Medical Project

XIAOCHUN LU, PhD 269-***-****

*** ******** **., ****** ****, NC 27516 ********.****@*****.***

RESEARCH SCIENTIST

Highly knowledgeable and results-driven Scientist with extensive experience managing experimentation in a variety of settings and disciplines including preclinical contract research organizations (CROs), molecular diagnostic laboratories and leading research institutions. Valued expertise in immunoassay and bioassay development & validation, drug discovery & efficacy study, DNA/RNA analysis, cell culture & manipulation. Well versed in GLP/GMP, disease animal model development and project management. Demonstrate high level of initiative and problem-solving skills in complex scientific environments. Design, execute, and supervise progressive studies and analyses that deliver practical solutions to desired client requirements. Bilingual (English and Chinese).

Pharmacology • Oncology • Immunology • Protein Assay • Tumor Cellular / Gene Therapy • Technical Support

Method Optimization • Research Methodology • Results Interpretation & Reporting • Sample Preparation / Staging

Data Analysis • Laboratory Management • Protocol Development • Research & Development (R&D) • Staff Training

QUALIFICATIONS SUMMARY

• Experienced in Immunoassay and Bioassay Development & Validation with significant achievements in diagnostic laboratories and preclinical CRO industry. PhD in molecular biology & biochemistry with strong knowledge in immunology, protein biochemistry, nucleic acid biochemistry, molecular biology, oncology and cell biology.

• Presided over establishment of two molecular diagnostic laboratories for University of North Carolina – Chapel Hill (UNC-CH) and Guilin South Biotechnology, Inc. (GSBI), designing and running qPCR and MSD/ELISA immunoassays, formulating protocols and standard operating procedures (SOPs) in adherence to GLP guidelines.

• At UNC-CH, developed & validated MSD based immunoassays and ELISA for PF4, Fractalkine and TNFβ with GLP compliances, ran over 20,000 tests independently with publication on Circulation: Cardiovascular Genetics; Designed and validated qPCR for virus, bacteria and parasites diagnosis on research animals.

• Proficient in immunostaining and flow cytometry analysis of surface markers on mature and immature dendritic cells (CD80, CD 86, MHC), MSCs (CD45, CD54 and CD90) and EPC (CD34, CD45), VEGF and EPO expression analysis after gene delivery in cultured cell lines while as a scientist in MPI research, Inc. and Duke University.

• Extensive experience with running numerous ELISA assays for EPO, VEGF, EGF, IL-2, 4, 6, 12, TNFα, β, GM-CSF, Hb, Insulin, and GHbA1c to serve preclinical CRO drug efficacy studies and academic research. Developed HCG ELISA kit for early pregnancy test that was enter into manufacturing under GMP regulation and applied to clinical diagnostic services while working as scientist at GSBI and Guilin Medical College.

• Expertise in immunohistochemistry analysis including renal fibrosis (SMA, E-cadherin) and vessel counting (VEGF & CD34), and CTL, ELISPOT for immune activation at Therapeutic Laboratory, Duke University Medical Center. Formulated series of bioassays including oral glucose tolerance test (OGTT), insulin tolerance test (ITT) and Collagen measurement for drug efficacy study at MPI Research, Inc.

* Refer to “ADDENDUM A: EXPERTISE & EXPERIENCE SUMMARY” & “ADDENDUM B: SKILLS PROFILE” for more details.

PROFESSIONAL EXPERIENCE

UNCCH, Division of Laboratory Animal Medicine – Chapel Hill, NC 2010–2012

SENIOR RESEARCH SPECIALIST

Enlisted to oversee startup of molecular diagnostic laboratory for top research university in the US. Functioned as mentor to PhDs, post-doc fellows, and technicians, sharing expertise in animal handling techniques and bioassay development including immunoassays such as ELISA, MSD, RT-PCR and qPCR. Managed day-to-day laboratory operations, designing and leading research projects to identify pathogens and diseases, structuring and implementing SOPs, and ensuring adherence to GLP guidelines and project objectives.

