Date: Tuesday 12th April 2022 Time: 14:00-15:00 BST | 15:00-16:00 CEST Speaker: Tim Holland-Letz
Who is this event intended for? Statisticians in Pharma.
What is the benefit of attending? The chance to learn about new study designs.
Registration
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = Free of charge
To register for the session, please click here.
Overview
In practical dose response trials, especially in a cell culture context, experimental designs to establish functional relationships between dose and effect of a substance are generally chosen based on simple rules of thumb. These designs are generally reasonably effective, but not optimal.
In this webinar we give an overview over the statistical optimal design approach in this context. We show how optimal designs can be constructed, covering mainly all-purpose designs (D-optimality) but also more specific designs (c-optimality). We introduce a graphical representation. Next, we show how these concepts can be extended to trials aiming to estimate the interaction between two different substances given simultaneously.
Finally, we present an R-Shiny application which allows construction of optimal designs in most of these contexts with a minimum of theoretical knowledge.
Speaker details
Speaker
Biography
Tim Holland-Letz
Tim Holland-Letz studied Statistics at the Technical University of Dortmund. In 2010, he completed his PhD in the same subject in cooperation with the Department of Mathematics of the Ruhr-University Bochum, focusing on the topic of optimal experimental design. At the same time he was employed at the Department of Medical Informatics and Biometry also at the Ruhr-University, working mainly on clinical studies and general applied statistics in medical research. In 2011, he moved to the Biostatistics Division within the Deutsches Krebsforschungszentrum (DKFZ) in Heidelberg. From this moment on, he has concentrated more on preclinical studies, with a special focus on optimal experimental designs and dose-response analysis. However, he still works on more or less all kinds of statistical problems arising in research and preclinical studies. In 2019 he completed his Habilitation in Medical Biostatistics at the University of Heidelberg.
Scientific Meetings
PSI Pre-Clinical SIG Webinar: Optimal experimental design in preclinical dose-response studies
Date: Tuesday 12th April 2022 Time: 14:00-15:00 BST | 15:00-16:00 CEST Speaker: Tim Holland-Letz
Who is this event intended for? Statisticians in Pharma.
What is the benefit of attending? The chance to learn about new study designs.
Registration
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = Free of charge
To register for the session, please click here.
Overview
In practical dose response trials, especially in a cell culture context, experimental designs to establish functional relationships between dose and effect of a substance are generally chosen based on simple rules of thumb. These designs are generally reasonably effective, but not optimal.
In this webinar we give an overview over the statistical optimal design approach in this context. We show how optimal designs can be constructed, covering mainly all-purpose designs (D-optimality) but also more specific designs (c-optimality). We introduce a graphical representation. Next, we show how these concepts can be extended to trials aiming to estimate the interaction between two different substances given simultaneously.
Finally, we present an R-Shiny application which allows construction of optimal designs in most of these contexts with a minimum of theoretical knowledge.
Speaker details
Speaker
Biography
Tim Holland-Letz
Tim Holland-Letz studied Statistics at the Technical University of Dortmund. In 2010, he completed his PhD in the same subject in cooperation with the Department of Mathematics of the Ruhr-University Bochum, focusing on the topic of optimal experimental design. At the same time he was employed at the Department of Medical Informatics and Biometry also at the Ruhr-University, working mainly on clinical studies and general applied statistics in medical research. In 2011, he moved to the Biostatistics Division within the Deutsches Krebsforschungszentrum (DKFZ) in Heidelberg. From this moment on, he has concentrated more on preclinical studies, with a special focus on optimal experimental designs and dose-response analysis. However, he still works on more or less all kinds of statistical problems arising in research and preclinical studies. In 2019 he completed his Habilitation in Medical Biostatistics at the University of Heidelberg.
Training Courses
PSI Pre-Clinical SIG Webinar: Optimal experimental design in preclinical dose-response studies
Date: Tuesday 12th April 2022 Time: 14:00-15:00 BST | 15:00-16:00 CEST Speaker: Tim Holland-Letz
Who is this event intended for? Statisticians in Pharma.
What is the benefit of attending? The chance to learn about new study designs.
Registration
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = Free of charge
To register for the session, please click here.
