Summary
Overview
Work History
Education
Skills
Publications
Timeline
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Xiaoyan Cathy Zou

Rockville,MD

Summary

Experienced in scientific review writing, project management and presentation. Multidisciplinary background in cell biology, immunology, and biomolecular engineering. Accomplished Staff Scientist demonstrating strong knowledge of various scientific methods and research skills. Highly organized, proactive and punctual with team-oriented mentality.

Overview

24
24
years of professional experience

Work History

Pharmaceutical Scientist

FDA
Silver Spring, Maryland
03.2023 - Current
  • Serve as the primary assessor for product quality (Chemistry, Manufacturing, and Control) in biologics BLAs and supplements, INDs and amendments, pre-approval meetings, and inspections.
  • Provided detailed review documents summarizing findings from reviews and analysis, and provided recommendations to customers.
  • Maintained communications with multidisciplinary teams to resolve multidisciplinary issues, and provide updates on the progress of reviews being conducted.
  • Provided timely information and work output to supervisors and team members.

Patent Examiner

United States Patent and Trademark Office
Alexandria, VA
06.2021 - Current

Reviewed and examined U.S. patent applications in Biotechnology area to ensure compliance with federal regulations and laws.

  • Prepared thorough, accurate and well-edited technical and legal review documents for cases, client communication and internal needs.
  • Researched federal laws, policies and regulations.
  • Participated in negotiation meetings with patent applicants and attorneys to assess legal compliance of inventions.
  • Successfully managed case docket, while meet productivity requirements.

Staff Scientist

HJF/Naval Medical Research Center, Malaria Program
Silver Spring, MD
01.2012 - 06.2021
  • Served as a Principal Investigator independently conducting scientific research projects.
  • Research area: Liver stage biology of malaria; Antibody kinetics of SARS-CoV-2 infected subjects.
  • Supervised a liver stage functional assay core facility to analyze animal/clinical antibody/sera samples for NMRC/WRAIR investigators.
  • Participated in COVID-19 Health Action Response for Marines (CHARM) study. Analyzed antibody kinetics and neutralizing activities using ELISA and in vitro neutralization assays (using pseudo viruses and flow cytometry analysis).
  • Prepared proposals for grant application and manuscripts for publication. Several proposals received fundings.
  • Provided scientific analysis and conducted evaluation of animal/clinical samples to screen and improve potential malaria vaccine candidates.
  • Assisted in developing and implementing research projects and recommending solution based on results.
  • Collaborated with scientists from various institutions to better understand research goals, experimentation plans and deadline dates for research.
  • Review and evaluate current scientific literature for new research methods to explore mechanisms of related biological processes.

Postdoctoral Research Associate

HJF/Naval Medical Research Center, Malaria Program
Silver Spring, MD
01.2009 - 12.2011
  • Development and optimization of malaria liver stage assays in vitro using immunological/molecular methods.
  • Identification of novel liver stage antigens for malaria vaccine development.
  • Presentations at regular group meetings, seminars and national meetings.

Research Associate

HJF/Naval Medical Research Center, Malaria Program
Silver Spring, MD
03.2006 - 12.2008
  • Planned, modified and executed research techniques, procedures and tests.
  • Maintained accurate records of laboratory methods, research conducted and results obtained.

Research Assistant

Ohio University
Athens, OH
09.2001 - 06.2005
  • Research area: molecular mechanisms of inflammation.
  • Investigated leukocyte and cancer cell adhesion to endothelial cells in vitro.
  • Using flow cytometry extensively to analyze expression profiles on leucocytes.
  • Studied nanoparticle targeted drug delivery system.

Education

Ph.D - Chemical and Biomolecular Engineering

Ohio University
2008

M.S - Chemical and Biomolecular Engineering

Ohio University
2003

B.S - Chemical Engineering

Zhejiang University
1995

Skills

  • Review CMC of biologic drug applications (BLAs, IND)
  • Review of biotechnology patent applications
  • Scientific proposal development
  • Manuscript preparation
  • Assay development and standardization
  • qRT-PCR
  • Flow Cytometry (FACS)
  • Operetta high-content imaging system
  • Antibody detection and functional assays

