Curriculum Vitae

Lie Li

**** **** ****,

Chapel Hill, NC, 27517, USA

Tel (cell): 662-***-****

Email: xes0sv@r.postjobfree.com

Status: Permanent resident of U.S.

Objective

A position in biopharmaceutical analysis, pharmacokinetic/pharmacodynamic (PK/PD) and drug discovery area providing the opportunity to make a strong contribution to organization goals through continued development of professional skills.

Education and training

2008-Now Postdoctoral Research Associate, Molecular Pharmaceutics, University of North Carolina, Chapel Hill, NC, USA.

2007-2008 Post-doc Research Associate, Pharmaceutics, Virginia Commonwealth University, Richmond, VA, USA.

2005-2007 Postdoctoral, Pharmaceutics, University of Mississippi, University, MS, USA.

2002-2005 Ph.D. Biotechnology and Pharmaceutics, Peking University, Beijing, China.

1999-2002 M.S. Pharmacognosy, China Pharmaceutical University, Nanjing, China.

1995-1999 B.S. Pharmaceutical Sciences, China Pharmaceutical University, Nanjing, China.

Publication Record

18 research papers published in peer-reviewed journals, 2 submitted. Please refer to the enclosed list of publications and research highlights in this CV for more details.

Career Summary

Eight years of research experience in pharmaceutical analysis, pharmacokinetic and bioanalysis area; Emphasizing biopharmaceutical analysis, pharmacokinetic and preclinical studies of the pro-drug, small molecular compounds, protein, peptide and traditional Chinese medicine; Experience working in GLP lab and evolving in GLP projects. Experience validating LCMSMS, GCMS, UPLC method for small molecular and macromolecules (protein and peptide). Experience encompasses broad range of disciplines including pro-drug development, formulation optimization, protein binding, quality control, protein quantification, isolation, identification and validation of fingerprint of herbal medicine. Research areas include pharmacokinetic, Pharmaceutical Analysis and Pharmcognosy.

Skills

• Pharmaceutical analysis and Bioanalysis: Expertise in investigation of novel instrumental and chemical approaches to provide improved selectivity and sensitivity for quantitative analysis of drugs in biological samples and application of analytical methods to pharmacokinetic studies.

• Pharmacokinetic and Pharmacodynamic study: Expertise in designing, conducting and interpreting preclinical pharmacokinetic studies. Proficient in pharmacokinetic studies including animal handling, oral and intravenous dosage to animal, plasma or tissue samples withdrawal and pretreatment of biological samples. Knowledge of optimization of oral and intravenous formulation to improve solubility of non-polar compound.

• Quantification on macromolecular (protein and peptide): Expertise in absolute quantification (AQUA) method for proteins and peptides.

• Quantitative analysis: Hands-on experience in operating and troubleshooting LCMS, GC and UPLC instruments including Waters triple-quadrupole mass spectrometry, API3000 and 4000 triple-quadrupole mass spectrometry and Thermo Finnigan ion-trap spectrometry.

• GLP experience: Strong experienced in conducting an analytical procedure in approaches to analytical method development and in validation and procedures used in a laboratory that meets the FDA requirements for Good Laboratory Practices (GLP).

• Hardware/operation system: Extensive experience with MassLynxTM, Analyst, Xcalibur and Chemstation software.

• PK/PD data analysis: Strong knowledge and experience in interpreting PK/PD data with WinNonlin software, officially trained by Pharsight Co.

Experiences and Research Areas

Molecular Pharmaceutics Department, University of North Carolina, Chapel Hill, NC, Postdoc Research Associate, 2008-2009

• Developed and validated HPLC-MS/MS method for absolute quantification of human uridin-diphosphate glucuronosyl transferase (UGT) enzyme isoforms 2B7, 2B15 and 2B4 in liver microsome. Including: Conducted in silico studies of UGT2Bs by UniproKB, NCBI Blast and so on。

• Developed HPLC-MS/MS method to determine the covalent protein binding of OSI (a mTOR inhibitor drug candidate) in animal tissues.