Overview
In practical dose response trials, especially in a cell culture context, experimental designs to establish functional relationships between dose and effect of a substance are generally chosen based on simple rules of thumb. These designs are generally reasonably effective, but not optimal.
In this webinar we give an overview over the statistical optimal design approach in this context. We show how optimal designs can be constructed, covering mainly all-purpose designs (D-optimality) but also more specific designs (c-optimality). We introduce a graphical representation. Next, we show how these concepts can be extended to trials aiming to estimate the interaction between two different substances given simultaneously.
Finally, we present an R-Shiny application which allows construction of optimal designs in most of these contexts with a minimum of theoretical knowledge.
Speaker details
Speaker
Biography
Tim Holland-Letz
Tim Holland-Letz studied Statistics at the Technical University of Dortmund. In 2010, he completed his PhD in the same subject in cooperation with the Department of Mathematics of the Ruhr-University Bochum, focusing on the topic of optimal experimental design. At the same time he was employed at the Department of Medical Informatics and Biometry also at the Ruhr-University, working mainly on clinical studies and general applied statistics in medical research. In 2011, he moved to the Biostatistics Division within the Deutsches Krebsforschungszentrum (DKFZ) in Heidelberg. From this moment on, he has concentrated more on preclinical studies, with a special focus on optimal experimental designs and dose-response analysis. However, he still works on more or less all kinds of statistical problems arising in research and preclinical studies. In 2019 he completed his Habilitation in Medical Biostatistics at the University of Heidelberg.
Journal Club
PSI Pre-Clinical SIG Webinar: Optimal experimental design in preclinical dose-response studies
Date: Tuesday 12th April 2022 Time: 14:00-15:00 BST | 15:00-16:00 CEST Speaker: Tim Holland-Letz
Who is this event intended for? Statisticians in Pharma.
What is the benefit of attending? The chance to learn about new study designs.
Registration
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = Free of charge
To register for the session, please click here.
Overview
In practical dose response trials, especially in a cell culture context, experimental designs to establish functional relationships between dose and effect of a substance are generally chosen based on simple rules of thumb. These designs are generally reasonably effective, but not optimal.
In this webinar we give an overview over the statistical optimal design approach in this context. We show how optimal designs can be constructed, covering mainly all-purpose designs (D-optimality) but also more specific designs (c-optimality). We introduce a graphical representation. Next, we show how these concepts can be extended to trials aiming to estimate the interaction between two different substances given simultaneously.
Finally, we present an R-Shiny application which allows construction of optimal designs in most of these contexts with a minimum of theoretical knowledge.
Speaker details
Speaker
Biography
Tim Holland-Letz
Tim Holland-Letz studied Statistics at the Technical University of Dortmund. In 2010, he completed his PhD in the same subject in cooperation with the Department of Mathematics of the Ruhr-University Bochum, focusing on the topic of optimal experimental design. At the same time he was employed at the Department of Medical Informatics and Biometry also at the Ruhr-University, working mainly on clinical studies and general applied statistics in medical research. In 2011, he moved to the Biostatistics Division within the Deutsches Krebsforschungszentrum (DKFZ) in Heidelberg. From this moment on, he has concentrated more on preclinical studies, with a special focus on optimal experimental designs and dose-response analysis. However, he still works on more or less all kinds of statistical problems arising in research and preclinical studies. In 2019 he completed his Habilitation in Medical Biostatistics at the University of Heidelberg.
Webinars
PSI Pre-Clinical SIG Webinar: Optimal experimental design in preclinical dose-response studies
Date: Tuesday 12th April 2022 Time: 14:00-15:00 BST | 15:00-16:00 CEST Speaker: Tim Holland-Letz
Who is this event intended for? Statisticians in Pharma.
What is the benefit of attending? The chance to learn about new study designs.
Registration
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = Free of charge
To register for the session, please click here.
Overview
In practical dose response trials, especially in a cell culture context, experimental designs to establish functional relationships between dose and effect of a substance are generally chosen based on simple rules of thumb. These designs are generally reasonably effective, but not optimal.
In this webinar we give an overview over the statistical optimal design approach in this context. We show how optimal designs can be constructed, covering mainly all-purpose designs (D-optimality) but also more specific designs (c-optimality). We introduce a graphical representation. Next, we show how these concepts can be extended to trials aiming to estimate the interaction between two different substances given simultaneously.
