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Clinical Development of In Vitro Companion Diagnostic Devices

Date: 24 Jan. 2014  |  Topic: Medical Device and Diagnostics
Ken Butz

Kenneth Butz

Manager, Medical Devices and Diagnostic Consulting
PPD® Consulting

PPD

Austin Combest

Austin Combest, Pharm.D.

Senior Director of Clinical Science and Information, Global Product Development
PPD

Holly Hilton

Holly Hilton, Ph.D.

Director, Biomarkers and Translational Sciences, Labs
PPD® Laboratories

Part three of PPD’s series on precision medicine focuses on the development and regulatory approval of in vitro companion diagnostic devices. The more efficient, yet challenging, pathway is the simultaneous development and validation of an in vitro companion diagnostic (IVD CoDx) with the therapeutic product. Keys to success include early identification of a biomarker and thorough up-front planning of the parallel development pathway for the therapeutic, biomarker and IVD CoDx.


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