Pharmaceutics Department, Virginia Commonwealth University, Richmond, VA

Postdoc Research Associate, 2007-2008

• Developed and validated bioanalytical methods on HPLC-MSMS or HPLC in support of in vivo and in vitro evaluation of drugs such as nicotine, cotinine, morphine, milbemycine oxime, melphalan. Developed extraction and analysis methods for prodrug candidates in biological fluids and tissues. Authored study and validation reports.

• Performed organizational duties for GLP project in GLP laboratory.

Department of Pharmaceutics, University of Mississippi, University, MS

Postdoctoral, 2005-2007

• Performed intravenous and oral ADME studies of a novel semi-synthetic artemisinin derivative (ARB-89-1) in rat. Developed, validated and utilized LC/MSMS methods for analysis of ARB1-89 in rat serum, urine and feces. Identified Putative metabolites. Evaluated PK parameters with WinNonlin software.

• Determined protein binding of antimalarials (ARB-89-1, artemisinin, arteether, CoQ10) by ultrafiltration and equilibrium dialysis techniques.

• Optimized intravenous and oral formulations for improved solubility. Investigated co-solvents, surfactants and complexation agents. The chosen resulting lead formulation increased the aqueous solubility of ARB-89-1 over 104 fold.

• Metabolism study of Benzo[]pyrene by cytochrome P450s. Benzo[]pyrene and its metabolites were identified and qualified in fish serum and bile. Relative bioavailability study of the prodrug of CoQ10. The methods of CoQ10 and its prodrug were established and validated. The pharmacokinetic and bioavailability of the prodrug were calculated and analyzed.

Department of Pharmacognosy & Biotechnology, Peking University, Beijing

Ph. D research, 2002-2005

• Studied the therapeutic basis of traditional Chinese medicine Panax notoginsen. HPLC and HPLC-MS technologies were used to establish the chromatographic fingerprints of Panax notoginseng and P. ginseng. The ADME of major saponins in P. notoginseng were studied after oral and intravenous administration of total saponins of P. notoginseng (PNS) to rats.

• Established and applied quantitative analysis methods of the major saponins in PNS to determine the contents of the major saponins in rat serum, urine, feces and tissues.

• Calculated and analyzed he pharmacokinetic models and parameters of the major saponins in rats.

• Modified the craftwork of the Xiangdan Injection and established the quantity standards for this injection according to the request of China Pharmacopoeia Committee.

Department of Pharmacognosy, China Pharmaceutical University, Nanjing.

M.S. research, 1999-2002

• Performed the quality evaluation and craftwork of solanesol from Nicotiana tobacum and investigated the species discrimination, chemical constituents, quantitative determination and its purity craftwork.

Training

1. 2008 Biopharmaceutic Analysis and GLP, Virginia Commonwealth University, Richmond, VA, USA.

2. 2006 WinNonlin Hands-on v5.1 course training. Pharsight Company, Mountain View, CA, USA.

2. 2006 English Academic Writing course. University of Mississippi, University, MS, USA.

3. 2004 Agilent HPLC training course, Agilent China, Ltd, Beijing, China.

Services as reviewer

2007 --Present: Reviewer for Journal of Pharmaceutical and Biomedical Anlysis.

2007—Present: Reviewer for Journal of Chromatographic Sciences

2007 --Present: Reviewer for Biomedical Chromatography

Rewards

2007 First prize of China University Science and Technology Award, by Ministry of Education of China.

Publications

1. Lie Li, Deepthi Pabbisetty, Paulo Carvalho, Mitchell A. Avery, Bonnie A. Avery, Analysis of CoQ10 in rat serum by ultra-performance liquid chromatography mass spectrometry after oral administration. Journal of Pharmaceutical and Biomedical Analysis 2008 46 (1) 137-142.

2. Lie Li, Mitchell A. Avery, Bonnie A. Avery, Urinary excretion study of coenzyme Q10 in rat by ultra-performance liquid chromatography-mass spectrometry. Journal of Chromatography Sciences 2008, 46: 215-219.

