Download our webinar to gain insights into how translational immunology is central to predictive modelling, and how these shifts are enabling safer, more effective therapeutic development across modalities.

As regulatory agencies accelerate the adoption of New Approach Methodologies (NAMs), the landscape of drug discovery is undergoing a profound transformation. This webinar with Hayley Gooding, Justyna Rzepecka explores how NAMs, immunology-driven platforms, and emerging technologies are reshaping nonclinical safety and efficacy assessments. They examine key initiatives including the FDA’s ISTAND and DILI programs, the NIH’s Organoid Centre at FDA Frederick, the Memorandum of understanding between FDA and NIH and its implications for collaborative innovation, and recent global regulatory signals from the FDA, EMA and MHRA on data submission practices.

Special attention has been given to the July 2025 FDA-NIH workshop on reducing reliance on traditional methods and the FDA plan to phase out animal testing for Monoclonal Antibodies and roadmap

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