Overview

The speaker will share her experience in extending/innovating methodology and concepts developed in vaccine statistics to the analyses of pre-efficacy and efficacy trials of monoclonal antibodies.

Who is this event intended for? Statisticians/researchers working in vaccine, monoclonal antibody or infectious diseases.

What is the benefit of attending? This webinar will help statisticians/researchers working in the vaccine and monoclonal antibody fields better understand each other's work and the potential synergies in collaborating with each other.

Presentation Abstract

Catalysed by the rapid research and development of preventive and therapeutic monoclonal antibodies in multiple biomedical fields, there is an increasing demand of innovative statistical research in the design and analysis of monoclonal antibody studies. Published in 2022, a new biomarker, called PT80 was identified as a promising surrogate endpoint to reliably predict the ability of broadly neutralizing monoclonal antibodies to prevent acquisition of HIV-1. Findings from this study build on the proof-of-concept Antibody Mediated Prevention (AMP) trials showing that an mAb called VRC01 was effective in preventing the acquisition of some – but not all – HIV strains. In this talk, I will share our journey in reaching the discovery of PT80 for VRC01 via extending/innovating methodology and concepts from vaccine statistics to the design and analysis of monoclonal antibody studies.