3. Lie Li, Deepthi Pabbisetty , Paulo Carvalho, Mitchell A. Avery, Bonnie A. Avery, Ultra-performance liquid chromatography – tandem mass spectrometric method for the determination of Artemisinin in rat serum and its application in pharmacokinetics. Journal of Chromatography B 2008,867 (1): 131-137.

4. Lie Li, Mahesh K. Gundluru, Deepthi Pabbisetty, Paulo Carvalho, Mitchell A. Avery, Bonnie A. Avery. Determination of β-arteether unbound drug concentration in serum and plasma by ultrafiltration and ultra-performance liquid chromatography-tandem mass spectrometry. Biomedical Chromatraphy, 2009, Submitted

5. Lie Li , Deepthi Pabbisetty, Mahesh K. Gundluru, Paulo Carvalho, Mitchell A. Avery, Bonnie A. Avery. Determination of ARB189 a new antimalarial drug in rat serum by ultra-performance liquid chromatography mass spectrometry and its application in pharmacokinetic. Biomedical Chromatography 2009, submitted.

6. Lie Li, Jin-lan Zhang, Yu-Xin Sheng, Shan-shan Wang and Dean Guo*. High-performance liuquid chromatographic assay for the active saponins from Panax notoginseng in rat tissues. Biomedical Chromatography 2006 20 (4): 327-335.

7. Lie Li, Jin-lan Zhang, Yu-xin Sheng, Qiao Wang, Hong-zhu Guo and Dean Guo*. Simutaneous quantification of six major active saponins of Panax notoginseng by High-performance liquid chromatography –UV method. Journal of Pharmaceutical and Biomedical Analysis. 2005 38(1): 45-51.

8. Lie Li, Yu-xin Sheng, Jin-lan Zhang and Dean Guo*. Determination of four active saponins of Panax notoginseng in rat feces by high-performance liquid chromatography. Journal of Chromatography Sciences. 2005 43(8): 421-42

9. Lie Li, Jin-lan Zhang, Yu-Xin Sheng, Guan Ye, Hong-zhu Guo and Dean Guo. Liquid chromatography method for determination of four active saponins from panax notoginseng in rat urine using solid-phase extraction. Journal of Chromatography B 2004.808: 177-183.

10. Lie Li, Yu-xin Sheng, Jin-lan Zhang, Ming Cui and Dean Guo*. HPLC determination of four active saponins from Panax notoginseng in rat serum and its application to pharmacokinetic studies. Biomedical Chromatography 2004 18: 849-856.

11. Lie Li, Qiu-xia Qian, Xiao-dong Cong. Determination of solanesol in Nicotiana tobaccum L. by HPLC-ELSD. Chinese Journal of Pharmaceutical Analysis. 2002.22(2): 103-105.

12. Lie Li, Xiao-dong Cong.TLC methods assay for solanesol in Nicotiana tobaccum L. Chinese Traditional and Herbal Drugs. 2002.33(5): 420-421.

13. Lie Li, Xiao-dong Cong. Extraction of solanesol from Nicotiana tobaccum L. by supercritical fluid CO2. Journal of China Pharmaceutical University. 2002. 33(4): 351-353.

14. Aihua Liu, Lie Li, Man Xu, Yanhua Lin, Hongzhu Guo, Dean Guo, Simultaneous quantification of six major phenolic acids in the roots of Salvia miltiorrhiza and four related traditional Chinese medicinal preparations by HPLC-DAD method. Journal of Pharmaceutical and Biomedical Analysis.2006. 41 (1): 48-56.

15. Shiqian Zhu, Lie Li, Paulo Carvalho, Bonnie A. Avery, Kristine Willett, Development and validation of UPLC/MS/MS method to study the metabolism of Benzo[]pyrene by cytochrome P450s. Journal of Chromatography B, 2008, 863(1): 141-149.

16. Yuxin Sheng, Lie Li, Chuan-she Wang, Yanyan Li and Dean Guo*. Solid-phase extraction-liquid chromatographic method for the determination and pharmacokinetic studies of albiflorin and paeoniflorin in rat serum after oral administration of Si-Wu decoction. Journal of Chromatography B 2004. 806:127-132.

