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Session 6: Novel Digital End Points
Session Chair(s)
Cécile Mathilde Ollivier, MS
VP Global Affairs
Critical Path Institute, 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.
Speaker(s)
Regulatory Perspective on Digital Endpoints
Lada Leyens, PhD, MSc
Takeda, Switzerland
Senior Director, EUCAN regulatory head GI
Digital endpoints
Babak Boroojerdi, DrMed, MBA
UCB Biosciences, Germany
Global Program Physician, Rare Disease Organization
SARAhome - a new Clinical Tool for assessing Ataxia at home
Marcus Grobe-Einsler, DrMed
German Center for Neurodegenerative Diseases (DZNE), Germany