Medical Device Research

SHARON K. NGWENYA, PH.D.

**** ****** ****, #***, *******, TX 77021

Phone: 678-***-**** E-mail: ******.*******@*****.***

Scientifically and clinically astute research professional skilled at developing strategic collaborations between

research institutions and the pharmaceutical and medical device industries. Demonstrated ability to present

complex clinical and non-clinical data at meetings and conferences, to investigators and clinicians. Background

includes acting as a key liaison with cross-functional teams and consistently meeting project goals and deadlines.

PROFESSIONAL EXPERIENCE

Houston Methodist Research Institute, Houston, TX 2011 –

Present

Senior Licensing Associate

Develop and manage relationships with clinical investigators and academic researchers to identify technologies

with commercial viability.

• Identify and evaluate biotechnologies and medical devices for commercial viability, patentability, and

licensing.

• Develop and execute commercialization strategy by identifing key personel within pharma, biotech and

medical device companies, making tailored scientific and business presentations to research and

development, business development and management teams within companies in order to foster research

collaborations and licensing activities.

• Negotiate and execute commercialization agreements for Methodist inventions.

• Manage multiple teams of investigators, regulatory, and legal personnel to ensure that appropriate

timelines are met and regulatory procedures are followed.

• Provide education and guidance on the patenting and commercialization process to researchers and

investigators.

• Perform technology reviews and comprehensive scientific and patent literature searches on medical devices

and research stemming from the departments of Neurosciences, Cardiology, Infectious Disease and

Genomic Medicine.

University of Tennessee Research Foundation (UTRF), Knoxville, TN 2010

– 2011

Licensing Associate

Reviewed new invention disclosures to determine patentability and patenting strategy. Managed IP portfolio of

over 300 active cases including engineering, chemical, agricultural, and life science inventions for the University of

Tennessee System.

• Negotiated commercialization agreements that resulted in over $4 million in upfront option and licensing

fees as well as terms that would produce income from royalty payments and milestone fees.

• Coordinated with patent counsel on the drafting and prosecution of patent applications.

• Conducted educational workshops and seminars for faculty, staff and students on the technology transfer

process, procedures and policies.

• Monitored and tracked licensing agreement compliance.

• Fostered research collaborations between clinical and research investigators and companies in the pharma,

biotech and medical device industries for developing, acquiring, and exploiting biomedical assets.

• Provided support to the start-up companies in the UTRF Business Incubator including commercialization

strategy counseling, coaching to management teams in preparation for presentations to potential investors.

• Traveled throughout the state of Tennessee and worked with other state and private agencies to promote

economic development, identify potential collaborations between private companies, entrepreneurs and

university investigators, encourage entrepreneurship, and promoting business opportunities throughout the

state.

Ballard Spahr Andrews & Ingersoll, Atlanta, GA 2008

– 2009

Technology Specialist

Reviewed and evaluated new inventions and coordinated with inventors, technology transfer professionals, and

foreign counsel in the drafting, filling and prosecution of US and international patent applications.

• Conducted patent, trademark and literature database searches.

• Prepared new patent and trademark applications for U.S. and foreign filing.

• Prepared amendments for patent and trademark prosecution, including conducting interviews with patent

and trademark examiners.

Emory University Office of Technology Transfer, Atlanta, GA 2007 –

2008

Technology Transfer Intern

Researched prior art and performed technical assessments of inventions including therapeutics, diagnostics, medical

devices, non-therapeutics, research tools, and vaccines.

• Performed market research, analyzed and developed marketing strategies, identified potential

corporate licensees, and wrote non-confidential technology briefs for marketing purposes.

Emory University School of Medicine, Division of Digestive Diseases, Atlanta, GA 2004 –

2008

Postdoctoral Research Fellow

Designed and conducted molecular biology and biochemical based research projects for the identification of

biomarkers of risk for colorectal cancer.

