State University Research

Melissa Marie Hamilton

*** ****** *****, ****** ******, MD 20901

Cell: 734-***-**** ***********@*******.***

PROFESSIONAL SUMMARY

Twenty-two years in vitro and in vivo research laboratory experience.

Eighteen years in laboratory research experience in the bio/pharmaceutical industry in compliance with GLP, FDA, AAALAC and OECD guidelines.

Eighteen years in vivo animal model development in areas of bacteriology, ophthalmology and oncology.

Ten years as R&D safety committee representative in a bio/pharmaceutical company.

Six years as IACUC team member serving three years as the IACUC chairperson in a bio/pharmaceutical company.

PROFESSIONAL EXPERIENCE Medimmune Inc, subsidiary of AstraZeneca, Gaithersburg, MD 2009-June 2017 Associate Scientist II

Responsible for the design, execution, data analysis and reporting of Gram negative/Gram positive bacterial treatments using in vivo cotton rat and mouse models (dermonecrosis, keratitis, nasal colonization, pneumonia, sepsis).

Responsible for in vivo model development for the infectious disease department.

Developed in vitro assays

Responsible for IACUC protocols for bacteriology department

Served as departmental in vivo training partner with IACUC incoming employees

Co-author on multiple publications

GenVec, Inc, Gaithersburg, MD 2001-2009

Senior Research Associate III 2008-2009

Senior Research Associate II 2007-2008

Senior Research Associate I 2003-2007

Research Associate II 2001-2003

Responsible for the design, execution, data analysis and reporting of adenovector-based drug efficacy using ophthalmology, oncology and vaccine in vitro and in vivo models.

Developed in vivo tumor and ophthalmology model in mice.

In vitro and in vivo pharmacokinetic profiling using marker genes.

Host immune responses using neutralizing antibody assays, ELISA, ELISPOT and flow cytometry techniques.

Participated in preparation and submission of NIH grant proposals (SBIR/R01/R21).

First author and co-author of publications, abstracts and oral presentations.

Train and guide junior staff on in vivo and in vitro techniques.

Served as department and team meeting/project coordinator.

Served as sub-committee chairperson for merger integration at company.

Represented research department as a company based safety committee member.

Served as IACUC member and chairperson.

Eli Lilly and Company, Indianapolis, IN 1999-2001

Biologist

Responsible for execution, data analysis and reporting of drug disposition, placental transfer and milk excretion studies in in vivo rodent models using tissue dissection and quantitative whole-body autoradiographic techniques in accordance with GLP regulations.

Functioned as a QC reviewer for raw data and final research reports to maintain department regulatory requirements.

Represented drug disposition & toxicology as a R&D safety committee member. Lab Support, Cincinnati, OH 1998

Contractor, Procter & Gamble, Mason, OH

Responsible for maintenance of multiple transformed cell lines, cell line transfections, DNA preps and western immunoblots to support identification and optimization of an anti-angiogenic compound. Wright State University, Dept. of Microbiology & Immunology, Fairborn OH 1997-1998 Laboratory Technician

Examined the cytokine expression profile in an in vivo mouse model of EMCV-infection using immunohistochemical analysis.

RELEVANT SKILLS Laboratory:

Bacterial and mammalian cell/organ culture techniques

Tissue necropsy in cotton rat, rat and mouse in vivo models

Animal dosing:

o Cotton rat: IM, IP, intranasal

o Mouse: IM, IP, IV, SC, intradermal, intranasal, intravitreal, subtenon, subretinal, and oral gavage o Rat: IP, oral gavage

In vitro/In vivo light and fluorescent microscopy

Imuno/histochemical tissue staining for light microscopy (cryo- and paraffin sections).]

