KEY QUALIFICATIONS

•  Ten years of experience designing, scheduling, performing, analyzing, and managing biomedical research projects, including toxicity studies.

•  Over two years of experience as a government contractor on six contracts for the Environmental Protection Agency, National Institute for Environmental Health Sciences, National Cancer Institute, Agency for Toxic Substance and Disease Registry, National Library of Medicine, and National Institute for Occupational Safety and Health.

•  Advise project officer about creating a Quantitative Structure Toxicity Relationship (QSTR) program to predict unknown toxicity endpoint values used for risk assessment.

•  Manage the toxicity endpoint data collection and evaluation task for the QSTR project with oversight of three people, subcontractor, and budget.

•  Review toxicity data relevant to carcinogenicity and write summaries of the data for both a scientific and non-scientific audience or for recommending chemicals to be tested by the National Toxicology Program.

•  Provide quality control and editing for government documents and databases.

•  Developed a novel curative chemoimmunotherapy for breast cancer in mice.

•  Characterized the toxicity of cytotoxic chemotherapy and cytokine immunotherapy combination treatments in the therapeutic dose range.

•  Documented a previously unreported toxicity of 5-fluorouracil in rats.

•  Characterized the pathology of a highly invasive and metastatic mouse breast cancer cell line.

•  Identified a serum based metabonomics biomarker for predicting response to a curative chemoimmunotherapy.

•  Studied the effectiveness of a novel chemoimmunotherapy for colon cancer in rats.

•  Characterized the immunological effects of cytotoxic chemotherapy and cytokine immunotherapy combination treatments.

•  Developed a novel method for diagnosis of chromosomal abnormalities.

•  Published nine scientific papers, four articles and five abstracts and in the process of writing a book on the toxicity of chemical weapons.

•  Presented data on research studies at thirteen local or national seminars or conferences in poster or lecture format.

•  Provided independent consultation of non-clinical genotoxicity testing to financial investors of the pharmaceutical drug development market.

•  Taught the 1-800-CDC-INFO tier three staff the principles of toxicology.

•  Taught a course on the biology of cancer to summer research interns and mentored two summer research interns.

•  Obtained certification in Regulatory Affairs Essentials for pharmaceutical development.

•  Completed a Project Management Essentials course.

KEY SKILLS

•  Ability to review and summarize scientific data, especially of toxicity or therapeutics studies.

•  Understanding of the risk assessment process and data requirements.

•  Document quality assurance review and editing.

•  Understanding of task, personnel, and budget management and the creation of guidelines and protocols.

EDUCATION

03/07 Completed – Crucial Conversations , VitalSmarts, www.CrucialConversations.com through Constella Group LLC, Durham, NC.

11/06-12/06 Completed (96.3/100) – Project Management Essentials , Thomson NTGg, www.Netglearning.com through Constella Group LLC, Durham, NC.

10/05-11/06 Certificate (4.0, 11hr) – Regulatory Affairs Essentials , Bioscience, University of California San Diego Extension, San Diego, CA.

05/97-01/04 Ph.D. (3.6, 76hr) , Molecular Pharmacology and Cancer Therapeutics (Pharmacology), Roswell Park Cancer Institute (RPCI) Division of the State University of New York at Buffalo, Buffalo NY.

Honors: Thomas B. Tomasi Fellowship, Woodburn Fellowship, 2 nd place at Roswell Park Graduate Student Poster Competition, participant at the Pathobiology of Cancer workshop sponsored by the AACR (1 week)

08/92-05/97 B.S. (Cum Laude) (3.4, 159hr) , Biochemistry and Nutrition, Virginia Polytechnic Institute & State University (VA Tech), Blacksburg VA.

Honors: W. R. Winslow Trust Scholarship, Wysor Scholarship, Dean's list (four times), Phi Sigma Biological Honor Society, Golden Key National Honor Society

09/88-05/92 Centreville High School, Clifton, VA.

EXPERIENCE

Post Graduate Employment:

11/06-Present Research Specialist III , Constella Group, LLC, Durham NC. Proposed to provide consultation for a task order to update Immediately Lethal or Dangerous to Health values for the National Institute for Occupational Safety and Health. Actively participated in assessment and discussions of the feasibility and approach of performing this activity, including personnel skills, personnel availability constraints, scheduling, and budget.

