Frank Bretz & Björn Bornkamp
Statistical Methodology and Consulting, Novartis Pharma
including regulatory perspectives from Rob Hemmings
Statistics and Pharmacokinetics Unit Manager, MHRA, UK
This course will introduce and discuss methods for Phase II dose finding studies, including a review of basic multiple comparisons and modelling methods, as traditionally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod, combining multiple comparisons and modelling, will be the focus of the course. Click here to see the full event flyer
The first day will provide an overview of dose finding in drug development. The application of multiple comparison procedures (MCP) and modelling approaches (Mod) will then be covered, including a review of contrast tests as well as nonlinear regression methods for dose response and target dose estimation. Then a step-by-step description of MCP-Mod will be provided, including a detailed discussion of its five main steps across the design and analysis stages:
Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
Derivation of optimum contrast coefficients, such that the marginal power to detect a specific dose response shape associated with the respective candidate model is maximized.
Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
Model selection or model averaging, provided statistical significance has been shown in the previous step.
Use the selected model(s) to produce inferences on adequate doses, employing a model-based approach.
MCP-Mod will first be introduced in its originally published version for a single, normally distributed efficacy endpoint. The extension of this framework will be described for count data and time-to-event endpoints as well as situations involving generalized non-linear models, linear and non-linear mixed effects models, and Cox proportional hazards models.
Day 2
On day two, considerations will be given to practical aspects around the design and analysis of dose finding trials using MCP-Mod. This includes importantly a discussion of its design aspects, in particular sample size derivations. As MCP-Mod is a hybrid procedure, focusing on hypothesis testing and estimation, sample size calculation procedures for both objectives will be presented and their application on the design illustrated with a real dose finding study. A variety of further practical considerations will be discussed that summarizes the collective experience over the past 10 years in using MCP-Mod in Phase II dose finding trials. The application of the DoseFinding R package will be demonstrated in detail, including a description of functions for the design and analysis of dose finding trials using MCP, Mod or MCP-Mod. Hands-on exercises allow the course attendees to the experience the capabilities of the DoseFinding R package and how to use its functions to implement the MCP-Mod methodology. The course ends with a review of regulatory considerations.
Speaker
About the Speaker
Frank Bretz
Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the incoming editor of Statistics in Biopharmaceutical Research. He has authored or co-authored more than 120 articles in peer-reviewed journals and four books.
Björn Bornkamp
Björn Bornkamp works as a Senior Expert Statistical Methodologist in the Statistical Methodology group at Novartis Pharmaceuticals. He has research and practical experience in the design and analysis of dose-finding studies and the interface of pharmacometrics and statistics. He joined Novartis in 2010 after obtaining a PhD in Statistics from the Dortmund University of Technology in Germany.
Rob Hemmings
Rob Hemmings has been with the Medicines and Healthcare products Regulatory Agency for 16 years and heads the group of medical statisticians and pharmacokineticists. Much of Rob’s time is spent educating medical colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a member of the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and the chair of the CHMP’s Scientific Advice Working Party. These positions, and involvement at the Biostatistics Working Party of CHMP and the EMA’s extrapolation and modelling and simulation groups, have presented the opportunity for pursue a particular interest in understanding ‘dose’ and he has been actively involved in recent EMA initiatives in this area.
Agenda
9.30 - 10.00
Registration
10.00 - 17.00
Day 1
9.00 - 16.30
Day 2
Registration
PSI Members
£495 + VAT
Non - Members
£570 + VAT (includes PSI membership for 1 year)
Registration costs includes lunch and refreshments PSI are holding a limited number of hotel rooms until the 31st January which will be allocated on a first come first served basis.
