Provide a platform for statisticians from sponsors and CROs to working in the launch and lifecycle management (including traditional medical affairs area, commercialization, HTA (in collaboration with the respective ESIG)) and new evolving areas) to help each other in areas of pre-competitive collaboration.
Shape the industry to increase the influence of statisticians in launch and lifecycle and show how good looks like for the work of statisticians e.g. through case studies.
Drive scientific projects and innovation forward related to the field of Launch and Lifecycle.
Create a homepage for external communication
Collect case studies of how good looks like
Publish manuscripts in journals and communicate via other channels about:
The role statisticians do and can play in medical affairs and their imapct.
Innovative designs in medical affairs.
Use of registries in medical affairs.
Use of historical data in medical affairs.
Implementation of pragmatic studies in medical affairs.
Organize workshops and conference sessions around the topics mentioned above.
Public relation activities to show how statisticians and adata can help make better decisions.
Collaboration with non-statistical associations (e.g. medical) working in the field to improve the role of statistics.
Develop best practices for statisticians to be successful and efficent (evidence dissemination and resources, planning and strategic thinking.)
Alexander Schacht (Veramed) (Chair)
Jenny Devenport (Roche) (Co-Chair)
Anny Stari
Bob Shaw
Cornelia Dunger-Baldauf
Daniel Saure
David Lawrence
Frank Langer
Gbenga Kazeem
Imi Faghmous
Knut Richert
Lucy DeCosta
Martin Blogg
Pierre Mancini
Stefan Franzen
Slides from PSI Annual Conference 2022
Poster from EFSPI Regulatory Conference 2022
Contact Alexander Schacht or Jenny Devenport
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 webinar consists of three presentations providing examples of where Bayesian methods have been used within confirmatory settings.
We will present the most frequently asked questions in the post-marketing space, the reasons why SATs are not able to address these questions, and how statisticians might reasonably influence decision makers to consider alternatives.
This course will introduce participants to the key concepts and methods relevant for analysing clinical trials when some data are missing.
The meeting will consider the importance of patient-centric input into regulatory and HTA decision-making discussing the latest developments in the field and presenting industry examples.
The next book we are reading is "The 7 Habits of Highly Effective People" by Stephen R. Covey. This is a classic in the personal development genre.
PD Dr. Tölch will present a framework to foster efficient evidence generation in preclinical experiments and will illustrate the proposed approach using examples from various projects. This will be followed by Q&A.
Our speaker will share her experience in extending/innovating methodology and concepts developed in vaccine statistics to the analyses of pre-efficacy and efficacy trials of monoclonal antibodies.
A careers talk about medical statistics and how it plays a crucial role in developing new medicines
Please join us to hear Kristian Brock and Ying Yuan present their recent work for our next Journal Club webinar, as sponsored by Wiley.
This course describes calculations for sample size estimation in the design of clinical trials. It will highlight how the objectives of a clinical trial will impact on sample size calculations. The course is a practical course and all methods will be illustrated with examples and case studies.
In this webinar, you will get to know how an innovative adaptive design can increase the probability of success of your early phase clinical trial as well as hear the latest and greatest of the Machine Learning workstream from the Biomarkers ESIG.
This one-day event will establish a forum to engage with colleagues from a diverse range of backgrounds who are actively working on effective master protocol design, analysis, and execution.
This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Over the course of two sessions, a panel of 8 esteemed speakers will give an introduction to the topic, followed by a presentation of case studies & interactive panel discussion.
