New Approach Methodologies (NAMS) and regulatory shifts driving safer, more predictive therapeutic outcomes

When: November 19th, 2025
Time: 15:00 GMT | 16:00 CET | 10:00 EST | 07:00 PST

As regulatory agencies accelerate the adoption of New Approach Methodologies (NAMs), the landscape of drug discovery is undergoing a profound transformation. This webinar explores how NAMs, immunology-driven platforms, and emerging technologies are reshaping nonclinical safety and efficacy assessments. We’ll 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 will be 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

Join 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.

You will learn about:

• Regulatory initiatives including the FDA’s ISTAND and DILI programs, and what these mean for your program.
• Recent global regulatory signals from the FDA, EMA and MHRA on data submission practices.
• Reducing reliance on traditional methods and the FDA plan to phase out animal testing for monoclonal antibodies.
• How innovation is supporting integration of NAMs for safer, more effective therapy development.

Join Dr Clive Roper, Toxicology Consultant and Dr Justyna Rzpecka, Immunology Associate Director at Concept Life Sciences, as they uncover what NAM adoption could mean for your discovery program.