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 Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
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.
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 Introduction to Industry Training (ITIT) Course - 2024/2025
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
PSI Training Course: Regulatory Guidelines for Statisticians
This 2-day course is designed to provide a comprehensive understanding of the regulatory guidelines affecting statisticians in the pharmaceutical industry, including the latest updates in the field. The course will cover key International Council for Harmonisation (ICH) guidelines and other key regional regulatory agency documents.
In this event, we’ll start with a general introduction to hierarchical composite endpoints and an overview of common analysis methods including win ratio, win odds, and net benefit. Then, the practical considerations will be illustrated through case studies from clinical trials in heart failure and chronic kidney disease. We conclude with a discussion and a Q&A.
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Statisticians in the Pharmaceutical Industry Executive Office: c/o MCI UK Ltd | Unit 24/22 South | Building 4000 | Langstone Park| Langstone Road | Havant | PO9 1SA | UK