David G. Alleva, Ph.D.
A Scientific Leader in Therapeutics R&D
(Immunology/Inflammation, Vaccines)
273 Meadowlark Drive, Bozeman, MT 59718
Cell: (858) 705-4843; davidalleva@gmail.com
http://www.linkedin.com/pub/david-alleva/0/80a/4ab
A successful scientific leader in the biopharmaceutical industry with a strong background in
Immunology (innate and adaptive), Inflammation and Pharmacology with management
interests in assay development, immunotherapeutic discovery and development
(preclinical/clinical), and translational medicine.
Twenty-three years of scientific experience including 15 years of drug discovery/development
and translation of therapeutics (small-molecule and biologics) and vaccines in autoimmune,
inflammatory, metabolic, angiogenic (oncology), and infectious disease areas.
Strong in leadership and management of functional teams and project teams, initiating and
promoting projects through advanced-lead stage to IND, and in leading translational research
for preclinical and clinical biomarker analysis. Excellent publication record.
Professional Experience
Alleva Biotech Consulting, LLC. (Bozeman, MT 59718)
August 2013 - present
 Developing teams of scientists that execute in vitro and in vivo laboratory
experimentation for drug discovery/development (small molecule, biologics, and
vaccines)
 Working with companies seeking government contracts for scientific-oriented projects,
including IT Cloud technology contracts for genomics research, and R&D contracts for
biodefense vaccines. Provide scientific education and advice, and contribute to the
preparation of white papers and contract proposals to RFPs.
Emergent Biosolutions, Inc. (Gaithersburg, MD 20879)
March 2010 – May 2013
Sr. Manager, Vaccine Potency Unit
 Led in vivo proof-of-concept (POC) studies for development stage vaccines and
antibody therapeutics
 Implemented potency assay development (in vivo and in vitro bioassays/immunoassays) for vaccine and antibody therapeutic characterization, stability, and lot
release (see publications)
 Translational Medicine: Designed/assessed clinical immune responses to infectious
agent vaccines (see publication)
 Built team of immunologists and high-performance assay development scientists
(PhD/MS level scientists) plus project analyst and admin with Quality system from 3 to
17 staff in 10 months
 Developed/managed budgets of ~ $5 M/year
 Implemented a corporate Culture Initiative to maintain employee job satisfaction, work
quality and productivity
 Managed CRO contracts for 3 years (> $6 million)
 Supported/wrote sections of Regulatory submissions with pre-clinical tox studies and
lot release assay development (IND, Assay Validation approvals; one vaccine in Ph2)
 Contributed to sections of four government grants/contracts (awards >$30M)
David Alleva

Pre-Clinical/Scientific member of corporate acquisition team engaged in due
diligence/corporate culture assimilation that led to successful acquisition and
integration of Trubion (Seattle) by Emergent Biosolutions.
Hollis-Eden Pharmaceuticals, Inc. (San Diego, CA 92121)
2007- 2009
Director, Immunology
Dec 2008 – August 2009
Sr. Scientific Investigator, Immunology
Sept 2007 - Dec 2008
 Directed research to identify target of lead anti-inflammatory/metabolic steroid
 Designed/conducted anti-inflammatory steroid discovery screening MOA studies
 Conducted in vivo POC pharmacology studies for lead immune-modulatory steroids mouse/rat arthritis, type 1 diabetes, EAE (multiple sclerosis model), and IBD
 Translational Medicine: Implemented 5 assays for clinical sample biomarkers for
clinical trials in IBD/Ulcerative Colitis, RA and type 2 diabetes (see publication)
 Hired and led Immunology group of 5 MS/PhD level scientists responsible for clinical
biomarker analysis, in vivo animal studies, immune-modulatory steroid screening and
MOA studies
 Established/managed CRO contract for in vitro MOA studies
 Conducted Pre-Clinical studies (POC and PK/PD) for regulatory submissions
 Wrote relevant pre-clinical sections of IND (one drug through Ph2)
 Wrote grant proposals for fund raising of Type 1 diabetes clinical trials and drug
development programs (via TrialNet; Immune Tolerance Network; NIH)
 Initiated and maintained productive collaborations with Key Opinion Leaders (KOLs)
XOMA (US) LLC (Berkeley, CA 94710)
Jan 2006 - August 2007
Group Leader, Immunopharmacology
 Managed the Immunopharmacology team and the Hybridoma team
o Immunopharmacology team was responsible for animal models of
inflammation, autoimmunity, and metabolism
o Hybridoma production lab was responsible for therapeutic antibody discovery
for multiple projects
 Led Project Team for antibody therapeutic discovery in angiogenesis
 Implemented in vitro bioassays and in vivo POC models for assessing specificity,
potency, and MOA of lead antibody therapeutics
o anti-IL-1beta for arthritis/Type 2 diabetes
o anti-angiogenesis target for macular degeneration and specific cancers
 Managed Pre-Clinical studies (non-GLP Tox and PK/PD) for regulatory submissions
of lead anti-IL-1 (currently in Ph2 and Ph3) and anti- angiogenesis therapeutics
 Translational Medicine: Designed and implemented biomarker strategies for
preclinical and clinical stage programs
 Initiated and maintained productive collaborations with KOLs
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
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David Alleva
Neurocrine Biosciences, Inc. (San Diego, CA)
1998 - 2005
Principal Scientist, Molecular Medicine
(2002-2005)
Senior Scientist, Immunology & Exploratory
(2000-2002)
Scientist II, Immunology
(1998-2000)
 Developed compound screening strategies including in vivo autoimmune/inflammation
animal models for POC in vitro chemokine assays for lead compound validation and
MOA (see publications)
 Designed and implemented Pre-Clinical non-GLP Tox and PK/PD studies of smallmolecule leads
 Developed and implemented in vitro and in vivo POC studies for Type 1 Diabetes
