Past PSI Events

Conferences

Dose Finding in Drug Development using MCP-Mod

Hilton Garden Inn Hotel, Heathrow Airport

presented by

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

CLICK HERE TO REGISTER!


Day 1

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:

  1. Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
  2. 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.
  3. Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
  4. Model selection or model averaging, provided statistical significance has been shown in the previous step.
  5. 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.

Rob Hemmings
Rob Hemmings
CLICK HERE TO REGISTER!

Please contact the PSI Secretariat on +44 (0) 1730 715 235 or at PSI@mci-group.com for further information.

Scientific Meetings

Dose Finding in Drug Development using MCP-Mod

Hilton Garden Inn Hotel, Heathrow Airport

presented by

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

CLICK HERE TO REGISTER!


Day 1

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:

  1. Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
  2. 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.
  3. Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
  4. Model selection or model averaging, provided statistical significance has been shown in the previous step.
  5. 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.

Rob Hemmings
Rob Hemmings
CLICK HERE TO REGISTER!

Please contact the PSI Secretariat on +44 (0) 1730 715 235 or at PSI@mci-group.com for further information.

Training Courses

Dose Finding in Drug Development using MCP-Mod

Hilton Garden Inn Hotel, Heathrow Airport

presented by

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

CLICK HERE TO REGISTER!


Day 1

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:

  1. Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
  2. 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.
  3. Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
  4. Model selection or model averaging, provided statistical significance has been shown in the previous step.
  5. 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.

Rob Hemmings
Rob Hemmings
CLICK HERE TO REGISTER!

Please contact the PSI Secretariat on +44 (0) 1730 715 235 or at PSI@mci-group.com for further information.

Journal Club

Dose Finding in Drug Development using MCP-Mod

Hilton Garden Inn Hotel, Heathrow Airport

presented by

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

CLICK HERE TO REGISTER!


Day 1

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:

  1. Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
  2. 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.
  3. Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
  4. Model selection or model averaging, provided statistical significance has been shown in the previous step.
  5. 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.

Rob Hemmings
Rob Hemmings
CLICK HERE TO REGISTER!

Please contact the PSI Secretariat on +44 (0) 1730 715 235 or at PSI@mci-group.com for further information.

Webinars

Dose Finding in Drug Development using MCP-Mod

Hilton Garden Inn Hotel, Heathrow Airport

presented by

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

CLICK HERE TO REGISTER!


Day 1

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:

  1. Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
  2. 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.
  3. Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
  4. Model selection or model averaging, provided statistical significance has been shown in the previous step.
  5. 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.

Rob Hemmings
Rob Hemmings
CLICK HERE TO REGISTER!

Please contact the PSI Secretariat on +44 (0) 1730 715 235 or at PSI@mci-group.com for further information.

Careers Meetings

Dose Finding in Drug Development using MCP-Mod

Hilton Garden Inn Hotel, Heathrow Airport

presented by

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

CLICK HERE TO REGISTER!


Day 1

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:

  1. Identification of candidate parametric models, which are likely to represent the underlying dose response shape.
  2. 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.
  3. Evaluation of the significance of the individual models in terms of a multiple contrast test based on the previously derived optimal contrast coefficients.
  4. Model selection or model averaging, provided statistical significance has been shown in the previous step.
  5. 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.

Rob Hemmings
Rob Hemmings
CLICK HERE TO REGISTER!

Please contact the PSI Secretariat on +44 (0) 1730 715 235 or at PSI@mci-group.com for further information.

Upcoming Events

PSI Introduction to Industry Training (ITIT) Course - 2025/2026

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.

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.

Urgent Meeting: Medical Statistician Apprenticeship Scheme

The UK government have recently announced that level 7 apprenticeships must be fully funded by the employer from January 2026, for any apprentice over the age of 21. With funding for MSc's at an all time low, and universities courses facing closures, the apprenticeship scheme remains as important as ever, as a tool to encourage new statisticians into our industry. In this dedicated meeting, Valerie Millar (chair of the apprenticeship scheme) will provide full updates on the government changes and seek feedback and ideas from employers, universities and apprentices on how to keep this scheme successfully running for many years to come.

PSI Webinar: Methodology and first results of the iRISE (improving Reproducibility In SciencE) consortium

This 1-hour webinar will be an opportunity to hear about the methodology and first results of the iRISE consortium. iRISE is working towards a better understanding of reproducibility and the interventions that work to improve it. At the end of the presentation there will also be the opportunity to ask questions.

One-day Event: Change Management for Moving to R/Open-Source

This one-day event focuses on the comprehensive management of transitioning to R/Open-Source, addressing the challenges and providing actionable insights. Attendees will participate in sessions covering essential topics such as training best practices, creating strategic plans, making the case to senior management, and managing both statistical and programming aspects of the transition.

PSI Vaccines SIG Webinar: Challenges in Estimating Vaccine Effectiveness Against Progression to Severe Disease

This is a free webinar on Challenges in Estimating Vaccine Effectiveness Against Progression to Severe Disease.

PSI Book Club - The Art of Explanation: How to Communicate with Clarity and Confidence

Develop your non-technical skills by reading The Art of Explanation by Ros Atkins and joining the Sept-Dec 2025 book club. You will be invited to join facilitated discussions of the concepts and ideas and apply skills from the book in-between sessions.

PSI Training Course: Pediatric Extrapolation

This course is aimed at biostatisticians with no or some pediatric drug development experience who are interested to further their understanding. We will give you an introduction to the pediatric drug development landscape. This will include identifying the key regulations and processes governing pediatric development, a discussion on the needs and challenges when conducting pediatric research and a focus on the ways to overcome these challenges from a statistical perspective.

PSI Career Young Virtual Event (Q3 2025)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

EFSPI/PSI Causal Inference SIG Webinar: Instrumental Variable Methods

The webinar is targeted at statisticians working in the pharmaceutical industry, and the objective is to 1) provide a basic understanding of IV methodology including how it relates to causal inference, and 2) present two inspirational pharma-relevant applications.

PSI Career Young Virtual Event (Q4 2025)

This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.

Latest Jobs

Principal Statistician - Labcorp

This is an exciting, new opportunity for an experienced Statistician looking to take the next step in their career. Offered as a remote or hybrid position aligned with our site in Harrogate, North Yorkshire.