CURRICULUM VITAE

MARINA LEWIS, MD., PhD. Medical Writer-Clinical/Scientific Affairs

Home Address Citizenship USA

**** ***** ****** ***

Denver, CO 80237

Phone: 720-***-****;

E-mail:

ac3bij@r.postjobfree.com

EDUCATION AND TRAINING

Graduate

Doctor of Philosophy in Medicine PhD 09/1991-06/1995

Pediatric Research Center

Russian Academy of Medical Sciences

Moscow, Russia

Doctor of Medicine MD 09/1981-06/1988

State University School of Medicine,

Moscow, Russia (USSR)

Post-Graduate

Postdoctoral Fellow 07/2007-07/2009

Department of Pediatrics/Critical Care,

University of Colorado at Denver

Aurora, CO

Postdoctoral Fellow 04/2002-03/2004

Department of Immunology

National Jewish Medical & Research Center (NJM&RC)

Denver, CO

Research Fellow 07/1996-06/1997

Department of Pathology,

University of Colorado Health Sciences Center (UCHSC)

Denver, CO.

Pediatric Resident 09/1988-06/1991

Pediatric Research Center

Russian Academy of Medical Sciences

Moscow, Russia

CERTIFICATIONS

2015-CITI Denver VA Medical Center, 1055 Clermont Street, Denver, CO

2006- FDA Rules and Regulations Certification. University of Colorado at Denver Cancer Center,

UCD, Aurora, CO 80045

2004- IRB/HIPPA/COMIRB Certification. University of Colorado at Denver Cancer Center,

UCD, Aurora, CO 80045

RESEARCH AND WORK EXPERIENCE

Medical Writer/ Medical Monitor 03/2016 to present

Terumo BCT Inc.,

Unlock the Potential of Blood, Medical Corporation,

Leukemia &Lymphoma Treatment

Global Clinical Safety and Translational Science

10810 West Collins Avenue, Lakewood, CO 80215

Blood Center Services, Therapeutic Apheresis, Cell Collections, Cell Therapy Technologies

Bio-processing, Additional Services.

Principal Medical/Safety position in the company

Evaluating all significant adverse effects resulting from the use of commercialized and investigational products of the company

Participating in the strategic planning, development and management of Terumo BCT clinical trials

Responsible for the medical interpretation of clinical trials/research for products in development

Conducting medical and safety monitoring activities for investigational and post-market clinical trials

Responsible for medical review of company documents requiring such review activities

ESSENTIAL DUTIES

Providing input to strategic decisions, leading the implementation, preparation and modification of Clinical Development Plans for Terumo BCT product lines

Developing policies and procedures to insure compliance with global safety reporting requirements

Medical monitor (including safety evaluation) for clinical trials ensuring the safety and ethical treatment of clinical trial subjects

Providing in-house medical expertise for clinical sites, and to project teams supporting the commercialization of all Terumo BCT products

Maintaining company’s safety database through review and editing of medical and clinical documents (e.g., protocols, amendments, safety management plans, final study reports, investigator brochures, investigator correspondence).

Providing medical expertise on company documents (e.g., Health Hazard Evaluation (HHE), Risk Benefit Analyses (RBA), Failure Mode Effects Analyses (FMEAs), Risk Evaluation Memos (REM), Medical Review Forms (MRF), Field Action Evaluation (FAE), and Engineering Change Order (ECO).

Providing Clinical Safety and Medical Expertise reviewing and editing; Clinical Evaluation Reports (CER), Product Risk Review (PRR) and Clinical Investigation Report (CIR)for Clinical Trials on Terumo BCT products

Ensuring highest medical standards and compliance to applicable regulations for FDA and other Global Regulatory Agenesis

Reviewing case report forms, database reports, edits, tables and listings for accuracy and quality, evaluating all significant adverse effects potentially related to the company’s products

Representing the Company at Scientific Conferences

Clinical safety lead in cross-functional meetings reviewing device deficiencies and safety reports to assess safety/risk profile and determining course of action

Producing product safety reports ( More than 30 reports written for Global Regulatory compliance)

Quality Improvement Specialist 01/2014-09/2016

Cardiac and Vascular Surgery Department

University of Colorado Hospital

Aurora CO

The Society of Thoracic Surgeons (STS) adult cardiac surgery database for quality improvement and patient safety among cardiothoracic surgeons

Epic-Database with the University of Colorado Hospital

Apollo-STS Database with the STS National Database for quality improvement.

