Sales Quality Assurance

Andrew Fedanov, Foreign MD, Ph.D.

Atlanta, Georgia, USA

Cell phone: 770-***-****

Home phone: 770-***-****

E-mail: ********@*********.***

OBJECTIVE

. Pharmaceutical, biotech, and clinical trials background. Program director

at a clinical trial company [Certificate - Clinical Trail Monitoring &

Research Site Coordination (CRC); The International Conference on

Harmonization (ICH); Good Clinical Practices (GCP)]. Experienced

manufacturing manager at a small biotechnology company. Result-oriented,

detailed knowledge of Good Manufacturing Practices and Quality System

Regulations. Head of pharmaceutical sales department. Sales

representative.

. Academic background. Excellent academic background at the leading

academic institutions. Excellent laboratory, analyzing, and planning

skills. Good presentation and writing experience.

. Personal characteristics. Result-oriented. Strategic thinking and problem

solving. Good interpersonal, writing, and presentation skills. Ability to

work in team and independently. Responsible decision-making skills. Good

negotiating skills.

PROFESSIONAL APPOINTMENTS

PHARMACEUTICAL, BIOTECH

2009 Sept - 2010 Apr Program Director, Atlanta Cardio-Pulmonary

Research Network, LLC, Decatur, Georgia, USA

Key Contributions

. Conceptualized, designed, and prepared two grant proposals:

"Combinatory treatment of PAH (pulmonary arterial hypertension) and

edema: use of echocardiography as a hemodynamic biomarker to guide

diuretic management in monocrotaline induced PAH rats", and

"Echocardiovascular Monitoring of Overweight and Obese Children and

Adolescents"

Responsibilities

. Developing a research projects: literature analysis, networking,

implementing new ultrasound methods, grant writing

2009 Jan - 2009 Aug Manufacturing consultant, Grace Laboratories, LLC,

Decatur, Georgia, USA

2007 Jan - 2009 Jan Manufacturing manager, Grace Laboratories, LLC,

Decatur, Georgia, USA

Key Contributions

. Established Good Manufacturing Practice and Quality Assurance. Two

products (ELISA kits) were developed, tested, and prepared for a

small scale manufacturing. Device Master Record was created for each

product. Implemented Quality System (QS) according to 21 CFR, 820

Responsibilities

. Designing and optimization of manufacturing processes

. ELISA kits development

. Stability and performance characteristics study

. Managing company operations, and facilities management

. Establishing of purchasing procedure, quality control of incoming

raw materials, storage system, inventory system, equipment

validation, and maintenance schedules

. Equipment troubleshooting. Monthly employee trainings, inventory

system, and laboratory record-keeping system

. Implementation of Good Laboratory Practice (GLP)

. Communication with vendors and preparation of vendor approved list

(for GMP)

Quality Assurance experience

. Very experienced in writing documentation to support manufacturing

processes, Good Manufacturing Practices (GMP), and Quality System

(QS) Regulation according to 21 CFR, 820, ISO

. Participation in IDE (Investigational Device Exemption), IND

(Investigational New Drug), and CLIA (Clinical Laboratory

Improvement Amendment) applications

. Contacting the Food and Drug Administration (FDA) and certified

consultants

. Writing Standard Operating Procedures (SOPs)

. Creating Device Master Records, Device Labeling, and Packaging

processes

. Performing company business in accordance with Environmental

Protection Agency (EPA), Occupational Safety and Health

Administration (OSHA)

. Organization of experimental procedures, conducting processes and

products validation according to Clinical and Laboratory Standards

Institute (CLSI)

. Implementation of the Corrective Action and Preventive Action (CAPA)

System

. Follow-up the device history records

. Validation of incoming reagents and final products

Quality Assurance knowledge

. Clinical Trail Monitoring & Research Site Coordination (CRC)

. FDA regulations

. The International Conference on Harmonization (ICH)

. Current Good Clinical Practices (cGCP)

. A Laboratory Information Management System (LIMS)

. Quality Risk Management. Change Control. Six-system Inspection. Six

Sigma. Design of Experiments (DOE)

1998 Sept - 1999 Aug "Prolek LTD-plus", LLC, Berdsk, Russia. Senior

manager and research scientist

Key Contributions

. Launched two new herbal products "Valerian Root" and "Prunella

vulgaris". Established "Data and Information Technology Unit",

company computer network, and costumer's database. Managing sales

representatives

Responsibilities

. Development of herbal products

. Contacting with vendors

. Raw material processing and packaging

. Product labeling according to local requirements (GOST)

. Managing sales representatives

1997 Feb - 1998 Aug "Delo", ZAO, Novosibirsk, Russia. Head of

pharmaceutical sales department: pharmaceutical whole sales development.

