| Natalya Ananyeva, PhD, is a Team Lead in the Hemostasis Branch of the Division of Plasma Protein Therapeutics (DPPT), the Office of Tissues and Advanced Therapies (OTAT) in the Center for Biologics Evaluation and Research (CBER) at FDA. She provides guidance and support in review and evaluation of information on Chemistry, Manufacturing and Controls (CMC) in regulatory submissions (INDs, BLAs, BLSs, PMAs) as it relates to the quality and safety of biological and combination products indicated for the treatment of congenital or acquired bleeding disorders and as adjuncts to hemostasis. She participates in CBER regulatory thought developing committees and working groups. Prior to joining FDA in 2009, she performed academic research on cell biology and biochemical mechanisms of atherosclerosis and hemophilia in the J. Holland Laboratory of American Red Cross and University of Maryland School of Medicine. |