In vivo/Ex vivo angiogenic assays (i.e. laser-induced choroidal neovascularization in mice; mouse aortic ring assay)

Immunoassays (neutralizing antibody, ELISA (antigen and whole-cell), ELISPOT, FACS)

Protein assays

Phosphor imaging techniques

In vitro/In vivo assays using radioisotopes (C14, P32 and I125)

Marker gene assays (GFP, luciferase)

Whole-body autoradiography in rats

Western blotting

Computer:

Microsoft Office (Excel, Powerpoint, Word)

Lab-related: CellQues/FlowJo, ImmunoSpot, ImageQuant, MesoScale, SoftMaxPro)

Graph/statistical-related: OriginPro, Photoshop, SPSS, SigmaPlot, Prism EDUCATION Wright State University, Dayton, OH 1999

Masters of Science, Biological Sciences

GPA: 3.95/4.00

Graduate Tuition Fellowship (1997-1998)

Research Thesis: "A Time course for Herpes Simplex Virus Type I (HSV-1) infection of bi-layered oral mucosal equivalents".

Advisor: Barbara Hull

The Ohio State University, Columbus, OH 1995

Bachelor of Science, Biology

PROFESSIONAL DEVELOPMENT

Flow Cytometry: Principles and Methods Workshop, NIH, Bethesda, MD (2009)

Project Management Workshop, GenVec, Inc, Gaithersburg, MD (2008)

Management Workshop for Mid-Level Management, GenVec, Inc, Gaithersburg, MD (2008)

National Animal Welfare Education Program, sponsored by OLAW, Gaithersburg, MD (2007)

- IACUC 101: "The Basics"

- IACUC 201 PLUS: "The Process" including IACUC Leadership Workshop for Institutional Officials, Chairs and Veterinarians

ELISPOT Wet Lab and Data Analysis Workshop, Cellular Technology Ltd, Cleveland, OH (2005)

Management Training Seminar/Workshop, GenVec, Inc, Gaithersburg, MD (2004) PATENTS Bret SELLMAN, Christine TKACZYK, Melissa HAMILTON, Lei Hua 1015 Methods of treating s. aureus-associated diseases . US patent EP20130853844

Reiter CE, Carrion M, Hamilton MM, Wei LL, King CR. 2009. Methods of regulating angiogenesis through stabilization of PEDF. US Patent 2009/0149381, filed October 10, 2008, and issued June 11, 2009. PUBLICATIONS Tkaczyk C, Hamilton MM, Sadowska A, Shi Y, Chang CS, Chowdhury P, Buonapane R, Xiao X, Warrener P, Mediavilla J, Kreiswirth B, Suzich J, Stover CK, Sellman BR. Targeting Alpha Toxin and ClfA with a Multimechanistic Monoclonal- Antibody-Based Approach for Prophylaxis of Serious Staphylococcus aureus Disease. MBio. 2016 Jun 28;7(3). Cohen TS, Hilliard JJ, Jones-Nelson O, Keller AE, O'Day T, Tkaczyk C, DiGiandomenico A, Hamilton M, Pelletier M, Wang Q, Diep BA, Le VT, Cheng L, Suzich J, Stover CK, Sellman Staphylococcus aureus α toxin potentiates opportunistic bacterial lung infections. BR.Sci Transl Med. 2016 Mar 9;8(329):329ra31. Hilliard JJ, Datta V, Tkaczyk C, Hamilton M, Sadowska A, Jones-Nelson O, O'Day T, Weiss WJ, Szarka S, Nguyen V, Prokai L, Suzich J, Stover CK, Sellman BR. Anti-alpha-toxin monoclonal antibody and antibiotic combination therapy improves disease outcome and accelerates healing in a Staphylococcus aureus dermonecrosis model. Antimicrob Agents Chemother. 2015 Jan;59(1):299-309. doi: 10.1128/AAC.03918-14. Epub 2014 Oct 27. Tkaczyk C, Hamilton MM, Datta V, Yang XP, Hilliard JJ, Stephens GL, Sadowska A, Hua L, O'Day T, Suzich J, Stover CK, Sellman BR. Staphylococcus aureus alpha toxin suppresses effective innate and adaptive immune responses in a murine dermonecrosis model. PLoS One. 2013 Oct 2;8(10):e75103. doi: 10.1371/journal.pone.0075103. Collection 2013. DiGiandomenico A, Warrener P, Hamilton M, Guillard S, Ravn P, Minter R, Camara MM, Venkatraman V, Macgill RS, Lin J, Wang Q, Keller AE, Bonnell. Identification of broadly protective human antibodies to Pseudomonas aeruginosa exopolysaccharide Psl by phenotypic screening.