Publications

1. Schneider CG, Fey J, Zou X, et al. Norovirus-VLPs expressing pre-erythrocytic malaria antigens induce functional immunity against sporozoite infection. Vaccine. 2022;40(31):4270-4280. 2. Langowski MD, Khan FA, Savransky S, Brown DR, Balasubramaniyam A, Harrison WB, Zou X, et al. Restricted valency (NPNA)n repeats and junctional epitope-based circumsporozoite protein vaccines against Plasmodium falciparum. NPJ Vaccines. 2022 Jan 27;7(1):13. 3. Mallory KL, Taylor JA, Zou X, et al. Messenger RNA expressing PfCSP induces functional, protective immune responses against malaria in mice. NPJ Vaccines. 2021;6(1):84. 4. Livingstone, M. C., Bitzer, A. A., Giri, A., Luo, K., Sankhala, R. S., Choe, M., Zou, X.,et al. In vitro and in vivo inhibition of malaria parasite infection by monoclonal antibodies against Plasmodium falciparum circumsporozoite protein (CSP). Scientific Reports. 2021 Mar 5;11(1):5318. 5. Langowski MD, Khan FA, Bitzer AA, Genito CJ, Schrader AJ, Martin ML, Soto K, Zou X, et al. Optimization of a Plasmodium falciparum circumsporozoite protein repeat vaccine using the tobacco mosaic virus platform. PNAS. 2020 Feb 11;117(6):3114-3122. 6. Winer B, Edgel KA, Zou X, et al. Identification of Plasmodium falciparum proteoforms from liver stage models. Malaria Journal. 2020 Jan 7;19(1):10. 7. Martin ML, Bitzer AA, Schrader A, Bergmann-Leitner ES, Soto K, Zou X, et al. Comparison of immunogenicity and safety outcomes of a malaria vaccine FMP013/ALFQ in rhesus macaques (Macaca mulatta) of Indian and Chinese origin. Malaria Journal. 2019 Nov 27;18(1):377. 8. Cawlfield A, Genito CJ, Beck Z, Bergmann-Leitner ES, Bitzer AA, Soto K, Zou X, et al. Safety, toxicity and immunogenicity of a malaria vaccine based on the circumsporozoite protein (FMP013) with the adjuvant army liposome formulation containing QS21 (ALFQ). Vaccine. 2019 Jun 27;37(29):3793-3803. 9. Zou X, House BL, Zyzak MD, et al. Towards an optimized inhibition of liver stage development assay (ILSDA) for Plasmodium falciparum. Malaria Journal. 2013 Nov 5;12:394. 10. McCoy ME, Golden HE, Doll TA, Yang Y, Kaba SA, Zou X, et al. Mechanisms of protective immune responses induced by the Plasmodium falciparum circumsporozoite protein-based, self-assembling protein nanoparticle vaccine. Malaria Journal. 2013 Apr 22;12:136. 11. Plassmeyer ML, Reiter K, Shimp RL Jr, Kotova S, Smith PD, Hurt DE, House B, Zou X, et al. Structure of the Plasmodium falciparum circumsporozoite protein, a leading malaria vaccine candidate. Journal of Biology Chemistry. 2009 Sep 25;284(39):26951-63. 12. Zou X, Shinde Patil VR, Dagia NM, et al. PSGL-1 derived from human neutrophils is a high-efficiency ligand for endothelium-expressed E-selectin under flow. American Journal of Physiology- Cell Physiology. 2005;289(2):C415-C424. 13. Sundd P, Zou X, Goetz DJ, Tees DF. Leukocyte adhesion in capillary-sized, P-selectin-coated micropipettes. Microcirculation. 2008;15(2):109-122.

Timeline

Pharmaceutical Scientist

FDA
03.2023 - Current

Patent Examiner

United States Patent and Trademark Office
06.2021 - Current

Staff Scientist

HJF/Naval Medical Research Center, Malaria Program
01.2012 - 06.2021

Postdoctoral Research Associate

HJF/Naval Medical Research Center, Malaria Program
01.2009 - 12.2011

Research Associate

HJF/Naval Medical Research Center, Malaria Program
03.2006 - 12.2008

Research Assistant

Ohio University
09.2001 - 06.2005

Ph.D - Chemical and Biomolecular Engineering

Ohio University

M.S - Chemical and Biomolecular Engineering

Ohio University

B.S - Chemical Engineering

Zhejiang University
Xiaoyan Cathy Zou