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Future of Evidence and Smart Health Conference
Session 6: Novel Digital End Points
Cécile Mathilde Ollivier, MS
- OCM Director - Regulatory Science Europe
- Critical Path Institute (C-Path), Netherlands
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.
Regulatory Perspective on Digital Endpoints
Lada Leyens, PhD, MSc
- Regulatory Program Director
- F. Hoffmann-La Roche Ltd., Switzerland
Babak Boroojerdi, DrMed, MBA
- Global Program Physician, Rare Disease Organization
- UCB Biosciences, Germany
SARAhome - a new Clinical Tool for assessing Ataxia at home
Marcus Grobe-Einsler, DrMed
- German Center for Neurodegenerative Diseases (DZNE), Germany