Attending weekly Cardiac Teaching Conferences and monthly meetings “Morbidity and Mortality” in Cardiac and Vascular Surgery Department

Attending cardiovascular surgical procedures :( Surgical valve replacement procedures, TAVR, Thoracic Endovascular Aortic Repair (TEVAR) Coronary Artery Bypass CAB)

Reviewing all post-cardiovascular surgical medical records, all anesthesia records, and all the lab results before and after cardiovascular surgery

Excellent communication and interpersonal skills with physicians and their offices to coordinate admission

Problem-solving skills to determine the best course of action which will be satisfactory to the patient, the physicians, and the hospital

Clinical and Research Project Coordinator 07/2009-05/2013

Special Program of Research Excellence (SPORE) in Lung Cancer

University of Colorado Cancer Center SPORE Tissue Bank

Department of Pathology, University of Colorado at Denver

Aurora, CO

"Early Detection of Lung Cancer in High Risk Groups"

Assisted during bronchoscopes and thoracotomy procedures at UC Hospital, at the VA Medical Center Hospital, and Presbyterian/St. Luke's Medical Center; collecting tissue for clinical and research trials

Clinical Trial a multicenter double-blind, randomized, phase II placebo-controlled trial of oral Iloprost in current or former smokers with sputum cytology atypia or endobronchial dysplasia.

Submitting study protocols for IRB, COMIRB, and CITI certified

Recruiting, consenting and enrolling patients, research study participants

Writing and submitting SOP protocols for clinical and research projects

Developing new techniques, new methods and adapting them for the lab

Immunohistochemistry (IHC) staining for biomarkers for early detection of lung cancer

Electron microscopy technique and imaging analysis for the bronchial map for clinical trials

Processing with human samples: pleural fluid, sputum, blood, plasma, serum

Preparing cytospine slides for FISH analysis

Microtome/Cryostat, embedding tissue and cell pellet

Cell culture of adenocarcinoma, squamous cell carcinoma in all thoracotomy cases

Inventory and reorganizing of the entire tissue bank from 1995-2012

Work with "Cortex" clinical and diagnostic database for patients and TES database.

Reporting data to the director of the SPORE study at UCCC and the SPORE Committee

Collaborating with external and internal principal investigators

Assisting with writing grants and presentations at NCI.

Coordinating, training and supervising PRAs, students and post-docs in the lab

Post-Doctoral Fellow, 07/2007-07/2009

Department of Pediatrics/Critical Care,

University of Colorado Health Sciences Center (UCHSC)

Denver, CO

"Inflammation, Progenitor Cells, Vascular Remodeling and Pulmonary Hypertension"

Blood preparation: Isolation of peripheral blood mononuclear cells (PBMNC) from rats, neonatal calves and adult bovines.

Cytospine with PBMNC, bronchoalveolar lavage (BAL), and cell lines

Fluorescence-activated cell sorting (FACS) analysis

Confocal fluorescence microscopy technique

Cell culture, analysis of different cell lines.

Easy step magnetic FITC selection on bovine MNC with CD45, CD11b.

Immunofluorescence staining (IFS). Immunohistochemistry (IHC) staining

Developing SOP protocols for the lab

Handling animals; Rapamune; (sirolimus (rapamycin)) study on rats.

Presenting data for publications and grants

Submitting NIH grant applications

Presenting data at the lab meetings in PowerPoint

Training PRAs in the lab using methods and technique for PBMNC isolation

Clinical and Research Project Coordinator 08/2004-06/2007

SPORE in Lung Cancer Biorepository Laboratory,

Department of Oncology, University of Colorado Cancer Center

University of Colorado Health Sciences Center (UCHSC)

Denver, CO

"Biomarkers for Use for Early Detection of Lung Cancer"

Immunohistochemistry (IHC) staining for the Ki 67 (MIB-I) biomarker

Imaging analysis (Microfire), (Picture Frame) of more than 5,000 images

Cell culture

Clinical trials on early detection of lung cancer study with pharmaceutical companies: Merck, AstraZeneca, Sanofi-Aventis, and OSI Pharmaceuticals. Preparing budget of expenses for Merck Inc., and Sanofi-Aventis

Developing protocols for COMIRB, HIPPA, FDA

Postdoctoral Fellow, Research Associate, 04/2002-03/2004

Department of Immunology

National Jewish Medical & Research Center (NJM&RC)