17. Yuxin Sheng, Lie Li, Jin-lan Zhang and Dean Guo*. Simultaneous determination of albiflorin and paeoniflorin in rat urine by solid-phase extraction and high-performance liquid chromatography following oral administration of Si-Wu decoction. Biomedical Chromatography 2004 18:785-790

18. Yu-Xin Sheng, Lie Li, Qiao Wang, Hong-Zhu Guo, De-An Guo*,Simultaneous determination of gallic acid, albiflorin, paeoniflorin, ferulic acid and benzoic acid in Si-Wu decoction by high-performance liquid chromatography DAD method. Journal of Pharmaceutical and Biomedical Analysis. 2005 37:805-810.

19. Jinlan Zhang , Yun He, Ming Cui, Lie Li, Dean Guo. Metabolic studies on the total phenolic acids from the roots of Salvia miltiorrhiza in rats. Biomedical Chromatography 2005 19:51-59

20. Jinlan Zhang, Hailan Yu, Yuxin Sheng, Lie Li, Min Ye, Dean Guo. HPLC determination and pharmacokinetic studies of salvianolic acid B in rat plasma after oral administration of Radix Salviae miltiorrihiza extract. Biomedical Chromatography. 2005 19:15-18

Poster Presentation

1. 2007 AAPS, San Diego, CA

Poster 1: Lie Li, Mitchell A. Avery, Bonnie A. Avery, Urinary excretion study of coenzyme Q10 in rat by ultra-performance liquid chromatography-mass spectrometry.

Poster 2: Lie Li, Deepthi Pabbisetty, Mahesh K. Gundluru, Paulo Carvalho, Mitchell A. Avery, Bonnie A. Avery. Determination of ARB189 a new antimalarial drug in rat serum by ultra-performance liquid chromatography mass spectrometry and its application in pharmacokinetic.

2. 2007 Society of Toxicology Annual Meeting, Charlotte, NC

Poster 1: Shiqian Zhu, Lie Li, Paulo Carvalho, Bonnie A. Avery, Kristine Willett, Development and validation of UPLC/MS/MS method to study the metabolism of Benzo[]pyrene by cytochrome P450s.

3. 2006 AAPS, San Antonio, TX.

Poster: Lie Li, Deepthi Pabbisetty , Paulo Carvalho, Mitchell A. Avery, Bonnie A. Avery Ultra-performance liquid chromatography – tandem mass spectrometric method for the determination of Artemisinin in rat serum and its application in pharmacokinetics.

4. 2006 Society of Environmental Toxicology and Chemistry, Montreal, Quebec, Canada.

Poster 1: Shiqian Zhu, Lie Li, Paulo Carvalho, Bonnie A. Avery, Kristine Willett, Development and validation of UPLC/MS/MS method to study the metabolism of Benzo[]pyrene by cytochrome P450s.

5. 2005 AAPS, Nashville, TN.

Referees

1. Dr. Bonnie A. Avery

Associate Professor, Department of Pharmaceutics,

University of Mississippi, University, MS, 38677

Tel: 662-***-****

Email: xes0sv@r.postjobfree.com

2. Dr. Paulo B. Carvalho

Assistant Professor, Department of Medicinal Chemistry,

University of Mississippi, University, MS, 38677

Tel: 662-***-****

Email: xes0sv@r.postjobfree.com

3. Dr. Matthew S Halquist

Director, Department of Pharmaceutics,

Virginia Commonwealth University, Richmond, VA, 23298

Tel: 804-***-****

Email: xes0sv@r.postjobfree.com

4. Dr. Kin Kai Hwang

Distinguished Scientist

Sanofi-Aventis Pharmaceuticals, Bridgewater, NJ, 08807

Tel: 908-***-****

Email: xes0sv@r.postjobfree.com

5. Dr. Karnes, H Thomas

Professor, Department of Pharmaceutics,

Virginia Commonwealth University, Richmond, VA, 23298

Email: xes0sv@r.postjobfree.com

Contact this candidate