The FDA’s newly published Roadmap to Reducing Animal Testing in Preclinical Safety Studies outlines a pivotal shift in how safety data for biologics, including monoclonal antibodies, will be generated and assessed. This initiative aims to not only improve animal welfare but also address the long-standing scientific limitations, recognizing that animal toxicology often fails to predict human response. 

Join us for an insightful webinar where we unpack the implications of this shift and explore how sponsors can adapt their strategies to align with evolving regulatory expectations.

Key topics

• What the FDA’s roadmap means for monoclonal antibody development and toxicology strategy. 

• How New Approach Methodologies (NAMs) may improve human relevance in safety assessment, and where validation gaps persist. 

• Practical implications for sponsors navigating this changing landscape. 

Speakers

• Nelia Padilla, Vice President, Consulting Strategy & Operations, Cytel
• Michael Fossler, Vice President, Quantitative Clinical Pharmacology, Cytel
• C. Edwin Garner, PhD, Founder, Mammoth Preclinical Consulting, LLC