As regulatory authorities accelerate the use of New Approach Methodologies (NAMs), the drug discovery landscape is changing dramatically. This webinar explores how NAMs, immunology-driven platforms, and upcoming technologies are transforming nonclinical safety and efficacy assessments.
The webinar will examine key initiatives, including the FDA's ISTAND and DILI programs, the NIH's Organoid Centre at the FDA's Frederick facility, the FDA-NIH Memorandum of Understanding, and its implications for collaborative innovation. It will also discuss recent global regulatory signals from the FDA, EMA, and MHRA regarding data submission practices.
The FDA-NIH workshop in July 2025 will focus on lowering reliance on traditional methods, as well as the FDA's intention to phase down animal testing for monoclonal antibodies and roadmap.
Join this webinar to learn how translational immunology is central to predictive modeling and how these advancements are enabling safer and more effective treatment development across multiple modalities.
You will learn about:
- Regulatory initiatives such as the FDA's ISTAND and DILI programs, and their impact on your program.
- Global regulatory signals from FDA, EMA, and MHRA on data filing practices.
- Reducing reliance on older methods and the FDA’s plan to phase out animal testing for monoclonal antibodies.
- Innovative approaches to integrating NAMs for safer and more effective treatment development.
Join Dr. Clive Roper, Toxicology Consultant, and Dr. Justyna Rzpecka, Immunology Associate Director at Concept Life Sciences, as they discuss what NAM adoption could mean for your research program.