Managing small group of two sales representatives

Key Contributions

. Successfully supported medication supply. Established wholesale

network.

Responsibilities

. Contacting with vendors

. Contra-deals for medication supply

. Control of cash flow

. Hiring and managing sales representatives

. Managing sales representatives

Independent consulting

. "Pharmaproduct, LLC", Novosibirsk, Russia (wholesale pharmaceutical

company). Consulting. Sales representative.

. "International Institute of Cosmic Anthropoecology", Novosibirsk, Russia.

Consulting. Sales development: lectureship and sales development of

herbal product. Achievements: established a retail sale network.

. "Laboratory automatic pipettes, LLC", Novosibirsk, Russia. Consulting.

Development strategy of adjustable volume pipettors. Achievements:

consultation on strategy and design of two adjustable volume pipettes.

ACADEMIC EXPERIENCE

Interests: immunology, mucosal immunology, innate immunity, vaccines,

pulmonary arterial hypertension, obesity, echocardiography

1999 Sep - 2007 Jan Postdoctoral Fellowship and then Research Associate

at Emory Vaccine Center, Emory University. Atlanta, GA, USA.

Responsibilities

. HIV research and vaccine development program with Dr Silvija

Staprans and Dr. Mark Feinberg), and malaria research program with

Dr. Mary Galinsky

Key Contributions

. Establishing histological and immunohistochemical methods. Developed

multi-color flow cytometry antibody panel. Participation in three

grant applications. Peer publications and presentations.

Participation in the research projects (at Emory Vaccine Center)

. Project Title: "Cellular Immune Responses and Aids Pathogenesis".

Principal Investigator: Feinberg, Mark. Project Number:

5R01AI049155. Years: 2001 - 2004

. Project Title: "Cellular Immune Responses in Aids Pathogenesis".

Principal Investigator: Feinberg, Mark. Project Number:

5P51RR000165. Years: 2003-2006

. Project Title: "Determinants of Non Pathogenic SIV Infection".

Principal Investigator: Staprans, Silvija. Project Number:

5P51RR000165. Years: 1999 - 2004

. Project Title: "Enhancing the Immunogenicity of Recombinant MVA

Vectors". Principal Investigator: Feinberg, Mark. Project Number:

5U19AI061728. Years: 2004 - 2006

. Project Title: "Host Specific Responses in SIV-Induced

Hematosuppression". Principal Investigator: Staprans, Silvija.

Project Number: 5R01HL075766. Years: 2003 - 2006

. Project Title: "Novel Method to Evaluate HIV-Specific CTL

Responses". Principal Investigator: Feinberg, Mark. Project Number:

1R21AI049089 . Years: 2001 - 2004

. Project Title: "Optimizing the Immunogenicity of MVA-Based AIDS

Vaccines". Principal Investigator: Feinberg, Mark. Project Number:

5U19AI061728. Yeas: 2004 - 2006

. Project Title: "Optimizing Routes of Vaccine Delivery". Principal

Investigator: Staprans, Silvija. Project Number: 5U19AI061728.

Years: 2004 - 2008

. Project Title: "Molecular analysis of plasmodium vivax surface

antigens". Principal Investigator: Galinski, Mary R. Project Number:

5P51RR000165. Years: 2005 - 2006

Laboratory skills

. Cell culture, intestinal organ culture - excellent experience

. Animal models: rat pulmonary arterial hypertension, SIV non-human

primate models (rhesus and sooty mangabeys), mouse, rat

. Flow cytometry - FACSCalibur, LSR, LSR II - excellent experience

. Histology - excellent experience

. Immunohistochemistry (IHC) - excellent experience

. ELISA - excellent experience

. Gel electrophoresis, SDS-PAGE

. Molecular cloning, RT-PCR - Applied Biosystems 7900

. Proteomics: malaria parasite proteome

. MALDI-MS/MS. HPLS

. Excellent knowledge of MS Office including Access, Excel, Word,

Project manager

1988 Jan - 1997 Jan Research scientist, Laboratory of Immunomorphology,

Institute of Clinical and Experimental Lymphology Siberian Branch of the

Russian Academy of Medical Science, Novosibirsk, Russia. Academician

Valeriy Trufakin lab (president of Siberian Branch of Russian Academy of

Medical Science).

