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What Does Differentiation Mean to You and How You Select Endpoints?
Session Chair(s)
William Jacobson, PhD, MSc
, Tekada, United States
Topics presented in this session include:
- All Stakeholders want differentiation – are we talking about the same thing?
- What is(are) the priority(ies)? How are these determined/traded off? Are there specific scenarios that influence this e.g. first in class, best in class, second generation of same mechanism of action (i.e. potential generic competition), etc.?
- Speaker representatives of the Stakeholder functions to participate
- The regulatory tight rope
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