Christine Vietz to become Deputy Office Director, Personalized Medicine | FDA
Life Science Partner has recruited Christine Vietz, PhD, formerly Senior Vice President of Product Development at Foundation Medicine, to become the Deputy Office Director, Personalized Medicine, for the FDA’s CDRH OHT 7 (In Vitro Diagnostics).
Vietz will oversee the 60+ person Division of Molecular Genetics and Pathology, and will continue to build out the emerging organization of regulatory scientists comprising the Personalized Medicine Team.
As the leader of the Personalized Medicine Team, she will also serve as a liaison to the medical device industry, as well as to the scientific and healthcare communities for personalized medicine related issues.
Under Vietz’s leadership, OHT7 seeks to grow its expertise in genetically based disease diagnosis and identification of targets for therapeutic intervention.
Vietz has over 20 years of leadership experience across diagnostic assay development, regulatory affairs, and clinical laboratory operations.
Under Vietz’s leadership, OHT7 seeks to grow its expertise in genetically based disease diagnosis and identification of targets for therapeutic intervention. Vietz has over 20 years of leadership experience across diagnostic assay development, regulatory affairs, and clinical laboratory operations.
Career Highlights and Contributions
Before joining the FDA, Dr. Vietz served as Senior Vice President of Product Development at Foundation Medicine. Her leadership enabled the company to achieve multiple industry firsts, including securing FDA approval for the FoundationOne CDx pan-tumor comprehensive genomic profiling assay under the Breakthrough Devices Program.
During her tenure at Foundation Medicine, she developed the regulatory strategy and built the diagnostic development teams that continued to expand Foundation Medicine’s IVD portfolio with approval of the liquid biopsy assay, FoundationOne Liquid CDx, as well as the many subsequent companion diagnostic claims added to the approved assays over the subsequent years.
“Christine stands out in her extraordinary ability to bring cutting-edge diagnostics tied to biopharmaceuticals development through the regulatory process,” said Tom Callaway, MD, founder of Life Science Partner. “Patients will have better outcomes thanks to the FDA’s forward-thinking, particularly in this era of AI and personalized therapeutics.“
Vietz earned her PhD in Biomedical and Medical Engineering and her Bachelor of Science in Chemical Engineering from the University of Rochester. Vietz’s commitment to innovation, regulatory excellence, and operational efficiency makes her uniquely suited for her new leadership role at the FDA.
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