Director, Immunology Antibody Therapeutic and Vaccine Development

Professional Experience

Emergent Biosolutions, Inc. (300 Professional Dr., Gaithersburg, MD 20879)

March 2010 – Present, Associate Director (Sr. Manager), Vaccine Potency Unit

• Leading a high-performance assay development/immunology Unit (17 PhD/MS level)

1. Built team from 3 to 17 scientists/project analyst/admin with a Quality system (non-GxP) in approximately 10 months

2. Potency assay development (in vivo and in vitro bioassays/immunoassays) for vaccine and antibody therapeutic characterization, stability, and lot release

3. In vivo POC studies for development stage vaccines and antibody therapeutics

4. Assessing clinical immune responses to infectious agent vaccines (bacterial/viral)

• Developed/managed internal budget and government EVMS (~ $5 M/year)

• Key internal leader of Mouse Potency Assay development (including FDA submission strategy/preparation; novel data analytical methods)

• Non-Clinical project team member of several vaccine projects

• Implemented a corporate Culture Initiative into Unit to maintain employee job satisfaction, work quality and productivity

• Non-Clinical member of corporate acquisition team (due diligence/corporate culture assimilation)

Hollis-Eden Pharmaceuticals, Inc. (9393 Towne Centre Dr., San Diego, CA 92121)

Dec 2008 – August 2009, Director, Immunology

Sept 2007-Dec 2008, Sr. Scientific Investigator, Immunology

• Led group responsible for: 1) analysis of biomarkers in clinical samples, 2) in vivo pharmacology, and 3) anti-inflammatory steroid drug discovery screening and mechanism-of-action studies

• Directed research to identify target of lead anti-inflammatory/metabolic drug

• Responsible for raising funds for clinical trials and drug development programs via grant proposals

• Collaboration Liaison: initiated and maintained productive collaborations with key academic opinion leaders/scientific advisors

• Hired and managed career development of scientists and RAs

XOMA (US) LLC (2910 Seventh Street, Berkeley, CA 94710)

Jan 2006-August 2007, Group Leader, Immunopharmacology

• Project Team Leader, antibody therapeutic discovery program in angiogenesis

• Group Leader, Immunopharmacology Unit responsible for animal models of inflammation, autoimmunity, and metabolism

• Manager and project team representative of hybridoma production lab responsible for therapeutic antibody discovery for multiple projects

• Immunopharmacology representative on Translational Medicine team: responsible for designing/implementing biomarker strategies for preclinical/clinical stage programs

• Collaboration Liaison: initiated and maintained productive collaborations with key academic opinion leaders

Market Access International, Inc. (Smyrna, GA/San Diego, CA)

May 2005-May 2006, Principal Biopharmaceutical Consultant

• Provided expert scientific advise and market analysis for business development needs of biotech and pharmaceutical clients in the public and private sectors

• Prepared proposals for contract bidding

Neurocrine Biosciences, Inc. (12790 El Camino Real, San Diego, CA)

2002-2005, Principal Scientist, Molecular Medicine

2000-2002, Senior Scientist, Immunology & Exploratory

1998-2000, Scientist II, Immunology

• Project Team Leader of a small-molecule GPCR drug discovery program (chemokine)

• Proposed series of chemokine and cytokine targets of which 3 were pursued in drug discovery projects and programs

• Developed compound screening strategies, in vitro chemokine assays for lead compound validation and mechanism of action, and in vivo autoimmune/inflammation animal models for proof-of-concept

• Research representative on clinical development program team for type 1 diabetes altered peptide ligand (APL) vaccine trials

• Managed in vitro and in vivo (NOD mouse model) proof-of-concept studies for IND application for diabetes APL vaccine trials

• Developed/implemented antigen-specific clinical assays for vaccine trials (i.e., ELISPOT, intracellular-cytokine staining, frequency assays); negotiated and managed service contracts with central laboratories