Bruder JT, Semenova E, Chen P, Limbach K, Patterson NB, Stefaniak ME, Konovalova S, Thomas C, Hamilton M, King CR, Richie TL, Doolan DL. Modification of ad5 hexon hypervariable regions circumvents pre-existing ad5 neutralizing antibodies and induces protective immune responses. PLoS One. 2012;7(3):e33920. Hamilton MM, Byrnes GA, Gall JG, Brough DE, King CR, Wei LL. Alternate serotype adenovector provides long-term therapeutic gene expression in the eye. Mol. Vis. 2008;14:2535-46. Chen P, Hamilton MM, Thomas CA, Kroeger K, Carrion M, MacGill RS, Gehlbach P, Brough DE, Wei LL, King CR, Bruder JT. Persistent expression of PEDF in the e ye using high-capacity adenovectors. Mol Ther. 2008;16 (12):1986- 94.

McVey D, Hamilton MM, Hsu C, King CR, Brough DE, Wei LL. Repeat administration of proteins to the eye with a single intraocular injection of an adenovirus vector. Mol Ther. 2008;16(8):1444-9. Hamilton MM, Brough DE, McVey D, Bruder JT, King CR, Wei LL. Repeated administration of adenovector in the eye results in efficient gene delivery. Invest Ophthalmol Vis Sci. 2006;47(1):299-305. Saishin Y, Silva RL, Kachi S, Aslam S, Gong YY, Lai H, Carrion M, Harris B, Hamilton MM, Wei LL, Campochiaro PA. Periocular gene transfer of pigment epithelium-derived factor inhibits choroidal neovascularization in a human-sized eye. Hum Gene Ther. 2005;16(4):473-8.

ABSTRACTS/PRESENTATIONS Ueyma K, Mori K, Hamilton MM, Omata H, Gehlbach PL, Wei LL, Toneya S. Comparison of Long-Term Transduction Efficiency of Reporter Genes after Subretinal Injection of the Adenovirus Vectors of Serotypes 5, 28, and 35. Association for Research in Vision and Ophthalmology, Ft. Lauderdale, FL 2012. Poster Presentation. Hamilton MM, Sadowska A, Tkaczyk C, Chang CS, Matinez J, Shi Y, Toll B, Gao C, Buonpane R, Pavlik P, Chowdhury P, Cepeda M, Shirinian L, Stover CK, Sellman BR. Efficacy of anti-MSCRAMM mAbs in a S. aureus Cotton Rat Nasal Colonization Model. Medimmune Science Fair, Gaithersburg, MD 2012. Poster Presentation. Tkaczyk C, Datta A, Hamilton MM, O' Day T, Shirinian L, Carlson M, Amin V, Gao C, Hua L, Barnes A, Stover CK, Sellman BR. Anti-Alpha Toxin mAb, MEDI4893, controls the inflammatory response in skin and accelerates bacteria clearance in a CA-MRSA USA300-mouse dermonecrosis model. Medimmune Science Fair, Gaithersburg, MD 2012. Poster Presentation.

Sadowska A, Hamilton MM, Chang CS, MacGill RS, Shirinian L, Chowdhury P, Rosenthal K, Tkaczyk C, Stover CK, Sellman BR. Identification and characterization of an anti-ClfA mAb to prevent S.aureus mediated sepsis. Medimmune Science Fair, Gaithersburg, MD 2012. Poster Presentation. Svabek C, Krishnan S, Zhang J, Hamilton MM, Shi Y, Hua L, Bonnell J, DiGiandomenico A, Blair W, Suzich J, Patera A. Procalcitonin in Serious Bacterial Infections - Novel target or biomarker? Medimmune Science Fair, Gaithersburg, MD 2012. Poster Presentation.

