BioCentury on BioBusiness,
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).
words displayed of
To read this article, you must be an Archives subscriber. Please choose one of the options below.
All contents Copyright © 1993-2015 BioCentury Publications, Inc. ALL RIGHTS RESERVED. All use of this Web Site and its contents is governed by the BioCentury User Agreement
. The contents of this Web Site are protected under U.S. and foreign copyright and intellectual property laws, and no part of this Web Site or its contents may be photocopied, reproduced or retransmitted in any form without the written consent of BioCentury, which may be requested from Reprints/Permissions
. BioCentury®; The Bernstein Report on BioBusiness™; The BioCentury 100™; The Clear Route to ROI™; Because Real Intelligence is Hard to Find™; BCIQ™; and BioPharma's Knowledge Center™; are trademarks of BioCentury Publications, Inc., P.O. Box 1246, San Carlos, CA 94070. SciBX® and SciBX: Science-Business eXchange® are trademarks of Nature America, Inc. that are jointly used by BioCentury Publications, Inc. and Nature America, Inc.
Whether you want an individual subscription or need a global group license, we have the products,
the experience and the customer support that biopharma executives, researchers, investors, service providers,
and industry stakeholders have trusted for nearly two decades.
Let our Subscriber Services team customize the best intelligence package available in the industry to meet your needs.
Free Trial 4 Weeks of Access
Get a 4-week free trial subscription to see the important articles you are missing.
Get 4 Weeks Free
Thanks for purchasing this article.
Please bookmark this url for future reference.
We have also sent you a confirming e-mail with a receipt and this same url for your
close [ X ]