Frank Bretz & Björn Bornkamp
Statistical Methodology and Consulting, Novartis Pharma
including regulatory perspectives from Rob Hemmings
Statistics and Pharmacokinetics Unit Manager, MHRA, UK
This course will introduce and discuss methods for Phase II dose finding studies, including a review of basic multiple comparisons and modelling methods, as traditionally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod, combining multiple comparisons and modelling, will be the focus of the course. Click here to see the full event flyer
The first day will provide an overview of dose finding in drug development. The application of multiple comparison procedures (MCP) and modelling approaches (Mod) will then be covered, including a review of contrast tests as well as nonlinear regression methods for dose response and target dose estimation. Then a step-by-step description of MCP-Mod will be provided, including a detailed discussion of its five main steps across the design and analysis stages:
Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
Derivation of optimum contrast coefficients, such that the marginal power to detect a specific dose response shape associated with the respective candidate model is maximized.
Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
Model selection or model averaging, provided statistical significance has been shown in the previous step.
Use the selected model(s) to produce inferences on adequate doses, employing a model-based approach.
MCP-Mod will first be introduced in its originally published version for a single, normally distributed efficacy endpoint. The extension of this framework will be described for count data and time-to-event endpoints as well as situations involving generalized non-linear models, linear and non-linear mixed effects models, and Cox proportional hazards models.
Day 2
On day two, considerations will be given to practical aspects around the design and analysis of dose finding trials using MCP-Mod. This includes importantly a discussion of its design aspects, in particular sample size derivations. As MCP-Mod is a hybrid procedure, focusing on hypothesis testing and estimation, sample size calculation procedures for both objectives will be presented and their application on the design illustrated with a real dose finding study. A variety of further practical considerations will be discussed that summarizes the collective experience over the past 10 years in using MCP-Mod in Phase II dose finding trials. The application of the DoseFinding R package will be demonstrated in detail, including a description of functions for the design and analysis of dose finding trials using MCP, Mod or MCP-Mod. Hands-on exercises allow the course attendees to the experience the capabilities of the DoseFinding R package and how to use its functions to implement the MCP-Mod methodology. The course ends with a review of regulatory considerations.
Speaker
About the Speaker
Frank Bretz
Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the incoming editor of Statistics in Biopharmaceutical Research. He has authored or co-authored more than 120 articles in peer-reviewed journals and four books.
Björn Bornkamp
Björn Bornkamp works as a Senior Expert Statistical Methodologist in the Statistical Methodology group at Novartis Pharmaceuticals. He has research and practical experience in the design and analysis of dose-finding studies and the interface of pharmacometrics and statistics. He joined Novartis in 2010 after obtaining a PhD in Statistics from the Dortmund University of Technology in Germany.
Rob Hemmings
Rob Hemmings has been with the Medicines and Healthcare products Regulatory Agency for 16 years and heads the group of medical statisticians and pharmacokineticists. Much of Rob’s time is spent educating medical colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a member of the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and the chair of the CHMP’s Scientific Advice Working Party. These positions, and involvement at the Biostatistics Working Party of CHMP and the EMA’s extrapolation and modelling and simulation groups, have presented the opportunity for pursue a particular interest in understanding ‘dose’ and he has been actively involved in recent EMA initiatives in this area.
Agenda
9.30 - 10.00
Registration
10.00 - 17.00
Day 1
9.00 - 16.30
Day 2
Registration
PSI Members
£495 + VAT
Non - Members
£570 + VAT (includes PSI membership for 1 year)
Registration costs includes lunch and refreshments PSI are holding a limited number of hotel rooms until the 31st January which will be allocated on a first come first served basis.
Frank Bretz & Björn Bornkamp
Statistical Methodology and Consulting, Novartis Pharma
including regulatory perspectives from Rob Hemmings
Statistics and Pharmacokinetics Unit Manager, MHRA, UK
This course will introduce and discuss methods for Phase II dose finding studies, including a review of basic multiple comparisons and modelling methods, as traditionally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod, combining multiple comparisons and modelling, will be the focus of the course. Click here to see the full event flyer
The first day will provide an overview of dose finding in drug development. The application of multiple comparison procedures (MCP) and modelling approaches (Mod) will then be covered, including a review of contrast tests as well as nonlinear regression methods for dose response and target dose estimation. Then a step-by-step description of MCP-Mod will be provided, including a detailed discussion of its five main steps across the design and analysis stages:
Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
Derivation of optimum contrast coefficients, such that the marginal power to detect a specific dose response shape associated with the respective candidate model is maximized.
Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
Model selection or model averaging, provided statistical significance has been shown in the previous step.
Use the selected model(s) to produce inferences on adequate doses, employing a model-based approach.
MCP-Mod will first be introduced in its originally published version for a single, normally distributed efficacy endpoint. The extension of this framework will be described for count data and time-to-event endpoints as well as situations involving generalized non-linear models, linear and non-linear mixed effects models, and Cox proportional hazards models.
Day 2
On day two, considerations will be given to practical aspects around the design and analysis of dose finding trials using MCP-Mod. This includes importantly a discussion of its design aspects, in particular sample size derivations. As MCP-Mod is a hybrid procedure, focusing on hypothesis testing and estimation, sample size calculation procedures for both objectives will be presented and their application on the design illustrated with a real dose finding study. A variety of further practical considerations will be discussed that summarizes the collective experience over the past 10 years in using MCP-Mod in Phase II dose finding trials. The application of the DoseFinding R package will be demonstrated in detail, including a description of functions for the design and analysis of dose finding trials using MCP, Mod or MCP-Mod. Hands-on exercises allow the course attendees to the experience the capabilities of the DoseFinding R package and how to use its functions to implement the MCP-Mod methodology. The course ends with a review of regulatory considerations.
Speaker
About the Speaker
Frank Bretz
Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the incoming editor of Statistics in Biopharmaceutical Research. He has authored or co-authored more than 120 articles in peer-reviewed journals and four books.
Björn Bornkamp
Björn Bornkamp works as a Senior Expert Statistical Methodologist in the Statistical Methodology group at Novartis Pharmaceuticals. He has research and practical experience in the design and analysis of dose-finding studies and the interface of pharmacometrics and statistics. He joined Novartis in 2010 after obtaining a PhD in Statistics from the Dortmund University of Technology in Germany.
Rob Hemmings
Rob Hemmings has been with the Medicines and Healthcare products Regulatory Agency for 16 years and heads the group of medical statisticians and pharmacokineticists. Much of Rob’s time is spent educating medical colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a member of the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and the chair of the CHMP’s Scientific Advice Working Party. These positions, and involvement at the Biostatistics Working Party of CHMP and the EMA’s extrapolation and modelling and simulation groups, have presented the opportunity for pursue a particular interest in understanding ‘dose’ and he has been actively involved in recent EMA initiatives in this area.
Agenda
9.30 - 10.00
Registration
10.00 - 17.00
Day 1
9.00 - 16.30
Day 2
Registration
PSI Members
£495 + VAT
Non - Members
£570 + VAT (includes PSI membership for 1 year)
Registration costs includes lunch and refreshments PSI are holding a limited number of hotel rooms until the 31st January which will be allocated on a first come first served basis.
Frank Bretz & Björn Bornkamp
Statistical Methodology and Consulting, Novartis Pharma
including regulatory perspectives from Rob Hemmings
Statistics and Pharmacokinetics Unit Manager, MHRA, UK
This course will introduce and discuss methods for Phase II dose finding studies, including a review of basic multiple comparisons and modelling methods, as traditionally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod, combining multiple comparisons and modelling, will be the focus of the course. Click here to see the full event flyer
The first day will provide an overview of dose finding in drug development. The application of multiple comparison procedures (MCP) and modelling approaches (Mod) will then be covered, including a review of contrast tests as well as nonlinear regression methods for dose response and target dose estimation. Then a step-by-step description of MCP-Mod will be provided, including a detailed discussion of its five main steps across the design and analysis stages:
Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
Derivation of optimum contrast coefficients, such that the marginal power to detect a specific dose response shape associated with the respective candidate model is maximized.
Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
Model selection or model averaging, provided statistical significance has been shown in the previous step.
Use the selected model(s) to produce inferences on adequate doses, employing a model-based approach.
MCP-Mod will first be introduced in its originally published version for a single, normally distributed efficacy endpoint. The extension of this framework will be described for count data and time-to-event endpoints as well as situations involving generalized non-linear models, linear and non-linear mixed effects models, and Cox proportional hazards models.
Day 2
On day two, considerations will be given to practical aspects around the design and analysis of dose finding trials using MCP-Mod. This includes importantly a discussion of its design aspects, in particular sample size derivations. As MCP-Mod is a hybrid procedure, focusing on hypothesis testing and estimation, sample size calculation procedures for both objectives will be presented and their application on the design illustrated with a real dose finding study. A variety of further practical considerations will be discussed that summarizes the collective experience over the past 10 years in using MCP-Mod in Phase II dose finding trials. The application of the DoseFinding R package will be demonstrated in detail, including a description of functions for the design and analysis of dose finding trials using MCP, Mod or MCP-Mod. Hands-on exercises allow the course attendees to the experience the capabilities of the DoseFinding R package and how to use its functions to implement the MCP-Mod methodology. The course ends with a review of regulatory considerations.
Speaker
About the Speaker
Frank Bretz
Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the incoming editor of Statistics in Biopharmaceutical Research. He has authored or co-authored more than 120 articles in peer-reviewed journals and four books.
Björn Bornkamp
Björn Bornkamp works as a Senior Expert Statistical Methodologist in the Statistical Methodology group at Novartis Pharmaceuticals. He has research and practical experience in the design and analysis of dose-finding studies and the interface of pharmacometrics and statistics. He joined Novartis in 2010 after obtaining a PhD in Statistics from the Dortmund University of Technology in Germany.
Rob Hemmings
Rob Hemmings has been with the Medicines and Healthcare products Regulatory Agency for 16 years and heads the group of medical statisticians and pharmacokineticists. Much of Rob’s time is spent educating medical colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a member of the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and the chair of the CHMP’s Scientific Advice Working Party. These positions, and involvement at the Biostatistics Working Party of CHMP and the EMA’s extrapolation and modelling and simulation groups, have presented the opportunity for pursue a particular interest in understanding ‘dose’ and he has been actively involved in recent EMA initiatives in this area.
Agenda
9.30 - 10.00
Registration
10.00 - 17.00
Day 1
9.00 - 16.30
Day 2
Registration
PSI Members
£495 + VAT
Non - Members
£570 + VAT (includes PSI membership for 1 year)
Registration costs includes lunch and refreshments PSI are holding a limited number of hotel rooms until the 31st January which will be allocated on a first come first served basis.
Frank Bretz & Björn Bornkamp
Statistical Methodology and Consulting, Novartis Pharma
including regulatory perspectives from Rob Hemmings
Statistics and Pharmacokinetics Unit Manager, MHRA, UK
This course will introduce and discuss methods for Phase II dose finding studies, including a review of basic multiple comparisons and modelling methods, as traditionally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod, combining multiple comparisons and modelling, will be the focus of the course. Click here to see the full event flyer
The first day will provide an overview of dose finding in drug development. The application of multiple comparison procedures (MCP) and modelling approaches (Mod) will then be covered, including a review of contrast tests as well as nonlinear regression methods for dose response and target dose estimation. Then a step-by-step description of MCP-Mod will be provided, including a detailed discussion of its five main steps across the design and analysis stages:
Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
Derivation of optimum contrast coefficients, such that the marginal power to detect a specific dose response shape associated with the respective candidate model is maximized.
Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
Model selection or model averaging, provided statistical significance has been shown in the previous step.
Use the selected model(s) to produce inferences on adequate doses, employing a model-based approach.