MacGill RS, Oganesyan V, Barnes A, Shi Y, Hamilton MM, Ulbrandt ND, Sellman BR, McCarthy M. Vaccination with Doubly Ablated Y14R-S33I Mutant SpA is Protective in Models of Staphylococcus aureus Infection. Medimmune Science Fair, Gaithersburg, MD 2012. Poster Presentation.

Zinsou RE, Hilliard JJ, Hua L, Shi Y, Hamilton MM, Tkaczyk C, Datta V, Sellman BR, Stover CK. Evaluation of an antibiotic (Vancomycin) for use in adjunctive therapy with anti-AT mAb (LC-10) in a murine S. aureus dermonecrosis model. Medimmune Science Fair, Gaithersburg, MD 2012. Poster Presentation Hamilton MM, Tkaczyk C, DiGiandomenico A, Camara M, Warrener P, Guillard S, Minter S, Sellman B, Stover CK. Prophylactic Efficacy of a Human Monoclonal a-PslA Antibody in a Murine Model of Pseudomonas aeruginosa Keratitis 2011 Mid-Atlantic Microbial Pathogenesis Meeting, Wintergreen VA. Abstract Hamilton MM, Tkaczyk C, DiGiandomenico A, Camara M, Warrener P, Sellman B, Stover CK. Prophylactic Efficacy of a Human (a-PslA) and mouse (a-PcrV) Monoclonal Antibodies in a Murine Model of Pseudomonas aeruginosa Keratitis. Medimmune Science Fair, Gaithersburg, MD 2011. Poster Presentation. Shi YY, Hua L, Tkaczyk C, Sadowska A, Hamilton MM, Buonpane R, Pavlik P, Shirinian L, Lin J, Varkey R, Chowdhury P, Stover C, Sellman BR. Evaluate the Efficacy of Anti-IsdH Monoclonal Antibodies in Murine Models and in Combination with Anti-Alpha Toxin mAb to Prevent Staphylococcal Infection. Medimmune Science Fair, Gaithersburg, MD 2011. Poster Presentation.

Sadowska A, Hua L, Shi Y, Hamilton M, Lekstrom K, Warrener P, Stover CK, Tkaczyk C, Sellman B. Staphylococcus aureus Alpha Toxin Conservation and Expression by Clinical Isolates. Medimmune Science Fair, Gaithersburg, MD 2011. Poster Presentation.

DiGiandomenico A, Hamilton MM, Warrener P, Tomich M, Guillard S, Minter R, Sellman B, Stover CK. Human monoclonal anti-Psl antibody CAM-003 promotes opsonophagocytic killing and protection from lethal Pseudomonas aeruginosa acute pneumonia. Medimmune Science Fair, Gaithersburg, MD 2010. Poster Presentation. Tomich M, MacGill RS, Warrener P, DiGiandomenico A, Hua L, Hamilton MM, Sellman, Stover CK. Strategy for Discovery of Antibodies that Potentiate Antibiotic Activity Against Pseudomonas aeruginosa. Medimmune Science Fair, Gaithersburg, MD 2010. Poster Presentation.

Warrener P, Hamilton MM, DiGiandomenico A, Tomich M, Guillard S, Minter R, Sellman B, Stover KC. Identification of the Target of anti-Pseudomonas Monoclonal Antibody CAM003: Exopolysaccharide psl, a key component of Pseudomonas Biofilms. Medimmune Science Fair, Gaithersburg, MD 2010. Poster Presentation. Ueyama K, Mori K, Hamilton MM, Omata H, Gehlbach PL, Wei LL, Yoneya S. Comparison of Transduction Efficiency and Intraocular Localization of Reporter Genes After Intravitreal and Subretinal Injection of the Adenovirus Vectors of Serotypes 5, 28, and 35 With Fiber Modifications. Associate for Research in Vision and Ophthalmology, Ft. Lauderdale, FL 2010. Poster Presentation.