. Key Contributions. PhD thesis defense. Research scientist. Peer

publications and presentations.

Laboratory skills

. Cell culture, intestinal organ culture

. Mouse and rat animal models

Other academic and work experiences

Postgraduate Student, Institute of Clinical Immunology, Siberian Branch

of the Russian Academy of Medical Science, Novosibirsk, Russia

Research scientist, Laboratory of Immunology, Central Scientific Research

Laboratory, Krasnoyarsk Medical State Academy, Krasnoyarsk, Russia

Emergency Medicine Physician, Emergency Medical Service, Krasnoyarsk,

Russia

EDUCATION

. 2009 Certificate: "Clinical Trail Monitoring & Research Site

Coordination (CRC); The International Conference on Harmonization (ICH);

Good Clinical Practices (GCP). The CRA Institute.

. 2009 Certificate: "Entrepreneur Success Series", Small Business

Development Center, the University of Georgia

. 1977 - 1983 Doctor of Medicine (MD), Krasnoyarsk Medical State

Academy, Krasnoyarsk, Russia

. 1985 - 1988 Graduate student in immunology, Institute of Clinical

Immunology, Siberian Branch of the Russian Academy of Medical Science,

Novosibirsk, Russia.

. 1996 Ph.D. in Histology, Cytology, and Embryology (14.00.23),

Institute of Clinical and Experimental Lymphology Siberian Branch of the

Russian Academy of Medical Science, Novosibirsk, Russia.

TRAINING PROGRAMS AND WORKSHOPS

. National Initiative for Children's Healthcare Quality (NICHQ). Annual

Forum for Improving Children's Healthcare and Childhood Obesity, March 8-

11, 2010, Atlanta, GA

. The Consortium for Southeastern Hypertension Control (COSEHC) 16th Annual

Scientific Sessions in Kingsport, Tennessee, October 22-24

. 2-dimentional proteomics, SDS-PAGE

. Multi-color Flow Cytometry

. Laser Capture Microdissection

GRANT AWARDS

. "Entrepreneur Success series" at University o Georgia

. "The Clinical Research Associates Institute" (The CRA Institute)

RECENT PUBLICATIONS

RESEARCH ARTICLES

. H. S. Gill, S. N. Andrews, S. K. Sakthivel, A. Fedanov, I. R. Williams,

D. A. Garber, F. H. Priddy, S. Yellin, M. B. Feinberg, S. I. Staprans and

M. R. Prausnitz, (2009). "Selective removal of stratum corneum by

microdermabrasion to increase skin permeability." Eur J Pharm Sci, 38(2):

p. 95-103

. G. Silvestri, A. Fedanov, S. Germon, N. Kozyr, W. J. Kaiser, D. A.

Garber, H. McClure, M. B. Feinberg and S. I. Staprans, (2005). "Divergent

host responses during primary simian immunodeficiency virus SIVsm

infection of natural sooty mangabey and nonnatural rhesus macaque hosts."

J Virol, 79(7): p. 4043-54.

. D. A. Garber, G. Silvestri, A. P. Barry, A. Fedanov, N. Kozyr, H.

McClure, D. C. Montefiori, C. P. Larsen, J. D. Altman, S. I. Staprans and

M. B. Feinberg, (2004). "Blockade of T cell costimulation reveals

interrelated actions of CD4+ and CD8+ T cells in control of SIV

replication." J Clin Invest, 113(6): p. 836-45.

SYMPOSIUM AND PRESENTATION CONTRIBUTIONS

. A. Fedanov, FMD PhD; S. Rosenthal, MD, C., FACC; R. Todd, BA, RDMS, RDCS;

N. Maslanka BSN, MA, ABD. "Echocardiovascular Observations in Childhood

Obesity - Rationale For Early Screening", booth presentation at the

Annual Forum for Improving Children's Healthcare and Childhood Obesity,

March 8-11, 2010, Atlanta, GA.

. A. Fedanov, G. Khunteev, A. Bagumyan, G. Izykenova, S. Dambinova, DSc.

"Performance Characteristics of the Gold Dot-1 NR2 Antibody Test". In

American Association of Clinical Chemistry Annual Meeting 2008, July 28 -

August 1, Washington, DC.

