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Drug Development Tools in a Digital Era
Session Chair(s)
Lauren Oliva, PharmD, RPh
US Lead, Global Regulatory Policy
Biogen, United States
TThis session will discuss the development and regulatory acceptance of digitally enabled endpoints and related drug development tools. The panel discussion will explore case studies to highlight opportunities and challenges to be addressed in the emerging field of digital technologies in clinical trials.
Speaker(s)
Panelist
Michelle Campbell, PhD
FDA, United States
Associate Director, Stakeholder Engagement and Clinical Outcomes, ON, OND, CDER
Panelist
Sonya Eremenco, MA
Critical Path Institute, United States
Executive Director, PRO Consortium
Panelist
Falk Ehmann, MD, PhD, MS
Regulatory Science and Innovation Task Force, European Medicines Agency, Netherlands
Head of Innovation and Development Accelerator – ad interim,
Shibeshih Belachew
Biogen, Switzerland
Senior Medical Director, Head of Early Clinical Development for MS
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