Hamilton MM, Einfeld DE, King CR, Wei LL. Alternate Serotype and Combination Anti-Antigenic Therapy in the Eye. Associate for Research in Vision and Ophthalmology, Ft. Lauderdale, FL 2008. Poster Presentation. Chen P, Semenova E, Thomas C, Hamilton MM, Patterson NB, Stefaniak ME, Limbach K, Gall JG, King CR, McVey D, Doolan DL, Bruder JT. Modification of Ad5 Hexon Hypervariable Regions Circumvents Pre-existing Ad5 Neutralizing Antibodies. American Society of Gene Therapy, Boston, MA 2008. Poster Presentation. Wei LL, Hamilton MM, Gall JG, Brough DE, King CR. Alternate Serotype Adenovector Gives Long-Term Expression in the Eye. Association for Research in Vision and Ophthalmology, Ft. Lauderdale, FL 2007. Poster Presentation. Murugesan SR, Hamilton MM, Akiyama M, Osborn R, Hritz D, West-Bushby L, Wei LL, King CR. Selective Delivery of Tumor Necrosis Factor to Disseminate Tumors in the Peritoneal Cavity Using Targeted Adenovirus Vectors. American Associate for Cancer Research, Los Angeles, CA 2007. Poster Presentation. Wei LL, Hamilton MM, King CR, McVey D, Brough DE. All Trans-Retinoic Acid Regulation of Transgene Expression in the Eye. Association for Research in Vision and Ophthalmology, Ft. Lauderdale, FL 2006. Poster Presentation. Reiter CD, Hamilton MM, King CR, Brough DE, Wei LL, Carrion ME. MMP-9 Modulates Pigment Epithelium Derived Factor Control of Angiogenesis via Proteolysis. Association for Research in Vision and Ophthalmology, Ft. Lauderdale, FL 2006. Poster Presentation.

Brough DE, Staicker H, Akiyama M, Hsu C, Murugesan S, Einfeld DA, Gall JG, Wei LL, Hamilton MM, McVey D, King CR. Adenoviral Vector Targeting-New Targets for Old Capsids. American Society of Gene Therapy, Boston, MA 2005. Poster Presentation.

MacGill RS, Hamilton MM, Osborn R, Hritz D, King CR. Local Therapy with TNFeradeTM and Radiation Suppresses Metastatic Disease in the Spontaneously Metastatic B16F10 Melanoma Model. American Association for Cancer Research. 2005. Poster Presentation.

Carrion ME, Hamilton MM, Harris B, King CR, Mori K, Wei LL. Ocular Pharmacokinetics of Pigment Epithelium-Derived Factor (PEDF) Following Adenovector-Based Gene Delivery Indicate that Low Doses of PEDF are Therapeutic. Association for Research in Vision and Ophthalmology, Ft. Lauderdale, FL 2005. Poster Presentation. Wei LL, Hamilton MM, Virjee M, Reiter C, Carrion ME. Pigment Epithelium-Derived Factor (PEDF) Protein Purification and Stabilization. National Institute of Health/Small Business Innovation Research II (NIH/SBIR II). 2005. Poster Presentation.

Gehlbach PL, Deering T, Callahan K, Carrion ME, Hamilton MM, Wei LL, Campochiaro PA. Periocular Gene Product Delivery of Pigment Epithelium-derived Factor Induces Regression of Ocular Neovascularization. Association for Research in Vision and Ophthalmology, Ft. Lauderdale, FL. 2004. Poster Presentation. Wei LL, Hamilton MM, McVey D, King CR, Brough DE. Repeat Dosing of Adenovector in the Eye. Association for Research in Vision and Ophthalmology, Ft. Lauderdale, FL. 2004. Poster Presentation. Bruder JT Chen P, Kroeger K, Hamilton MM, Carrion ME, Brough DE, Wei LL, King CR, Campochiaro PA, Gehlbach P. Persistent PEDF Expression Following Intravitreal Administration of High-Capacity Adenovectors. American Society of Gene Therapy. 2004. Poster Presentation.

