Speakers
Hans-Georg Eichler
Senior Medical Officer,
European Medicines Agency, European Union
Richard Bergström
Director General,
European Federation of Pharmaceutical Industries and Associations (EFPIA)
Gigi Hirsch
Executive Director,
Massachusetts Institute of Technology (MIT) Center For Biomedical Innovation
Steve Rosenberg
Senior Vice President and General Manager,
Oracle Health Sciences
Duane Schulthess
Managing Director,
VitalTransformation
(chair)
Europe and the US are experimenting with ways to develop therapies based on their actual ‘real world’ performance. This session will discuss the benefits and challenges of outcomes-based health care, as well as the remaining barriers to implementation.
Learning Objectives
Describe the concept of outcomes-based health care; Define real world evidence, Adaptive Pathways, and Precision Medicine; Identify how we can use health data to improve the efficiency of clinical trials and research (better targeting, smaller trials, flexible models); Recognize the links between failures rates, trial sizes, and investments into new therapies.
Towards this end, the project has gathered valuable insight from stakeholders and decision-makers on the value of real-world evidence and the acceptability of approaches to gather that evidence to support marketing authorisation and subsequent HTA assessment.
In addition to providing an update on progress with the GetReal project, the webinar will introduce the framework that is being developed for use by all parties to help plan for assessing relative effectiveness of new therapies.
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