Scott Gottlieb trumps competition as FDA Commissioner nominee
Keapstone Therapeutics created as new virtual biotech for Parkinson’s
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Novo Nordisk, Servier, Otsuka, Teva among top sponsors
Patient-centric study design still needed
Sites wrestle with protocol design complexity
Design decisions burdening site execution and study volunteer participation
Reassessing site engagement activities
New approaches include earlier involvement, reducing burden, more permanent collaboration
The need for—and barriers to—adopting eSource
New regulation and partnership may finally end poor interoperability and the aversion to change
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