Carrion ME, Hamilton MM, Harris B, Brough D, Gehlbach P, King CR, Wei LL. Ocular Sublocalization and Pharmacokinetics of Expression of Pigment Epithelium-Derived Factor in Murine Eyes Following Adenovirus-Based Intravitreous Gene Delivery. Association for Research in Vision and Ophthalmology, Ft. Lauderdale, FL 2003. Poster Presentation.

McVey D, Wei LL, Hsu C, Hamilton MM, King CR, Brough DE. Adenoviral Gene Delivery for the Treatment of Ocular Disease. Association for Research in Vision and Ophthalmology, Ft. Lauderdale, FL. 2003. Poster Presentation. Carrion ME, Hamilton MM, Harris B, Brough D, Gehlbach P, King CR, Wei LL. Pharmacokinetics of Expression of Pigment Epithelium-Derived Factor Following Adenovirus-Based Ocular Gene Delivery. American Society of Gene Therapy. 2003. Poster Presentation.

Carrion ME, Harris B, McVey D, Butman B, Hamilton MM, Brough B, King CR, Mori K, Gehlbach P, Campochiaro PA, Wei LL. Intravitreous Administration of PEDF-Expressing Adenovirus: A Quantitative Expression Profile. Association for Research in Vision and Ophthalmology, Ft. Lauderdale, FL. 2002. Poster Presentation. Chay SH, Hamilton MM, Herman JL, He MM, Czeskis BA, Donnelly KB. Quantitative Whole Body Autoradiographic Disposition of Radioactivity Associated with of 14 LY368842 in Male Fischer 344 Rats After a Single Oral 10-mg/kg Dose Administered as the Flycolate Salt. Society for Whole-body Autoradiograph, New Orleans, Louisiana. 2001. Poster Presentation.

Hamilton MM, Herman JL, VanBelle KR, Chay SH. Quantitative Whole Body Autoradiographic Disposition for Radioactivity Associated with 14 LY397584 in Male Long Evans Rats Following a Single Oral 5-mg/kg Dose Administered as the Succinate Salt. Society for Whole-body Autoradiography, New Orleans, Louisiana. 2001. Poster Presentation. Chay SH, Herman JL, Hamilton MM, O' Bannon DD, Garner CO. Quantitative Whole Body Autoradiographic Disposition of 14 LY333531 in Female Fischer 344 Rats after Single and Multiple (7 and 14 days) 5-mg/kg Oral Doses Administered as the Mesylate Monohydrate Salt. European Society for Autoradiography, Paris, France. 2000. Poster Presentation. Hamilton MM, Herman JL, Sauer JM, Kuo F, Chay SH. Placental Transfer and Milk Excretion in Rats After a Single Oral 50-mg/kg Dose of 14 Tomoxetine Administered as the Hydrochloride Salt. European Society for Autoradiography, Paris, France. 2000. Poster Presentation.

Herman JL, Hamilton MM, Philips DL, Chay SH. Placental Transfer and Milk Excretion of Radiocarbon in Female Fischer 344 Rats Following a Single Oral 10-mg/k Dose of 14 IC351. Lilly Expo 2000. Indianapolis, IN 2000. Poster Presentation.

Hamilton MM, Herman JL, Sauer JM, Kuo F, Chay SH. Placental Transfer and Milk Excretion in Rats After a Single Oral 50-mg/kg Dose of 14 Tomoxetine Administered as the Hydrochloride Salt. Lilly Expo 2000. Indianapolis, IN 2000. Poster Presentation.

Hamilton MM. A Time Course for Herpes Simplex Virus Type 1 (HSV-1) Infection of Bilayered oral Mucosal Equivalents. Wright State University, Fairborn, OH. 1999. Master of Science Thesis Oral Defense. Hamilton MM. Optimum Cell Culture Conditions for Oral Mucosal Keratinocyte Monolayers and Bilayered Oral Mucosal Equivalents. Wright State University, Fairborn, OH: Spring Sing 1998. Oral Presentation. Others: if asked for

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