08/06-Present Research Specialist III/Task Manager , Constella Group, LLC, Durham NC. Designed and manage the toxicity data extraction task and provide overall consultation for a contract to develop a quantitative structure toxicity relationship program to predict toxicity endpoints for risk assessment for the Environmental Protection Agency - National Homeland Security Research Center. My responsibilities for this project include the following: oversee three people and a subcontractor within a $70,000 budget, evaluate dataset quality, clarify project guidelines, advise project officer about the appropriate approach to complete the project, identify additional sources for toxicity endpoint data suitable for risk assessment, coauthored an amendment to the contract which provided for an additional $70,000 for a new task, created guidelines for the creation of a database by a subcontractor, created a protocol for data extraction, and provide data quality assurance. Participated in an assessment of the feasibility and approach of performing this activity, including personnel skills, personnel availability constraints, scheduling, and budget.

06/06-Present Research Specialist III , Constella Group, LLC, Durham NC. Provided toxicology principles training to tier three staff of the three tier call center for the Centers for Disease Control and Prevention, 1-800-CDC-INFO. Topics include inquiries covered by the Agency for Toxic Substance and Disease Registry and soon by the National Institute for Occupational Safety and Health. Continue to provide consultation by writing background summary reports, helping to answer difficult inquiries and recommending information search strategies. Developed and formalized the process of answering difficult inquiries. Proposed to develop a database of sources of data for answering future anticipated inquiries. Identified issues to be addressed in clarifying project guidelines and specifications. Actively participated in assessment and discussions of the feasibility and approach of performing this activity, including personnel skills, personnel availability constraints, scheduling, and budget.

12/05-Present Research Specialist III , Constella Group, LLC, Durham NC. Update, edit and provide quality assurance review of the 12 th Report on Carcinogens for the National Institute of Environmental Health Sciences. Review data relevant to carcinogenicity and write the Carcinogenicity and Additional Data Relevant to Carcinogenicity sections. Review and provide quality assurance for the remaining sections, which include exposure and environmental fate data. Developed methods and procedures to improve the processes of data collection and analysis, and created standardized wording for appropriate data. Created a database to track the progress of collecting and reviewing primary data sources.

10/05-Present Independant Consultant , Clinical Advisors, New York, NY. Provide consultation to financial investors of the pharmaceutical development industry. Evaluated data from non-clinical genotoxicity assays to be used in support of a drug research/marketing application.

01/05-09/05 Toxicologist , Technical Resources International, Bethesda, MD. Evaluated and summarized toxicity, exposure and environmental fate data to estimate the carcinogenic potential and potential risk of specific chemicals, relevant analogs, metabolites, and degradation products. Recommended the nomination of chemicals for carcinogenicity and genotoxicity testing by the National Toxicology Program, through the National Cancer Institute. Data evaluation included structure activity relationship analyses when appropriate. Provided quality assurance of evaluations made by others in the department.

03/05-09/05 Toxicologist , Technical Resources International, Bethesda, MD. Edited and provided quality assurance for toxicological information of updated drug and chemical records of the Hazardous Substance Data Bank for the National Library of Medicine and proposed changes and clarifications to the guidelines.

01/04-05/04 Researcher , Pharmacology, RPCI, Buffalo NY. Studied specificity of doxorubicin and IL-2 chemoimmunotherapy induced immune memory.

Research Performed:

01/98-01/04 Thesis Project , Pharmacology, RPCI, Buffalo NY. Studied efficacy, toxicity, immune mechanisms and biomarkers for anti-cancer response of doxorubicin and IL-2 chemoimmunotherapy in a mouse breast cancer model. Studied the pathological progression of a breast cancer model. Studied immune aspects, as well as novel and known toxic effects of IL-15, 5-fluorouracil and leucovorin chemoimmunotherapy in a rat colon cancer model.

05/97-01/98 Laboratory Rotations , Pharmacology, RPCI, Buffalo NY. Studied structure activity relationships of taxane based Pgp multidrug resistant efflux pump inhibitors

05/96-08/96 Summer Internship (10 weeks), Roswell Park Summer Research Participation Program, RPCI, Buffalo, NY. Studied activation state of Ran guanidine nucleotide binding protein.

