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Showing papers by "Jane Fridlyand published in 2013"

Journal Article•DOI•
Considerations for the successful co-development of targeted cancer therapies and companion diagnostics

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Jane Fridlyand1, Richard M. Simon, Jessica C. Walrath2, Nancy Roach, Richard Buller3, David P. Schenkein4, Keith T. Flaherty5, Jeff Allen2, Ellen V. Sigal2, Howard I. Scher6 •
Genentech1, Friends of Cancer Research2, Pfizer3, Agios Pharmaceuticals4, Harvard University5, Memorial Sloan Kettering Cancer Center6
01 Oct 2013-Nature Reviews Drug Discovery
TL;DR: In this article, the authors discuss issues relating to the co-development of targeted cancer therapies and companion diagnostics that were not covered in depth in the draft guidance released by the US Food and Drug Administration in 2011.
Abstract: Here, the authors discuss issues relating to the co-development of targeted cancer therapies and companion diagnostics that were not covered in depth in the draft guidance released by the US Food and Drug Administration in 2011. They propose potential strategies that will be useful to mitigate challenges and to help guide the future co-development of drugs and diagnostics.

68 citations

Journal Article•DOI•
An industry statistician's perspective on PHC drug development.

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Jane Fridlyand1, Ru-Fang Yeh, Howard Mackey, Thomas Bengtsson, Paul Delmar, Greg Spaniolo, Grazyna Lieberman •
Genentech1
01 Nov 2013-Contemporary Clinical Trials
TL;DR: This paper will outline the basic concepts behind co-development with predictive biomarkers and summarize the current regulatory paradigm, and present guiding principles of personalized health care (PHC) development and review the statistical, strategic, regulatory and operational challenges that statisticians regularly encounter on development programs with a PHC component.

6 citations