Elizabeth “Liz” Mansfield, PhD, serves as the Vice President of Regulatory Policy at Foundation Medicine. She has over 20 years of experience in regulatory affairs, during which she has helped to shape policies and guidance around the regulation of pharmacogenetic tests, companion diagnostics, next generation sequencing assays and direct to consumer genetic tests.
At Foundation Medicine, Dr. Mansfield has helped to secure FDA approval for the company’s liquid biopsy comprehensive genomic profiling test, FoundationOne®Liquid CDx, as well as Breakthrough Device Designation for its tissue-informed circulating tumor DNA monitoring test, FoundationOne®Tracker. She has also overseen more than a dozen companion diagnostic approvals from the FDA for FoundationOne®CDx and FoundationOne®Liquid CDx.
For more than a decade, Dr. Mansfield worked at the FDA on in vitro diagnostics review and policy. Most recently, she served as Associate Office Director for Personalized Medicine in the Office of In Vitro Diagnostics within the FDA’s Center for Devices and Radiological Health where her work emphasized developing policy for FDA oversight of laboratory developed tests.
Dr. Mansfield received her bachelor’s degree in biology from the University of Pennsylvania and her PhD in biochemistry from The Johns Hopkins University.
At Foundation Medicine, Dr. Mansfield has helped to secure FDA approval for the company’s liquid biopsy comprehensive genomic profiling test, FoundationOne®Liquid CDx, as well as Breakthrough Device Designation for its tissue-informed circulating tumor DNA monitoring test, FoundationOne®Tracker. She has also overseen more than a dozen companion diagnostic approvals from the FDA for FoundationOne®CDx and FoundationOne®Liquid CDx.
For more than a decade, Dr. Mansfield worked at the FDA on in vitro diagnostics review and policy. Most recently, she served as Associate Office Director for Personalized Medicine in the Office of In Vitro Diagnostics within the FDA’s Center for Devices and Radiological Health where her work emphasized developing policy for FDA oversight of laboratory developed tests.
Dr. Mansfield received her bachelor’s degree in biology from the University of Pennsylvania and her PhD in biochemistry from The Johns Hopkins University.
Speaking In
1:00 PM - 2:00 PM
Thursday, June 8
