Launch & Lifecycle ESIG

Purpose

  • Provide a platform for statisticians from sponsors and CROs to working in the launch and lifecycle management (including traditional medical affairs area, commercialization, HTA (in collaboration with the respective ESIG)) and new evolving areas) to help each other in areas of pre-competitive collaboration.

  • Shape the industry to increase the influence of statisticians in launch and lifecycle and show how good looks like for the work of statisticians e.g. through case studies.

  • Drive scientific projects and innovation forward related to the field of Launch and Lifecycle.

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

Alexander Schacht (Veramed) (Chair)

Jenny Devenport (Roche) (Co-Chair)

Daniel Saure (BI)

Pierre Mancini (Sanofi)

How to get in touch

Contact Alexander Schacht or Jenny Devenport

Upcoming Events

PSI VisSIG Wonderful Wednesday Webinar Series

This is a good opportunity to develop your knowledge by thinking through a practical example, practicing how to apply graphics principles, and developing your coding skills.

PSI Pre-Clinical SIG Webinar: Assay Qualification by Linear Mixed Model: Confidence, Prediction & Tolerance Intervals

Dr Francq will discuss the need for analytical methods to deliver unbiased and precise results and talk in detail on confidence, prediction and tolerance intervals work in linear mixed models and the interpretation of statistical results. This will be followed by Q&A.

PSI Training Course: An Interactive Introduction to Agile Ways of Working

During this session you will explore how we best execute change within our roles, build your practical understanding of agile tools and techniques, and inspire you to experiment with the new ways of working to deliver your goals.

PSI EIWG Webinar: Impact of estimands

To understand how the estimand framework changed the development of clinical trials.

PSI Training Course: Hybrid Frequentist / Bayesian Power and Bayesian Power in Planning Clinical Trials

Aimed at Statisticians working on the design of Clinical Trials, participants will learn how to use Expected Power, Average Power, Predicted Power, Probability of Success and Assurance, and Bayesian Power when planning clinical trials.

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