05/95-08/95 Summer Employment , Cancer Genetics Department/Amniotic Fluid Department, Genetics and IVF Institute, Fairfax, VA. Developed a novel technique for enhanced cytogenetic analysis of clinical tissue. Performed staining, photo processing and general karyotyping of patient's amniotic fluid and bone marrow samples.

01/95-05/97 Undergraduate Research Project , Biochemistry and Nutrition Department, VA Tech, Blacksburg, VA. Worked on characterization of GlpR dimerization in E. Coli.

05/94-08/94 Summer Internship (8 weeks) /Employment , Cancer Genetics Department/Amniotic Fluid Department, Genetics and IVF Institute, Fairfax, VA. Studied fluorescent in situ hybridization as a prognostic tool in simulated sex-mismatched bone marrow transplantation. Employed following internship for staining, photo processing and general karyotyping of patient's amniotic fluid samples.

Leadership Positions:

01/07-Present Committee Member , Disability Advocacy Committee, National Institute of Environmental Health Sciences, Durham NC.

•  Working to recruit three speakers for Disability Awareness Month

•  Working to develop a workshop for Disability Awareness Month

•  Working to develop the committee website

•  Discussed various business issues

05/04-Present Secretary and Member of Board of Directors , National Council for Support of Disability Issues, Haymarket VA. (Executive Director,

•  Initiated and recruited artist for “Able Crew” comic of kids with disabilities that have heroic abilities www.theablecrew.org

•  Wrote article for Able Crew Activity Pages website

•  Technical director and technical editor for the movie, Able Crew episode I www.theablecrew.org/movie/able.htm

•  Discussed and voted on various business decisions www.ncsd.org

SUMMARY OF RESEARCH SKILLS

In vitro/ ex vivo Techniques Used:

3 H-thymidine uptake assay, 51 Cr-release immune cell and compliment mediated cytotoxicity assay, agarose gel electrophoresis, b -galactosidase activity assay, bacterial and mammalian cell culture, bone marrow fixation/microscope slide mounting, cell irradiation, colcemid induced block at metaphase, DNA sequencing, electroporation, drug equivalency calibration, ficoll-paque leukocyte enrichment, fluorescent in situ hybridization, fluorescent microscopy/digital image manipulation, hemacytometer cell counting, immunofluorescent and DNA content flow cytometry, immunoprecipitation, MTT cytotoxicity assay, partial plasmid digestion, plasmid and genomic DNA isolation, plasmid mutagenesis, polymerase chain reaction/primer design, sonication, SRB cytotoxicity assay, thin layer and high pressure liquid chromatography, Wright staining/de-staining, x-ray film processing

In vivo Techniques Used:

Animal handling (mouse and rat), breeding of transgenic mice requiring foster mothers, euthanasia by cervical dislocation, CO 2 asphyxiation and ether, general anesthesia (ether, ketamine and xylazine), injections (i.v., i.p., s.c. using needle, over the needle catheter and trocar), necropsy with gross and histologic exam, noninvasive observation for clinical signs of toxicity, organ harvesting for immune activity measurement, peritoneal fluid and blood collection, surgery/suture, total/differential blood cell count, tumor size caliper measurements

Computer Programs Utilized:

Microsoft Word, Excel, Access and Power Point; Minitab statistical software; G-Plate dose response analysis software; File Maker Pro database; CellQuest and Winlist flow cytometry software; TOXNET, PubMed, and numerous other internet search engines; Chemwindow, ISIS/Draw chemical structure drawing software; Topkat, Advanced ChemID Plus, DEREK, and METEOR structure activity software; SMILES chemical notation; Endnote and Reference Manager bibliographic software

MEMBERSHIP

•  Active Member , Regulatory Affairs Professionals Society (RAPS), Rockville, MD.

•  Affiliate Member , American Association for Cancer Research (AACR), Philadelphia, PA.

•  Affiliate Member , American Society of Clinical Oncology (ASCO), Alexandria, VA.

ORAL COMMUNICATIONS

08/97-01/04 Annual Student Seminar Presentation , Pharmacology Department, RPCI, Buffalo, NY.

08/99-05/03 Abstracts 1 to 5 mentioned below were presented in poster form .

05/01-08/01 Lectured High School Interns , Roswell Park Summer Research Participation Program, RPCI, Buffalo, NY.

12/00 Recruitment Presentation , Pharmacology Department, RPCI, Buffalo, NY.

