Edmund Leung

Email: abou79@r.postjobfree.com

Address: ** ***** *****

City: Poughkeepsie

State: NY

Zip: 12603

Country: USA

Phone: 585-***-****

Skill Level: Experienced

Salary Range: 60

Willing to Relocate

Primary Skills/Experience:

See Resume

Educational Background:

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Job History / Details:

Edmund C. Leung, Ph.D.

Research Scientist

Accomplished Research Scientist with experience and expertise in researching, validating, and evaluating drug candidates. Earned Doctor of Philosophy (Ph.D.) in Pathology and Molecular Immunology from the University of Florida Medical Center, with additional studies at the graduate level in Dentistry, Mathematics, Public Health and Math/Science/Technology Education. Recently completed a Continuing Education Certificate Program in Chemistry in Regulatory Affairs from Lehigh University. Expertise Includes:

Statistical Analysis a Regression a Data Analysis Research and Development a Validation Risk Assessments a Method Validation

Client Liaison a Supervising Staff a Teaching Design of Experiments a Project Management Standard Operating Procedures a Protocols

Medical Device Regulation Process Scale Up a Process Troubleshooting Feasibility Studies a Optimization

Recombinant DNA Technology Cell Surface Receptor Biology a Molecular Expression a Oncology Gene Cloning a Genomics

Phosphorylation a Apoptosis Immunohistochemistry a In Situ Mutagenesis a Animal Models Cell Signaling a Cell Sorting

SELECTED ACCOMPLISHMENTS

a Authored a comprehensive, 13-page report on aIntellectual Property and Patent Issues for Biosimilars,a describing and making conclusions on the competitive environment and issues surrounding biosimilars following the passage of the Biologics Price Competition Act and Innovation Act of 2009 by conducting extensive literature research and analyzing more than 33 references.

a Saved Bausch & Lomb $240,000/year with an improved method to evaluate candidate drug efficacy and toxicity by bringing the drug candidate screen analysis in-house and removing need for outside contractor charging $1,200/test plate

a Reduced production costs 75% to produce labeled secondary antibody for troponin for Johnson & Johnson by validating a new scale up process. Ensured uninterrupted production of 4 lots of validated products, meeting all FDA requirements while preventing production loss, by successfully conducting validation testing.

a Published results as a Postdoctoral Researcher based on successful studies in how mechanical stimuli by fluid shear stress leads to cellular responses that suppress atherosclerosis and additional successful studies on B lymphocytes which expressed peroxisome proliferator activated (PPAR)-gamma receptors to validate their suppression of cancer on lung fibroblasts and severity of lung fibrosis.

a Wrote dissertation, Characterization of the pathogenesis of amelanosis in the Smyth Line chicken: a model of the human autoimmune disease vitiligo.

a Gained knowledge and expertise in Federal Government operations as a Biological Technician and Health Services Officer for the National Institutes of Health and Uniformed Services University of the Health Sciences.

PROFESSIONAL EXPERIENCE

Family Foundation School, Hancock, NY 10/2006 - Present

Biology and Math Instructor (College and High School Level), Academic Coordinator a Bridge Program Liaison/Administrator

Satellite Instructor, SUNY Broome Community College, Binghamton, NY a Lackawanna College, Scranton, PA a SUNY College at Delhi, Delhi, NY

Promote student learning as a Biology and Math Instructor, Academic Coordinator, and Bridge Program Liaison/Administrator for a private, therapeutic boarding school serving currently 85 at-risk teens in grades 9 through 12 by offering a rigorous, college-preparatory curriculum.

a Improved student abilities by providing excellent courses and curriculum and increasing access to college level curriculum:

o Taught students Statistics and Algebra 1 by using expertise in statistics and math to develop the curriculum,

o Established and taught a well-subscribed Honors Forensic Sciences Course which sparked student interest by supplementing course with a web-based virtual laboratory teaching environment, with college credit granted by Lackawanna College since 1/2011.