MPI Research, Inc. – Mattawan, MI 2008–2010

SCIENTIST/STUDY DIRECTOR

Led investigation and design of new in vitro, in vivo, and ex vivo processes for drug efficacy studies for leading preclinical research CRO. Created animal disease models and bioassays for efficacy, PK, PD, and toxicity studies. Drafted proposals, protocols, and SOPs to confirm compliance with GLP standards. Conducted studies from clients and sponsors in collaboration with core facility staff and third parties.

Duke University Medical Center, MEMS, Therapeutic Laboratory – Durham, NC 2002–2008

RESEARCH SCIENTIST/POST-DOC

Originally hired while completing PhD research project: “Ultrasound-Mediated Gene Transfer Mechanisms, Optimizations, and Applications.” Oversaw investigations on gene delivery, tumor gene therapy, tumor immunotherapy and cell therapy, heat inducible gene activation and gene expression analysis in vivo and in vitro, and mechanism of immune response induced by in situ tumor lysing. Assisted with writing proposals, protocols, manuscripts, and presentations.

Peking University, Biochemistry & Molecular Biology Department – Peking, China 1998–2002

RESEARCH SCIENTIST/PhD CANDIDATE

Provided valued teaching and research expertise in biochemistry, biotechnology, and drug discovery for leading Chinese university. Studied gene and recombinant protein therapy on anemia and thrombus diseases focusing on functional gene cloning, vector design, disease model construction, gene delivery, and bioeffects endpoint evaluation. Developed animal models for renal anemia and hind lime ischemia gene therapy. Mentored fellow scientists, handled proposal writing and protocol development, and contributed to publications and presentations.

Additional Working Experience: R&D SCIENTIST/ASSOCIATE DIRECTOR at Guilin South Biotechnology, Inc., Guilin Medical College-Guilin, China (1994–1998); FERMENTATION AND QC SCIENTIST at Guilin Jiqi Pharmaceutical Group, Inc.-Guilin, China (1991–1994).

EDUCATION & CERTIFICATION

PhD in Molecular Biology & Biochemistry, Peking University – Beijing, China (Thesis finished at Duke University).

MS in Molecular Biology & Biochemistry, Peking University – Beijing, China

BS in Biochemistry & Molecular Biology, Peking University – Beijing, China

Laboratory Animal Technologist (LATG), American Association for Laboratory Animal Science (AALAS) – 2009

AFFILIATIONS

American Society for Pharmacology and Experimental Therapeutics (ASPET)

Institute of Electrical and Electronics Engineers (IEEE)

International Society of Intelligent Biological Medicine (ISIBM)

Chinese Society of Biochemistry and Molecular Biology (CSBMB)

ADDENDUM

A: EXPERTISE & EXPERIENCE SUMMARY

• Drug Discovery & Efficacy Research

- Highly experienced in Drug Discovery & Efficacy Research in preclinical CRO, biopharma industry and academic research. PhD in molecular biology & biochemistry with strong knowledge in oncology, immunology, protein & nucleic acid biochemistry, molecular biology and cell biology. More than ten years of research on anti-tumor therapeutics, cardiovascular diseases, anemia, gene delivery methodologies and gene therapy.

- As Scientist and Study Director for MPI Research, Inc., a leading preclinical CRO, led and conducted more than 20 studies from clients on compounds screening and drug efficacy including melanoma cellular therapy and immunotherapy, anti-tumor effects of DNA vaccination on transgenic APC tumor model, autoimmune diseases, infectious diseases and metabolic disorders.

- Formulated series of disease animal models for drug efficacy research at MPI Research, Inc. including xenograft melanoma models, APC transgenic tumor model, diabetes, insulin resistance, obesity, collagen-induced type II arthritis, PLP-induced EAE, adjuvant induced acute arthritis (AIA), diet-induced hypertriglyceridemia. Established xenograft tumor models including 4T1 breast cancer, MC38 colon carcinoma and b16 melanoma, and created melanoma metastasis rodent model while at Duke University.

- Drafted successful grant application for NIH R21A project: “Novel Ultrasound System for EPO Gene Therapy”. Made key findings in tumor cellular and immunotherapy, HIFU induced tumor necrosis, in situ tumor lysing mediated anti-tumor immune activation, gene delivery methodologies, and site-specific gene activation and gene therapy while as Post-Doctoral Research Scientist with Duke University Medical Center.

