Experienced scientific researcher with a wide-ranging skill set including a strong biochemistry and analytical chemistry background in addition to broad expertise in FDA regulation.
•FDA/CBER New Reviewer Training Course: “The Lifecycle Approach” (4 day course) (Jan 14, 2009)
•FDA CBER OCBQ Manufacturing Technology Seminar: Single use upstream manufacturing including purification technologies and extractable leachables considerations (Feb 4, 2010)
•FDA CBER Analytical Technology Series Session 2 Proteomics: Principles and Methods (Feb 23, 2010)
•FDA CBER Manufacturing Process Science: Cell Culture, Fermentation and Bioreactor Technology (July 23, 1010)
•FDA CBER Manufacturing Process Science Series: Introduction to Downstream Processing Chromatography, Filtration, Precipitation & Centrifugation (Sept 23, 2011)
•FDA CBER Fundamentals of Bioassay Practices (Oct 27, 2011)
•FDA OCBQ Manufacturing Technology Seminar: Overview of Viral Clearance Technologies including virus inactivation at low pH, chromatography and nanofiltration (May 10, 2012)
•FDA OCBQ Manufacturing Technology Seminar: Basic Filtration including microfiltration, nanofiltration, and ultrafiltration (July 26, 2012)
•Technical Writing for Reviewers (Sept 10-11 )
•Biostatistics for Non-statisticians (3-day course) (Nov 13, 2012)
•FDA CBER Writing for Success using Plain Language (Mar 27, 2013)
•Basic Principles of Immunology and Hypersensitivity (audit FAES course NIH)
•Principles of Clinical Pharmacology (Clinical Center Sept 2, 2010-April 28, 2011-received certificate for 70% attendance of classes)
Harman, C. A., Rieke, C. J., Garavito, R. M., and Smith, W. L. Crystal structure of arachidonic acid bound to a mutant of Prostaglandin Endoperoxide Synthase-1 that forms predominantly 11-HPETE. J. Biol. Chem. (2004), 279: 42429-35.
Harman, C. A, Kozak, K. R, Marnett, L. J., Smith, W. L., and Garavito, R. M. Structural basis of enantioselective inhibition of COX-1 by (S)--substituted indomethacin ethanolamides. J. Biol. Chem. (2007), 282: 28096-28105.
Lim, P.J., Danner, R., Liang, J., Doong H., Harman, C., Srinivasan D., Rothenberg, C., Wang, H., Ye, Y., Fang, S., and Monteiro, M.J. Ubiquilin and p97/VCP bind Erasin, forming a complex involved in ERAD. J. Cell Biol. (2009), 187(2): 201-17.
Duan, H., Kachko, A., Zhong, L., Struble, Evi., Pandey S., Yan, H., Harman, C., Virata-Theimer, M.L., Deng, L., Zhao, Z., Major, M., Feinstone, S., & Zhang, P. Amino Acid Residue-Specific Neutralization and Non-Neutralization of Hepatitis C Virus by Monoclonal Antibodies to the E2 Protein (2012) J. Virology 86(23): 12686-94
Deng, L., Zhong, L., Struble, E., Ma, L., Harman, C., Yan, H., Virata-Theimer, M.L., Zhao, Z., Feinstone, S., Alter, H., & Zhang, P. Structural Evidence for a bifurcated mode of action in the antibody-mediated neutralization of hepatitis C virus (2013) Proc Natl Acad Sci USA 110(18): 7418-22.
Harman, C., Zhong, L., Deng, L., Duan, Hongying, D., Zhong, Z., Ma, L., Liu, Peter., Struble, E., Yan, H., Feinstone, S., and Zhang, P. A View of the CD81-E2 Interface at the Binding Site of a Neutralizing Antibody against Hepatitis C Virus (in preparation 2013)
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