Zivana Tezak

Živana Težak, Ph.D., is an Associate Director for Science and Technology, Personalized Medicine, in the OIR/OHT7: In Vitro Diagnostics and Radiological Health, Office of Product Evaluation and Quality at the Center for Devices and Radiological Health, Food and Drug Administration (FDA). Prior to joining the FDA in 24, as a scientific reviewer in microbiology, genomics and molecular biology, Dr. Težak worked in biotechnology industry, holding research and development scientist positions in a bioinformatics and array developer company. Dr. Težak received a Ph.D. in Biochemistry/Molecular Biology from Florida State University in 1997. From 1998 to 21 she was a research fellow at the University of Pittsburgh Medical Center and Children’s National Medical Center, Research Center for Genetic Medicine, working on neuromuscular disorders, human genetics, gene therapy, and high-throughput screening technologies. Her work resulted in a number of publications in peer-reviewed journals, book chapters and proceedings.

Dr. Težak has 15 years of in vitro devices regulatory expertise, focused on areas of molecular testing, genetics, genomics, serology, pathology and infectious diseases, handling high visibility and highly complex first of a kind submissions and projects including novel approaches, while working across FDA Centers. Part of her work included developing and communicating companion diagnostics related policies protocols, and tracking. Her leadership has been instrumental in developing successful collaborations with internal and external stakeholders and leading efforts towards flexible regulatory policies for innovative tests, including next-generation sequencing and near-patient tests, to enable their smoother translation into the clinic.

Since March 22, Dr. Težak has been additionally working to support FDA’s COVID-19 emergency response efforts, assuming the role of management lead for CDRH’s IVD Shortages Team in June 22.