MCP-Mod will first be introduced in its originally published version for a single, normally distributed efficacy endpoint. The extension of this framework will be described for count data and time-to-event endpoints as well as situations involving generalized non-linear models, linear and non-linear mixed effects models, and Cox proportional hazards models.
Day 2
On day two, considerations will be given to practical aspects around the design and analysis of dose finding trials using MCP-Mod. This includes importantly a discussion of its design aspects, in particular sample size derivations. As MCP-Mod is a hybrid procedure, focusing on hypothesis testing and estimation, sample size calculation procedures for both objectives will be presented and their application on the design illustrated with a real dose finding study. A variety of further practical considerations will be discussed that summarizes the collective experience over the past 10 years in using MCP-Mod in Phase II dose finding trials. The application of the DoseFinding R package will be demonstrated in detail, including a description of functions for the design and analysis of dose finding trials using MCP, Mod or MCP-Mod. Hands-on exercises allow the course attendees to the experience the capabilities of the DoseFinding R package and how to use its functions to implement the MCP-Mod methodology. The course ends with a review of regulatory considerations.
Speaker
About the Speaker
Frank Bretz
Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the incoming editor of Statistics in Biopharmaceutical Research. He has authored or co-authored more than 120 articles in peer-reviewed journals and four books.
Björn Bornkamp
Björn Bornkamp works as a Senior Expert Statistical Methodologist in the Statistical Methodology group at Novartis Pharmaceuticals. He has research and practical experience in the design and analysis of dose-finding studies and the interface of pharmacometrics and statistics. He joined Novartis in 2010 after obtaining a PhD in Statistics from the Dortmund University of Technology in Germany.
Rob Hemmings
Rob Hemmings has been with the Medicines and Healthcare products Regulatory Agency for 16 years and heads the group of medical statisticians and pharmacokineticists. Much of Rob’s time is spent educating medical colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a member of the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and the chair of the CHMP’s Scientific Advice Working Party. These positions, and involvement at the Biostatistics Working Party of CHMP and the EMA’s extrapolation and modelling and simulation groups, have presented the opportunity for pursue a particular interest in understanding ‘dose’ and he has been actively involved in recent EMA initiatives in this area.
Agenda
9.30 - 10.00
Registration
10.00 - 17.00
Day 1
9.00 - 16.30
Day 2
Registration
PSI Members
£495 + VAT
Non - Members
£570 + VAT (includes PSI membership for 1 year)
Registration costs includes lunch and refreshments PSI are holding a limited number of hotel rooms until the 31st January which will be allocated on a first come first served basis.
Frank Bretz & Björn Bornkamp
Statistical Methodology and Consulting, Novartis Pharma
including regulatory perspectives from Rob Hemmings
Statistics and Pharmacokinetics Unit Manager, MHRA, UK
This course will introduce and discuss methods for Phase II dose finding studies, including a review of basic multiple comparisons and modelling methods, as traditionally used in these studies. A unified strategy for designing and analysing dose finding trials denoted MCP-Mod, combining multiple comparisons and modelling, will be the focus of the course. Click here to see the full event flyer
The first day will provide an overview of dose finding in drug development. The application of multiple comparison procedures (MCP) and modelling approaches (Mod) will then be covered, including a review of contrast tests as well as nonlinear regression methods for dose response and target dose estimation. Then a step-by-step description of MCP-Mod will be provided, including a detailed discussion of its five main steps across the design and analysis stages:
Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
Derivation of optimum contrast coefficients, such that the marginal power to detect a specific dose response shape associated with the respective candidate model is maximized.
Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
Model selection or model averaging, provided statistical significance has been shown in the previous step.
Use the selected model(s) to produce inferences on adequate doses, employing a model-based approach.
MCP-Mod will first be introduced in its originally published version for a single, normally distributed efficacy endpoint. The extension of this framework will be described for count data and time-to-event endpoints as well as situations involving generalized non-linear models, linear and non-linear mixed effects models, and Cox proportional hazards models.
