NINA V. MALKEVICH, PHD

571-***-****

abz19w@r.postjobfree.com

Project Management Leadership and Coordination FDA and GLP Compliance

Vendor and Client Relationship Pre-clinical Development Government Contracts

QUALIFICATIONS PROFILE

Knowledgeable and highly productive professional, offering extensive hands-on experience in the area of the pharmaceutical and academic pre-clinical development pertaining vaccines and therapeutics in the field of infectious diseases. Self-starter to apply 5 years of experience in pharmaceutical industry, 12 years of academia and 9 years of government contracting experience. An author of more than 20 scientific publications; successfully completed more than 40 animal studies (efficacy, pharmacokinetic, immunogenicity and toxicity). Skilled at implementing project management and research-driven best practices to ensure successful completion of the pre-clinical programs. Armed with expertise in strategic planning, along with organization and analysis of workflow systems in the pharmaceutical industry. Known for strong leadership skills and comprehensive understanding of all phases of product development; along with remarkable analytical, documentation, writing and presentation. Excellent presenter with strong communication, interpersonal and public relations abilities.

PROFESSIONAL EXPERIENCE

EMERGENT BIOSOLUTIONS, INC. - GAITHERSBURG, MD

Principal Scientist/Sr. Manager- BioDefense Division, Non-clinical Department 2008-Present

- Accomplish the creation of nonclinical project plans, GANTT, timelines, resource requirements and budgets

- Evaluate and author comprehensive statement of works, contract proposals, technical and status reports, as well as scientific manuscripts; present significant data to Emergent Program Team, senior management and US Government clients (NIAID and BARDA)

- Ensure overall adherence to FDA’s Animal Rule with regard to the development and execution of pre-clinical programs for the licensure of anthrax therapeutics and vaccines

- Facilitate and lead meetings, project risk, analyses, and ad hoc discussions within the organization

- Function as an effective control account manager for the Earned Value Management System (EVMS) and take charge of monitoring of project budget

- Lead the development of cross-functional teams in handling specific projects to guarantee completion of pre-clinical studies within program goals, budget and deadlines

- Study and analyze scientific documents to be utilized for the company’s Business Development Group working on the organization’s merger and acquisition program

- Fostered strong relationship and management of the vendors, contract research organizations (CROs), academia and USG clients

- Provide strategic direction and management over multiple government mandated protocols and operations to secure strict compliance with the established Federal Acquisition Regulations (FARs)

- Take charge of developing necessary documents for FDA submissions (pre-IND, IND packages, annual reports)

- Successfully conducted an audit of the vendors for the GLP compliance

NAVAL MEDICAL RESEARCH CENTER - SILVER SPRING, MD

Staff Scientist - Trauma and Resuscitative Medicine Department 2005-2008

- Preside over training for two research assistant technicians with regard to immune bioassays

- Led the management of the overall immunology program aimed at discovering solutions for specific questions concerning hemorrhagic shock and resuscitation in animal studies; conducted extensive experimental work on different animal samples

- Successfully authored numerous grants, scientific proposals, manuscripts, annual reports, and standard operating procedures; delivered project presentations during conferences and symposiums

NATIONAL INSTITUTES OF HEALTH - NATIONAL CANCER INSTITUTE - BETHESDA, MD

Postdoctoral Fellow - Vaccine Branch, Section on Immune Biology of Retroviral Infection 2001-2005

- Effectively directed a team of four staff in conducting hands-on vaccine animal studies; oversaw and educated post-doctoral fellows, graduate students, and technicians regarding laboratory operations and procedures

- Employed excellent information management practices throughout the collection, organization, and interpretation of collected data on experiments and vaccine animal studies

- Authored numerous vaccine and technical protocols, troubleshooting processes, and scientific papers

- Served as a credible judge for scientific abstracts during the NCI retreat in immunology and cell biology, and offered professional expertise as a reviewer for Expert Review of Vaccines

- Reported project progress and results on various scientific conferences, think-tank meetings, vaccine branch meetings, and group seminars

- Utilized ELISA in quantifying the antibody secretions present in nasal, saliva, rectal swabs, and viral replication

- Studied and assessed different cellular responses through the use of ELISPOT, LUMINEX, and ELISA

- Completed the processing and stocking of cells from different peripheral blood and tissues observed in humans, rhesus macaques, cynomolgus monkeys, mice, and swine

- Demonstrated capabilities in conducting a 4-Color Flow Cytometry to determine the intracellular secretion of cytokines as well as cell surface markers of adhesion, activation, and apoptosis in blood and tissue samples

