Chemistry, Manufacturing and Control Statisticians, working in Europe for pharmaceutical companies and CROs active in R&D, and we seek to collaborate and exchange in any precompetitive topic of our field.
Formed as a SIG in 2024, we seek to:
CMC Statistical Network Europe (CSNE) are the application of statistics, data science, modelling and computing methods related to CMC technical development. The CSNE chair and steering committee are responsible for the oversight and implementation of CSNE initiatives as well as those of the CSNE Working Group (CSNEWG).
A. Primary interests of the CSNE:
(i) The biological, chemical, physical, engineering, analytical and pharmaceutical sciences for formulation, product development and manufacturing.
(ii) Regulatory issues governing statistical practices associated with (i).
b. In pursuit of these primary interests the CSNE seeks to:
(i) Promote the improvement of policies and regulations governing statistical practices and associated guidelines specific to CMC space.
(ii) Improve the practice of statistics as related to design, computing, evaluation, and reporting in the CMC space.
(iii) Promote research that adds tools to improve decision making and further the understanding of scientific studies in the CMC space.
| Name | Company/Institution |
|---|---|
| Kevin Lief (chair) | GSK |
| Beate Presser | Boehringer-Ingelheim |
| Christian Schmid | Roche |
| Jens Lamerz | |
| Martin Otava | Johnson & Johnson |
If you are interested in joining the CMC SIG, please email Kevin Lief.
Dates: Wednesday 2nd & Thursday 3rd October 2024 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.
Date: Tuesday 8th October 2024 This 1-hour webinar will be an opportunity to hear how JMP have been influential in the toxicity testing of an oncology formulation in a pre-clinical setting. At the end of the presentation there will also be the opportunity to ask questions.
Date: The Second Wednesday of every Month 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.
Date: Thursday 17th October 2024 In this webinar we will review the range of statistical methodologies used to harness the potential of Real-World Data (RWD) in clinical development, particularly in the context of rare diseases and small populations like paediatrics. The session will include theoretical understanding and practical case studies, with a special focus on Bayesian methods and causal inference.
Date: Wednesday 23rd October 2024 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.
Date: Wednesday 6th November 2024 A careers talk about medical statistics and how it plays a crucial role in developing new medicines
Date: Tuesday 19th November 2024 This webinar will discuss opportunities in applying causal inference methodology during the analysis of RCT data.
Dates: Module 1 - Wednesday 20th November Module 2 - Tuesday 26th November Module 3 - Thursday 28th November This interactive and hands on online course, aimed at beginner Bayesians who have little or no experience in Bayesian statistics, is split into 3 modules. Module 1 introduces Bayesian concepts and looks at how Bayes has been used recently in the Pharmaceutical Industry, and participants will undertake their own data collection exercise in order to analyse a simple Bayesian trial. Module 2 takes a look at the concepts of Bayesian statistics and key terminology and provides a chance to analyse some data using a simple Bayesian approach. Module 3 takes a further look at the use of Bayesian statistics in drug development and regulatory requirements and digs deeper into analysis issues.
Date: 20 October 2024 This event is aimed at students with an interest in the field of Medical Statistics, for example within pharmaceuticals, healthcare and/or medical research.
Date: Re-scheduled to Tuesday 26th November 2024 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.
Date: Tuesday 10th December 2024 This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
Date: October 2024 - July 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.
An exciting opportunity has arisen for a Senior Medical Statistician & Statistical Programmer to join the UKCRC fully registered Derby Clinical Trials Support Unit (Derby CTSU).
To provide expert statistical and strategic support to asset development programs in GSK Vaccines pipeline.
Novartis recently established a Virtual Analytics Network in the UK and we are currently recruiting PhD graduates to join this exciting group!
