Yun-Fu Hu

WORK HISTORY

EDUCATION

ABOUT YUN-FU HU

More than 10 years of service at Food and Drug Administration (FDA) with increasing responsibilities, leading a staff tasked with regulation of in vitro diagnostic devices (IVDs) and laboratory-developed tests (LDTs) for genetic testing, molecular cancer diagnostics (e.g, liquid biopsy, cancer screening, monitoring, minimal residual diseases), companion / complementary diagnostics, radiodosimetry, digital pathology and artificial intelligence devices.• Proven ability to provide a staff of scientists, engineers, consumer safety officers, and medical officers with oversight, guidance and technical directions in the regulatory and scientific reviews of all premarket and postmarket submissions as well as compliance activities.• More than 10 years of experience in diagnostic and pharmaceutical industries, leading a staff in biomarker discovery and diagnostic development in regulated environment, interacting with Federal Agencies and key opinion leaders, fostering internal and external collaborations and building high efficient teams.• Strong analytical, interpersonal, communication and leadership skills for training and management of staff, identification of program and staffing needs, and development of program plans and goals.• Comprehensive knowledge in oncology, personalized medicine, co-development, liquid biopsies, LDT diagnostics, GMP/QSR and statistics.• Extensive experience in technologies for genetic, genomic, proteomic and metabolomic studies.• Serving on advisory committees or as subject expert in national and international scientific, standards and global harmonization organizations (e.g, CLSI, ISO, MDIC).