Denver, CO

"Which Properties of Thymic Epithelial Cells is Necessary to Support Thymocyte-Positive selection In Vitro"

FACS analysis (staining for a different markers and analysis with Cell Quest and FlowJo)

Cells culture. (fibroblast, thymic epithelial cell lines (TEC), thymocytes)

PCR, RT-PCR

RNA isolation from the thymic epithelial cells

Gene chip array (analysis Excel, Gene Spring)

PowerPoint Microsoft

Research Associate 12/2000-04/2002

Department of Pediatrics

National Jewish Medical & Research Center (NJM&RC)

Denver, CO

"Glucocorticosteroid Resistance in Acute Lung Injury"

Blood preparation: Isolation PBMNC and neutrophils

Confocal fluorescence microscopy

Immunofluorescence staining

PLB-985 cell culture and differentiation

Four color FACS analysis (CELL Quest and FlowJo)

Data and imaging analysis (Excel, JMP, Slidebook, Adobe Photoshop)

ELISA

Lymphocyte proliferation assay

Research Scholar 02/1998-12/2000

Nocturnal Asthma Research Center

Department of Medicine

National Jewish Medical & Research Center (NJM&RC)

Denver, CO

Blood preparation: Isolation of PBMNC, plasma, serum.

Cytospines with BAL, sputum, and PBMNC

Microscopy, morphometry slides with endobronchial tissue, and BAL slides

Immunohistochemistry (IHC) staining of BAL and tissue slides

Apoptosis staining. Terminal deoxynucleotidyl transferase dUTP nick end labeling (TUNEL) staining of BAL cells and tissue

Processing endobronchial biopsy and BAL.

Processing sputum. Cell differential.

Fibroblast cell culture

Research Associate 07/1997-12/1997

Department of Biochemistry & Molecular Biology

University of Arkansas for Medical Sciences

Little Rock, AR

DNA cloning

Purification and isolation of plasmid DNA

Handling animals (mice)

Handling insects: Anopheles gambiae mosquito (malaria), Aedes mosquito variants (Japanese encephalitis), Drosophila fruit fly.

Research Fellow 07/1995-06/1996

Department of Pathology

University of Colorado Health Sciences Center (UCHSC)

Denver, CO

Mammalian mitochondria

Preparation of culture media, reagents and buffers

High performance liquid chromatography (HPLC)

Dot blotting

SDS-PAGE

ELISA

Physician 08/1995-03/1996

Department of Pulmonary Function Diagnosis

Children's Respiratory Rehabilitation Center, Moscow, Russia

Post-graduate fellow (physician) 09/1991-06/1995

Department of Allergy and Asthma,

Pediatric Research Center, Russian Academy of Medical Science, Moscow, Russia

"The Diagnostic Criteria and Therapeutic Correction of Bronchial Hyperreactivity in Children with Asthma"

Drug studies Phase I-IV

Spirometry study with different drugs before and after treatment on patients of age from 6-14

Bronchoprovocation challenges (histamine) on patients of age from 6-14

Immunotherapy of children with asthma and allergic and/or atopic dermatitis

Nasal allergen challenges

Graded exercise (treadmill)

Skin allergen testing

Resident 09/1998-07/1991

Pediatric Research Center

Russian Academy of Medical Sciences, Moscow, Russia

LANGUAGES

English

Russian

PUBLICATIONS

Application of SNP Microarrays to the Genome-Wide Analysis of Chromosomal Instability in Premalignant Airway Lesions

Ichiro Nakachi1, Jessica L. Rice1, Christopher D. Coldren6, Michael G. Edwards1, Robert S. Stearman1, Steven C. Glidewell1, Marileila Varella-Garcia2,3, Wilbur A. Franklin3, Robert L. Keith1,5, Marina T. Lewis3, Bifeng Gao1, Daniel T. Merrick4, York E. Miller1,5, and Mark W. Geraci1. Cancer Prevention Research February 2014 7;255. Published Online First December 17, 2013; doi: 10.1158/1940-6207. CAP R-12-0485

Eicosanoid Profiling in Lung Cancer by Mass Spectrometry Demonstrates Selective Production of Leukotrienes by Cells of the Microenvironment

Joanna Poczobutt1, Miguel Gijon4, Jay Amin1, Dwight Hanson1, Howard Li1,2, Deandra Walker1, Daniel Merrick2, Marina Lewis3, Wilbur Franklin3, Michael Chan1, Mary Weiser-Evans1, Xian Lu5, Michael G. Edwards1, Robert Murphy4, and Raphael A. Nemenoff1,4,6. 2013.