- Pioneered electroporation mediated EPO gene therapy for renal anemia at Peking University. Invented tumor therapy strategy by applying in vitro activated T cells ex vivo infusion that was entered clinical trial while working as R&D scientist at Guilin South Biotechnology, Inc. and Guilin Medical College.

- At University of North Carolina-Chapel Hill (UNCCH), successfully directed NIH RO1 project: “Inflammation and Platelet Activation in Cardiovascular Health Disparities”. Evaluated PF4, Fractalkine and TNFβ in serum and its correlation with genetic variants.

• DNA/RNA analysis and manipulation

- Well trained through education and experienced in academic research and biopharma/biotech industry on DNA/RNA analysis and manipulation including: DNA/RNA preparation, RT-PCR, real-time PCR, DNA sequencing, gene alignment, genome analysis, mutation and SNP analysis, expression vector design, functional gene cloning, RNAi and gene silencing, tissue-specific and special gene activation, gene expression analysis, biological software packages (Vector NTI, ContigExpress, Bioinformatics Tools).

- At UNC, designed and validated RT-PCR & qPCR for mouse hepatitis virus (MHV), mouse parvovirus (MPV), epizootic diarrhea of infant mice (EDIM), human rotavirus, parasites, and microorganism pathogens in adherence to GLP; prepared DNA/RNA samples from fecal pellets, tissue samples; used wed-based bioinformatics tools to analyze genome sequence, gene alignment.

- As Scientist at MPI Research, Inc., investigated DNA vaccination on transgenic APC tumor model, designed PCR for human cell bio-distribution in rodent model after tail vein injection, mutation analysis for APC model genotyping.

- While working at Duke University, designed qPCR for VEGF, EGF, EPO, GAPDH, HiF1 expression analysis, constructed plasmid/EPO expression vector driven by Hsp70 promoter, prepared DNA and RNA from tissues and cultured cells for transgene analysis, prepared plasmid DNA for gene delivery research including bacteria transfection, positive clone selection, scale up and bacteria harvest, plasmid preparation using QIAGEN kit. Gel analysis, concentration and purity measurement by OD260/280, plasmid DNA formulation for gene delivery.

- Cloned human EPO gene; designed and constructed pcDNA3/EPO with SV40 promoter; designed and ran RT-PCR, qPCR and gel analysis for human EPO and VEGF expression in tissues and cultured cells. Prepared plasmid DNA from cultured bacteria and applied to various gene therapy projects while as PhD candidate at Peking University.

• Cell Culture & Manipulation

- More than ten years of extensive working experience with cell culture and maintenance, tissue and blood cell isolation, cell characterization including tumor cell lines, stem cells, immunocytes, PBMCs, and primary cells with focusing on gene delivery and gene therapy, gene expression analysis, gene activation, tumor immune and cellular therapeutics, compounds screening and novel experimental therapeutic strategies evaluation.

- At MPI Research, Inc., isolated bone marrow cells from mice and cultured with GM-CSF/IL-4, identified by surface marker staining and flow cytometry, modified with retrovirus and applied on xenograft tumor model for ex vivo tumor cellular therapy and immunotherapy with GLP compliances; Prepared PBMCs from animal blood and stimulated with LPS in vitro; Prepared and formulated neural stem cells and applied on surgical spinal injury model for neuron regeneration.

- In GSBI, a biopharma industry as R & D scientist, invented T cell mediated tumor therapy strategy. T cells were isolated from peripheral blood, cultured in vitro with stimulation of tumor lysate and IL-2, and applied ex vivo for tumor cellular and immunotherapy that was entered into clinical trial.

- In academic research at Duke University, established bone marrow derived stem cell in vitro production protocol encompassing isolation, differentiation, genetic modification, identification and scale up for Mesenchymal Stem Cells (MSCs), endothelial progenitor cells (EPCs), and dendritic cells (DCs).