o Developed a successful first-semester College Biology course from scratch, with college credit granted by Lackawanna College by delivering a comprehensive concept-based essay-driven content course.

o Heightened teaching standards by upgrading and modernizing courses and expanding the genetics and biotechnology content.

o Brought the deoxyribonucleic acid (DNA) fingerprinting training workshop as hands-on introduction to biotechnology by inviting a guest professor through collaboration with the Cornell Institute of Biology Teachers (CIBT).

o Challenged students explore the Impact of Science in Modern Society by co-developing a SUNY College accredited college interdisciplinary college-level course (biology, chemistry, and physics).

a Increased student social and public speaking confidence by establishing a program based on Toastmastersa techniques, curriculum and courses which will build 20 studentsa critical thinking of controversial issues in Science, Technology, and Democratic Society.

a Broome Community College (BCC): Enable Family Foundation School regular and fast forward program students to obtain a college-level education at no additional cost, saving up to $3,000/student, as liaison creating the Bridge Program and teaching a college-level Science Technology and Democratic Society course starting fall 2012.

a Lackawanna College: Increase college preparatory studentsa knowledge by teaching classes in College Biology (from January 2007 to fall 2009), Forensic Sciences (since January 2010), and Introductory Statistics 1 (since January 2010).

a SUNY College at Delhi: Improved college preparatory studentsa knowledge by teaching 4 classes in Science in Modern Society (from January 2007 to fall 2009).

Bausch & Lomb, Rochester, NY 8/2004 - 6/2006

Senior Scientist Pharmacology

Recruited as part of a team to jumpstart a new pharmaceuticals department to develop a drug for treating macular degeneration in the adult eye by providing the ability for the team to screen drugs already found suppressive in tumors and proposed as candidates to be licensed for a new eye application with a collaborator.

Enabled team to screen drug candidates by developing and establishing a live culture cell-based enzyme-linked immunosorbent assay (ELISA) assay to represent endothelial cells of the vasculature in the choroid of the eye and their response to vascular endothelial growth factor (VEGF), which stimulates new vascular growth. Conducted literature research and performed linear regression analysis. Generated technical reports and Standard Operating Procedures (SOPs) for the validated system in a Good Laboratory Practices (cGLP), Food and Drug Administration (FDA) regulated environment.

a Detected new disease state targets for validation and chose new technical methods by accessing and reading scientific journal databases.

a Saved Bausch & Lomb $240,000/year with an improved method to evaluate candidate drug efficacy and toxicity by bringing the drug candidate screen analysis in-house and removing need for outside contractor charging $1,200/test plate

o Rescued the 2-year project by optimizing, validating and improving the poorly managed, incomplete, contractor-supported cell-based signaling assay to detect tissue responsiveness.

o Improved immunoassay reliability and detection range 10 times, which allowed detection of tissue responsiveness to stimulatory environmental signals, including growth factors, cytokines and inflammation by recommending and implementing a switch to a chemiluminescent detection method.

a Enabled company to recommend 2 candidates for in-vivo preclinical testing in animals by collaborating with an 8-person team and contributing to the final decision through successfully evaluating the efficacy of 4 candidate drugs.

Ortho Clinical Diagnostics / Johnson & Johnson (contractor through Kelly Scientific), Rochester, NY 9/2002 - 12/2003

Senior Scientist - Materials and Process Development

Validated new component products needed for a large, automated, Vitros 950 platform, a high throughput medical device used for performing discrete clinical chemistry tests on body fluid specimens, by leading, supervising, organizing, scheduling, and assigning testing and platform work to a 4-technician group. Conducted post market compliance testing of new production lots of a primary capturing antibody to detect damaged heart protein in a serum supernatant-based enzyme-linked immunosorbent assay (ELISA) by using the Tecan / Vitros 950 automated sampler platform capability to analyze multiple analytes found in patient serum.

