Abstract
A well-defined pathway for the accelerated development and approval of targeted cancer therapies and companion diagnostics would reduce uncertainty, improve efficiency in development and provide an effective incentive for developers.
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Acknowledgements
P. Keegan of the US FDA provided comments on a draft. E. Karnes, M. Morrison, R. Anderson and E. Khoong of the Brookings Institution, and L. Fahey McGrath of Novartis, contributed to background research and assisted in drafting. The recommendations are based on a discussion at the Conference on Cancer Clinical Research, 14 September 2009, hosted by the Brookings Institution and Friends of Cancer Research.
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David Epstein is CEO of novartis Oncology. Richard Schilsky has served on the scientific advisory board of Foundation medicine. Joshua Benner, Cindy Geoghegan, Stephen Friend, David Kessler, Mark McClellan, David Sidransky and Ray Woosley declare no competing financial interests.
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McClellan, M., Benner, J., Schilsky, R. et al. An accelerated pathway for targeted cancer therapies. Nat Rev Drug Discov 10, 79–80 (2011). https://doi.org/10.1038/nrd3360
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DOI: https://doi.org/10.1038/nrd3360
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