Purpose
- Maintain a collaborative platform for statisticians to work together on
precompetitive topics and tools related to product Launch and Lifecycle
management.
- Shape the industry and highlight the opportunities for statisticians to optimize
evidence generation for stakeholders beyond health authorities in order to ensure
that new medicines reach appropriate patients.
- Drive scientific projects and innovation related to the fields of Launch and Lifecycle
such as medical affairs area, commercialization or HTA. Identify research
questions, data sources, and methods to support that goal.
Objectives
Maintain a homepage for external communication of SIG activities
Collect case studies for showcasing great work
Publish manuscripts in journals and communicate via other channels about
medical affairs including:
- The impactful role that statisticians can and do play
- Innovative designs
- Use of registries
- Use of historical data
- Implementation of pragmatic studies
- Use of AI in medical affairs with a focus on statistical topics
Organize workshops and conference sessions around the topics mentioned above.
Public relation activities to show how statisticians and data can help optimize
decision making.
Collaboration with non-statistical associations (e.g. medical) working in the field to
improve the role of statistics by jointly developing solutions for questions common
to both communities (e.g. study design)
Current activities
- ICH E9 R1 / Estimands for studies of the use of medications in routine clinical
practice
- Develop best practices for statisticians to be successful and efficient (evidence
dissemination and resources, planning and strategic thinking).
- Single arm trials for rare diseases – building on our previous manuscript (RealiseD)
Who we are
Jenny Devenport (Roche) (Co-Chair)
Yulia Dyachkova (Merck) (Co-Chair)
Alexander Schacht
Aontonia Ridolfi
Cornelia Dunger-Baldauf, Cornelia
Daniel Saure
Frank Langer
Gbenga Kazeem
Iftekhar Khan
Knut Richert
Lada Mitchell
Lorenzo Acciarri
Lucy Wright
Martin Blogg
Nathalie Barbier
Patrick Moneuse
Pierre Mancini
Sajjad Rafiq
Stefan Franzén
Thomas Kuenzel
Véronique Robert
How to get in touch
Contact Jenny Devenport or Yulia Dyachkova