JOHN F. WARNER, Ph.D.

2654 Calistoga Ct., Livermore, CA 94550

(925) 997-3250 (m)
jwf2df84@westpost.net
RESEARCH & DEVELOPMENT MANAGEMENT
Research and development science professional in the biotechnology and pharmaceu
tical industries seeking a challenging management opportunity where expertise in
driving R&D initiatives through later-stage development, strategic planning, pr
oactive project management, decisive leadership and strong communication can be
effectively applied towards defining and achieving company objectives. A proven
track record of developing novel product-driven vaccine and gene-based technolog
ies for the treatment of infectious diseases and cancer. Successful management
of the challenges that confront early-stage technology development with a histor
y of positive interactions with regulatory agencies for IND submissions and init
iation of clinical trials. Successfully managed scientific aspects of domestic a
nd international corporate partnerships with a strong understanding of the requi
rements necessary for diverse and demanding technology development environments.
Value-Added Expertise and Experience in:
* Leadership to Drive Scientific Programs
* Vaccine and Gene-Based Product Development
* Liposomal and Viral Delivery Systems
* Venture Financing, Grant Preparation, and Corporate Partnering
* Regulatory & Compliance Requirements
* Oversight of Patent Portfolios
Contributed significantly in the development of novel vaccine technologies for t
he treatment of infectious diseases and cancer. Thorough understanding of immune
mechanisms (innate & adaptive immunity), vaccine development as well as types o
f vaccines (protein, peptide, polysaccharide). Participated in numerous presenta
tions to the FDA and corporate partners. Prominent role as corporate scientific
spokesperson with refined written communication and presentation skills.
Accomplished in managing, driving and contributing to R&D initiatives and scient
ific programs, patent management, securing venture financing and National Instit
utes of Health (NIH) grants, corporate partnering, regulatory interactions, FDA-
approved Investigational New Drug (IND) submissions, and managing multimillion-d
ollar budgets with staffs of highly motivated scientists.
PROFESSIONAL EXPERIENCE:
2009 - Present: Biotechnology Consultant
Expertise in Immunology and Microbiology, vaccine development, IND preparati
on, regulatory agency interactions (FDA, RAC), grant preparation, and scientific
presentations for investment and corporate groups
2003 - 2009: Chief Scientific Officer, Vice President of Operations, Co-Founder
Juvaris BioTherapeutics, Inc., Burlingame, CA
Juvaris Biotherapeutics is a private start-up biotechnology company focused
on the use of immunostimulatory liposome-DNA complexes in the development of nov
el vaccine adjuvants and immunotherapeutics for the treatment of infectious dise
ases and cancer.
Leadership of R&D Programs and Management of Patent Portfolio:
* Responsible for preclinical Research & Development vaccine/immunotherapeutic
programs (Staff of 14, 4 PhDs; $3.0 million budget) involving infectious disease
s and cancer leading to successful initiation of clinical trials
* Successfully managed scientific interactions and licensing requirements for c
orporate and academic partners
* Successfully recruited DNA manufacturing team during company startup, which u
ltimately resulted in manufacturing supply capability for corporate partner
* Responsible for oversight of DNA manufacturing group (GLP pilot plant in-hous
e & GMP off-site) leading to successful production of GMP-grade clinical materia
l
* Managed complex corporate patent portfolio and successfully provided technica
l clarifications for investor/corporate inquiries that ultimately lead to ventur
e investment and a corporate partnership
Financing, Grants, and Corporate Partnering:
* Company co-founder; provided initial interaction to commit subsequent co-foun
ders and investors
* Significant contribution to the completion of series A venture funding of $16
.8 million from the Kleiner, Perkins, Caufield & Byers (KPBC) venture group as w
ell as initial angel investments totaling $2.5 million
* Supervised and participated in obtaining over $12 million of NIH funding (5 g
rants) for vaccines and immunotherapy
* Integrated technology description, preclinical data and product development s
trategies into business plans leading to subsequent successful venture capital i
nvestment
* Developed and provided R&D presentations and complete due-diligence documenta
tion that lead to corporate partnership with Bayer HealthCare, LLC
Regulatory Activities:
* Oversight and preparation of preclinical and CMC documentation for three FDA-
approved IND submissions (Influenza vaccine, HCV immunotherapeutic, leukemia imm
unotherapeutic) within six-month timeframe
* Initiated and directed the process to bring previous toxicology study into GL
P compliance for IND submissions, thereby saving the company significant time (6
-8 months) and resources (~$800,000)
* Successfully prepared and provided scientific presentations to regulatory age
ncies (FDA, RAC, IRB), ultimately leading to the initiation of Phase 1 and Phase
2 adjuvanted-vaccine clinical trials
2000 - 2003: Vice President, Research & Technology
Collateral Therapeutics, Inc., San Diego, CA
Collateral Therapeutics was a publicly traded (NASDAQ) biopharmaceutical com
pany focused on the development of non-surgical adenoviral-based gene therapy pr
oducts for the treatment of cardiovascular disease. The company was acquired by
Schering, AG (2003).