• Strategic planning for research division by proposing and reviewing new drug targets

• Secured funding via NIH SBIR grants for novel target drug discovery

• Hired and managed the career development of scientists, RAs, and interns

• Translational Medicine: Discovery of molecular biomarkers for rheumatoid arthritis via molecular characterization of rat arthritis using gene array analysis

Boston University Medical Center (Boston, MA)

1994-1998: Postdoctoral Fellow, Immunology

Advisor: David I. Beller, Ph.D.; Research focus: Genetically-Programmed Defective Cytokine Expression in Macrophages from Autoimmune-Prone Mice

Virginia Tech (Blacksburg, VA)

1991-1994: Graduate teaching for the following independent undergraduate laboratory courses: Microbial Physiology, Principles of Biology, Physiology of Microorganisms

NIH/FDA (Bethesda, MD)

1989 summer, Laboratory technician in bacterial genetics; Supervisor: Ken Rudd, Ph.D.

Education

• 1989-1994: Ph.D., Immunology: Virginia Tech, Blacksburg, VA; Mentor, Klaus D. Elgert, Ph.D.; Dissertation, “Regulation of Macrophage Activities by Tumor Growth: Mechanisms of Immunosuppression”

• 1987: B.S., Biology: Indiana University, Bloomington, IN

Grants (The National Institutes of Health, Small Business Innovative Research)

• 2004. Alleva, D. G. CRTH2 Antagonists and Allergic Disease. NIH SBIR Phase I

• 2004. Alleva, D. G. Immunosuppressive antagonist of CC chemokine receptor 7. NIH SBIR Phase II

• 2001. Alleva, D.G. Immunosuppressive antagonist of CC chemokine receptor 7. NIH SBIR Phase I

Patent Applications

Therapeutic use of anti-IL-1 antibody inhibitors (filed 2007)

Scientific Leadership

2005. Chair of “Tolerance and Autoimmunity” symposium at the Experimental Biology 2005 (FASEB) Meeting, San Diego, CA

Memberships

• The American Association of Immunologists

• The Society for Leukocyte Biology

Bibliography

1. Wang, T., S. Villegas, F. Parviz, Y. Huang, S.K. White, C. Ahlem, M. Lu, J.M. Olefsky, C. Reading, J. Frincke, D.G. Alleva, and J. Flores-Riveros. 2010. Amelioration of Glucose Intolerance by the Synthetic Androstene HE3286: Link to Inflammatory Pathways. J. Pharm. Exp. Ther. 333:70.

2. Soto, H., P. Hevezi, R. B. Roth, A. Pahuja, D. G. Alleva, H. M. Acosta, A. Ortega, R. Araiza-Casillas, and A. Zlotnik. 2008. Gene array analysis comparison between rat collagen-induced arthritis and human rheumatoid arthritis. Scand. J. Immunol. 68:43.

3. Pahuja, A., R. A. Maki, P. A. Hevezi, A. Chen, G. M. Verge, S. M. Lechner, R. B. Roth, A. Zlotnik, and D. G. Alleva. 2006. Experimental autoimmune encephalomyelitis develops in CC chemokine receptor 7-deficient mice with altered T-cell responses. Scand J Immunol 64:361.

4. Alleva, D. G., R. A. Maki, A. L. Putnam, J. M. Robinson, M. S. Kipnes, P. Dandona, J. B. Marks, D. L. Simmons, C. J. Greenbaum, R. G. Jimenez, P. J. Conlon, and P. A. Gottlieb. 2006. Immunomodulation in type 1 diabetes by NBI-6024, an altered peptide ligand of the insulin B epitope. Scand J Immunol 63:59.

5. Ott, T. R., A. Pahuja, F. M. Lio, M. S. Mistry, M. Gross, S. C. Hudson, W. S. Wade, P. B. Simpson, R. S. Struthers, and D. G. Alleva. 2005. A high-throughput chemotaxis assay for pharmacological characterization of chemokine receptors: Utilization of U937 monocytic cells. J Pharmacol Toxicol Methods 51:105.

