Launch & Lifecycle ESIG

Purpose

  • Create a collaborative platform for statisticians from sponsors and CROs to work together on pre-competitive topics related to product Launch and Lifecycle management.

  • Shape the industry to increase the influence of statisticians and show ‘what good looks like’ for the work of statisticians in this space.
  • Drive scientific projects and innovation forward related to the fields of Launch and Lifecycle such as medical affairs area, commercialization or HTA.

Objectives

  • 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.)

Who we are

Jenny Devenport (Roche) (Co-Chair)

Yulia Dyachkova (Merck) (Co-Chair)

Alexander Schacht

Anny Stari 

Aontonia Ridolfi

Bob Shaw 

Cornelia Dunger-Baldauf, Cornelia

Daniel Saure

Gbenga Kazeem

Giacomo Mordenti

Knut Richert 

Frank Langer 

Lada Mitchell

Lucy Wright 

Martin Blogg 

Nathalie Barbier

Pierre Mancini

Stefan Franzén

Thomas Kuenzel

Véronique Robert

 

Recent Conference presence

Slides from PSI Annual Conference 2022

Poster from EFSPI Regulatory Conference 2022

 

How to get in touch

Contact Jenny Devenport or Yulia Dyachkova

Upcoming Events

Joint PSI/EFSPI Visualisation SIG 'Wonderful Wednesday' Webinars

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.

PSI Career Young Virtual Event (Q4 2024)

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.

PSI Journal Club: Group Sequential Designs

Date: Thursday 12th December 2024 Chaired by Jenny Devenport, join us to hear Andy Grieve and Zhiwei Zhang discuss their recent work on group sequential designs.

PSI Introduction to Industry Training (ITIT) Course - 2024/2025

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.

PSI Training Course: Mixed Models and Repeated Measures

Dates: Monday 3rd February 2025: 08:30-13:00 BST Tuesday 4th February 2025: 08:30 - 13:00 BST Wednesday 5th February 2025: 08:30 - 13:00 BST Thursday 6th February 2025: 08:30 - 13:00 BST This course is presented through lectures and practical sessions using SAS code. It is suitable for statisticians working on clinical trials, who already have a good understanding of linear and generalised linear models.