In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
Registration
This Webinar is free to attend, to register please click here.
Jürgen Hummel joined PPD near Glasgow (Scotland) in 2006, where he is Senior Director, Statistical Science. He heads up the statistical science track within PPD Biostatistics and provides statistical consultancy both internally and externally. Specifically, he has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up 8 year ago. In his career he held a variety of technical and managerial positions within the biostatistics department of different organizations, predominantly within the CRO industry. Jürgen earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and has been a chartered statistician with the Royal Statistical Society since 2006.
Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 companies and works on various topics around estimands in oncology. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 20 years in clinical research and development in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
Scientific Meetings
PSI Webinar: Adaptive design: updated draft FDA guidance and its implications
In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
Registration
This Webinar is free to attend, to register please click here.
Jürgen Hummel joined PPD near Glasgow (Scotland) in 2006, where he is Senior Director, Statistical Science. He heads up the statistical science track within PPD Biostatistics and provides statistical consultancy both internally and externally. Specifically, he has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up 8 year ago. In his career he held a variety of technical and managerial positions within the biostatistics department of different organizations, predominantly within the CRO industry. Jürgen earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and has been a chartered statistician with the Royal Statistical Society since 2006.
Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 companies and works on various topics around estimands in oncology. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 20 years in clinical research and development in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
Training Courses
PSI Webinar: Adaptive design: updated draft FDA guidance and its implications
In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
Registration
This Webinar is free to attend, to register please click here.
Jürgen Hummel joined PPD near Glasgow (Scotland) in 2006, where he is Senior Director, Statistical Science. He heads up the statistical science track within PPD Biostatistics and provides statistical consultancy both internally and externally. Specifically, he has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up 8 year ago. In his career he held a variety of technical and managerial positions within the biostatistics department of different organizations, predominantly within the CRO industry. Jürgen earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and has been a chartered statistician with the Royal Statistical Society since 2006.
Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 companies and works on various topics around estimands in oncology. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 20 years in clinical research and development in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
Journal Club
PSI Webinar: Adaptive design: updated draft FDA guidance and its implications
In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
Registration
This Webinar is free to attend, to register please click here.
Jürgen Hummel joined PPD near Glasgow (Scotland) in 2006, where he is Senior Director, Statistical Science. He heads up the statistical science track within PPD Biostatistics and provides statistical consultancy both internally and externally. Specifically, he has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up 8 year ago. In his career he held a variety of technical and managerial positions within the biostatistics department of different organizations, predominantly within the CRO industry. Jürgen earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and has been a chartered statistician with the Royal Statistical Society since 2006.
Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 companies and works on various topics around estimands in oncology. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 20 years in clinical research and development in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
Webinars
PSI Webinar: Adaptive design: updated draft FDA guidance and its implications
In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
Registration
This Webinar is free to attend, to register please click here.
Jürgen Hummel joined PPD near Glasgow (Scotland) in 2006, where he is Senior Director, Statistical Science. He heads up the statistical science track within PPD Biostatistics and provides statistical consultancy both internally and externally. Specifically, he has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up 8 year ago. In his career he held a variety of technical and managerial positions within the biostatistics department of different organizations, predominantly within the CRO industry. Jürgen earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and has been a chartered statistician with the Royal Statistical Society since 2006.
Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 companies and works on various topics around estimands in oncology. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 20 years in clinical research and development in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
Careers Meetings
PSI Webinar: Adaptive design: updated draft FDA guidance and its implications
In September 2018 the FDA published a guidance on adaptive design for clinical trials of drugs and biologics, updating (not finalizing) its initial draft from February 2010. The main focus of the webinar will be to provide an overview of its main contents, which will be presented by Jürgen Hummel (PPD). In addition, Kaspar Rufibach (Roche) will introduce an open-source statistical software for adaptive designs, RPACT (an R package that enables the design and analysis of confirmatory adaptive clinical trials). Kit Roes will also comment on the guidance from a European Regulatory perspective, which will be followed by a brief panel discussion.
Registration
This Webinar is free to attend, to register please click here.
Jürgen Hummel joined PPD near Glasgow (Scotland) in 2006, where he is Senior Director, Statistical Science. He heads up the statistical science track within PPD Biostatistics and provides statistical consultancy both internally and externally. Specifically, he has been leading PPD’s cross-departmental Adaptive Design Working Group since it was set up 8 year ago. In his career he held a variety of technical and managerial positions within the biostatistics department of different organizations, predominantly within the CRO industry. Jürgen earned a Diplom (German equivalent of a master’s degree) in mathematics and economics at Augsburg University, Germany, and has been a chartered statistician with the Royal Statistical Society since 2006.
Kaspar Rufibach is a member of Roche's Methods, Collaboration, and Outreach group and located in Basel. He does methodological research, provides consulting to Roche statisticians and broader project teams, gives biostatistics trainings for statisticians and non-statisticians in- and externally, mentors students, and interacts with external partners in industry and the academic community in various working groups. He has co-founded and co-leads the Oncology estimand Working group that currently has 31 members from 19 companies and works on various topics around estimands in oncology. Research interests are methods to optimize study designs, advanced survival analysis, probability of success, estimands, estimation of treatment effects in subgroups, and general nonparametric statistics. Before joining Roche, Kaspar received training and worked as a statistician at the Universities of Bern, Stanford, and Zurich.
Kit Roes is Professor of Clinical Trial Methodology at the Julius Center of the University Medical Center Utrecht. His research focus is on design and analysis of clinical trials, with an emphasis of innovative designs, rare diseases and bridging the gap between clinical trials and real world evidence. He participates in the Regulatory Science Network Netherlands, is chair of Methodology at the Dutch Medicine Evaluation Board and member of the Biostatistics Working Party of the EMA. He serves on multiple Data and Safety Monitoring Boards. His experience includes over 20 years in clinical research and development in the pharmaceutical industry and academic life sciences, serving clinical research and drug development as expert as well as in different (international) senior management positions.
Upcoming Events
Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars
Our monthly webinar explores examples of innovative data visualisations relevant to our day to day work. Each month a new dataset is provided from a clinical trial or other relevant example, and participants are invited to submit a graphic that communicates interesting and relevant characteristics of the data.
The event will open with an overview on drug development in women’s health from a clinician perspective. This talk is followed by talks about statistical challenges when planning IVF studies and analysing the menstrual cycles.
This webinar will provide an overview of surrogacy for licensing and reimbursement. In turn, the need of extensions of the SPIRIT and CONSORT statement will be defined and outlined, with case studies to support.
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.
Joint PSI/EFSPI Data Science SIG Webinar: Developing Digital Measures (Digital Biomarkers) in Drug Development – insights from Mobilise D consortium
We will share a brief overview of what Mobilise D is and why it is an important step stone in the development of digital biomarkers, and how Mobilise D outputs can be relevant for you.
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 Webinar: Development of Gene Therapies: Strategic, Scientific, Regulatory and Access Considerations
This webinar will cover the history of cell/gene therapy, major regulatory advances, the role of quantitative scientists in drug development of these novel therapeutics, and discuss opportunities for innovation and product advancement.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
PSI Introduction to Industry Training (ITIT) Course - 2024/2025
An introductory course giving an overview of the pharmaceutical industry and the drug development process as a whole, aimed at those with 1-3 years' experience. It comprises of six 2-day sessions covering a range of topics including Research and Development, Toxicology, Data Management and the Role of a CRO, Clinical Trials, Reimbursement, and Marketing.
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