6. Heise, C. E., A. Pahuja, S. C. Hudson, M. S. Mistry, A. L. Putnam, M. M. Gross, P. A. Gottlieb, W. S. Wade, M. Kiankarimi, D. Schwarz, P. Crowe, A. Zlotnik, and D. G. Alleva. 2005. Pharmacological characterization of CXC chemokine receptor 3 ligands and a small molecule antagonist. J Pharmacol Exp Ther 313:1263.

7. Ott, T. R., A. Pahuja, S. A. Nickolls, D. G. Alleva, and R. S. Struthers. 2004. Identification of CC chemokine receptor 7 residues important for receptor activation. J Biol Chem 279:42383.

8. Simpson, P. B., M. S. Mistry, R. A. Maki, W. Yang, D. A. Schwarz, E. B. Johnson, F. M. Lio, and D. G. Alleva. 2003. Cutting edge: diabetes-associated quantitative trait locus, Idd4, is responsible for the IL-12p40 over-expression defect in non-obese diabetic (NOD) mice. J Immunol 171:3333.

9. Kim, H. J., J. P. Antel, P. Duquette, D. G. Alleva, P. J. Conlon, and A. Bar-Or. 2002. Persistence of immune responses to altered and native myelin antigens in patients with multiple sclerosis treated with altered peptide ligand. Clin Immunol 104:105.

10. Alleva, D. G., E. B. Johnson, F. M. Lio, S. A. Boehme, P. J. Conlon, and P. D. Crowe. 2002. Regulation of murine macrophage pro-inflammatory and anti-inflammatory cytokines by ligands for peroxisome proliferator-activated receptor-gamma: counter-regulatory activity by IFN-gamma. J Leukoc Biol 71:677.

11. Alleva, D. G., A. Gaur, L. Jin, D. Wegmann, P. A. Gottlieb, A. Pahuja, E. B. Johnson, T. Motheral, A. Putnam, P. D. Crowe, N. Ling, S. A. Boehme, and P. J. Conlon. 2002. Immunological characterization and therapeutic activity of an altered-peptide ligand, NBI-6024, based on the immunodominant type 1 diabetes autoantigen insulin B-chain (9-23) peptide. Diabetes 51:2126.

12. Alleva, D. G., P. D. Crowe, L. Jin, W. W. Kwok, N. Ling, M. Gottschalk, P. J. Conlon, P. A. Gottlieb, A. L. Putnam, and A. Gaur. 2001. A disease-associated cellular immune response in type 1 diabetics to an immunodominant epitope of insulin. J Clin Invest 107:173.

13. Alleva, D. G., E. B. Johnson, J. Wilson, D. I. Beller, and P. J. Conlon. 2001. SJL and NOD macrophages are uniquely characterized by genetically programmed, elevated expression of the IL-12(p40) gene, suggesting a conserved pathway for the induction of organ-specific autoimmunity. J Leukoc Biol 69:440.

14. Kappos, L., G. Comi, H. Panitch, J. Oger, J. Antel, P. Conlon, and L. Steinman (Alleva included in The Altered Peptide Ligand in Relapsing MS Study Group). 2000. Induction of a non-encephalitogenic type 2 T helper-cell autoimmune response in multiple sclerosis after administration of an altered peptide ligand in a placebo-controlled, randomized phase II trial. Nat Med 6:1176.

15. Alleva, D. G., R. P. Pavlovich, C. Grant, S. B. Kaser, and D. I. Beller. 2000. Aberrant macrophage cytokine production is a conserved feature among autoimmune-prone mouse strains: elevated interleukin (IL)-12 and an imbalance in tumor necrosis factor-alpha and IL-10 define a unique cytokine profile in macrophages from young non-obese diabetic mice. Diabetes 49:1106.