Endobronchial miRNAs as Biomarkers in Lung Cancer Chemoprevention

Celine Mascaux, William J. Feser, Marina T. Lewis, Anna E. Baron, Christopher D. Coldren, Daniel T. Merrick, Timothy C. Kennedy, John I. Eckelberger, Leslie M. Rozeboom, Wilbur A. Franklin, John D. Minna, Paul A. Bunn, York E. Miller, Robert L. Keith, and Fred R. Hirsch. "http://www.ncbi.nlm.nih.gov/pubmed" \o "Cancer prevention research (Philadelphia, Pa Cancer Prev Res (Phila). 2013 Feb;6(2):100-8. doi: 10.1158/1940-6207.CAPR-12-0382. Epub 2012 Dec 26.

A Randomized Phase II Chemoprevention Trial Of 13-Cis Retinoic Acid /- Alpha Tocopherol or Observation In Subjects at High Risk for Lung Cancer

Karen Kelly, John Kittelson, Wilbur Franklin, Timothy Kennedy, Catherine Klein, Robert Keith, Edward Dempsey, Marina Lewis, Mary Jackson, Fred Hirsch, Paul Bunn, York Miller. Submitted to American Association for Cancer Research, December, 2008.

Chromosomal aneusomy in bronchial high-grade lesions is associated with invasive lung cancer. Am J Respir Crit Care Med. 2008 Feb 1; 177(3): 342-7. Epub 2007 Nov 7. PMID: 17989344[PubMed-indexed for MEDLINE]

Jonsson S, Varella-Garcia M, Miller YE, Wolf HJ, Byers T, Braudrick S, Kiatsimkul P, Lewis M, Kennedy TC, Keith RL, Bjornsson J, McWilliams A, Lam S, Hirsch FR, Franklin WA.

Bronchial epithelial Ki-67 index is related to histology, smoking, and gender, but not lung cancer or chronic obstructive pulmonary disease. Cancer Epidemiol Biomarkers Prev. 2007 Nov; 16(11):2425-31.

"http://www.ncbi.nlm.nih.gov/pubmed/18006932?ordinalpos=1&itool=EntrezSystem2.PEntrez.Pubmed.Pubmed_ResultsPanel.Pubmed_RVDocSum" Miller YE, Blatchford P, Hyun DS, Keith RL, Kennedy TC, Wolf H, Byers T, Bunn PA Jr, Lewis MT, Franklin WA, Hirsch FR, Kittelson J.

M.T. Shugunova. The Diagnostic Criteria and Therapeutic Correction of

Bronchial Hyperreactivity in Children with Asthma. Ph.D. Thesis, Research Center of Pediatrics,Russian Academy of Medical Sciences, Moscow, 1995,140 pp.

M.T. Shugunova. The Diagnostic Criteria and Therapeutic Correction of

Bronchial Hyperreactivity in Children with Asthma. Abstract of Ph.D. Thesis. Moscow, 1995, 20pp.

I.I. Balabolkin, I.V. Ryleeva, N.V. Yuhtina, L.S. Namasova, Sh.A. Suleymanov and M.T.Shugunova. New Approaches to Specific Immunotherapy in Asthmatic Children. The lst International Congress on Immunorehabilitation, International Journal Immunorehabilitation of, 1994, p. 45.

I.S. Shirjaeva, N.U. Pereverseva, M.T. Shugunova and V.S. Reutova: Methods of Functional Diagnosis of Bronchial Hyperreactivity in Children with Asthma.

In: Journal of the lst Republican Meeting of Allergists and Immunologists of Azerbaydjan, Baku, 1992, p. 266-267.

I.I. Balabolkin, I.V. Ryleeva, M.T. Shugunova, M.A. Stepushina, A.B. Kudrjavzeva, A.V. Lapunov: Antirelapse Treannent of Bronchial Asthma in Children.

In: Journal of the 3rd scientific conference "Essential Problems in Clinical Pediatrics, Obstetrics and Gynecology", 1994, p. 19-20.

ABSTRACTS/POSTER PRESENTATIONS

Poster Presentation:

American Thoracic Society International Conference May 16-21, 2008

Toronto, Canada.

SR Riddle, DL Burke, D Strassheim, MT Lewis, MG Frid and KR Stenmark.

