Launch & Lifecycle ESIG

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

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