Management Project

Guixuan (Kathy) Chai, Ph.D.

Email: *******@*****.*** , US address: 2522 Sandvalley Way, League City, TX 77573

Phone: 086-21-51320535 (Office, China); 086-1-510-***-****(Cell, China); +1-936-***-**** (VoIP)

U.S. Permanent Resident

PROFESSIONAL EXPERIENCES

April 2010 - present, Research Fellow of Toxicology, Shanghai Chempartner CO., LTD, China

• Head of toxicology group, responsible for enhancing existing toxicology services and developing new technologies in elevating the compatibility and quality of preclinical services

• Scientific management: leading toxicology group in 4 different functional areas: in vitro toxicology, rodent toxicology, large animal toxicology and pathology laboratory; Ensure data quality and compliance with protocols and regulatory requirements including unexpected observations, adequacy of tests and data recording

• Review entire data generated and study reports, supervising studies for effectiveness and efficiency

• Financial management: propose cost estimates of studies including expenses and expected profit margin

• Business management: coordinate services and communication among the study team, upper-management and clients

Feb. 2009- - April 2010, HD Biosciences Inc., Shanghai, China

• , responsible for designing and performing in vivo preclinical safety studies and developing in vitro toxicity screening assays using high throughput screening (HTS) to evaluate cytotoxicity, hepatoxicity and genotoxicity for several clients including big US and European pharmaceutical companies;

• Designed and executed in vitro ADME programs including CYP inhibition/induction, Caco2 assay, molecule stability assay, and drug transporter assay;

• Supervised and trained in vitro DMPK group with scientific guidance and techniques in study principles, strategies and performance of toxicological experiments and DMPK screenings;

• Drew SOP and project-specific protocols, and prepared final study reports;

• Encouraged personal and professional development between the group and customers by providing high quality data and good communications;

• Participated and initiated management of the animal facility, set-up animal welfare regulation systems, IACUC protocol and SOP documentations for the application of AAALAC compliance;

• Management and marketing development including efforts of all scientific perspectives, price estimates and negotiations.

Feb. 2004 – June. 2008, Toxicology Scientist, Department of Drug Metabolism, Pharmacokinetics and Toxicology (DPMKT), Lexicon Pharmaceuticals Inc., Houston, USA

• Regulatory knowledge in toxicology: Knowledgeable in good laboratory practice (GLP), regulations and global regulatory (FDA, ICH, OECD, etc.) guidance

• Scientific knowledge: Provided molecular/cellular based technical support in studying project-specific issues and unmet needs of toxicology e.g. reproductive and ocular toxicology

• Outcomes: In charge of in vitro toxicity assay development to support drug discovery programs and participated in vivo toxicology data review. Worked out over 15 drug discovery projects for the toxicity and risk assessment

• Established qPCR array method to evaluate or predict the activation of toxic signaling pathways

• Performed drug-drug interaction assays in cultured primary hepatocytes and cell line by using LC-MS and QPCR detection methods

• Developed a high throughput PXR mediated cell-based assay to assess CYP3A4 inducers and metabolic stability, wrote reports; Knowledgeable of transcription-factor mediated toxicity pathways

• Developed and performed CYP inhibition assays including major human CYPs (3A4, 2B6, 2D6, 1A2, 2C9) and familiar with metabolic stability assay

• Prepared manuscripts for peer-review publications

• Supervisory management: Mentored and trained fresh scientists and technicians in a variety of tests and assays, promoted them to become an independent project player

Oct. 2001- Feb. 2004 Scientist, Department of Molecular Genetics, Lexicon Pharmaceuticals, Inc., Houston, USA

• Team Leader, supervised two research associates and generated over 120 knock-out mouse models by homologous recombination including genotyping, target strategy design, cloning, screening and confirming target ES cell clones and interpreting KO mice phenotypes. My team was the most productive team out of all 15 department teams in 2003.

• Participated in 5000 drugable gene KO model program including gene analysis, drug target analysis and KO phenotype analysis

1999- 2001 Postdoctoral Fellow, Department of Pathology, Yale University School of Medicine, USA

• Studied function of STAT3 (Signal Transducer and Activator of Transcription) protein in control of cell proliferation and human diseases

• Generated STAT3 conditional knockout mice and produced STAT3 liver and heart specific KO mice; established liver cirrhosis models

• Examined gene expression during liver regeneration by micro-arrays and investigated roles of STAT3 in the pathogenesis of liver cirrhosis, diabetes and heart diseases

1995-1999 D. Candidate, Max-Delbrück-Center(MDC) for Molecular Medicine, Berlin, Germany

• Developed embryonic stem (ES) cell technology in rats; Generated OCT-neo transgenic rat; isolated undifferentiated embryonic stem cell-like and facilitated ES cell derivation and cultivation; Discovered the ability of rat embryonic stem cells with high expression of Fas ligand (CD95L) to engraft and down-regulate host’s immune response in an allo-specific manner