* Implemented a successful and amicable transition of scientific co-founder fro
m the company
* Positive leadership of Research programs (Staff of 45; 12 Ph.D. /M.D.) throug
h emphasis on quality control and open communication. Programs included myocard
ial ischemia, congestive heart failure, and heart muscle protection.
* Head of R&D Center functions including facility operations and animal (rodent
s and pigs) facility
* Initiated cardiovascular functional genomics (cardiomics) program for functio
nal target validation
1998 - 2000: Vice President, Research & Development; Head of Burlingame Center
Valentis, Inc., Burlingame, CA
Valentis was a publicly traded (NASDAQ) biotechnology company involved in the
development of liposomal delivery systems focused on gene-based products for th
e treatment of cancer. Valentis, Inc. was created from the merger of Megabios a
nd GeneMedicine in 1999.
* Headed the Burlingame Research Center, which included resource allocation and
supervisory responsibility (staff of 25) for project teams, process development
, and manufacturing
* Initiated research program re-alignment and consolidation to facilitate more
efficient technology development
* Assisted in the implementation of merger restructuring and maintained core or
ganizational focus/motivation during merger process
1995 - 1998: Vice President, Gene Therapy and Immunology
INEX Pharmaceuticals Corp., Vancouver, B.C., Canada
INEX Pharmaceuticals is a publicly traded (Toronto Stock Exchange) biopharma
ceutical company involved in the development of liposome-encapsulated genetic-
and small molecule-based delivery systems for cancer applications.
* Established gene therapy program development with emphasis on the use of lipo
somal delivery systems for gene delivery and immune activation (staff of 10, 5 P
hDs)
* Successfully reorganized research program to project team structure for more
efficient product candidate focus
* Facilitated improved relations with academic collaborators and corporate part
ner (Schering-Plough/Canji)
1988 - 1995: Director, Immunobiology/HIV Immunotherapeutic Vaccine Program
Viagene, Inc., San Diego, CA
Viagene, Inc. was the first publicly traded (NASDAQ) biotechnology gene ther
apy company involved in the development of retroviral vector gene delivery techn
ology. The company initiated the first HIV immunotherapeutic vaccine Phase 1 an
d 2 clinical trials utilizing viral-vector gene delivery technology. Viagene was
acquired by Chiron Corporation in 1995.
* Successfully established and directed Immunobiology group and HIV vaccine res
earch program (staff of 40; 15 PhDs) resulting in an FDA-approved Phase 1 clinic
al trial
* Prepared and provided scientific presentations/documentation that lead to ven
ture investments, pharmaceutical partner agreements (Green Cross Corp. Osaka, Ja
pan; Chiron Corp., USA), and FDA-approved clinical trials
* Successfully implemented and managed the first retroviral vector gene therapy
toxicology studies
* Provided positive and trusted impact on the management of scientific aspects
of international corporate
partnership (Green Cross Corp., Osaka, Japan) which resulted in increased corpor
ate partner investment
* Significant contribution to the design and supervision of a biological safety
level-3 (BSL-3) containment facility
1985 - 1988: Senior Research Scientist, Immunology Group
Johnson & Johnson Biotechnology Center, San Diego, CA
The J & J Biotechnology Center was established as a technology evaluation/de
velopment group by Johnson & Johnson, Inc., through an alliance with Scripps Cli
nic & Research Foundation (La Jolla, CA). The center's primary focus was the de
velopment of synthetic peptide vaccines for infectious diseases.
* Successfully established immunology group/program and assay capabilities for
the development of peptide vaccines
1984 - 1985: Research Scientist, Human Monoclonal Antibody Group
Hybritech Incorporated, San Diego, CA
Hybritech, Inc. was one of the first publicly traded (NASDAQ) monoclonal ant
ibody companies involved in the development of antibody-based diagnostic and the
rapeutic products. The company was purchased by Eli Lilly Pharmaceuticals in 198
6.
* Established and directed in vitro sensitization project for human B cell mono
clonal antibody development
EDUCATION:
Ph.D., Microbiology/Immunology, State University of New York, Buffalo, NY
Graduate Researcher, Immunohematology, Hopital St. Louis, Paris, France
(Laboratory of Dr. Jean Dausset, 1980 Nobel Laureate in Physiology/Medicine-Disc
overy of HLA system)
M.S. and B.Sc., Bacteriology, University of Idaho, Moscow, Idaho
POST-DOCTORAL TRAINING:
The Salk Institute for Biological Studies, La Jolla, CA
Research Associate, Dept. of Cancer Biology
* Determined the in vivo functional role of cloned natural killer (NK) cells in
the context of leukemogenesis, bone marrow graft rejection, and the control of
Leishmania infections
University of California, San Diego, CA
Postdoctoral Fellow, Dept. of Biology
* Focus on B and T cell cytokine functions and cellular interactions