Microsoft Word - LowLactose_ERP-Proposal-May2019

 2000 - 2007: Research/Teaching Assistant , Interdisciplinary Toxicology Program, University of Georgia, Athens, GA (Advisor: Prof. James V. Bruckner). 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. Served as a representative of NAB in the national and international scientific conferences (including AOAC International) and other FDA conferences (FDA Science Forum, FDA Food and Veterinary Medicine Science and Research Conference, ORCE Research Summit) and FDA-sponsored trainings, and ad hoc reviewer of manuscripts submitted to peer-reviewed journals. 6. Rich experiences in analytical method developments for the bioorganic compounds (and metabolites) in diverse sample matrices using different analytical instruments including LC-MS, LC with different detectors (e.g., UV, FLD, RID and others), GC-MS, GC-FID, FT-ATR-IR, elemental analyzer, and NMR, etc. a. Method development, validation, verification, and matrix extension of a number of methods for the micronutrient analysis in foods and characterization of adulteration b. Review of analytical packages (including the ones submitted by the private laboratories) c. Participation in the multi-lab validation studies 7. 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 c. pharmacokinetic studies of with stable isotope-labeled compounds) experiments.in in vitro experiments including enzyme kinetics (CYP450 induction/inhibition, esterases and Phase II enzymes) studies allergen assay, and d. Excellent skills of animal husbandry (rats, mice, rabbits and minipigs, etc), dosing, necropsy and simple surgery. 8. Proficiency in software a. Software for analytical instruments (esp. mass spec): Analyst, Xcaliber, MassHunter (Chemstation), Empower, etc; b. AcslX ® (PBPK modeling); WinNonlin ® (pharmacokinetics), SigmaPlot ® and Prism ® (data presentation); c. QIMacros and R; ChemBioOffice (chemistry);

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