Generated individual and master calibration curves for each platform by importing results into proprietary statistical software, supplemented by Minitab and Excel Exstat, and performing regression analysis. Ensured conformity to the Food and Drug Administration (FDA) license while authoring technical reports. Designed the validation experiments by using proper Design of Experiments and statistical techniques. Ensured proper quality by following requirements and standards, including ICH Q2, 21 CFR 211 parts 11, 600, and 800; and Critical Quality Attributes.

a Reduced production costs 75% to produce labeled secondary antibody for troponin by validating a new scale up process.

a Ensured uninterrupted production of 4 lots of validated products, meeting all FDA requirements while preventing production loss, by successfully conducting validation testing, then presenting and defending technical reports on the testing results to 5 department directors.

a Developed initial design of experiments to test the feasibility of a universal process change for all Vitros 950 platform chemistries to reduce processing time with new surface activation and coating processes by conducting risk assessments on 6 representative chemistries.

o Conducted initial tests by leading 2 technicians to perform surface activation and coating and a third technician to run samples on the Vitros 950 platform and analyzing data. Determined the proposed universal process change not successful based on initial testing.

University of Rochester Medical Center, Rochester, NY 1/1999 - 7/2002

Postdoctoral Fellow, Cardiovascular Research (2/2001 - 7/2002) a Postdoctoral Fellow, Environmental Medicine (1/1999 - 2/2001)

Cardiovascular Research: Joined a lab intensely involved in studying how mechanical stimulation over cells lining vasculature by fluid shear stress leads to cellular responses that suppress atherosclerosis. Environmental Medicine Research: Conducted projects studying B lymphocytes which expressed peroxisome proliferator activated (PPAR)-gamma receptors and determined their possible role in suppression of cancer. Promoted antiproliferative responses in B cells leading to induced cell death and apoptosis by binding PPAR-gamma agonists. Coauthored papers.

a Evaluated shear stress activation of extracellular-signal-regulated kinases (Erk 1/2) and independently, big mitogen-activated protein kinase 1 (BMK1) as suppressive to c-Jun NH2-terminal kinase (JNK), which is activated by inflammatory cytokine tumor necrosis factor (TNF-alpha). Contributed to the overall picture of MAP kinases on the effects on atherosclerosis by helping to isolate the contributions of Erk, BMK1 and JNK.

a Determined that binding of PPAR-gamma by natural agonist, 15 deoxy-prostaglandin J2 (PGJ2) demonstrated a dose dependent antiproliferative effect. Confirmed that PPAR-gamma interaction with a PPAR-gamma agonist was cytotoxic in an apoptotic fashion by using Annexin V-FITC and TUNEL staining.

a Identified fourfold increased expression of Fas and tumor necrosis factor receptor-associated factor (TRAF) genes, both indicating apoptotic death pathways indicated by mRNA selectively bound to Atlas MICROARRAY cDNA profiling membranes after treatment of lung fibroblast cultures with CD40 ligand.

a Confirmed Fas protein expression and the up-regulation can be detected by immunocytochemistry and flow cytometry after incubating fibroblast cultures with inflammatory cytokines, especially with TNF and IFN gamma.

a Presented and published results based on research successes:

o Fluid shear stress inhibits TNF-mediated JNK activation via MEK5-BMK1 in endothelial cells. Biochem. Biophys. Res. Commun. 370: 159-163.

o Human B-lymphocytes and B lymphomas express PPAR-gamma and are killed by PPAR-gamma agonists. Clin. Immunol. 103(1): 22-33.

o Fibroblasts as sentinel cells: role of the CDcd40-CDcd40 ligand system in fibroblast activation and lung inflammation and fibrosis. Chest 120 (Suppl.): 53S-55S.

o Determination of extracellular matrix molecules regulated by human lung fibroblasts through CDcd40 engagement: insights into pulmonary inflammation and fibrosis. Presentation: University of Rochester Cancer Center 4th Annual Scientific Symposium, Rochester, NY.