EARLIER EXPERIENCE

NATIONAL INSTITUTES OF HEALTH - NATIONAL INSTITUTE OF CHILD HEALTH AND HUMAN DEVELOPMENT - BETHESDA, MD

Pre-doctoral Exchange Student - Laboratory of Cellular and Molecular Biophysics 1997-2000

EDUCATION

Doctor of Philosophy in Biochemistry - Moscow State University, Moscow, Russia

Dissertation: Viral co-receptor usage and immunopathogenesis of HIV-1 in human lymphoid tissue ex vivo

Master of Science in Microbiology - Moscow State University, Moscow, Russia

Thesis: Formation and decay of intermediate M in the photocycle of the Halobacterium salinarium bacteriorhodopsin

AWARDS

Emergent BioSolutions Recognition Award for the High Productivity and Earned Revenue in a High Profile Project (2012)

Emergent BioSolutions Achievement Award for Superior Performance and Completion of a High Impact Project (2010)

NIH Fellows Award for Research Excellence - Recognition in Biomedical Research, Third Award (2004, 2000, 1994)

SELECTED ABSTRACTS AND PRESENTATIONS

Malkevich, N. (2009). AVP-21D9, a human monoclonal antibody against B. anthracis protective antigen, for the treatment of inhalation anthrax. Bacillus ACT, Santa-Fe, NM.

Malkevich, N. (2006). Immune effects of HBOC-201+/-rFVIIa and LR in uncontrolled hemorrhagic shock with and without traumatic brain injury in porcine model. Biopure Corporation Trauma Meeting, Crystal City, VA.

Malkevich, N. (2005). Protective role of CD8+ T cells elicited by Ad5-SIV vaccination against a second SIVmac251 challenge. HIV Drug Resistance Program Think Tank Meeting, Frederick, MD.

Malkevich, N., Patterson, J., Aldrich, K., Richardson, E., and Robert-Guroff, M. (2002). Potent induction of CTL activity in Mamu A*01 rhesus macaques by sequential Ad5hr-SIVv/rev and SIV gag immunization. HIV-1 Protection and Control by Vaccination, Keystone, CO.

Malkevich, N., Patterson, L.J., and Robert-Guroff, M. (2003). An Ad-SIV priming/subunit boosting vaccine regimen elicits durable protection against a second pathogenic SIVmac251 challenge in previously protected rhesus macaques. AIDS Vaccine Conference, New York, NY.

SELECTED PUBLICATIONS

Malkevich, N., Basu, S., Rudge, T., Clement, K., Chakrabarti, A., Aimes, R., Nabors, G., Skiadopoulos, M., Ionin, B. (2013). Effect of Anthrax Immune Globulin Intravenous (AIGIV) on BioThrax®-induced immune response in New Zealand White (NZW) rabbits. Antimicrobial Agents and Chemotherapy. Submitted.

Malkevich, N., Hopkins, R., Meister, G., Vela, E., Clement, J., Aimes, R., Skiadopoulos, M., Ionin, B. (2013). An anthrax monoclonal antibody, AVP-21D9, is safe in humans and highly efficacious against lethal anthrax infection in animal models. J Immunology. In preparation.

Malkevich, N., McCarron, R.M., Mahon, R.T. (2010). Decompression from saturation using oxygen: Its effects on DCS and RNA in large swine. Aviat Space Environ Med. 81(1), 15-21.

Demberg, T., Boyer, J.D., Malkevich, N., et al. (2008). Sequential priming with SIV DNA vaccines, with or without encoded cytokines, and replicating adenovirus-SIV recombinant followed by protein boosting does not control a pathogenic SIVmac251 mucosal challenge. J Virol. 82(21), 10911-21.

Malkevich, N.V., Vander Molen, C., et al. (2008). Innate immune responses and mortality in uncontrolled liver injury hemorrhagic shock in swine model resuscitated with HBOC-201 with and without recombinant factor VIIa. Journal of Trauma. 64(6), 1498-510.

Patterson, L.J., Beal, J., Demberg, T., Malkevich, N., et al. (2008). Contribution of a protein boost to protection from a SHIV89.6P challenge in Mamu-A*01 negative rhesus macaques following priming with replicating adenovirus HIV/SIV recombinants. J. Immunology. 374(2), 322-327.

Hall, C., Malkevich, N., et al. (2007). Innate immune responses in swine resuscitated from severe traumatic hemorrhagic shock with hemoglobin-based oxygen carrier-201. Artificial Cells, Blood Substitutes and Biotechnology. 35(3), 259-274.

