G LOBAL V ACCINES
A NOT-FOR-PROFIT VACCINE COMPANY
Photograph by Dr. Clive Gray
Photograph by Clive Gray
Biography
Robert E. Johnston, Ph.D.
• Academic Positions
•Assistant, Associate, Full Professor of Microbiology, North Carolina State University (1976-1989)
•Professor of Microbiology and Immunology, University of North Carolina (1989-present)
•Director, Carolina Vaccine Institute, University of North Carolina (2002-present)
• Research
•Molecular Genetics of Viral Disease
•Design of Vaccines
•Development of New Vaccine Technologies
•Vaccine for clade C Human Immunodeficiency Virus
• Fourteen U. S. Patents
• $14.8MM in Active Research Grants
• Business Experience
•Principal Co-Founder, Chairman and CEO of AlphaVax, Inc. (1997-2001)
•Secured over $5MM in licensing, grant and equity funding
Global Vaccines, Inc.
Concept for a UNC Vaccine Center
Academic Vaccine
Research Center
Fundamental Aspects of
Vaccines
Antigenic Structure and
Pathogenesis
Vaccine Technologies
Vaccine and Vaccine
Technology Development
Vaccine R & D
Teams for Diseases
of Resource Poor
Populations
In-licensing Vaccine
Technology
Business Infrastructure for
Vaccine Development
Partnerships with Commercial
Vaccine Manufacturers
Not-for-Profit
Business
Carolina Vaccine Institute,
University of North
Carolina Chapel Hill
Global Vaccines, Inc.,
Research Triangle Park,
North Carolina
Global Vaccines, Inc.
A Not-for-Profit Vaccine Company
Mission Statement
Global Vaccines will apply state-of-the-art
vaccine technologies and innovative business
strategies to the design and development of
affordable vaccines for diseases of resource
poor nations.
Global Vaccines, Inc.
Global Vaccines: Scientific Advisors
•Mary Estes, Ph.D. – Baylor College of Medicine; Former Member, Vaccines
Advisory Committee, FDA.
•Harry B. Greenberg, M.D. – Stanford University; Former Chief Scientific
Officer, Aviron.
•Samuel Katz, M.D. – Duke University; Inventor of the measles vaccine;
Chairman, Board of Trustees, International Vaccine Institute, Seoul, Korea;
Former Member, Vaccines Advisory Committee, FDA.
•Thomas Monath, M.D. – Former Chief Scientific Officer, Acambis, plc; Adjunct
Professor, Harvard School of Public Health; Senior Advisor, Kleiner Perkins
Caufield & Byers.
•Peter Palese, Ph.D. – Mount Sinai School of Medicine; Member, Vaccines
Advisory Committee, FDA; Member, National Academy of Sciences.
•Barbara Sherry, Ph.D. – North Carolina State University; Veterinary vaccines.
•Catherine Wilfert, M.D. – Duke University; Scientific Director, Elizabeth
Glaser Pediatric AIDS Foundation.
Global Vaccines, Inc.
Global Vaccines: Founding Board of Directors
•Joseph S. Pagano, Chairman
Director Emeritus, Lineberger Comprehensive Cancer Center,
Professor of Medicine, University of North Carolina
•Dennis McNamara, Secretary
Vice-President, Business Development, Pozen Corporation
•Robert E. Johnston, Executive Director
Director, Carolina Vaccine Institute, Professor of Microbiology
and Immunology, University of North Carolina
Global Vaccines, Inc.
Rationale for Global Vaccines, Inc.
• The developing world caries an enormous disease
burden, e.g. HIV, tuberculosis, dengue fever and
malaria.
• Causative organisms known for decades; still no
effective, affordable vaccines.
• Why this stunning lack of success?
• Substantial technological challenges.
• Insufficient projected market potential for the
commercial vaccine industry.
Global Vaccines, Inc.
Vaccine development and distribution
choices are dictated by market forces
rather than global public health need.
AN
EFFECTIVE
UNAFFORDABLE
=
NO
VACCINE
VACCINE
Global Vaccines, Inc.
Global Vaccines, Inc.
Limitations of the Vaccine Enterprise
• Commercial Vaccine Companies – Fiduciary
responsibilities to shareholders; internal rate of return
relative to other endeavors.
• University Laboratories – We make discoveries, but
we seldom make products.
• University Technology Offices – No alternative
licensing pathways other than commercial concerns.
• Low Cost Vaccine Manufacturers – Operate like
generic drug companies relying on vaccines coming
off patent as a product pipeline.
Global Vaccines, Inc.
Global Vaccines, Inc.
Traditional Technology Licensing Strategy
Proof-ofConcept
Commercial Company
License to
Company
License
Fee
Royalties, etc.
University Vaccine
Technology
Global Vaccines
Non-Commercial Vaccine
Markets; Orphan Vaccines
License for
Resource Poor
Countries
Commercial Vaccines;
Non-Vaccine
Applications
• Black eye syndrome
• Gray market product
• Technology leakage
Global Vaccines, Inc.
Traditional Technology Licensing Strategy
Proof-ofConcept
Commercial Company
License to
Company
License
Fee
Royalties, etc.
