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FDA's Personalized Medicine Leader Leaving for Liquid Biopsy Startup Grail

NEW YORK (GenomeWeb) – Elizabeth Mansfield, who currently heads the US Food and Drug Administration's personalized medicine group within the device division, is leaving the agency this month to join Grail, which aims to develop a blood test for early cancer detection.

According to an FDA spokesperson, Mansfield, currently the deputy director for personalized medicine at the agency's Office of In Vitro Diagnostics and Radiological Health, will be leaving the post on February 17. Mansfield joined the agency in 2006 and led efforts to advance regulations for precision medicine and next-generation sequencing.

"Dr. Mansfield's leadership at FDA helped turn personalized medicine from aspiration to reality," Personalized Medicine Coalition President Edward Abrahams said in a statement. "As director and coordinator of the agency's manifold personalized medicine programs, she pushed to replace antiquated regulatory policies with smart proactive ones that encouraged innovation while also protecting patients." As a result of her efforts, he highlighted that more than 20 percent of all new molecular entities the FDA has approved for the last three years are personalized medicines.

At Grail, Mansfield will be head of regulatory strategy. The liquid biopsy startup secured over $100 million in Series A financing from Illumina, ARCH Venture Partners, and participating investors Bezos Expeditions, Bill Gates, Sutter Hill Ventures, and GV. In January, the company announced its goal to raise $1 billion in a series B financing round.

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