Associate Director for Science and Technology, Office of In Vitro Diagnostics and Radiological Health (OIR), CDRH, U.S. Food and Drug AdministrationBiography
Živana Težak, Ph.D., is an Associate Director for Science and Technology, Personalized Medicine Staff, in the Office of In Vitro Diagnostic Device (IVD) Evaluation and Safety (OIR), at the Center for Devices and Radiological Health, Food and Drug Administration (FDA). Prior to joining the FDA in 2004, 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 2001 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. In her current position, Dr. Težak has been leading efforts to develop flexible regulatory policies for novel technology based IVDs, such as chromosomal microarrays and next-generation sequencing, in order to enable their smoother translation into the clinic.