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Will Big Data Change Drug Development’s Approach?

Track:
DIAmond Sessions

Day & Time:
April 17, 2:00PM - 3:30PM (Central Europe Standard Time)

Session Number:
DMD4

Room Number:
Montreal

Type:
Session

Title:
Will Big Data Change Drug Development’s Approach?

Chair(s):
Thomas Senderovitz, DrMed, MD
Director General
Danish Medicines Agency, Denmark

Description:

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.



Presentation(s) & Speaker(s):
Panel Discussion
Christa Wirthumer-Hoche, PhD
Head; Chair, EMA Management Board
Austrian Medicines and Medical Devices Agency (AGES), Austria

Panel Discussion
Ameet Nathwani
Group Chief Medical Officer, Executive Vice-President
Sanofi, France

Panel Discussion
Dimitrios Athanasiou, MBA
Patient Advocate
WORLD DUCHENNE ORGANIZATION (WDO) , MDA HELLAS, Greece

Panel Discussion
Sy Pretorius, MD, MBA, MS, MSc
Senior Vice President and Chief Scientific Officer
PAREXEL, United States