Jan Simak, Ph.D.

Principal Investigator at the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration

Dr. Simak is a Principal Investigator at the Center for Biologics Evaluation and Research, U.S. Food and Drug Administration. His research program is focused on studies of extracellular vesicles and protein aggregates in blood and blood products and on interaction of engineered nanoparticles with blood platelets and vascular endothelial cells.  Dr. Simak also serves as a scientific lead reviewer (CMC) on several types of submissions related to cellular blood products and transfusion devices.

Dr. Simak received his Ph.D. in Biochemistry in 1992 at the Institute of Hematology and Blood Transfusion / Univ. of Chemistry and Technology in Prague, Czech Republic. In 1992 – 2000, he served as Assistant Professor/PI at the 1st Faculty of Medicine, Charles University in Prague, and at the Neonatal Intensive Care, Institute for the Care of Mother and Child in Prague. Dr. Simak joined CBER FDA in February 2000.

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