Chairs: Jeffrey Brown & Andreas Stucki
The US Food and Drug Administration (FDA) announced its plans to eliminate the use of animals to meet regulatory testing requirements for monoclonal antibody drugs within a 3 to 5 year time frame. To accelerate this process, in the US and elsewhere, we present a number of strategies that have proven to be useful in regulatory engagements seeking to achieve this goal for drugs in this class prior to the publication of the FDA’s roadmap to achieve this goal. This includes detailed discussion of the feedback received in support of a nonanimal preclinical testing approach for a therapeutic human monoclonal diphtheria antitoxin from the FDA (via pre-IND), the European Medicines Agency (via Scientific Advice and Innovation Task Force meetings), and the Paul-Ehrlich-Institut (via Scientific Advice meeting). Other case studies will be presented for related drugs in this and other drug classes that have reached various stages of regulatory approval. These case studies can serve as templates for parties interested in pursuing regulatory submissions using innovative animal replacement strategies.
Speakers
- Esther Wenzel – Validation and application of NAMs for developmental toxicity testing to predict human safety
- Jeffrey Brown – Application of NAMs in a regulatory context: the pursuit of confidence
- Leander Grode – A DEFINED APPROACH BASED ON NAMS FOR ASSESSING TERATOGENICITY