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.
Registration
This event is free to both Members of PSI and Non-Members.
To register for this event, please click here.
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.
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.
Speaker details
Speaker
Biography
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.
Scientific Meetings
PSI Vaccine SIG Webinar: A Vaccine Statistician’s Journey in Designing and Analyzing Monoclonal Antibody Studies
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.
Registration
This event is free to both Members of PSI and Non-Members.
To register for this event, please click here.
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.
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.
Speaker details
Speaker
Biography
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.
Training Courses
PSI Vaccine SIG Webinar: A Vaccine Statistician’s Journey in Designing and Analyzing Monoclonal Antibody Studies
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.
Registration
This event is free to both Members of PSI and Non-Members.
To register for this event, please click here.
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.
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.
Speaker details
Speaker
Biography
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.
Journal Club
PSI Vaccine SIG Webinar: A Vaccine Statistician’s Journey in Designing and Analyzing Monoclonal Antibody Studies
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.
Registration
This event is free to both Members of PSI and Non-Members.
To register for this event, please click here.
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.
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.
Speaker details
Speaker
Biography
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.
Webinars
PSI Vaccine SIG Webinar: A Vaccine Statistician’s Journey in Designing and Analyzing Monoclonal Antibody Studies
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.
Registration
This event is free to both Members of PSI and Non-Members.
To register for this event, please click here.
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.
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.
Speaker details
Speaker
Biography
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.
Careers Meetings
PSI Vaccine SIG Webinar: A Vaccine Statistician’s Journey in Designing and Analyzing Monoclonal Antibody Studies
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.
Registration
This event is free to both Members of PSI and Non-Members.
To register for this event, please click here.
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.
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.
Speaker details
Speaker
Biography
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.
Upcoming Events
PSI Book Club - The Art of Explanation: How to Communicate with Clarity and Confidence
Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
Topic: R Package Basics.
Our monthly webinar series allows attendees to gain practical knowledge and skills in open-source coding and tools, with a focus on applications in the pharmaceutical industry. This month’s session, “R Package Basics,” will introduce the fundamentals of working with R packages—covering how to install, load, and manage them effectively to support data analysis and reproducible research. The session will provide a solid starting point, clarify common misconceptions, and offer valuable resources for continued learning.
Pre-Clinical SIG Webinar: Modern Algorithms for Animal Randomization in Preclinical Studies
A 1 hour online event, that includes a presentation followed by Q&A.
This webinar will first define terminology in causal inference/data fusion and illustrate their use with two case studies.
Date: 19 November 2025
This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Book Club Lunch and Learn: Communicating with Clarity and Confidence
If you have read Ros Atkins’ book The Art of Explanation or want to listen to the BBC’s ‘Communicator in Chief’, you are invited to join the PSI Book Club Lunch and Learn, to discuss the content and application with the author, Ros Atkins. Having written the book within the context of the news industry, Ros is keen to hear how we have applied the ideas as statisticians within drug development and clinical trials. There will be dedicated time during the webinar to ASK THE AUTHOR any questions – don’t miss out on this exclusive PSI Book Club event!
Haven’t read the book yet? Pick up a copy today and join us.
Explanation - identifying and communicating what we want to say - is described as an art, in the title of his book. However, the creativity comes from Ros’ discernment in identifying and describing a clear step-by-step process to follow and practice. Readers can learn Ros’ rules, developed and polished throughout his career as a journalist, to help communicate complex written or spoken information clearly.