Finally, we present an R-Shiny application which allows construction of optimal designs in most of these contexts with a minimum of theoretical knowledge.
Speaker details
Speaker
Biography
Tim Holland-Letz
Tim Holland-Letz studied Statistics at the Technical University of Dortmund. In 2010, he completed his PhD in the same subject in cooperation with the Department of Mathematics of the Ruhr-University Bochum, focusing on the topic of optimal experimental design. At the same time he was employed at the Department of Medical Informatics and Biometry also at the Ruhr-University, working mainly on clinical studies and general applied statistics in medical research. In 2011, he moved to the Biostatistics Division within the Deutsches Krebsforschungszentrum (DKFZ) in Heidelberg. From this moment on, he has concentrated more on preclinical studies, with a special focus on optimal experimental designs and dose-response analysis. However, he still works on more or less all kinds of statistical problems arising in research and preclinical studies. In 2019 he completed his Habilitation in Medical Biostatistics at the University of Heidelberg.
Careers Meetings
PSI Pre-Clinical SIG Webinar: Optimal experimental design in preclinical dose-response studies
Date: Tuesday 12th April 2022 Time: 14:00-15:00 BST | 15:00-16:00 CEST Speaker: Tim Holland-Letz
Who is this event intended for? Statisticians in Pharma.
What is the benefit of attending? The chance to learn about new study designs.
Registration
You can now register for this event. Registration fees are as follows:
- Members of PSI = Free of charge
- Non-Members of PSI = Free of charge
To register for the session, please click here.
Overview
In practical dose response trials, especially in a cell culture context, experimental designs to establish functional relationships between dose and effect of a substance are generally chosen based on simple rules of thumb. These designs are generally reasonably effective, but not optimal.
In this webinar we give an overview over the statistical optimal design approach in this context. We show how optimal designs can be constructed, covering mainly all-purpose designs (D-optimality) but also more specific designs (c-optimality). We introduce a graphical representation. Next, we show how these concepts can be extended to trials aiming to estimate the interaction between two different substances given simultaneously.
Finally, we present an R-Shiny application which allows construction of optimal designs in most of these contexts with a minimum of theoretical knowledge.
Speaker details
Speaker
Biography
Tim Holland-Letz
Tim Holland-Letz studied Statistics at the Technical University of Dortmund. In 2010, he completed his PhD in the same subject in cooperation with the Department of Mathematics of the Ruhr-University Bochum, focusing on the topic of optimal experimental design. At the same time he was employed at the Department of Medical Informatics and Biometry also at the Ruhr-University, working mainly on clinical studies and general applied statistics in medical research. In 2011, he moved to the Biostatistics Division within the Deutsches Krebsforschungszentrum (DKFZ) in Heidelberg. From this moment on, he has concentrated more on preclinical studies, with a special focus on optimal experimental designs and dose-response analysis. However, he still works on more or less all kinds of statistical problems arising in research and preclinical studies. In 2019 he completed his Habilitation in Medical Biostatistics at the University of Heidelberg.
Upcoming Events
PSI Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Introduction to Industry Training (ITIT) Course - 2024/2025
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
PSI Training Course: Regulatory Guidelines for Statisticians
This 2-day course is designed to provide a comprehensive understanding of the regulatory guidelines affecting statisticians in the pharmaceutical industry, including the latest updates in the field. The course will cover key International Council for Harmonisation (ICH) guidelines and other key regional regulatory agency documents.
In this event, we’ll start with a general introduction to hierarchical composite endpoints and an overview of common analysis methods including win ratio, win odds, and net benefit. Then, the practical considerations will be illustrated through case studies from clinical trials in heart failure and chronic kidney disease. We conclude with a discussion and a Q&A.
Joint PSI/EFSPI Pre-Clinical SIG Webinar: Virtual Control Groups in Toxicity Studies
Lea Vaas will present how replacement of concurrent control animals by Virtual Control Groups (VCGs) in systemic toxicity studies may help in contributing to the 3R's principle of animal experimentation: Reduce, Refine, Replace.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Statisticians in the Pharmaceutical Industry Executive Office: c/o MCI UK Ltd | Unit 24/22 South | Building 4000 | Langstone Park| Langstone Road | Havant | PO9 1SA | UK