Biologics Drug Development Gets an Upgrade with Humanized Animal Models

While humanized animal models are relatively new to drug development compared to their non-humanized counterparts, they are critical tools in the landscape of biologic drug development. Their success is due to the ability of humanized models to mimic the precise in vivo pathology and interactions more accurately between the human and the proposed biologic. With these insights, developers can refine their therapies to boost efficacy and reduce toxicity which is crucial for advancing them to the clinic.

In this GEN webinar, Aaron Rose, PhD, explores how biological therapeutics are reshaping the traditional drug development process and why humanized models are essential for advancing biologics programs. He will delve into the details of lead selection, efficacy, pharmacokinetics/pharmacodynamics, and toxicity assessments for these therapeutics. And he will discuss the pivotal role of human peripheral blood mononuclear cells (PBMCs) and CD34 humanized mouse models in reshaping biologic drug pipelines. Key topics covered in the webinar include:

• The central role that human-specific protein-receptor interactions play in elucidating mechanisms of action (MOA) for biologic therapeutics.

• Anticipated challenges posed by the inadequacy of traditional rodent, canine, and non-human primate models in predicting efficacy and toxicity.

• The critical need for viable in vivo human cellular models to bridge the gap in preclinical testing.

A live Q&A session followed the presentation, offering a chance to pose questions to our expert panelist.