•  Big Creek High School in War, WV for the Roswell Park Summer Research Participation Program

•  VA Tech in Blacksburg, VA for the RPCI Pharmacology Ph.D. Program

05/00-08/00 Mentor of Research Intern , Roswell Park Summer Research Participation Program, RPCI, Buffalo, NY.

08/96 Research Seminar Presentation , Roswell Park Summer Research Participation Program, RPCI, Buffalo, NY.

05/95-08/95 Mentor of Research Intern , Cancer Genetics Department, Genetics and IVF Institute, Fairfax, VA.

08/94 Research Seminar Presentation , Cancer Genetics Department/Amniotic Fluid Department, Genetics and IVF Institute, Fairfax, VA.

WRITTEN COMMUNICATIONS

Research Articles:

•  Ewens A., Mihich E., Kanter, P., Alderfer J., Wollman R. and Ehrke J., Efficacy, toxicity and mechanism of interleukin-2 plus doxorubicin chemoimmunotherapy against breast cancer in mice. Cancer Res., 66:5419-26, 2006.

•  Ewens A., Mihich E. & Ehrke J., Distant Metastasis from Subcutaneously Grown E0771 Medullary Breast Adenocarcinoma. Anticancer Research 25:3905-3916, 2005.

•  Ewens A., Mihich E. & Ehrke J., Fluorouracil plus leucovorin induced submandibular salivary gland enlargement in rats. Toxicologic Pathology, 33:507-515, 2005.

•  Ewens A., Custodio C. and Stanley W., Superimposition of routine G-banded and FISH chromosome images. Cell Vision, 4(1):81-83, 1997.

Abstracts:

•  Ewens A., Mihich E., Alderfer J., Wollman R. and Ehrke J., Mechanism of doxorubicin plus interleukin-2 chemoimmunotherapy in a syngeneic mouse breast tumor model, Roswell Park Graduate Student Poster Competition, Buffalo, NY, 2003.

•  Ewens A., Mihich E., Alderfer J., Wollman R. and Ehrke J., Mechanism of doxorubicin plus interleukin-2 chemoimmunotherapy in a syngeneic mouse breast tumor model, Proceedings of the American Society of Clinical Oncology, 22:181, 2003. www.asco.org/ac/1,1003,_12-002511-00_18-0023-00_19-002033,00.asp

•  Luo, L., Ewens, A., Ehrke, M.J. and Mihich, E., Immunomodulation –dependent therapeutic effects of doxorubicin plus interleukin 2, Proc. AACR 43: 972, 2002.

•  Ewens A., Eppolito C., Cao S. and Ehrke J., Immune involvement in the enhancement of 5-fluorouracil plus leucovorin induced anti-cancer response by the addition of IL-15, Proceedings of the American Association for Cancer Research, 42:4693, 2001.

•  Ewens A., Eppolito C., Mihich E. and Ehrke J., Roles of interleukin-15, fluorouracil and leucovorin in combination treatment of rat Ward colon cancer, American Association for Cancer Research's Pathobiology of Cancer Workshop poster session, Keystone, CO, 2000.

•  Ehrke J., Eppolito C., Ewens A., Cao S. and Mihich E., Investigation of the role of the host defenses in the efficacy of the FURA + LV + IL-15 combination treatment of rats bearing the Ward colon tumor. Regional Cancer Center Consortium for Biological Therapy of Cancer, (Symposium Proceedings) 2:25-27, 1999.

Other Writings

•  Andrew Ewens and Trish Fink, First Aid at a Motorcycle Crash, Stories and Articles, Two Wheel Touring (http://www.2wheeltouring.net/stories.htm).

•  Andrew Ewens and Trish Fink, How the Brain Works, The Able Crew Activity Pages, National Council for Support of Disability Issues (http://www.theablecrew.org/interactive/interactive.htm).

•  Andrew Damian Ewens. Efficacy, Toxicity and Mechanism of Cytokine and Cytotoxic Drug Combination Chemoimmunotherapy in Rodent Models, Molecular Pharmacology and Cancer Therapeutics Department Ph.D. Dissertation, Roswell Park Cancer Institute, Buffalo, NY.

•  Andrew Ewens. Preparatory Information for the Roswell Park Summer Internship Program Cancer Class, Roswell Park Summer Research Participation Program, RPCI, Buffalo, NY.