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September 10, 2020
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Development of RNA-Based Predictive Response Signatures as Companion Diagnostics


Founder and Executive Partner, Opus Three

Senior Vice President, Clinical & Corporate Development, GeneCentric Therapeutics

This webinar, Part 2 of the “Advances in RNA-based Biomarker Development for Precision Oncology” webinar series sponsored by GeneCentric Therapeutics, will focus on the development of RNA-based companion diagnostics for oncology.

The path to developing a companion diagnostic (CDx) is becoming increasingly complex as available technologies and therapeutic advancements outpace regulatory standards and procedures. RNA-based approaches require heightened awareness and vigilance in combination with a well-defined and robust bioinformatics process. This webinar will cover the processof developing RNA-based predictive response signatures for cancer therapeutics; clinical and therapeutic implications for this approach; and the regulatory requirements, tools, and milestones necessary for successful advancement of an RNA-based CDx.

Felix Frueh, founder of regulatory consultancy Opus Three, will provide a deep dive into the regulatory considerations of developing RNA-based companion diagnostics. He will contrast the development of companion diagnostics with non-companion diagnostics and will illustrate key differences using a series of examples. Particular emphasis will be paid to potential future RNA-based companion diagnostics and currently marketed RNA-based diagnostics.

Joel Eisner of GeneCentric Therapeutics will follow with a clinical and bioinformatics perspective on the development of RNA-based predictive response signatures as companion diagnostics. His presentation will touch on the development of prototype response signatures using in silico analysis of public datasets, the curation of retrospective clinical data to further develop prototype predictive response signatures, and other points.

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