Sue Nie Park
Dr. Sue-Nie Park received her Ph.D from Dept. Microbiology/Public Health & Bacteriology of Washington State Univ.(Pullman, USA) in 1987 after obtaining BS at Sogang Univ., MS at Seoul National Univ.. Further she completed her 2 years’ postdoctoral fellowship in Molecular Biology Lab./Biochem. at KIST(Korea Institute of Science and Technology) in 1989. Then, she joined Molecular & Cell Biology Group at KRIBB(Korea Research Institute of Bioscience and Bioengineering), Immunology group and finishing her career there as a chief of Virology/Oncology Lab. in 1999 with a three-year leave of absence to KFDA(MFDS).
She moved to Korean FDA and has served as directors of many divisions evaluating biological products for approving licensure of such as vaccines, blood products, diagnostics, recombinant products, cell and tissue engineered therapeutics which included all the conventional and advanced products for 8 years. During this period, she served as a leader for the improvement of KFDA review system and national lot release system including WHO-PQ establishment. Further, she served as directors for divisions of preclinical area such as general and genetic toxicology for 4 years. Since Jan. 2011, Dr. Park served Director of Division of Hazardous Substances Analysis and finishing her career as Director General of Center for Food and Drug Analysis in KFDA. In 2013 she joined EuBiologics. Co, Ltd. after 15 years’ serving as a government official.
She also has served for several positions at universities and scientific societies, including as Adjunct Professor at Korea University (BioScience College at KU) and Sogang University. At KU she has been teaching graduate students on regulatory affairs including QC, QA and RA for 13 years. She served as a liason for MOU(LOA) between NCTR/FDA(USA)-NITR/KFDA(Korea), 2007 and a co-organizer for Joint workshop held in 2008 at Arkansas, NCTR/FDA(USA) for the first time in KFDA history.
She served as a WHO expert advisory panel on biological standardization (2005-2009), also a temporary advisor since 2000, an advisory member for OECD/IPCS toxicogenomics program (2006-2008), OECD molecular screening & toxicogenomics program (2008-present) and a leader for OECD/Cancer epigenetics subgroup(2008-present). She also has been serving as a Board member for International Papillomavirus Society since 2004.
She was awarded with a National Science & Technology Decoration (Hoonjang) from Korea Government (2003, President) on her achievements as a scientist on virus and immunology area and awarded with a Ministry of Health & Welfare Award (2013) on her efforts for improving KFDA regulatory affairs. During 2011~ 2014, she was recognized as Who’s Who in the World in the medical area. Dr. Park has published more than 150 original papers. She has been in charge of many projects on biopharmaceuticals, foods additives, toxicology area and organized many national and international symposia. Thus, she has unique and extensive experiences in both researches and regulatory area (including nonclinical area) which could be pivotal for biopharmaceutical developments in Biopharmaceutical field including EuBiologics Co, Ltd. Currently she functions as principle investigator for OCV, TCV and PCV projects.