Day 2
On day two, considerations will be given to practical aspects around the design and analysis of dose finding trials using MCP-Mod. This includes importantly a discussion of its design aspects, in particular sample size derivations. As MCP-Mod is a hybrid procedure, focusing on hypothesis testing and estimation, sample size calculation procedures for both objectives will be presented and their application on the design illustrated with a real dose finding study. A variety of further practical considerations will be discussed that summarizes the collective experience over the past 10 years in using MCP-Mod in Phase II dose finding trials. The application of the DoseFinding R package will be demonstrated in detail, including a description of functions for the design and analysis of dose finding trials using MCP, Mod or MCP-Mod. Hands-on exercises allow the course attendees to the experience the capabilities of the DoseFinding R package and how to use its functions to implement the MCP-Mod methodology. The course ends with a review of regulatory considerations.
Speaker
About the Speaker
Frank Bretz
Frank Bretz joined Novartis in 2004, where he is currently Global Head of the Statistical Methodology and Consulting group. He has supported the methodological development in various areas of drug development, including dose-finding, multiple comparisons, and adaptive designs. He is a co-founding editor of the Springer Series in Pharmaceutical Statistics and the incoming editor of Statistics in Biopharmaceutical Research. He has authored or co-authored more than 120 articles in peer-reviewed journals and four books.
Björn Bornkamp
Björn Bornkamp works as a Senior Expert Statistical Methodologist in the Statistical Methodology group at Novartis Pharmaceuticals. He has research and practical experience in the design and analysis of dose-finding studies and the interface of pharmacometrics and statistics. He joined Novartis in 2010 after obtaining a PhD in Statistics from the Dortmund University of Technology in Germany.
Rob Hemmings
Rob Hemmings has been with the Medicines and Healthcare products Regulatory Agency for 16 years and heads the group of medical statisticians and pharmacokineticists. Much of Rob’s time is spent educating medical colleagues in the importance and artistry of clinical trial statistics; their use in proof and in obfuscation. Rob is a member of the European Medicines Agency Committee for Medicinal Products for Human Use (CHMP) and the chair of the CHMP’s Scientific Advice Working Party. These positions, and involvement at the Biostatistics Working Party of CHMP and the EMA’s extrapolation and modelling and simulation groups, have presented the opportunity for pursue a particular interest in understanding ‘dose’ and he has been actively involved in recent EMA initiatives in this area.
Agenda
9.30 - 10.00
Registration
10.00 - 17.00
Day 1
9.00 - 16.30
Day 2
Registration
PSI Members
£495 + VAT
Non - Members
£570 + VAT (includes PSI membership for 1 year)
Registration costs includes lunch and refreshments PSI are holding a limited number of hotel rooms until the 31st January which will be allocated on a first come first served basis.
PSI Book Club: Change: How organisations achieve hard-to-imagine results in uncertain and volatile times
Organizations have to adapt to the transforming landscape of our industry to ensure they continue to be successful in the future. Many of us are feeling the impact of organizational change. By reading John P Kotter’s book we can understand about organizational change and learn how to thrive, rather than just survive, through change.
Change, by John P Kotter (and his team), is a summary of all that he has learned over his decades of research and leading change. His book describes why many current approaches to change are inadequate and explains why new solutions need to give people a voice and a role in a new, change-embracing organization.
Develop your understanding of organisational change and become empowered to be part of your organisation’s change, by reading Change by John P Kotter and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply knowledge 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.
PSI Training Course: Propensity Scores: Practical Application in Non-randomised Studies
The course will introduce the topic of propensity scores and the use of external data. Covering the topics of matching and weighting as well as more advance topics of high dimension propensity scores, multi-valued treatments, double robustness and time-varying scenarios. There will be the opportunity to participate in some hands on practical exercises in R.
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.
