SPSFAM_Sugar_ERP-92018Proposal

25

o Explored in vitro and in vivo enzyme kinetic (induction/inhibition) profiles of CYP450s and their effects on PK of volatile organic compounds with animal models. For example, the effects of the induction of CYP450 2E1 activities on the ADME of volatile organic compounds. o Collaborated with other scientists to develop a PBPK model for the pharmacokinetic and pharmacodynamics modesl in animal and human models after the exposure to the volatile organic compounds. o Taught pharmacy Skills Lab for the first year Pharm D. students.  1997 - 2000: Research/Teaching Assistant , Department of Chemistry, University of Pittsburgh, Pittsburgh, PA (Advisor: Prof. Dennis P. Curran). o Studied the characteristics of perfluorinated chemicals and applications in combinatorial chemistry.  1996 - 1997: Undergrad Lab Coordinator/NMR operator , Department of Chemistry, Seoul National University (SNU), Seoul, South Korea. o Taught Organic Chemistry Lab for sophomores of Chemistry major and supervised about 100 teaching assistants for chemistry lab offered to first year students in Science/Engineering Schools of SNU. HIGHLIGHTS AND TECHNICAL SKILLS 1. Strong background in analytical chemistry (chromatography and mass spectrometry), toxicology, organic chemistry, ADME, pharmacokinetics and pharmacodynamics (PK/PD), and PBPK modeling. 2. Data review, summary and technical report writing with an advanced level of the statistical interpretation. 3. Good understanding of laws (e.g., 21 CFR 101), rules, regulations and policies regarding FDA-regulated food products and industries, especially, infant formulas, dietary supplements and related topics including, food safety, labeling requirements, and adulteration. 4. Good understanding of the requirements for the laboratory quality management systems, QA/QC guidelines and standards (such as ISO/IEC 17025, A2LA and others) pertinent to the requirements mandated by FSMA. 5. Co-chair of Food Additives and Nutrients TAG of Chemistry Research Coordination Group (CRSC) of Office of Food and Veterinary Medicine (OFVM), a member of Chemistry Expert/Technical Lead (Nutrition Program) for the private laboratory review, a member of Chemistry SME for STARLIMS implementation. Also served as a member of Course Advisory Group (CAG) in FDA training course LB246 (offered by DHRD of ORA) for the lab personnel in the various FDA field labs, 6. Served as a representative of NAB in the national and international scientific conferences (including SPIFAN, SPSFAM of AOAC International) and other FDA-sponsored trainings, and ad hoc reviewer of manuscripts submitted to peer-reviewed journals. 7. Rich experiences in analytical method developments for the bioorganic compounds (and metabolites) in diverse sample matrices using different analytical instruments including LC-MS (Q-TRAP, Orbitrap, Velos, QQQ and Q-ToF instruments from diverse vendors including Sciex, Thermo, Agilent and Waters), LC with different detectors (e.g., UV, FLD, RID and others), GC-MS (Agilent and Thermo), GC-FID, FT-ATR-IR, elemental analyzer, and NMR, etc. a. Method development, validation and verification for the micronutrient analysis (including, fat soluble vitamins, water soluble vitamins, sugars and polyols), food additives (natural sweeteners including steviol glycosides), omega-3 analysis in foods and characterization of adulteration (olive oils, milk fats, juice, honey and others). b. Review of analytical packages (including the ones submitted by the private laboratories) with a variety of analytical techniques in nutrient analysis in addition to the adulteration or product authentication. c. Participation in the validation/verification of multi-lab collaborations, including vitamin D analysis by LC-MS/MS (via AOAC), water soluble vitamin analysis by LC-MS/MS (AOAC), β-carotene analysis by LC, SRM1869 inter- laboratory study (NIST) and others. 8. Technical skills related to in vitro , in vivo and in silico toxicology. a. Managed (as a Study monitor) large-scale animal studies (preclinical Phase I trials) for chelating drugs in development. b. Extensive experiences in vivo metabolism studies

Sookwang Lee, Ph.D., D.A.B.T.