Edmund C. Leung, Ph.D.

Hancock, NY 13783  Cell Phone: 585-208-7147  e.leung@juno.com

ASSAY AND DEVELOPMENT SCIENTIST

Research Scientist with over 10 years experience focused on providing biochemical and
analytical expertise in both molecular and cellular immunoassays, focusing on antibody based
detection assays. Delivers versatile, flexible, reliable, research and problem solving skills.
Recognized for technical proficiencies and expertise in quality assurance and validation testing,
evaluation of pre-and post-market medical devices in product/process validations, and effective
in maintaining/calibrating analytical instrumentation.
• Research/Develop • Gene Expression/Cell • Project Management/Product
ment Signaling Development
• Quality Assurance • Assay • Cellular/Molecular Immunology
Development/ELISA
• Technical Writing • Gradient • Immune Assays/Protein Biochemistry
centrifugation
• Flow • Cellular • Circulatory/Cardiovascular/Pulmonary
Cytometry/FACS Techniques/Processes study areas
• Column • Statistical Analysis • Risk assessments
chromatography

CURRENT EXPERIENCE

Employed, since 2006, as a biology instructor teaching both high school and college curriculums

PRODUCT/P ROCESS DEVELOPMENT EXPERIENCE

BAUSCH & LOMB, INC., Rochester, NY – 2004 to 2006
Senior Scientist – Biology/Pharmacology
BIOCHEMICAL ASSAY DEVELOPER AND VALIDATION
• Developed, established, and validated a cell based ELISA assay utilized to detect
activation of cells to growth factors (antibody based recognition, chemiluminescent
detection); saved the organization $1200 per test by bringing the system in-house.
• Determined optimum culture conditions and density, incubation times, antibodies to
phosphoproteins, conjugated secondary antibodies, luminol detection substrate
concentration and exposure time, culture fixing conditions, washing procedures.
• Designed comprehensive plans and strategies to assess utility of proposed drugs for vital
treatments of diseases of the eye, including diabetic retinopathy and age-related macular
degeneration.
PHARMACEUTICAL BIOMARKER SCREENER/TESTER
• Screened investigational candidate drugs (APIs) previously found effective
(antineoangiogenic) against tumors to in-license new application in the eye.
• Conducted evaluations to determine the efficacy of four candidate compounds in
advancement of research preventing new vascularization, which led to department
recommendations of two candidate compounds for in vivo preclinical testing in test
animals.
LEAD DATA ANALYST, PROBLEM SOLVER AND TECHNICAL WRITER:
• Analyzed and compiled analytical data and developed general technical reports and
standard operating procedures (SOPs) for execution in a cGLP environment for this FDA
regulated producer of eye care products.

ORTHO CLINICAL DIAGNOSTICS (A JOHNSON & JOHNSON COMPANY), Rochester, NY – 2002 to 2003
Senior Scientist, Project Leader, Department of Materials & Process Development
P ROJECT/PROCESS VALIDATION AND SUPERVISOR:
• Contracted to manage post market compliance quality assurance projects for
advancement of product and process scale-up validations for a large automated blood
sample analyzer (Double Antibody Sandwich-ELISA antibody based recognition,
chemiluminescent detection) in clinical samples.
• Confirmed efficacy of new lots compared to control lots of antibody to detect cardiac
troponin. Executed quality assurance tests lot to lot and analyzer to analyzer using
calibration curves for consistency of performance. Ensured integrity and CFR21 part 11
data compliance. Maintained validation parameters including precision, linearity,
calibration intervals, correlation, analytical sensitivity, interferents, and cross reactivity.
• Conferred with vendors and negotiated purchase of external test reagent samples for use
in validation experiments.

Edmund C. Leung  Page 2  Cell Phone: 585-208-7147  e.leung@juno.com

•

ORTHO CLINICAL DIAGNOSTICS (CONTINUED)