and Multiple Sclerosis Altered Peptide Ligand (APL) programs (mouse models and
human samples) (see publications)
 Developed and implemented antigen-specific clinical assays for APL trials (i.e.,
ELISPOT, intracellular-cytokine staining, frequency assays) (see publications)
 Translational Medicine:
o Discovered molecular biomarkers for rheumatoid arthritis via molecular
characterization of rat, mouse, human arthritis using gene array analysis (see
publication)
o Discovered ELISPOT response unique to type 1 diabetes subjects (see
publications)
 Led Project Teams for three small-molecule GPCR drug discovery programs
(immune-modulatory chemokine antagonists)
 Hired and managed career development of five scientists/RAs/interns
 Research representative on clinical development program team for Type 1 Diabetes
altered peptide ligand trials
 Managed CRO contracts with central laboratories for clinical trial assays
 Supported IND submission of Type 1 diabetes APL trials by conducting and directing
in vitro/in vivo POC studies (human samples and NOD mouse model) and
preparing/writing relevant pre-clinical sections
 Aggressively engaged in strategic planning for research division by preparing (and
reviewing) new drug target proposals (chemokine and cytokine targets), 3 of which
were initiated in drug discovery projects
 Secured funding via NIH SBIR grants for novel target drug discovery (see Grants)
 Initiated and maintained productive collaborations with key academic opinion leaders
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)
Laboratory technician in bacterial genetics; Supervisor: Ken Rudd, Ph.D.
1989 summer
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David Alleva
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/Patents/Memberships
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)
Invitations to meetings
2005. Chair of “Tolerance and Autoimmunity” symposium at the Experimental Biology 2005
(FASEB) Meeting, San Diego, CA
2013: Invited speaker at the “5th Annual USP Workshop”, Rockville, MD
Memberships


The American Association of Immunologists
The Society for Leukocyte Biology
Bibliography
1. Baranji, K., Catania, J., Sweeny, D., Lathey, J., Lu, H., Sanford, H., Sapru, K.,
Patamawenu, T., Chen, J-H., Ng, A., Fesseha, Z., Kluepfel-Stahl, S., and Alleva, D.
2013. A multi-vaccine reference serum for the anthrax toxin neutralization assay based
on common response characteristics among immune sera derived from different anthrax
vaccines. (submitted)
2. Minang, J.T., J.R. Inglefield, M. Lacy, J. Lathey, D.G. Alleva, D. Sweeney, and E.
Bernton. 2014. Co-administration of Biothrax™ with CpG7909, as Adjuvant, Markedly
Enhances Early Innate and Th1 Cell-Mediated Responses in Vaccinated Subjects.
Vaccine (accepted)
3. Lu, H., J. Catania, K. Baranji, J. Feng, M. Gu, J. Lathey, D. Sweeny, H. Sanford, K.
Sapru, T. Patamawenu, J. Chen, A. Ng, Z. Fesseha, S. Kluepfel-Stahl, J. Minang, and D.
Alleva. 2013. Characterization of the native form of Anthrax Lethal Factor for use in the
Toxin Neutralization Assay. Clin Vaccine Immunol 20:986.
4. 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.
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David Alleva
5. 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.
6. 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.
7. 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.
8. 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.
9. 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.
10. 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.
11. 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.
12. 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.
13. 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: counterregulatory activity by IFN-gamma. J Leukoc Biol 71:677.
14. 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, NBI6024, based on the immunodominant type 1 diabetes autoantigen insulin B-chain (9-23)
peptide. Diabetes 51:2126.
15. 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.
16. 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.
17. 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.
18. 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 factor5
David Alleva
alpha and IL-10 define a unique cytokine profile in macrophages from young non-obese
diabetic mice. Diabetes 49:1106.
19. Elgert, K. D., D. G. Alleva, and D. W. Mullins. 1998. Tumor-induced immune dysfunction:
the macrophage connection. J Leukoc Biol 64:275.
20. 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.
21. Mullins, D. W., D. G. Alleva, C. J. Burger, and K. D. Elgert. 1997. Taxol, a microtubulestabilizing antineoplastic agent, differentially regulates normal and tumor-bearing host
macrophage nitric oxide production. Immunopharmacology 37:63.
22. 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.
23. 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.
24. 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.
25. 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.
26. 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.
27. 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 interferongamma. Scand J Immunol 39:31.
28. 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 IL10, TGF-beta, and prostaglandin E2. J Immunol 153:1674.
29. 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.
30. Alleva, D. G., C. J. Burger, and K. D. Elgert. 1993. Interferon-gamma reduces tumorinduced Ia- macrophage-mediated suppression: role of prostaglandin E2, Ia, and tumor
necrosis factor-alpha. Immunopharmacology 25:215.
31. Alleva, D. G., C. J. Burger, and K. D. Elgert. 1993. Tumor growth increases Iamacrophage synthesis of tumor necrosis factor-alpha and prostaglandin E2: changes in
macrophage suppressor activity. J Leukoc Biol 53:550.
32. 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.
33. 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.
References: Available Upon Request
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