- Solid background knowledge in cell biology with proficiency in cell based assays development including proliferation, inhibition, migration, apoptosis, viability assay and survival rate, cytotoxicity, cell membrane permeability, morphology, metabolic activity analysis. Developed various cell-based assays to support research projects.

B: SKILLS PROFILE

Gene Delivery: Sonoporation (Cavitation/Micro Jet), Shear Stress, Electroporation, Pulse Electrophoresis, Wound Healing, Lipofection and Polymer, Microinjection, Hydrodynamic Injection, Viral and Plasmid Vectors, Gene Gun Technology, Virus Purification

DNA/RNA Manipulation: DNA/RNA Preparation, RT-PCR, Real-Time PCR, DNA Sequencing, Gene Alignment, Genome Analysis, Mutation and SNP Analysis, Expression Vector Design, Functional Gene Cloning, RNAi and Gene Silencing, Tissue-Specific and Special Gene Activation, Gene Expression Analysis, Biological Software Packages (Vector NTI, ContigExpress, Web-based Bioinformatics Tools)

Protein Biochemistry: Protein Expression and Purification, Immunoprecipitation, Immunoelectrophoresis, Western Blotting, Spectrophotometry, Enzyme Activity Measurement, Xenogen Photonic Technology, Gel Electrophoresis and 2D Mapping, HPLC, SDS-PAGE, Size-Exclusive Chromatography, Gelfiltration and Membrane Ultrafiltration, Affinity Chromatography, Bradford Protein Assay, Electrofocusing

Cell-based Assays: Proliferation, Inhibition, Migration, Apoptosis, Viability Assay and Survival Rate, Cytotoxicity, Cell Membrane Permeability, Morphology, Metabolic Activity Analysis

Immunoassays: Immunostaining and Flow Cytometry, Antibody Purification and Labeling, ELISA Development and Optimization, Meso Scale Discovery (MSD), Luminex Technology, Fluorescence-activated cell sorting (FACS)

Cell Biology: Cell Culture and Cell Line Maintenance, Genetic Cell Modification using Retroviral and Lenti-Viral Vector, Cell Purification using Miltenyi Technology, Cell Isolation from Tissue and Blood, Phenotyping and Characterization

Microbiology: Microorganism Inoculation/Culture/Scale Up, Viability Assay, Bioluminescence ATP Assay, Gram Staining, OD600 Concentration Measurement, Laboratory and Industrial Fermentation, Recombinant Protein and DNA Production, Aseptic Techniques, High Output Strain Selection, BSL2/BSL3

Animal Handling: Animal Protocol Writing, Clinical Observation, Dosing (Oral Gavage, Intradermal, Subcutaneous, Intramuscular, Intraperitoneal, Intravenous, Intratracheal, Intracardiac, Topical), Bleeding (Cardiac Puncture, Orbital Sinus, Intravenous, Vena Cava, Maxillary, Jugular Vein, Tail Vein), Body Fluid Collection, Small Surgery, Transgenic Animal Breeding and Genotyping, Immunocompromise Animal Maintenance, Pain Assessment, OGTT, ITT, EAE scoring

Disease Animal Modeling: Diabetes, Insulin Resistance, Obesity, Collagen-Induced Type II Arthritis, PLP-Induced EAE, Diet-Induced Hypertriglyceridemia, Renal Anemia, Surgical Ischemia, Syngeneic & Xenograft Tumor Models, APC Transgenic Tumor Model, Metastasis Model, Adenine-Induced Renal Failure Model

C: PUBLICATIONS & PRESENTATIONS

PUBLICATIONS & ABSTRACTS

1. Pallav Bhatnagar, Xiaochun Lu, Michele K. Evans, Thomas A. LaVeist, Alan B. Zonderman, Darryl L. Carter, Dan E. Arking, and Craig A. Fletcher: Genetic variants in Platelet Factor 4 modulate inflammatory and platelet activation biomarkers. Circulation: Cardiovascular Genetics. Accepted, June 2012.

2. Yifei Xing, Eric C Pua, Xiaochun Lu, and Pei Zhong: Low Amplitude Ultrasound Enhances hydrodynamic-Based Gene Delivery to Rat Kidney. Biochemical and Biophysical Research Communications, 2009 Aug. 14; 386(1): 217–22.

