platforms to capture human-specific toxicities that are poorly predicted by animal models

Speaker

Dr Emily Richardson

Biology Group Leader

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.

Dr Justina Then

Senior Scientist

Dr Justina Then is a senior scientist at CN Bio, focusing on liver toxicology within the R&D team. Her academic foundation includes a PhD in experimental medicine and rheumatology and postdoctoral work at the William Harvey Research Institute (QMUL), where she spent her time investigating the potential of nanotechnology for drug development in rheumatoid arthritis and synovial fibroblasts.
With nine years in academia and three years in industry, she brings a wealth of expertise to advancing biological research and practical applications.