Patricia C. Walter, Senior Medical Editor/Writer at Connexion Healthcare, has won a third APEX Award for Publication Excellence, this time in the category of Electronic Publications for her white paper on Companion Diagnostics and Personalized Medicine ― Part II. She had won an APEX Award for Part I in 2016, and in 2014 she received an APEX Award in the category of Health & Medical Writing for a white paper on palliative care, Bridging the Gap: Physician-Patient Communication in Palliative Care.
Part II of this two-part series on companion diagnostics and personalized medicine addresses some of the complexities of the development of drug and companion diagnostics, while providing introductions to target and marker discovery and validation and an overview of the co-development process. Issues of significance concerning in vitro diagnostic (IVD) devices and laboratory developed tests (LDTs) are addressed, as well as the dynamic regulatory environment.
Specifically, this white paper discusses the phases of drug development and companion diagnostic device development within the context of a co-development process, and illustrates why the synchronization of these processes is so difficult; describes IVDs relative to LDTs, the regulatory bodies, and contexts of the regulations that govern the use of these devices; reviews the regulatory roles of some of the varied agencies responsible for approving drugs and diagnostic devices; and discusses the rationale behind classifications of these devices. Finally, expert suggestions are offered to simplify and expedite the co-development process.
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For further information regarding the Oncology Center of Excellence at Connexion Healthcare and how we can develop oncology communications to differentiate therapies by their unique attributes, contact:
R. Steven Lang
Senior Vice President, Oncology
Val Sudakin, PhD
Senior Vice President, Head of Scientific Services