Date: Thursday 9th November 2023 Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET Speakers: Kristian Brock and Peter Thall Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy. What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
Registration
This event is free to attend for both Members of PSI and Non-Members.
To register, please click here.
Overview
Please join us to hear Kristian Brock and Peter Thall present their recent work.
Presenters & Papers: 1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials' https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers are available to view prior to the meeting (see above) and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
Speaker details
Speaker
Biography
Peter Thall
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes.
Kristian Brock
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing.
Chair
Sebastian Weber
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development.
Scientific Meetings
PSI Journal Club: Bayesian Approaches in Efficacy and Safety
Date: Thursday 9th November 2023 Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET Speakers: Kristian Brock and Peter Thall Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy. What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
Registration
This event is free to attend for both Members of PSI and Non-Members.
To register, please click here.
Overview
Please join us to hear Kristian Brock and Peter Thall present their recent work.
Presenters & Papers: 1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials' https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers are available to view prior to the meeting (see above) and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
Speaker details
Speaker
Biography
Peter Thall
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes.
Kristian Brock
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing.
Chair
Sebastian Weber
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development.
Training Courses
PSI Journal Club: Bayesian Approaches in Efficacy and Safety
Date: Thursday 9th November 2023 Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET Speakers: Kristian Brock and Peter Thall Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy. What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
Registration
This event is free to attend for both Members of PSI and Non-Members.
To register, please click here.
Overview
Please join us to hear Kristian Brock and Peter Thall present their recent work.
Presenters & Papers: 1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials' https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers are available to view prior to the meeting (see above) and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
Speaker details
Speaker
Biography
Peter Thall
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes.
Kristian Brock
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing.
Chair
Sebastian Weber
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development.
Journal Club
PSI Journal Club: Bayesian Approaches in Efficacy and Safety
Date: Thursday 9th November 2023 Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET Speakers: Kristian Brock and Peter Thall Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy. What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
Registration
This event is free to attend for both Members of PSI and Non-Members.
To register, please click here.
Overview
Please join us to hear Kristian Brock and Peter Thall present their recent work.
Presenters & Papers: 1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials' https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers are available to view prior to the meeting (see above) and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
Speaker details
Speaker
Biography
Peter Thall
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes.
Kristian Brock
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing.
Chair
Sebastian Weber
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development.
Webinars
PSI Journal Club: Bayesian Approaches in Efficacy and Safety
Date: Thursday 9th November 2023 Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET Speakers: Kristian Brock and Peter Thall Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy. What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
Registration
This event is free to attend for both Members of PSI and Non-Members.
To register, please click here.
Overview
Please join us to hear Kristian Brock and Peter Thall present their recent work.
Presenters & Papers: 1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials' https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers are available to view prior to the meeting (see above) and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
Speaker details
Speaker
Biography
Peter Thall
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes.
Kristian Brock
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing.
Chair
Sebastian Weber
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development.
Careers Meetings
PSI Journal Club: Bayesian Approaches in Efficacy and Safety
Date: Thursday 9th November 2023 Time: 11:00-12:00 EST | 16:00-17:00 GMT | 17:00-18:00 CET Speakers: Kristian Brock and Peter Thall Chair: Sebastian Weber
Who is this event intended for? Anyone interested in learning more about Bayesian approaches in safety and efficacy. What is the benefit of attending? People should attend to learn more about the different techniques and application of Bayesian methods for efficacy and safety endpoints.
Registration
This event is free to attend for both Members of PSI and Non-Members.
To register, please click here.
Overview
Please join us to hear Kristian Brock and Peter Thall present their recent work.
Presenters & Papers: 1. Kristian Brock, Chen Chen, Shuyen Ho, Greg Fuller, Jared Woolfolk, Cindy McShea, Nils Penard: 'A Bayesian method for safety signal detection in ongoing blinded randomised controlled trials' https://onlinelibrary.wiley.com/doi/10.1002/pst.2278
PSI Journal Club is sponsored by Wiley. For each of these published papers there will be a 20 minute presentation by author followed by a 10 minute discussion.
Papers are available to view prior to the meeting (see above) and presentation slides will be available a week before the JC. Journal subscribers can access papers at any time. Audio recordings will be available shortly after the JC to download from the PSI website.
Speaker details
Speaker
Biography
Peter Thall
Peter Thall is a Professor in the Department of Biostatistics at M.D. Anderson Cancer Center. He is a Fellow of the American Statistical Association and the Society for Clinical Trials, and received the Don Owen Award in 2014. Dr. Thall has over 300 publications in the statistical and medical literature, including the books Bayesian Designs for Phase I-II Clinical Trials (2016) and Statistical Remedies for Medical Researchers (2020). His research areas include Bayesian statistics, clinical trial design, precision medicine, and dynamic treatment regimes.
Kristian Brock
Kristian is a methodologist statistician interested in Bayesian and computational methods currently working in AstraZeneca’s Statistical Innovation team. He started his biostatistical career in 2014 at the Cancer Research UK Clinical Trials Unit at the University of Birmingham, focusing mostly on phase I and II trials in cancer. Whilst at Birmingham, he obtained a PhD in clinical trial methodology, publishing work on seamless phase I/II dose-finding, and incorporating a predictive biomarker in a phase II trial with co-primary efficacy and toxicity outcomes. In 2020, he joined UCB as a methodologist. There he built tools to calculate trial probability of success, and published a Bayesian method for monitoring safety signals in ongoing blinded studies using a meta-analytic predictive prior. He is a keen programmer, with a particular interest in R, Stan, Julia, Turing. He has published CRAN packages on dose-finding methods. Outside of work, Kristian enjoys travelling, cycling and sailing.
Chair
Sebastian Weber
Sebastian Weber is working as Director in the Department of Advanced Methodology and Data Science at Novartis. He has worked extensivley on enabling the use of historical (control) information in clinical trials through consulting and working on tools to facilitate the application of historical control information from trial design to analysis. Furthermore, Sebastian has experience in designing Oncology phase I dose-escalation trails and is also involved in pediatric drug development programs, where he applies extrapolation concepts. His research interests include the application of pharmacometrics in statistics, model-based drug development and application of Bayesian methods for drug development.
Upcoming Events
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.
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.
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.
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.
This apprenticeship role offers a unique opportunity to learn and work in a global healthcare consultancy company alongside a team of statisticians, psychometricians and programmers.
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