University of Florida College of Medicine, Gainesville, FL 9/1991 - 5/1998

Doctoral Student, Department of Pathology

Created DNA gene expression constructs (gene cloning) including site directed mutagenesis analysis in transfected (electroporated) cells. Created gene expression constructs to study chicken immunoglobulin gene conversion in chicken antibodies by mutation analysis. Achieved diversity by copying pseudo gene sequences into functional gene sequences via homologous recombination. Demonstrated model of gene conversion in chicken B cells requiring subcloning homologous recombinants.

a Found evidence suggesting T cell infiltrates mount destruction of pigment producing melanocytes in a Smyth line autoimmune chicken after harvesting and comparing developing breast feather tissue from Smith and Brown strains as one target site of T cell destruction of melanocytes

a Established likelihood of disease inheritability through repeated discovery of 4 endogenous retroviral integrations in genomes of chicken model with high incidence/ correlation to the autoimmune phenotype.

a Induced feather depigmentation in 5 host Brown Line chickens through adoptive transfer of T-cells from autoimmune Smyth donors.

a Authored and obtained approval for dissertation, Characterization of the pathogenesis of amelanosis in the Smyth Line chicken: a model of the human autoimmune disease vitiligo.

Prior Experience:

Research Assistant II, Division of Molecular Virology and Immunology, Georgetown University Rockville Division, Rockville, MD

Biological Laboratory Technician, Department of Biochemistry, Uniformed Services University of the Health Sciences, Bethesda, MD

Industrial Hygiene Technician, Tracor-Jitco Inc. / Biospherics Inc., Rockville, MD

Health Services Officer, Public Health Service, National Institutes of Health, National Institute of Dental Research, Bethesda, MD

Biological Laboratory Technician, National Institutes of Health, National Institute of Aging, Gerontology Center, Bethesda, MD

Biological Laboratory Technician, IBM, East Fishkill, NY

SELECTED EDUCATION

Continuing Education Certificate Program in Chemistry Regulatory Affairs, Lehigh University, Bethlehem, PA

Graduate Studies in Public Health, University of Rochester, Rochester, NY

Doctor of Philosophy (Ph.D.) in Pathology and Molecular Immunology, University of Florida Medical Center, Gainesville, FL

Graduate Studies in Dentistry, Medical College of Virginia, School of Dentistry, Richmond, VA

Bachelor of Science (B.S.) in Biology (minor in Chemistry), Hofstra University, Hempstead, NY

Beta Beta Beta Biology Honor Society a Alpha Epsilon Delta Pre-Medical Honor Society a Deanas List

JOB RELATED SKILLS

a Analysis, Equipment, and Methodology: Affinity Binding, Antisense Oligonucleotides, Binding Assays, Bioanalytical Assays, Caspase Assays, Cell and Tissue Culture, Cell Proliferation Assays, Cell Protein Purification, Cell-Based Assays, Deoxyribonucleic Acid (DNA) Affinity Immunoblotting, DNA and Protein Expression, DNA Binding Proteins, DNA Fragmentation, DNA Library Construction, DNAstar, Electrochemilumunescent Assays, Electroporation, Enzyme-Linked Immunosorbent Assay (ELISA), FACScan, Filter Binding Assays, Flow Cytometry, Functional Assays, Gas Chromatography / Mass Spectrometry (GC-MS), Gel Electrophoresis, Gradient Centrifugation, High Pressure Liquid Chromatography (HPLC), Histopathology, Identification Molecular Targets, Immunoassays, In Vivo Models, Intracellular Signaling, Microarrays, 3-(4, 5-dimethylthiazol-2-yl)-2,5-diphenyltetrazolium bromide (MTT) viability substrate, Nucleic Acid Isolation, Oligowalk, Proliferation Assays, Protein Characterization, Protein Extraction, Purification, Receptor Validation, Reverse Transcriptase Polymerase Chain Reaction (RT-PCR), Design PCR Primers, Sequencher, Sequencing and Analysis, Southern Blot, Suspension Cell Cultures, Sodium Dodecyl Sulfate (SDS) Polyacrylamide Gel Electrophoresis (SDS PAGE), Terminal Transferase deoxyuridine triphosphate (dUTP) Nick End Labeling (TUNEL) Assay, Viability Assays, Viral Vectors, Western Blot