. S. Dambinova, G. Khunteev, D. Olson, G. Izykenova, R Heath, A. Fedanov,

J. Weissman. "NR2 Peptide Indicates Transient Ischemic Attack and Acute

Ischemic Stroke". In American Association of Clinical Chemistry Annual

Meeting 2008, July 28 - August 1, Washington, DC.

. Cindy Korir, Andrew Fedanov, Stacey Lapp, John Barnwell, Mary Galinski.

Proteomic Insights into the Make-up of P. vivax and P. knowlesi Blood

Stage Parasites. in 55th Annual Meeting of American Society of Tropical

Medicine and Hygiene. 2006. November 12-16, 2006 Atlanta Marriott

Marquis, Atlanta, Georgia USA.

. R. Chavan, A. Fedanov, J. Miller, S. Staprans, M.B. Feinberg. Expression

MIP-3alpha, GM-CSF and Flt3 ligand from Recombinant Modified Vaccinia

Ankara can Enhance Antigen Specific Immune Responses. in AIDS Vaccine

2003. 2003. Hilton New York, NY, USA.

. S. Staprans, D. A. Garber, G. Silvestri, N. Kozyr, A. Barry, A. Fedanov,

R Regoes, H. McClure, J. D. Altman, J. Cohen, M. B. Feinberg. Viral and

host determinants of primary SIV replication dynamics. in HIV Dynamics &

Evolution. 9TH International Workshop. 2002. UCLA Conference Center, Lake

Arrowhead, CA.

. D. A. Garber, G. Silvestri, A. Fedanov, N. Kozyr, A. Barry, C. Ibegbu, A.

Carter, A. Anderson, X. Wang, R. Mittler, H. McClure, C. P. Larsen, J. D.

Altman, S. Staprans, M. B. Feinberg. Blockade of T-Cell Co-Stimulation

during Acute SIV Infection in Rhesus Macaques Blunts SIV-Specific

Cellular Immune Responses but Does not Protect Them from AIDS. In 9th

Conference on Retroviruses and Opportunistic Infections. 2002. Washington

State Convention and Trade Center, Seattle, WA.

. S. Staprans, G. Silvestri, L. Perry, N. Kozyr, A. Fedanov, D. A. Garber,

H. McClure, M. B. Feinberg. AIDS Pathogenesis Elucidated by Divergent

Host Responses during SIV Infection of Natural and Non-Natural Hosts. in

AIDS Vaccine 2001. 2001. Philadelphia Marriott, Philadelphia, PA, USA.

. S. Staprans, G. Silvestri, L. Perry, S. Germon, N. Kozyr, A. Fedanov, D.

A. Garber, H. McClure, M. B. Feinberg. AIDS pathogenesis elucidated by

divergent host response during SIV infection of natural and non-natural

hosts. in Keystone Symposia. HIV Pathogenesis. 2001. Keystone Resort,

Keystone, Colorado.

. S. Staprans, D. A. Garber, C. Ibegbu, L. Perry, S. Germon, N. Kozyr, A.

Fedanov, H. McClure, J. D. Altman, G. Silvestri, M. B. Feinberg. CD4 and

CD8 T cell dynamics during primary SIV infection and their relationship

to virus replication. in 8th Annual International Discussion Meeting on

HIV Dynamics and Evolution. 2001. Paris, France.

. D. A. Garber, G. Silvestri, A. Fedanov, R Regoes, A. Barry, N. Kozyr, C.

P. Larsen, H. McClure, D. Montefiori, J. D. Altman, S. Staprans, M. B.

Feinberg. Use of T-Cell Costimulatory Blockade during Acute SIV Infection

of Rhesus Macaques to Define the Relative Importance of Cellular and

Humoral Immune Responses in Control of Viremia and Disease Progression.

in AIDS Vaccine 2001. 2001. Philadelphia Marriott, Philadelphia, PA, USA.

. D.A. Garber, G. Silvestri, A. Fedanov, N. Kozyr, A. Barry, C. Ibegbu, A.

Carter, D. Anderson, X. Wang, R. Mittler, H. McClure, C.P. Larsen, J.D.

Altman, S. Staprans, M.B. Feinberg. Blockade of T-cell costimulation

during acute siv infection in rhesus macaques blunts siv-specific

cellular immune responses but does not protect them from AIDS. in 19-th

annual symposium on nonhuman primate models AIDS. 2001. San Juan, Puerto

Rico: Journal of Medical Primatology 2002.

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