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Will Big Data Change Drug Development’s Approach?
Session Chair(s)
Thomas Senderovitz, DrMed, MD
Senior Vice President, Data Science
NovoNordisk, Denmark
Will Big Data enable change in clinical development and how? Hear the view of senior leaders from the industry in this DIAmond session.
Personalised Medicine, demand for early treatment, genomic treatment and increased complexity of trials force us to rethink the way we approach clinical development. Moving from 7-12 years of work to 3-5 years for most of the products:
- We need to understand how to increase the number of conclusive trials and come with smarter designs
- We must move away from the sequential RCTs to multi-channel studies of different type
- We need to understand how to leverage clinical care data and mHealth in addition to legacy clinical trial data
- We must adapt collaboration models between regulators/HTA and sponsors
- We need to secure the right level of skill sets across the industry
This will enable to bring drug faster to patients, at a more sustainable cost. However it will change the risk paradigm, increasing risk during post approval.
Speaker(s)
Panel Discussion
Christa Wirthumer-Hoche, PhD
Austrian Medicines & Medical Devices Agency (AGES), Austria
Chair, EMA Management Board, Head
Panel Discussion
Ameet Nathwani
Sanofi, France
Group Chief Medical Officer, Executive Vice-President
Panel Discussion
Dimitrios Athanasiou, MBA
WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS, Greece
Patient Advocate
Panel Discussion
Sy Pretorius, MD, MBA, MS, MSc
Eversana, United States
Chief Operating Officer and President, Outsourced Solutions
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