• Generated smooth muscle myosin heavy chain (SHMMC) knock-out mouse; Analyzed neonatal lethal phenotype and further discovered that smooth muscle contraction is independent of smooth muscle myosin

1992-1995 Graduate Student, Department of Life Sciences, Peking University, P.R. China

• Established ES cell lines from C57BL/6J embryos and generated chimeric mice by blastocyst /8-cell injection

1986-1992 Lecturer, Department of Biology, Henan University, P.R. China

• Lecturer of Zoology and Cell Biology

• Set up the anatomy lab and open the class of Experimental Comparative Vertebrate Anatomy

EDUCATIONS AND TRAININGS

• Mid-America Toxicology Course, MO, USA 2006

• Postdoctoral Fellow, Yale University, 1999-2001

• Ph.D., Human Medicine, Free University of Berlin, Germany, 1999

• M.S., Genetics, Peking University, Beijing, P. R. China, 1995

• B.S., Zoology, Shandong University, Jinan, P. R. China, 1986

PUBLICATIONS

1. X. Liu, J.A. Kramer, J. Swaffield, Y. Hu, GX. Chai and A.G. E. Wilson. Development of a highthroughput yeast-based assay for detection of metabolically activated genotoxins. Mutat Res. /Genetic Toxicology and Environmental Mutagenesis. April 1, 2008.

2. C. Cayla, M. Todiras, R. Iliescu, V.V. Saul, V. Gross, B. Pilz, GX. Chai, V.F. Merino, JB. Pesquero, OC. Baltatu, and M. Bader. Mice deficient for both kinin receptors are normotensive and protected from endotoxin-induced hypotension. FASEB J. 2007; 21: 1689-1698.

3. A. Moh, Y. Iwamoto, GX. Chai (co-first author), S.SM. Zhang, A. Kano, DD. Yang, WJ. Zhang, J. Wang, JJ. Jacoby, B. Gao, RA. Flavell and XY. Fu. Role of STAT3 in liver regeneration: survival, DNA synthesis, inflammatory reaction and liver mass recovery. Lab Invest. 2007; 87 (issue 10): 1018-1028.

4. Y. Hong, C. Winkler, TM. Liu, GX. Chai and M. Schart. Activation of the mouse Oct4 promoter in medaka embryonic stem cells and its use for ablation of spontaneous differentiation. Mech Dev. 2004 Jul; 121(7-8):933-43.

5. A. Kano, MJ. Wolfgang, Q. Gao, J. Jacoby, GX. Chai, W. Hansen, Y. Iwamoto, J.S. Pober, R.A. Flavell and XY Fu. Endothelial cells require STAT3 for protection against endotoxin-induced inflammation. J Exp Med. 2003 Nov 17; 198(10):1517-25.

6. J.J. Jacoby, A. Kalinowski, MG Liu, S.SM. Zhang, Q. Gao, GX. Chai, L. Ji, Y. Iwamoto, E. Li, M. Schneider, K.S. Russell and XY Fu. Cardiomyocyte-restricted knockout of STAT3 results in higher sensitivity to inflammation, cardiac fibrosis, and heart failure with advanced age. Proc Natl Acad Sci U S A. 2003 Oct 28; 100(22):12929-34.

7. F. Fändrich (PI), XB Lin (PI), GX. Chai, M. Schulze, D. Ganten, M. Bader, J. Holle, DS. Huang, R. Parwaresch, N. Zavazava and B. Binas. Preimplantation-stage stem cells induce long-term allogeneic graft acceptance without supplementary host conditioning. Nat Med. 2002 Feb; 8(2):171-8.

8. M. Loehn, D. Kmpf, GX Chai, H. Haller, F.C. Luft and M. Gollasch. Regulation of arterial tone by smooth muscle myosin type II. Am J Physiol Cell Physiol. 283: C1383–C1389, 2002.

9. I. Morano (PI), GX. Chai (co-first author), L.G. Baltas, V. Lamounier-Zepter, G. Lutsch, M. Kott, H. Haase and M. Bader. Smooth-muscle contraction without smooth-muscle myosin. Nat Cell Biol. 2, 371-375 (2000).

10. Chai, GX. and Shang K. Establishment and characterization ES cell lines from C57BL/6J. Chinese J Cell Biol, 18, 121-126 (1996).

11. Han R, Chai, GX. and Shang, K. The effect of rat heart conditioned medium in forming mouse ES cell colonies. Acta Scientiarum Naturalium University Prkinensis, 33, 185-188 (1997).

PATENT

PCT/DE01/04512 Appl. No.: 01995556.6, Use of cells derived from embryonic stem cells for increasing transplantation tolerance and for repairing damaged tissue

REFERENCES: available upon request.

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