a Regulations: 21CFR [Code of Federal Regulations] (Parts 11, 211, 800, 600), Good Laboratory Practices (cGLP)

a Computers: Molecular Analysis Software, SigmaStat, Microsoft Office (Word, Excel, PowerPoint, Access, Outlook), Minitab, Excel Exstat, Windows, Vista Business, Ortho Clinical Diagnostics Proprietary Statistical Software, SigmaPlot, Adobe Reader, NITRO Reader, DNAStar, Sequencher, DNA Align, OligoWalk, Whitehead Institute Mapmaker, Primer3, IDT Oligo Analyzer, Nikon (Capture NX,View NX), Innovue

MEMBERSHIPS

Member, Association for Research in Vision and Ophthalmology

Secretary/Treasurer, Toastmasters International, Club 2584, Endicott, NY

Member, American Association of Pharmaceutical Scientists

PUBLICATIONS

a Li, L., Tatake, R.J., Natarajan, K., Taba, Y., Garin, G., Tai, C., Leung, E., Surapisitchat, J., Yoshizumi, M., Yan, C., Abe, J., and Berk, B.C. (2008). Fluid shear stress inhibits TNF-mediated JNK activation via MEK5-BMK1 in endothelial cells. Biochem. Biophys. Res. Commun. 370: 159-163.

a Padilla, J., Leung, E.C., and Phipps, R.P. (2002, April). Human B-lymphocytes and B lymphomas express PPAR-gamma and are killed by PPAR-gamma agonists. Clin. Immunol. 103(1): 22-33.

a Kaufman, J., Graf, B.A., Leung, E.C., Pollock, S.J., Koumas, L., Reddy, S.Y., Blieden, T.M., Smith, T.J., and Phipps, R.P. (2001, July). Fibroblasts as sentinel cells: role of the CDcd40-CDcd40 ligand system in fibroblast activation and lung inflammation and fibrosis. Chest 120 (Suppl.): 53S-55S.

a Phipps, R.P., Koumas, L., Leung, E.C., Reddy, S.Y., Blieden, T.M., and Kaufman, J. (2000, June). The CD40-CD40 ligand system: a potential therapeutic target in arteriosclerosis. Curr. Opin. Investig. Drugs 2(6): 773-777.

a Leung, E.C., Armstrong, D., Padilla, J., Kaufman, J., and Phipps, R.P. (2000, October). Fas-Fas ligand induced apoptosis in non- and fibrosing fibroblasts. University of Rochester Cancer Center 5th Annual Scientific Symposium, Rochester, NY.

a Leung, E.C., and Phipps, R.P. (1999, October 15). Determination of extracellular matrix molecules regulated by human lung fibroblasts through CDcd40 engagement: insights into pulmonary inflammation and fibrosis. University of Rochester Cancer Center 4th Annual Scientific Symposium, Rochester, NY.

a Leung, E.C., Gill, D.J., Miles, R.D., and McCormack, W.T. (1998). Endogenous viral loci in the Smyth line chicken model for the autoimmune disease vitiligo, Not Published.

a Leung, E.C., Erf, G.F., and McCormack, W.T. (1998). T-cell receptor gamma repertoire analysis of the expanded peripheral blood gamma-delta T cell population during avian autoimmune amelanosis. Not Published.

a Leung, E.C., Utley, L., Ramiya, V., Smyth, J.R., Jr., and McCormack, W.T. (1996). Molecular pathogenesis of amelanosis in the Smyth line chicken, a model of human vitiligo. FASEB J. 10(6): A1316.

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