Journal of Molecular Biomarkers & Diagnosis
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n this era of personalized medicine, the development of targeted therapeutics goes hand-in-hand with the development of
targeted diagnostics or Companion Diagnostics (CDx). These diagnostics are critical with respect to getting the right drug to
the right patient at the right time and are required for regulatory approval of the therapeutic. However, the development paths for
diagnostics and therapeutics are separate and unique from analytical studies through to regulatory pathways and aligning their
development such that simultaneous regulatory submissions can occur is, at the very least, a challenge. This is especially true since
the identification of the biomarker that goes into the development of the diagnostic be it a selection, prediction, efficacy or other
clinical application of a biomarker often occurs in phase 2 clinical trials of the drug. Note that the biomarker is not a diagnostic,
it is a component of a diagnostic, and there is a defined development path, governed by regulatory requirements, for diagnostics
once the biomarker has been identified. It is essential, therefore, that not only biomarker discovery/validation efforts, but also
diagnostic development efforts be initiated early in the drug development program, albeit at risk. This presentation will describe
the diagnostic development pathway and ways to mitigate risk while achieving synergy in the diagnostic and drug development
Daniel J. O?Shannessy
received his Ph.D. in Biochemistry from the University of Auckland, New Zealand.
He has over 20 years of experience in a
combination of scientific, business development and strategic planning roles within the biopharmaceutical industry and specifically diagnostics. In his
current position as Director Diagnostics Development at Morphotek, he is responsible for all aspects of Companion Diagnostics (CDx) development
from concept through to commercialization. In recent years he has held the positions of Chief Operating Officer, Senior Director of Strategic Planning,
Oncology Diagnostics, and Chief Scientific Officer at various diagnostics companies.
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