PSI Vaccine SIG Webinar: A Vaccine Statistician’s Journey in Designing and Analyzing Monoclonal Antibody Studies
Date: Thursday 26th October 2023
Time: 15:00-16:00 BST
Speaker: Yunda Huang, Ph.D
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.
This event is free to both Members of PSI and Non-Members.
To register for this event, please click here.
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.
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.
Dr. Yunda Huang
Dr. Huang’s research areas have focused on the statistical design and analysis of vaccine clinical trials, monoclonal antibody clinical trials and immunological biomarker studies related to the prevention and treatment of HIV and other infectious diseases. She has worked closely with academic, regulatory and industrial collaborators in providing statistical leadership for 20+ phase 1/2/2b pre-efficacy and efficacy trials, and on the immune correlates studies for several landmark HIV prevention and therapeutic efficacy trials. In recent years, she spearheaded fruitful collaborations in bridging the gap between statistical methodology and pharmacometric applications in the design and analysis of single and combination HIV monoclonal antibody trials. Dr. Huang has published 100+ scientific papers in both methodological and applied statistical journals, as well as in biomedical and pharmacokinetics journals.
Dr. Huang obtained her B.S. degree in Statistics from the Renmin University of China, and her Ph.D. degree in Biostatistics from the University of California, Los Angeles.