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G L O B A L V A C C I N E S A NOT-FOR-PROFIT VACCINE COMPANY
G L O B A L V A C C I N E SA NOT-FOR-PROFIT VACCINE COMPANY
Photograph by Dr. Clive Gray Photograph by Clive Gray
BiographyRobert 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.
Academic Vaccine Research Center
Fundamental Aspects of Vaccines
Antigenic Structure and Pathogenesis
Vaccine Technologies
Not-for-Profit Business
Vaccine R & D Teams for Diseases
of Resource Poor Populations
Vaccine and Vaccine Technology Development
In-licensing Vaccine Technology
Business Infrastructure for Vaccine Development
Partnerships with Commercial Vaccine Manufacturers
Concept for a UNC Vaccine Center
Global Vaccines, Inc., Research Triangle Park,
North Carolina
Carolina Vaccine Institute, University of North Carolina Chapel Hill
Global Vaccines, Inc.A Not-for-Profit Vaccine Company
Global Vaccines, Inc.
Mission StatementGlobal 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.
•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: Scientific Advisors
Global Vaccines, Inc.
•Joseph S. Pagano, ChairmanDirector Emeritus, Lineberger Comprehensive Cancer Center, Professor of Medicine, University of North Carolina
•Dennis McNamara, SecretaryVice-President, Business Development, Pozen Corporation
•Robert E. Johnston, Executive DirectorDirector, Carolina Vaccine Institute, Professor of Microbiology and Immunology, University of North Carolina
Global Vaccines: Founding Board of Directors
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.
AN
EFFECTIVE
UNAFFORDABLE
VACCINE
NO
VACCINE=
Global Vaccines, Inc.
Vaccine development and distribution choices are dictated by market forces rather than global public health need.
Global Vaccines, Inc.
• 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.
Limitations of the Vaccine Enterprise
Global Vaccines, Inc.
Global Vaccines, Inc.
Proof-of-Concept
Traditional Technology Licensing Strategy
License Fee
License to Company
Commercial Company
Global VaccinesNon-Commercial Vaccine Markets; Orphan Vaccines
Commercial Vaccines; Non-Vaccine Applications
Royalties, etc.
License for Resource Poor Countries
Global Vaccines, Inc.
• Black eye syndrome
• Gray market product
• Technology leakage
University Vaccine Technology
Proof-of-Concept
Traditional Technology Licensing Strategy
License Fee
License to Company
Commercial Company
Global VaccinesNon-Commercial Vaccine Markets; Orphan Vaccines
Commercial Vaccines; Non-Vaccine Applications
Royalties, etc.
Wait 20 years for patent expiration
Global Vaccines, Inc.
University Vaccine Technology
University Vaccine Technology
Proof-of-Concept
Traditional Technology Licensing Strategy
License Fee
License to Company
Commercial Company
Commercial Vaccines; Non-Vaccine Applications
Royalties, etc.
Global Vaccines, Inc.
Government Grants
Philanthropies
The useful benefits of academic science, overwhelmingly funded from government and philanthropic sources, are most often provided only to wealthy countries with little or no benefit to those populations most in need.
How does Global Vaccines propose to intervene in this cycle and overcome
these limitations?
Global Vaccines, Inc.
University Vaccine Technology
Proof-of-Concept
Global Vaccines
License to GVI
License Fee, Royalties, etc.
GVI Technology Licensing and Partnering Strategy
Initial License
Fee
Commercial PartnerCommercial Vaccine Markets;
Non-Vaccine Applications
Global VaccinesNon-Commercial Vaccine Markets; Orphan Vaccines
Global Vaccines, Inc.
HIV
Dengue Added Value
Low CostManufacturing
Partner
VaccineProduct
License Fee, Royalties, etc.
Commercial Sublicense
Grant Supported Joint Research
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.
Is there any chance at all that Global Vaccines can succeed?
Global Vaccines, Inc.
• 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 (12/1/05-12/30/12, $3.5M); Bill and Melinda Gates Foundation through IAVI (7/13/06-7/12/11, $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.
Philanthropic Support Needed:
Business Infrastructure
Initial License Fees / Patent Costs
Preliminary Data in Support of Research Grant Applications
Link with Low Cost Partners
University Vaccine Technology
Proof-of-Concept
Global Vaccines
License to GVI
Grant Supported Joint Research
License Fee, Royalties, etc.
GVI Technology Licensing and Partnering Strategy
Initial License
Fee
Commercial PartnerCommercial Vaccine Markets;
Non-Vaccine Applications
Global VaccinesNon-Commercial Vaccine Markets; Orphan Vaccines
Global Vaccines, Inc.
HIV
Dengue Added Value
Low CostManufacturing
Partner
VaccineProduct
License Fee, Royalties, etc.
Commercial Sublicense
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.
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0.1 1.0I-Flu Dose (ug)
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Serum IgG Fecal IgG Fecal IgA
Footpad Immunization with Inactivated Influenza Virions and Null VRP
Academic Vaccine Research Center
Fundamental Aspects of Vaccines
Antigenic Structure and Pathogenesis
Vaccine Technologies
Not-for-Profit Business
Vaccine R & D Teams for Diseases
of Resource Poor Populations
Vaccine and Vaccine Technology Development
In-licensing Vaccine Technology
Business Infrastructure for Vaccine Development
Partnerships with Commercial Vaccine Manufacturers
Vaccines at the University of North Carolina
Knowing is not enough; we must apply.Willing is not enough; we must do.
(Goethe)Photograph by Dr. Kim Lindblade
G L O B A L V A C C I N E SA NOT-FOR-PROFIT VACCINE COMPANY
