Re-evaluating the need for mAb chronic toxicity studies

This webinar was held in April 2023 in collaboration with the European Partnership for Alternative Approaches to Animal Testing (EPAA). Its aim is to provide an overview of the key results and recommendations emerging from a EPAA supported and funded project, focused on chronic toxicity studies for monoclonal antibodies (mAbs).

Two journal publications from the project are discussed during the webinar:

• Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach

• The use of recovery animals in nonclinical safety assessment studies with monoclonal antibodies: further 3Rs opportunities remain

Webinar agenda:

• Welcome and brief background to the project
  Lucinda Weir, GSK, UK (CHAIR)

• Re-evaluating the need for chronic toxicity studies with therapeutic monoclonal antibodies, using a weight of evidence approach
  Peter van Meer, Medicines Evaluation Board, The Netherlands

• Recovery animal use and other 3Rs opportunities in nonclinical safety assessment studies with monoclonal antibodies
  Helen Prior, NC3Rs, UK

• Panel discussion and audience Q&A

• Concluding remarks
  Lucinda Weir, GSK, UK