• Investigated the mechanism of action of lipopolysaccharide (LPS) in inflammation of intestinal

epithelial cells.

• Designed research project to investigate the role of the Wnt11 gene molecular genetics of

colorectal cancer.

• Managed laboratory technicians and graduate students working on collaborative lab projects.

• Engaged in formal pedagogical training and gained experience in curriculum development, teaching and

medical education for undergraduate and graduate students, as well as healthcare professionals in the

classroom and professional meetings.

Sharon K. Ngwenya, Ph.D . Page

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• Taught science courses as an adjunct and visiting professor at area colleges and universities as part of the

Fellowships in Research and Science Teaching program.

• Served as a peer reviewer for manuscripts submitted to the Gastroenterology Journal for

publication.

Texas A&M University, College Station, TX 1999 –

2004

Graduate Research Assistant

Designed and executed research focused on the molecular biology and pharmacodynamics of hormone/growth

factor-induced gene expression of genes such as E2F-1in breast cancer cells.

• Investigated the mechanism of action of preclinical and clinical breast cancer drugs in combination with

new mechanism-based drugs for treatment of hormone-dependent tumors.

• Investigated the role of enzymes involved in the synthesis of neurotransmitters is substrate specificity CNS

diseases.

• Assisted with Biochemistry class and lab; wrote test questions and graded exams.

EDUCATION & PROFESSIONAL DEVELOPMENT

Ph.D., Biochemistry, 2004

Texas A&M University, College Station, TX

B.S., Biochemistry, 1998

Oakwood College, Department of Chemistry, Huntsville, AL

Clinical Training

Clinical Research Professional Development Program, 2007

Kriger Research Center, Inc.

• Program provided extensive training on ICH Guidelines, GCPs, study planning, updating

investigator brochures, identifying and recruiting investigators, and Institutional Review Boards

(IRBs).

Certificate, NIH Clinical Research Training Course, 2007

NIH Clinical Center, National Institutes of Health, Bethesda, MD

• Satisfactorily completed training on Ethical Issues in Human Subjects Research, Roles and

Responsibilities of the Investigator, Roles and Responsibilities of the Institution, Institutional

Review Boards, Regulatory Issues, and Clinical Investigators and the Mass Media

Selected Honors & Awards

• First Place Poster of Distinction Award, Digestive Diseases Week, 2008

• Emory University Office of Postdoctoral Education Planning Committee, 2007

• International Biopharmaceutical Association Scholarship for Clinical Research, 2007

• Emory University/NIH Fellowship in Research and Scientific Teaching (FIRST), 2005

• First Place Poster Competition, Gulf Coast Society of Toxicology, Galveston, TX, 2003

Sharon K. Ngwenya, Ph.D . Page

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Professional Memberships

• Association of University Technology Managers (AUTM)

• Licensing Executives Society (LES)

• BioHouston

• Rice Alliance for Technology and Entrepreneurship

Publications

1. Ngwenya, S, Bialkowska, A, Chanchevalap, A, and Yang, VW. Gastroenterology. April 2008;

134(4): 293. Induction of Krüppel-like factor 5 (KLF5) by lipopolysaccharide (LPS) in intestinal

epithelial cells is mediated by mitogen-activated protein kinase (MAPK) and phosphoinositol 3 kinase

(PI3K) pathways.

2. Qin, C, Samudio, I, Ngwenya, S, Safe, S. Molecular Carcinogenesis. Jul 2003; 40(3):160-170.

Estrogen-dependent regulation of ornithine decarboxylase in breast cancer cells through activation of

nongenomic cAMP-dependent pathways.

3. Ngwenya, S and Safe, S. Endocrinology, May 2003; 144(5): 1675-1685 Cell context-dependent

differences in the induction of E2F-1 gene expression by 17β -estradiol in MCF-7 and ZR-75 cells.

4. Ngwenya, S and Safe, S. Submitted to Endocrinology. Inhibition of E2F-1 gene expression in breast

cancer cells: Mechanism of inhibition by aryl hydrocarbon receptor agonists.