PROJECT/PROCESS VALIDATION AND SUPERVISOR:
• Played an instrumental role in conducting validation protocol for process scale-up for HRP
conjugate labeling and column chromatography concentration and purification of
monoclonal secondary antibody in advancement of manufacturing.
• Led a high-performance team of four technicians on five critical projects and exceeded
timeline/execution objectives.
LEAD DATA ANALYST AND PROBLEM SOLVER:
• Utilized proprietary statistical software to generate format conducive to compare new
production lot to previously validated lots. Recognized discrepancies including trending
bias between lots, determined solutions, and resumed testing and still completed projects
ahead of schedule. Ensured data integrity, CFR 21 Part 11 data and cGLP compliance.
Statistical software: Minitab, Excel Exstat.
• Co-developed comprehensive risk assessments and prototype feasibility plans/protocols,
supervised, and analyzed pilot tests focused on executing universal process changes,
affecting all tests performed by this multi-analyte capable platform. Supervised 2
additional technicians resourced for pilot testing.
TECHNICAL WRITER AND PRESENTER:
• Wrote SOPs and presented technical dossiers on analyzed experimental data to 5 member
multi departmental management team for approval before release to manufacturing.
Answered concerns, revised sections.

UNIVERSITY OF ROCHESTER MEDICAL CENTER, Rochester, NY – 1999 to 2002

Postdoctoral Fellow, Center for Cardiovascular Research / Postdoctoral Fellow, Cancer
Center
RESEARCHER IN ENVIRONMENTAL IMPACT AND TECHNICAL WRITER:
C ARDIOVASCULAR:
• Substantiated in vascular endothelial cells how fluid shear stress generates stimuli-
induced signaling pathways (MAP kinases) that are atheroprotective and suppressive
toward inflammatory cytokine-induced (TNF-alpha) pathways affecting JNK and NF-KB
activation and VCAM expression on cardiovascular health.
• Generated shear stress over cultured cells, incubations of cultures with inflammatory
cytokines or growth factors, lysis of cultures, detection of activated target
phosphoproteins by gel electrophoresis and antibodies or immunoprecipitation.
• To substantiate role of blood flow, modified gene expression using transfections of
plasmids, antisense oligonucleotides, and adenovirus vectors; altered gene expression
using kinase selective inhibitory drugs.

ENVIRONMENTAL MEDICINE– C ANCER:

 • Confirmed and validated the role of CD40-CD40L system between inflammatory cells and
target cells; disruption can reduce inflammation and fibrosis in lungs.
• Identified new inflammatory induced biomarkers on target cells (PPAR-gamma, Fas) via
MicroArray cDNA profiling, immunohistochemistry, and flow cytometry.
• Confirmed functional dose dependent proliferative or cytotoxic effects of PPAR-gamma
agonists or activation of Fas by Fas Ligand (MMT viability tests, [(3)H]thymidine
incorporation).
• Showed that Fas gene expression in primary lung fibroblasts under inflammatory
conditions and cross linking by Fas Ligand enhanced the effects of apoptosis (DNA
fragmentation (TUNEL), caspase detection) and contributed to increased pulmonary
fibrosis and lung scarring.
• Demonstrated susceptibility of B cell lines and B cell lymphomas to PPAR-gamma agonists
via their PPAR-gamma receptors by similar assays using PPAR-gamma agonists.

UNIVERSITY OF FLORIDA , COLLEGE OF MEDICINE, Gainesville, FL– 1992 to 1998

Doctoral Student, Department of Pathology, Immunology, & Laboratory Medicine.
Dissertation: “Characterization of Amelanosis in the Smyth Line Chicken”.

RESEARCHER IN MOLECULAR BIOLOGY, GENOMICS, AND TECHNICAL WRITER:

• Successfully induced feather depigmentation in five host “Brown Line” chickens through
adoptive transfer of T-cells from autoimmune “Smyth Line” donors (T-cell component in
disease).
• Analyzed expressed (mRNA) T-cell receptor repertoire of transformed E. coli clones
(neomycin selection) for evidence of antigen driven oligoclonal selection; discovered no
selection of T cell usage in peripheral blood.

Edmund C. Leung  Page 3  Cell Phone: 585-208-7147  e.leung@juno.com

UNIVERSITY OF FLORIDA (CONTINUED)

• Established likelihood of disease inheritability through repeated discovery of four
endogenous retroviral integrations in genomes of chicken model (viral UTR probe) with
high incidence and correlation to the autoimmune phenotype.
• Developed multiple step protocol for separating nucleic acids from pigmented proteins in
pigmented feather tissue.
• Created recombination constructs to study chicken immunoglobulin gene conversion by
mutation analysis. Constructs transfected into chicken B lines with dual selection of clones
(transfection success with hygromycin, successful completion of gene conversion with
neomycin).
• Relied on various molecular biology and microbiology techniques, nucleic acid isolation,
isolation by magnetic beads, RT-PCR with loci specific primers, manual/automated
sequencing, PCR primer designing, electroporation, site-directed mutagenesis,
transfections of eukaryotic cultures, transformations of E. coli, subtractive membrane
hybridization, gradient centrifugation, western and southern blots, antibody concentration.