16. Elgert, K. D., D. G. Alleva, and D. W. Mullins. 1998. Tumor-induced immune dysfunction: the macrophage connection. J Leukoc Biol 64:275.

17. Alleva, D. G., S. B. Kaser, and D. I. Beller. 1998. Intrinsic defects in macrophage IL-12 production associated with immune dysfunction in the MRL/++ and New Zealand Black/White F1 lupus-prone mice and the Leishmania major-susceptible BALB/c strain. J Immunol 161:6878.

18. Mullins, D. W., D. G. Alleva, C. J. Burger, and K. D. Elgert. 1997. Taxol, a microtubule-stabilizing antineoplastic agent, differentially regulates normal and tumor-bearing host macrophage nitric oxide production. Immunopharmacology 37:63.

19. Alleva, D. G., S. B. Kaser, M. A. Monroy, M. J. Fenton, and D. I. Beller. 1997. IL-15 functions as a potent autocrine regulator of macrophage pro-inflammatory cytokine production: evidence for differential receptor subunit utilization associated with stimulation or inhibition. J Immunol 159:2941.

20. Alleva, D. G., S. B. Kaser, and D. I. Beller. 1997. Aberrant cytokine expression and autocrine regulation characterize macrophages from young MRL+/+ and NZB/W F1 lupus-prone mice. J Immunol 159:5610.

21. Alleva, D. G., and K. D. Elgert. 1995. Promotion of macrophage-stimulated autoreactive T cell proliferation by interleukin-10: counteraction of macrophage suppressor activity during tumor growth. Immunobiology 192:155.

22. Alleva, D. G., T. M. Walker, and K. D. Elgert. 1995. Induction of macrophage suppressor activity by fibrosarcoma-derived transforming growth factor-beta 1: contrasting effects on resting and activated macrophages. J Leukoc Biol 57:919.

23. Alleva, D. G., C. J. Burger, and K. D. Elgert. 1994. Increased sensitivity of tumor-bearing host macrophages to interleukin-10: a counter-balancing action to macrophage-mediated suppression. Oncol Res 6:219.

24. Alleva, D. G., C. J. Burger, and K. D. Elgert. 1994. Tumour growth causes suppression of autoreactive T-cell proliferation by disrupting macrophage responsiveness to interferon-gamma. Scand J Immunol 39:31.

25. Alleva, D. G., C. J. Burger, and K. D. Elgert. 1994. Tumor-induced regulation of suppressor macrophage nitric oxide and TNF-alpha production. Role of tumor-derived IL-10, TGF-beta, and prostaglandin E2. J Immunol 153:1674.

26. Alleva, D. G., D. Askew, C. J. Burger, and K. D. Elgert. 1994. Macrophage priming and activation during fibrosarcoma growth: expression of c-myb, c-myc, c-fos, and c-fms. Immunol Invest 23:457.

27. Alleva, D. G., C. J. Burger, and K. D. Elgert. 1993. Interferon-gamma reduces tumor-induced Ia- macrophage-mediated suppression: role of prostaglandin E2, Ia, and tumor necrosis factor-alpha. Immunopharmacology 25:215.

28. Alleva, D. G., C. J. Burger, and K. D. Elgert. 1993. Tumor growth increases Ia- macrophage synthesis of tumor necrosis factor-alpha and prostaglandin E2: changes in macrophage suppressor activity. J Leukoc Biol 53:550.

29. Alleva, D. G., C. J. Burger, and K. D. Elgert. 1993. Tumor-induced macrophage tumor necrosis factor-alpha production suppresses autoreactive T cell proliferation. Immunobiology 188:430.

30. Alleva, D. G., D. Askew, C. J. Burger, and K. D. Elgert. 1993. Fibrosarcoma-induced increase in macrophage tumor necrosis factor alpha synthesis suppresses T cell responses. J Leukoc Biol 54:152.

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