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.
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.
Date: Ongoing 6 month cycle beginning late April/early May 2026
Are you a member of PSI looking to further your career or help develop others - why not sign up to the PSI Mentoring scheme? You can expand your network, improve your leadership skills and learn from more senior colleagues in the industry.
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.
PSI Training Course: Effective Leadership – the keys to growing your leadership capabilities
This course will consist of three online half-day workshops. The first will be aimed at building trust, the backbone of leadership and a key to becoming effective. This is key to building a solid foundation.
The second will be on improving communication as a technical leader. This workshop will focus on communication strategies for different stakeholders and will involve tips on effective communication and how to develop the skills of active listening, coaching and what improv can teach us about good communication.
The final workshop will bring these two components together to help leaders become more influential. This will also focus on how to use Steven Covey’s 7-Habits, in particular Habits 4, 5 and 6, which are called the habits of communication.
The workshops will be interactive, allowing you to practice the concepts discussed. There will be plenty of time for questions and discussion. There will also be reflective time where you can think about what you are learning and how you might experiment with it.