EARLIER ROLES:
• GEORGETOWN UNIVERSITY, Washington, DC, Research Assistant II. Researched mechanisms
involved in the susceptibility of human red blood cells to malarial infection, Plasmodium
falciparum, by isolating the blood cell’s target receptor, glycophorin. As lab manager,
organized investigator’s move into new facilities.
• GEORGETOWN UNIVERSITY, DIVISION OF MOLECULAR VIROLOGY AND IMMUNOLOGY, Rockville, MD,
Research Assistant II. Premarket validation of western blot and immune based assays for
detection of HIV in clinical trial samples. Performed cell proliferation assays of hepatitis
infected lymphocytes using various stimulatory and suppressive mitogens.
• UNIFORMED SERVICES UNIVERSITY OF THE HEALTH SCIENCES, Bethesda, MD, Biological Laboratory
Technician, Department of Biochemistry. Studies of ICP8, a major DNA binding protein of
the herpes simplex virus. Binding tested by filter binding assays, electron microscopy.
 Virus (low MOI) propagated on mammalian cultures and harvested by size exclusion and
affinity chromatography.
• NATIONAL INSTITUTES OF HEALTH, NATIONAL INSTITUTE OF AGING, GERONTOLOGY CENTER, Baltimore,
MD. Compared differences in components of urine released during aging process as
analyzed by HPLC.

ADDITIONAL PROFESSIONAL EXPERIENCE

FAMILY FOUNDATION SCHOOL, Hancock, NY – 2006 to Present

Biology Instructor
Developed rigorous curriculum focused on theory and best practices, which provides students
with relevant cultural perspectives at the high school and college levels. Students earn college
credit from Lackawanna College, Scranton, PA and SUNY College at Delhi (NY).
• Heightened the standards in development of high school curriculum; upgraded and
modernized coursework and equipment, and expanded modern genetics/biotechnology
content.
• Established (since Spring 2009) collaboration with Cornell Institute for Biology Teachers to
teach DNA fingerprinting as hands-on introduction to biotechnology for the high school
level student.
• Developed from the ground up a successful first semester College Biology course
endorsed by Lackawanna College.
• Co-developed interdisciplinary (biology, chemistry, and physics) college course that
challenges students to explore Impact of Science in Modern Society (college credit granted
by SUNY College at Delhi, Delhi, NY).
• Currently developing two college level courses: 1) Forensic Science and 2) Environmental
Impact of Science both set for spring 2011 launch.
• Currently planning a Toastmasters junior edition program to help students develop social
confidence.

EDUCATION & TRAINING

• LEHIGH UNIVERSITY, Bethlehem, PA, Certificate Program of Continuing Education in

Regulatory Affairs, Dept. of Chemistry, 4th of 4 courses, in Progress, 2010. Course titles:
Pharmaceutical Regulatory Affairs I: Drug Discovery to Approval, Biomarkers for
Pharmaceutics and Diagnostics: Laws & Regulations, Validation of analytical assays,
Commercial Production, Validation, and Process Qualification.
• UNIVERSITY OF FLORIDA, Gainesville, FL, Ph.D., Immunology & Molecular Pathology, College of
Medicine.
• HOFSTRA UNIVERSITY, Hempstead, NY, B.A., Biology, Chemistry Minor, College of Arts and
Sciences

Edmund C. Leung  Page 4  Cell Phone: 585-208-7147  e.leung@juno.com

PUBLICATIONS AND PRESENTATIONS

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

AFFILIATIONS

• Cornell
Institute for Biology Teachers, Cornell University (2008 to Present)
• American
Association of Pharmaceutical Scientists (2006 to Present)
• Association
for Research in Vision and Ophthalmology (ARVO) (2004 to Present)
• Toastmaster
s International - Club 1831, District 65; Rochester, New York (2003 to Present)
• National
Research Service Award (1999 to 2002)
• American
Association for the Advancement of Science (1993 to 2002)
• Federation
of American Societies of Experimental Biology (1993 to 1998)
• Commission
ed Officer, United States Public Health Service (1983)