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 to hear about our events, please email Kevin Lief.
SIG News
New - Round Table Discussion Group: ICH Stability ICH Q1/Q5C Revision - 22nd July 12 noon CET
Join our inaugural discussion group, for members only, to share thoughts and comments on the current revision. Welcome to come along and discussl or listen to others viewpoints. Take away how other CMC statisticians view the draft revision, and share as you see appropriate.
If you are not currently a member of our SIG, please e-mail Kevin.R.Lief@gsk.com to join and participate in the discussion!
New CMCSNE Workshop Announcement – Stability Modelling, Tuesday 21st October:
Firstly, we have the exciting news that we will hold an online workshop on the topic of stability modelling on the 21st October 2025. This will be a fantastic opportunity to delve into this crucial area and share insights with a broader audience.
If you are interested in presenting a contribution (of about 20-30 minutes), please e-mail Martin Otava (motava@ITS.JNJ.com) with a short proposal (one or two sentences).
Opportunity to Comment on ICH Q1 Revision:
The Steering Team wish to raise awareness that ICH are gathering comments on the stability testing of drug substances and drug products, via the Q1 Expert Working Group. The ICH Quality Guidelines website states:
“Further to the ICH Management Committee’s endorsement of the Q1/Q5C Concept Paper and Business Plan in November 2022, the Q1/Q5C EWG was established to revise the current ICH Stability Guideline Series Q1A-F and Q5C by:
The envisioned result is a combined guideline, ICH Q1, with integrated annexes and/or appendices that address specific topics beyond the core stability recommendations and principles. Addressing drug product types including substances, intermediates, and devices.”
Questions from CSNE Steering Team:
Please contact Kevin (Kevin.R.Lief@gsk.com)
Opportunity to Run and Host Part of the PSI introduction to Industry training Course:
There is an opportunity for companies to host the PSI Introduction to Industry Training (ITIT) course. This is a 1.5 to 2-day session that is run by the host company, with content provided by the host. If your company is interested in hearing the background information on what is involved in hosting this course, please contact " Kevin.R.Lief@gsk.com" for further information.
non-SIG Events
Here are a couple of upcoming events that may be of interest:
CMC Statistical Network Europe will be represented at the EFSPI Regulatory Statistics workshop from 10th to 12th September, at Biozentrum, Basel.
The European Network for Business and Industrial Statistics (ENBIS) annual conference will be hosted by the University of Piraeus and will take place at the central building in the city center of Piraeus (Greece), from September 14th to 18th.
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.
Our monthly webinar will allow attendees to gain practical knowledge and skills in Open-Source coding and tools, with a focus on applications in the pharmaceutical industry. The sessions will provide starting points in a number of areas, correct any common misconceptions and provide valuable resources for further learning.
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.
Date: Tuesday 9th September 2025 Join us to hear Sofia Weigle and Weng-Kee Wong present their recent work.
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.
This networking event is aimed at statisticians that are new to the pharmaceutical industry who wish to meet colleagues from different companies and backgrounds.
AI agents are large language models equipped with tools that can autonomously tackle challenging tasks. This talk will explore how generative AI agents can enable biomedical discovery.
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.
The Pre-Clinical Special Interest Group (SIG) Workshop 2025 will take place over two half-days on 7 - 8 October in Verona, Italy, bringing together experts from industry, academia, and regulatory institutions to discuss key challenges and innovations in pre-clinical research.
Four sessions will include ML foundation (including an introduction, data exploration for ML and dimensionality reduction and feature selection), Supervised learning (including support vector machines and model evaluation and interpretation), model optimization and unsupervised learning (including clustering) and advanced topics (including neural networks, deep learning and large language models).
The program will feature insightful sessions led by distinguished invited speakers, alongside a poster session showcasing the latest advancements in the field. Further details will be provided.
Date: Wednesday 5th November 2025 A careers talk about medical statistics and how it plays a crucial role in developing new medicines
Date: 19 November 2025 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.
As an Associate Director Biostatistics Early Development, you will be a key member of our biostatistics group, you will play a crucial role in the design, analysis, and interpretation of clinical trials for early development programs.
If you are passionate about biostatistics and real-world data, and are looking for an exciting opportunity to contribute to groundbreaking research, we encourage you to apply.
Are you passionate about making a difference in the world of healthcare? Novartis is seeking a dynamic and experienced professional to join our team in London at The Westworks.
As the Director of HTA Biostatistics & Medical Affairs, you will play a pivotal role in shaping the future of healthcare by providing strategic biostatistical leadership and expertise.
As a Senior Principal Biostatistician, you will be responsible and accountable for all statistical work, both scientific and operational, for one or more assigned clinical trials
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