Chronic Hypoxia Induced Upregulation of Adhesion Molecule Expression in pulmonary Artery Fibroblasts and Increased Adherence of Circulating Mononuclear Cells: a Process Prevented by Rapamycin Treatment. ATS 2008 TORONTO.

Preanalytical Processing Enhances Yield from Archived Sputum Samples for FISH and other Molecular Tests. Wilbur Franklin, Dan Merrick, Marina Lewis, Margaret Skokan, Mary Jackson, Anna Baron, Shannon Pretzel, Bill Feser, Holly Wolf,, York Miller, Marileila Varella-Garcia Colorado SPORE in Lung Cancer, University of Colorado Anschutz Medical Center, Aurora, CO 80045

Wilbur A. Franklin, Margaret Skokan, Marina T. Lewis, William J. Feser, Holly Wolf, York E. Miller, Daniel Merrick, Anna E. Baron, Marileila Varella-Garcia

Defining a FISH chromosomal aneusomy panel for predicting lung cancer in the setting of CT detected lung nodules

Miller Y, Hyun D, Blatchford P, Lewis M, Kennedy T, Franklin W, Kittelson J, Hirsch F.

Ki67 proliferation index in endobronchial biopsies: Association with lung cancer, airflow obstruction and smoking history. IASLC 12th World Conference on Lung Cancer September 2-6, 2007

Jason Oh, Marina T. Lewis, Steve Katman, Uwe Staers" Elucidating the Necessary Role of Thymic Epithelial Accessory Cells During Thymocyte Selection". 90th Anniversary Annual Meeting, American Association of Immunologists AAI, May 2003, Denver. Poster Presentation:

Qing Xu, Kevin O Kisich, Ian Strickland, Marina T. Lewis, Donald YM Leung

Increased Expression of SR Protein P30 in Neutrophils. Nationa Jewish Medical

& Research Center In: Abstracts of the 58th Annual Meeting of AAAAI, New York, N.Y. March 2002

M. Kraft, M.D. Rex, A.D. Stevens, M.T. Shugunova, Q.A. Hamid, D.Y.M. Leung.

Steroid Responsivness of Alveolar Macrophages in Asthma is Linked to

Interleukin (IL)-4 and (IL)-13. Nationa Jewish Medical & Research Ctr, Denver,

CO & Meakins-Christie Laboratories, McGill University, Montreal, Quebec,

Canada In: Abstract of the 2000 ALA/ATS INTERNATIONAL CONFERENCE

S.N. Vakhrameeva and M.T. Shugunova. Significance of Family in the

Formation of Bronchial Asthma in Schoolchildren Who Suffered from Allergy at

an Early Age. In: Abstracts of the European Respiratory Society, Annual Congress Stockholm, 1996.

I.I. Balabolkin, M.V. Bykova, Z.D. Ksenzova, A.B. Lapunov, V.S. Reutova, M.A.

Stepushina and M.T Shugunova. Antirelapse Treatment of Asthma in Children:

Therapeutic Methods and Effectiveness. In: Abstracts of the National Congress:

"Human and Medicine", Moscow, 1995.

I.S. Shirjaiva, V.S. Reutova and M.T. Shugunova. Criteria in Functional Diagnosis of Bronchial Hyperreactivity in Children with Asthma. In: Abstracts of the 5th National Congress of Lung Diseases, Moscow, 1995.

M.T. Shugunova. The Influence of Therapy on Bronchial Hyperreactivity in

Children with Bronchial Asthma. In: Abstracts of the 5th National Congress of

Lung Diseases, Moscow, 1995.

M.T. Shugunova, II. Balabolkin and S.N. Vakhrameeva: Study of Bronchial

Hyperreactivity in Asthmatic Children with Inhaled Magnesium Sulphate

Aerosol. In: Abstracts of the European Respiratory Society Annual Congress,

Stockholm, 1996.

V.S. Reutova, I.S. Shirjaeva, I.I. Balabolkin, N.F. Dorohova, M.T. Shugunova and

M.V. Bykova: Investigation of Bronchial Hyperreactivity in Children with Bronchial

Asthma. In: Abstracts of the European Respiratory Society Annual Congress,

Stockholm, 1996.

P.I. Sichnenko, M.T. Shugunova, V.S. Reutova and N.U. Pereverzeva:

Treatment of Asthmatic Children with Ksidifon In: Abstracts of International Symposium on Allergology and Clinical Immunology. Alma-Ata, Kazakhstan, 1992, p. 185.

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