3. Xiaochun Lu, Georgy Sankin, Eric C Pua, John Madden, and Pei Zhong: Activation of transgene expression in skeletal muscle by focused ultrasound. Biochemical and Biophysical Research Communications, 2009 Feb. 6; 379(2): 428–33.

4. Yifei Xing, Xiaochun Lu, Eric C Pua, and Pei Zhong: The Effect of High Intensity Focused Ultrasound Treatment on Metastases in a Murine Melanoma Model. Biochemical and Biophysical Research Communications, 2008 Oct. 31; 375 (4):645–50.

5. Xiaochun Lu, Georgy Sankin, John Madden, and Pei Zhong: “Focused Ultrasound-Induced Transgene Activation in Skeletal Muscles.” Molecular Therapy: The Journal of the American Society of Gene Therapy. V (13), S127, May 2006.

6. Yunbo Liu, Zhenlin Hu, Xiaochun Lu, T. Kon, Chuanyuan Li, Pei Zhong: “High Intensity Focus Ultrasound (HIFU) Induced Trans-Gene Activation in Solid Tumors.” Molecular Therapy: The Journal of the American Society of Gene Therapy. V (13), S368, May 2006.

7. Xiaochun Lu and Pei Zhong: “Ultrasound-induced cell detachment and gene transfection to adherent cells in vitro.” Acoustic Research Letter Online (ARLO), Vol: 6 (3), 195–200, July 2005.

8. Wen-Shiang Chen, Xiaochun Lu (Co-first author), Yunbo Liu, and Pei Zhong: “The effect of surface agitation on ultrasound-mediated gene transfer in vitro.” Journal of the Acoustical Society of America (JASA), Vol.116 (4): 2440–50, Oct. 2004.

9. Xiaochun Lu, Airu Zhou, and Pei Zhong: “Ultrasound-mediated gene transfection- Mechanisms, Optimizations and Applications.” Ph.D. Dissertation. Peking University Health Science Center-electronic dissertation, Oct. 2004.

10. Xiaochun Lu, Airu Zhou, and Caike Jin. “The effects of electroporation-mediated erythropoietin (EPO) gene transfer into skeleton muscle on renal anemia,” (Article in Chinese, abstract in English). Chinese Medical Journal (Zhong Hua Yi Xue Za Zhi), Vol.80 (3):222-5, Mar. 2000.

PRESENTATIONS

1. Xiaochun Lu, Georgy Sankin, John Madden, and Pei Zhong: “Focused Ultrasound-Induced Transgene Activation in Skeletal Muscles.” ASGT 10th Annual Meeting, Batimore, VA, USA. May 30–June 3, 2007.

2. Yunbo Liu, Zhenlin Hu, Xiaochun Lu, T. Kon, Chungyuan Li, and Pei Zhong: “High Intensity Focus Ultrasound (HIFU) Induced Trans-Gene Activation in Solid Tumors.” ASGT 10th Annual Meeting, Batimore, VA, USA. May 30–June 3, 2007.

3. Xiaochun Lu, Zhenlin Hu, and P. Zhong: “Ultrasound-mediated gene transfer in skeletal muscle.” BMES Annual Fall Meeting, Philadelphia, PA, Oct. 2004.

4. Yifei Xing, Xiaochun Lu, Christ Pau, and Pei Zhong: The Effect of HIFU Treatment on Metastases in a Murine Melanoma Model. 8th International Symposium on Therapeutic Ultrasound, Hilton Minneapolis, USA, Sept. 10–13, 2008.

5. Wen-Shiang Chen, Xiaochun Lu, and Pei Zhong: The Effect of Surface Agitation on Ultrasound-Mediated Gene Transfer in vitro. 5th International Symposium on Therapeutic Ultrasound, Boston, Massachusetts (USA), Oct. 27–29, 2005.

6. Chen W, Lu X, Liu Y, and Zhong P: Acoustic Cavitation and Ultrasound-Mediated Gene Transfection in vitro, BMES Annual Fall Meeting, Nashville, TN, Oct. 2003.

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