5. Ngwenya, S and Safe, S. TXSpace, Aug 2005; Regulation of E2F-1 gene expression in human breast

cancer cells.

Oral Presentations

• “Identification of biomarkers of risk for colorectal cancer,” Elizabeth City State University, Elizabeth

City, NC, 2006

• “The development of AhR agonists as breast cancer drugs,” Solvay Pharmaceuticals, Atlanta, GA,

2006

• “The Role of Dioxin in Breast Cancer,” Zygogen, Atlanta, GA, 2006

• “Molecular biology of hormone/growth factor-induced gene expression in breast cancer cells,”

Spelman College, Atlanta, GA, 2005

• “Regulation of E2F-1 in human breast cancer cells,” Emory University School of Medicine, Atlanta,

GA, 2004

• “Cell context-dependent differences in the induction of E2F-1 gene expression by 17β -estradiol in

MCF-7 and ZR-75 cells,” University of Texas, M.D. Anderson Cancer Research Branch, Houston,

TX, 2004

• “A study of the role of neurotransmitter enzymes in determining substrate specificity of drug therapies

” Texas A&M University, 2002.

Poster Presentations

• Induction of Krüppel-like factor 5 (KLF5) by lipopolysaccharide (LPS) in intestinal epithelial cells is

mediated by mitogen-activated protein kinase (MAPK) and phosphoinositol 3 kinase (PI3K)

pathways, IRACDA, San Diego, CA, 2007

• MIC 216 cells secrete proteins that induce apoptosis in intestinal epithelial cells, IRACDA, Kansas

City, KS, 2006

• Inhibition of E2F-1 gene expression in breast cancer cells: Mechanism of inhibition by aryl

hydrocarbon receptor agonists, Society of Toxicology, Baltimore, MD, 2004

Sharon K. Ngwenya, Ph.D . Page

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• Cell context-dependent differences in the induction of E2F-1 gene expression by 17β -estradiol in

MCF-7 and ZR-75 cells, Gulf Coast Society of Toxicology, Galveston, TX, 2003

• The role of estrogen in E2F-1 gene expression in human breast cancer cell, Texas Forum on Female

Reproduction, Houston, TX, 2003

• Cell context-dependent differences in the induction of E2F-1 gene expression by 17β -estradiol in

MCF-7 and ZR-75 cells, Gulf Coast Society of Toxicology, Society of Toxicology, Salt Lake City, UT,

2003

• Regulation of E2F-1 gene expression in human breast cancer cell lines, Gulf Coast Society of

Toxicology, College Station, TX, 2002

• Development of mechanism-based drugs for treatment of breast cancer and the differential activation

of estrogen receptor by endocrine disruptors, Texas Forum on Female Reproduction, Houston, TX,

2002

• The role of estrogen in E2F-1 gene expression, Society of Toxicology, Nashville, TN, 2002

• The role of estrogen in E2F-1 gene expression, Society of Toxicology, San Francisco, CA, 2001

• Estrogen induction of Connexin 43 in human breast cancer cells, Gulf Coast Society of Toxicology,

Austin, TX, 2000

• Estrogen induction of Connexin 43 in human breast cancer cells, Society of Toxicology, Philadelphia,

PA, 2000

• Role of tryptophan hydroxylase phe313, a serotonin synthesis enzyme, in determining substrate

specificity, Texas A&M University Graduate Student Forum, 1999.

• Aged garlic extract attenuates the cytotoxicity of β-amyloid on undifferentiated PC12 cells, Oakwood

Oakwood Research Studies, 1998.

• The protection of PC12 cells, a model of sympatheic neurons, against benzol peroxide cytotoxicity,

Oakwood College Research Studies 1997.

• Neurobehavioral effects of Δ 9THC and cannabinoid (CB1) receptor gene expression in mice,

Oakwood College Research Studies, 1996.

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