Date: Thursday 26th October 2023
Time: 15:00-16:00 BST
Location: Online
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.
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Speaker |
Biography |
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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. |
Date: Thursday 26th October 2023
Time: 15:00-16:00 BST
Location: Online
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.
|
Speaker |
Biography |
|
|
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. |
Date: Thursday 26th October 2023
Time: 15:00-16:00 BST
Location: Online
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.
|
Speaker |
Biography |
|
|
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. |
Date: Thursday 26th October 2023
Time: 15:00-16:00 BST
Location: Online
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.
|
Speaker |
Biography |
|
|
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. |
Date: Thursday 26th October 2023
Time: 15:00-16:00 BST
Location: Online
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.
|
Speaker |
Biography |
|
|
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. |
Date: Thursday 26th October 2023
Time: 15:00-16:00 BST
Location: Online
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.
|
Speaker |
Biography |
|
|
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. |
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.
This is an interactive online training workshop providing an in-depth review of the estimand framework as laid out by ICH E9(R1) addendum with inputs from estimand experts, case studies, quizzes and opportunity for discussions. You will develop an estimand in a therapeutic area of interest to your company. In an online break-out room, you will join a series of team discussions to implement the estimand framework in a case study, aligning estimands, design, conduct, analysis, (assumptions + sensitivity analyses) to the clinical objective and therapeutic setting.
Webinar dedicated to the topic of dissolution of oral solid dosage forms; opportunity to hear from statisticians working in the CMC field, with open question and answers. In addition, the CMC Statistical Network Europe special interest group will discuss advocacy opportunities, have your say to contribute to the future direction.
Initially a brief introduction to AI will be given, followed by a presentation of various applications in medicinal product lifecycle. Several aspects will be discussed including performance, theoretical and practical conditions and also regulatory guidelines.
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.
Who is this event intended for? Statisticians with an interest understanding dose-finding in oncology. What is the benefit of attending? Learn about the state of oncology dose finding, particularly in light of current FDA guidance.
The book club’s usual focus is to read and discuss professional development books. In this short format event you can more easily develop you career without the commitment of reading the whole book - simply listen to the 1-hour long podcast before joining the interactive session on 21 May.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
The Institute of Cancer Research are seeking to appoint a Research Group Leader to join The CRUK Clinical Trials and Statistics Unit at the ICR.
The BioMarin internship programme will enable students to gain valuable experience and knowledge of the processes and systems within BioMarin, whilst gaining an insight into the pharmaceutical/biotech industry.
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