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Future of Evidence and Smart Health Conference

Leveraging RWE to advance healthcare decision-making.


Session 6: Novel Digital End Points

Session Chair(s)

Cécile Mathilde Ollivier, MS

Cécile Mathilde Ollivier, MS

  • OCM Director - Regulatory Science Europe
  • Critical Path Institute (C-Path), Netherlands
Solène  Thieffry, MSc

Solène Thieffry, MSc

  • Global RWE Policy Lead
  • UCB, Belgium
Most endpoints used in clinical trials are not necessarily patients-preferred nor easy to collect in routine care on the long term. Enhancing endpoints measurement continuously from clinical practice to real-word would facilitate better healthcare decision making for individual patients and population-level health. The aim of the session is to provide regulatory requirements and current use cases to develop novel digital endpoints that would help to bridge the gap in endpoints measurement across drug life cycle.

Speaker(s)

Lada  Leyens, PhD, MSc

Regulatory Perspective on Digital Endpoints

Lada Leyens, PhD, MSc

  • Regulatory Program Director
  • F. Hoffmann-La Roche Ltd., Switzerland
Babak  Boroojerdi, DrMed, MBA

Digital endpoints

Babak Boroojerdi, DrMed, MBA

  • Global Program Physician, Rare Disease Organization
  • UCB Biosciences, Germany
Marcus  Grobe-Einsler, DrMed

SARAhome - a new Clinical Tool for assessing Ataxia at home

Marcus Grobe-Einsler, DrMed

  • German Center for Neurodegenerative Diseases (DZNE), Germany

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