Ahead of FDA’s Workshop on NGS, Friends of Cancer Research is Releasing the Final Whitepaper from our September 2014 Meeting
WASHINGTON, DC (February 18, 2015) – Today, Friends of Cancer Research (Friends) released a whitepaper titled: “A Blueprint for Drug/Diagnostic Co-Development; Next Generation Sequencing (NGS) in Oncology.”
The original draft of this whitepaper was released at the 3rd annual conference on Drug/Diagnostic Co-development hosted by Friends of Cancer Research and Alexandria Real Estate Equities, Inc. This conference brought together researchers, sponsors, advocates, and regulators to discuss how use of Next Generation Sequencing (NGS) technology as a companion diagnostic can greatly enhance future drug development and cancer care.
A collaborative group of experts, utilizing multi-stakeholder input from this meeting, compiled this report being released today in final form. The report proposes several mechanisms to optimize NGS development, standardization, and use as a diagnostic tool.
FDA Meeting & Webinar:
Optimizing Regulatory Oversight of NGS Diagnostic Tests Public Workshop
This report is being released ahead of a workshop, being hosted by the U.S. Food and Drug Administration (FDA) entitled: “Optimizing FDA’s Regulatory Oversight of Next Generation Sequencing Diagnostic Tests.” The purpose of this workshop is to discuss and receive feedback from the community on FDA’s regulatory approach to diagnostic tests for human genetics or genomics using Next Generation Sequencing (NGS) technology.
The meeting is being held on the National Institutes of Health (NIH) campus on February 20, 2015 and is also being webcast.
For more information, and to register to attend in person or via webcast CLICK HERE