University Vaccine
Technology
Global Vaccines
Commercial Vaccines;
Non-Vaccine
Applications
Wait 20 years for
patent expiration
Non-Commercial Vaccine
Markets; Orphan Vaccines
Global Vaccines, Inc.
Traditional Technology Licensing Strategy
Proof-ofConcept
Commercial Company
The useful benefits of academic science,
overwhelmingly funded from government and
philanthropic sources, are most often provided
License to
License
only
to
wealthy
countries with little or no
Company
Fee
benefit to those populations most in need.
Royalties, etc.
University Vaccine
Technology
Commercial Vaccines;
Non-Vaccine
Applications
Government Grants
Philanthropies
Global Vaccines, Inc.
How does Global Vaccines propose to
intervene in this cycle and overcome
these limitations?
Global Vaccines, Inc.
GVI Technology Licensing and Partnering Strategy
Commercial Partner
Grant Supported
Joint Research
Commercial Vaccine Markets;
Non-Vaccine Applications
Commercial
Sublicense
Global
Vaccines
License to GVI
Initial
License
Fee
HIV
Dengue
Proof-ofConcept
Added Value
License Fee,
Royalties, etc.
VaccineP
roduct
University Vaccine
Technology
Global Vaccines
License Fee,
Royalties, etc.
Non-Commercial Vaccine
Markets; Orphan Vaccines
Low Cost
Manufacturing
Partner
Global Vaccines, Inc.
Everyone Wins
• Poor populations get needed vaccines.
• Inventors and their universities get a potentially larger
and more timely return on their inventions.
• Developing country manufacturers get a high
technology product pipeline relevant to the populations
they serve.
• Commercial vaccine companies get the opportunity to
license more mature and less risky technology for use in
commercial vaccine markets.
Global Vaccines, Inc.
Is there any chance at all that Global
Vaccines can succeed?
• Are there high quality platform vaccine technologies available for Global
Vaccines to license?
• YES. A number of exciting, early stage technologies are available for
licensing.
• Can Global Vaccines compete in licensing University technologies?
• YES. We have successfully licensed two important new technologies from
the University of North Carolina.
• Can Global Vaccines pursue proof-of-concept research?
• YES. We have successfully competed for grant funding in support of our
two licensed technologies. International AIDS Vaccine Initiative (12/1/0512/30/12, $3.5M); Bill and Melinda Gates Foundation through IAVI (7/13/067/12/11, $1.75M); and National Institutes of Health (9/1/06-8/31/10, $5.4M).
• Can Global Vaccines finance business development and patenting
strategies?
• MAYBE. These costs must be covered with non-research grant funds such
as private contributions, foundation support or partnering revenue.
Global Vaccines, Inc.
GVI Technology Licensing and Partnering Strategy
Philanthropic Support Needed:
Business Infrastructure
Commercial Partner
Grant Supported
Initial License Fees / Patent Costs
Preliminary Data in Support of
Research Grant Applications
Commercial Vaccine Markets;
Non-Vaccine Applications
Joint Research
Link with Low Cost Partners
Commercial
Sublicense
Global
Vaccines
License to GVI
Initial
License
Fee
HIV
Dengue
Proof-ofConcept
Added Value
License Fee,
Royalties, etc.
VaccineP
roduct
University Vaccine
Technology
Global Vaccines
License Fee,
Royalties, etc.
Non-Commercial Vaccine
Markets; Orphan Vaccines
Low Cost
Manufacturing
Partner
Global Vaccines, Inc.
GVI Licensed Technologies
• Live Virus Vaccines – Vaccines designed and built
from scratch.
Chimeric Particle Production in
Vero Cells
Carolina Vaccine Institute
GVI Licensed Technologies
• Live Virus Vaccines – Self-replicating immunogens
designed and built from scratch.
• Mucosal Adjuvant – System capable of boosting the
effectiveness of inactivated vaccines like polio,
influenza and HPV by 10-100 fold and inducing
protection against pathogens transmitted by the
respiratory or sexual routes.
Footpad Immunization with Inactivated Influenza
Virions and Null VRP
120
600
200
Fecal I gA
Fecal I gG
Ser um I gG
175
100
500
150
60
ELI SA Tit er
400
ELI SA Tit er
4
ELI SA ( x10
)
80
300
125
100
75
40
200
50
20
100
25
0
0. 1
1. 0
I - Flu Dose ( ug)
0
0. 1
1. 0
I - Flu Dose ( ug)
0
0. 1
1. 0
I - Flu Dose ( ug)
Vaccines at the University of North Carolina
Academic Vaccine
Research Center
Fundamental Aspects of
Vaccines
Antigenic Structure and
Pathogenesis
Vaccine Technologies
Vaccine and Vaccine
Technology Development
Vaccine R & D
Teams for Diseases
of Resource Poor
Populations
In-licensing Vaccine
Technology
Business Infrastructure for
Vaccine Development
Partnerships with Commercial
Vaccine Manufacturers
Not-for-Profit
Business
Photograph by Dr. Kim Lindblade
Knowing is not enough; we must apply.
Willing is not enough; we must do.
(Goethe)
G LOBAL V ACCINES
A NOT-FOR-PROFIT VACCINE COMPANY