Making Estimands Work - Practical Approaches with Implementation in Data Standards
This event will discuss the impact of the estimand framework on data flow and data handling for analysis datasets (ADaM). What are the considerations to produce data sets suitable for estimation of estimands and traceability of the occurrence of intercurrent events. This webinar will include tips for best practice, based on the White paper Implementation of ICH E9(R1) Estimands Framework using Data Standards.
PSI/EFSPI Biomarker SIG Webinar: Statistical Methods for ctDNA Data
This webinar will describe what ctDNA is and what the key challenges are for analysing it. We will then summarise and review methods that were published over the last few years for analysing ctDNA data.
The morning will be dedicated to networking opportunities, helping attendees build connections with peers and professionals. In the afternoon, participants can attend a series of talks and workshops, including a career panel featuring speakers from both academia and industry, offering insights into various career paths. There will also be a statistical workshop, as well as the opportunity to learn about and debate some of the hot topics in the world of medical statistics. To wrap up the day, we’re exploring interest in an informal after-work networking event for those keen to continue the conversation.
Joint PSI/EFSPI, Phuse, ASA Safety Working Group Webinar Series: Overview of safety analysis and implementation process of safety surveillance in ongoing studies
The session will have three speakers and a discussant. This session will be the first in a series of webinars around safety in clinical trials. The series is co-organized by PSI, ASA-Biopharm safety working group and PHUSE.
This two-afternoon virtual course provides a practical introduction to adaptive clinical trials, focusing on the concepts, applications, and regulatory principles outlined in ICH E20 through real-world examples and case studies.
PSI Vaccines SIG Webinar: Statistical Immune Correlate Analysis of Hemagglutination Inhibition Titers for an mRNA-based Influenza Vaccine
This 1-hour webinar is designed for statisticians with an interest in vaccine development, to learn about the recent application of statistical immune correlate analysis in vaccine development. Specifically, an application of such analyses to evaluate hemagglutination inhibition titers for an influenza vaccine
PSI Careers - MEDMathS: Medicine Empowered by Data, Maths and Statistics
Date: Wednesday 4th November 2026
A careers talk about medical statistics and how it plays a crucial role in developing new medicines. Learn about the field of medical statistics and how it plays a crucial role in developing groundbreaking new medicines, vaccines and healthcare products.
Date: 18 November 2026
This is an excellent opportunity for students to find out more about the field of medical statistics, talk to people from different organisations and make contacts for the future. All students currently studying for a mathematics or statistics-related BSc, MSc or PhD are invited to attend, and we welcome interest from exhibitors too.
Aligning Estimation with the Clinical Question of Interest
This webinar will focus on aligning estimation to estimands. How do different strategies for handling intercurrent events and missing data handling influence the choice of estimation method, with illustration using a case study.
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 Careers Coaching Series: Peer Support Initiative
This 10-month peer support programme is aimed at professionals with five or more years of experience who are seeking structured development and connection with peers at a similar career stage. Through 5 bi-monthly topics, participants will engage in coach-led presentations, small-group discussions, and regular progress reviews focused on achieving tangible outcomes.
In this vital role you will generate evidence to meet Health Technology Assessment (HTA) requirements, while ensuring that the analyses performed meet required standards and are robust and valid.
Bristol Myers Squibb - Director, Statistical Methodology and Innovation
Lead the development of innovative statistical methods, provides expert consulting, oversees tools and software, and mentors team members while collaborating cross-functionally to address complex drug development challenges.
Phastar – Associate Director, Statistics – Real World Evidence (RWE)
As an Associate Director, Statistics (RWE) you will focus on supporting one of our key pharmaceutical clients within our FSP function. This will be a hands-on technical role, with oversight responsibilities and cross-functional exposure.
Phastar – Principal Statistician – Real World Evidence (RWE)
We are seeking an experienced Statistician to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients, at Principal level.
We are seeking an experienced Statistician to join our FSP team to support one of our fantastic and well-known global pharmaceutical clients, at either Senior or Principal levels.
This position is deal for a statistician who values ownership, collaboration, and using data to enable confident development decisions and to support regulatory submissions.
