Manager, Regulatory Operations
Through previous collaborative efforts, I got to know Emmes staff as consistently competent and a pleasure to work with. I was further attracted to Emmes by their consistent growth and reputation. I am excited to be a part of the Emmes Regulatory team and enjoy being a part of the many success stories.How do you describe Emmes to other people
Emmes has a very talented and intelligent workforce. I’m impressed by our accomplishments and our ability to customize our approach to the unique needs of each project. It is no surprise that Emmes is routinely ranked as one of The Washington Post’s “Best Places to Work” in the DC area.A bit about me
I spend my time away from work with my wife and our little girl. When I can, I like to be active and enjoy the outdoors (e.g., playing hockey, skiing, mountain biking, canoeing, camping, etc.).How I chose my career
I consider myself lucky. I have always been interested in biomedical research and enjoyed testing my abilities with computers. Regulatory Operations allows me to be a part of exciting clinical research and provides the technological challenges to keep me engaged.Best part about working at Emmes
I enjoy the unique challenges of each project, and working with a variety of clients and products. My colleagues here are amazing to work with, and I appreciate being a part of such an accomplished team of experts.Background
Out of college, I worked as a lab technician in an HIV research laboratory at the University of Pennsylvania. When I transitioned to Regulatory Affairs, I gained experience ranging from regulatory document authoring to review, publishing, and transmission of submissions to FDA in various paper and electronic formats.Education
B.S. Biochemistry/Molecular Biology, The Richard Stockton College of NJ
M.S. Bioscience Regulatory Affairs, Johns Hopkins University
Leah Giambarresi, Scott Garrand, Michelle Chakrabarti, Vanessa Eccard, Angel Gonzalez, Tom Harvey, Jennnifer Hertsch, Lydia Lacuesta, Molly Buehn. The Electronic Common Technical Document: One Organization’s Experience. 2012 NIH Spring Research Festival.
Ryzhova E, Aye P, Harvey T, Cao W, Lackner A, González-Scarano F. 2009. Intrathecal humoral responses are inversely associated with the frequency of simian immunodeficiency virus macrophage-tropic variants in the central nervous system. JV. 83:8282-8286.
Harrist AV, Ryzhova EV, Harvey T, González-Scarano F. 2009. Anx2 interacts with HIV-1 Gag at phosphatidylinositol (4,5) bisphosphate-containing lipid rafts and increases viral production in 293T cells. PLoS ONE. 4:e5020.
Harrist AV, Ryzhova EV, Harvey T, and Gonzalez-Scarano F. Annexin 2 overexpression in 293T cells increases HIV-1 Gag mRNA and protein levels and facilitates viral release. J. Neurovirology, 2006. Vol 12.
Ryzhova EV, Vos RM, Albright AV, Harrist AV, Harvey T, and Gonzalez-Scarano F., Annexin 2: a novel human immunodeficiency virus type 1 Gag binding protein involved in replication in monocyte-derived macrophages. J. Virology, March 2006.
Gene Edited Hematopoietic Cell Therapy Trial (commercial)
Stem Cell Research Studies (commercial)
Universal Influenza and Clinical Trials Support, Vaccine Research Center (NIH)
Encephalitis Vaccine Study, Vaccine Research Center (NIH)