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Product Discovery & Development
Vertex's Kalydeco for cystic fibrosis validates venture philanthropy model
Monday, March 5, 2012
FDA's approval of Kalydeco ivacaftor for a small subset
of cystic fibrosis patients - three months ahead of the PDUFA goal and five and
a half years after Vertex
Pharmaceuticals Inc. started the first clinical trial of the molecule -
is powerful proof that the alignment of venture philanthropy; smart, aggressive
drug development; and efficient regulatory oversight can accelerate the
creation of a breakthrough therapy.
Some aspects of the story are unique to Kalydeco, but many of
the lessons learned could be broadly applied, according to FDA officials,
senior managers at Vertex and the Cystic
Fibrosis Foundation (CFF).
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