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Current Trends and Solutions in Global Clinical Operations
Session Chair(s)
Peter Schueler, DrMed, MD
Senior Vice President, Drug Development Neurosciences
ICON plc (CRO), Germany
Precision medicine targets better defined, but smaller populations. More drugs get developed in such smaller populations. Orphan drug designations (FDA) increased steadily from 195 in 2010 to 354 in 2015. This creates new challenges from site and subject identification to subject adherence and retention. Real-world data play a new role to support the adaptive and conditional approval process. Patient centricity is finally understood as a key to success for development.
Speaker(s)
Evidence-Based Feasibility and Protocol Design
Joachim Luithle, PHARMD
Bayer AG, Germany
Head of Clinical Development Operations
Novel Use of Real World Data in Clinical Trials and Interventional Studies
Janet Valentine, PHD
MHRA, United Kingdom
Director of Clinical Practice Research Datalink (CPRD)
The Patient Registry for Patient Pool Enrichment and Post-Approval Evidence
Peter Schueler, DrMed, MD
ICON plc (CRO), Germany
Senior Vice President, Drug Development Neurosciences
What Do ‘Digital Immigrant’ and’ Digital Native’ Patients Want?
Jacqueline Bowman-Busato
Adipositas Pact Stichting, Belgium
Co-Founder,Engagement and Projects Lead
A Platform Approach to Make Precision Medicine Studies Doable
Sarah Cooper, PHD
NIHR, United Kingdom
Business Development Manager (commercial)