VanderMolen, C., Malkevich, N., et al. (2007). Innate immune effects of resuscitation with hemoglobin-based oxygen carriers with varying concentrations of low-molecular weight hemoglobin in a swine model of controlled hemorrhage. Artificial Cells, Blood Substitutes and Biotechnology. 35(3), 507-517.

Zhou, Q., Hidajat, R., Peng, B., Venzon, D., Aldrich, M.K., Richardson, E., Lee, E.M., Kalyanaraman, V.S., Grimes, G., Gómez-Román, V.R., Malkevich, N., Robert-Guroff, M. (2007). Comparative evaluation of oral and intranasal priming with replication-competent adenovirus 5 host range mutant (Ad5hr)-simian immunodeficiency virus (SIV) recombinant vaccines on immunogenicity and protective efficacy against SIVmac251. Vaccine. 25(47), 8021-35.

Malkevitch, N.V., Patterson, L.J., et al. (2006). A replicating Adenovirus-SIV multigene prime/boost vaccine regimen elicits long-lasting, potent SIV-specific CD8+ T cell responses that contribute to protection of rhesus macaques against a second pathogenic SIVmac251 rectal challenge. Virology. 353(1), 83-98.

Pinczewski, J., Zhao, J., Malkevitch, N., et al. (2005). Enhanced immunity and protective efficacy against SIVmac251 intrarectal challenge following Ad-SIV priming by multiple mucosal routes and gp120 boosting in MPL-SE. Viral Immunol. 18(1), 236-243.

Malkevitch, N., et al. (2004). Evaluation of combination DNA/replication competent Ad-SIV recombinant immunization regimens in rhesus macaques. AIDS Res. Human Retroviruses. 20, 235-244.

Malkevitch, N., et al. (2004). Evaluation of combination DNA/replication competent Ad-SIV recombinant immunization regimens in rhesus macaques. AIDS Res. Human Retroviruses. 20, 235-244.

Malkevitch, N.V. and Robert-Guroff, M. (2004). A call for replicating vector prime/protein boost strategies in HIV vaccine design. Expert Rev. Vaccines, Suppl. 3, 89-101.

Malkevitch, N.V. and Robert-Guroff, M. (2004). A call for replicating vector prime/protein boost strategies in HIV vaccine design. Expert Rev. Vaccines, Suppl. 3, 89-101.

Malkevitch, N., et al. (2003). A replication competent Ad5hr-SIV recombinant priming/subunit protein boosting vaccine regimen induces broad, persistent SIV-specific cellular immunity to dominant and subdominant epitopes in Mamu-A*01 rhesus macaques. J. Immunol., 170, 4281-4289.

Patterson, L.J., Malkevitch, N., et al. (2004). Protection against mucosal SIVmac251 challenge using replicating adenovirus-SIV multi-gene vaccine priming and subunit boosting. J.Virol. 78, 2212-2221.

Zhao, J., Lou, Y., Pinczewski, J., Malkevitch, N., et al. (2003). Boosting of SIV-specific cellular immune responses in rhesus macaques by repeated administration of Ad5hr-SIV env/rev and Ad5hr-SIV gag recombinants. Vaccine. 21, 4022-4035.

Patterson, L.J., Malkevitch, N.V., et al. (2002). Potent, persistent cellular immune responses elicited by sequential immunization of rhesus macaques with Ad5 host range mutant recombinants encoding SIV Rev and SIV Nef. DNA Cell Biol. 21, 627-635.

Malkevitch N.V., et al. (2001). Coreceptor choice and T cell depletion by R5-, X4- and R5X4 HIV-1 variants in CCR5-deficient (CCR5-32) and normal human lymphoid tissue. Virology. 281(2), 239-247.

Malkevich N.V., et al. (2001). Human immunodeficiency virus type 1 (HIV-1) Non-B subtypes are similar to HIV subtype B in that coreceptor specificity is a determinant of cytopathicity in human lymphoid tissue infected ex vivo. Journal of Virology. 75, 105**-*****.

Grivel J-C., Malkevitch N.V., et al. (2000). HIV-1 induces apoptosis in CD4+ T cells but not in CD8+ T cells in ex vivo infected human lymphoid tissue. Journal of virology. 74(17), 8077-8084.

Malkevitch N., et al. (1997). Thyroxine induces cyclosporin A-insensitive Ca2+ - dependent reversible permeability transition pore in rat liver mitochondria. FEBS Letters. 412, 173-178.

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