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Clinical Trials Go Digital – Electronic Endpoints: Opportunities and Challenges
Session Chair(s)
Mireille Muller, DrSc, PhD, MSc
Regulatory Policy & Intelligence Director
Novartis Pharma AG, Switzerland
The digital endpoint field is rapidly evolving and maturing, with ever more examples emerging of how technology and analytics are helping us understand patient lives. As we advance in this area, more questions arise: What are the hurdles of clinical deployment of these approaches across functional domains such as mobility, cognition and fatigue and what value can digital endpoints bring? What are the regulatory questions triggered by using these technologies? Despite the challenges, do digital endpoints give us a chance to deliver the right therapy, to the right patient, at the right time?
Learning Objective : In this session participants will be able to gain a better understanding of the impact of digital endpoints, reflective of patient needs, increasing chances for successful development of much needed therapies. These digital tools should objectively measure patient relevant parameters linked to clinical disease stage with increased accuracy for a meaningful decision making process by stakeholders
Speaker(s)
Using patient-relevant digital endpoints and biomarkers in clinical trials
Mireille Muller, DrSc, PhD, MSc
Novartis Pharma AG, Switzerland
Regulatory Policy & Intelligence Director
Patient Centricity and Role of Innovation in Medical Digital Devices
Chris Van Hoof, PhD
imec, Belgium
Vice President R&D
Regulatory expectations on digital endpoints in clinical trials
Lisbeth Bregnhoj, PhD, MPharm
Danish Medicines Agency (DKMA), Denmark
Medicines Inspector, GCP
Fabian Model, PhD
Roche, Switzerland
Director of Biostatistics
Industry Examples – Notified Bodies, Clinical and Operational Challenges
Ieuan Clay, PhD
Digital Medicine Society (DiMe), Germany
Chief Scientific Officer
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