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G L O B A L V A C C I N E S A N OT -F OR -P ROFIT V ACCINE C OMPANY

G L O B A L V A C C I N E S A N OT -F OR -P ROFIT V ACCINE C OMPANY. 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)

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G L O B A L V A C C I N E S A N OT -F OR -P ROFIT V ACCINE C OMPANY

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  1. GLOBAL VACCINES A NOT-FOR-PROFIT VACCINE COMPANY

  2. Photograph by Dr. Clive Gray Photograph by Clive Gray

  3. 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.

  4. Academic Vaccine Research Center Not-for-Profit Business Concept for a UNC Vaccine Center Vaccine and Vaccine Technology Development In-licensing Vaccine Technology Business Infrastructure for Vaccine Development Partnerships with Commercial Vaccine Manufacturers Fundamental Aspects of Vaccines Antigenic Structure and Pathogenesis Vaccine Technologies Vaccine R & D Teams for Diseases of Resource Poor Populations

  5. Global Vaccines, Inc., Research Triangle Park, North Carolina Carolina Vaccine Institute, University of North Carolina Chapel Hill

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. Vaccine development and distribution choices are dictated by market forces rather than global public health need. AN EFFECTIVE UNAFFORDABLE VACCINE NO VACCINE = Global Vaccines, Inc.

  11. Global Vaccines, Inc.

  12. 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.

  13. Global Vaccines, Inc.

  14. Commercial Company Commercial Vaccines; Non-Vaccine Applications Proof-of-Concept License to Company License Fee University Vaccine Technology Royalties, etc. License for Resource Poor Countries Global Vaccines Non-Commercial Vaccine Markets; Orphan Vaccines Traditional Technology Licensing Strategy • Black eye syndrome • Gray market product • Technology leakage Global Vaccines, Inc.

  15. Commercial Company Commercial Vaccines; Non-Vaccine Applications Proof-of-Concept License to Company License Fee University Vaccine Technology Royalties, etc. Wait 20 years for patent expiration Global Vaccines Non-Commercial Vaccine Markets; Orphan Vaccines Traditional Technology Licensing Strategy Global Vaccines, Inc.

  16. Commercial Company Commercial Vaccines; Non-Vaccine Applications Proof-of-Concept License to Company License Fee University Vaccine Technology Royalties, etc. Government Grants Philanthropies Traditional Technology Licensing Strategy 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. Global Vaccines, Inc.

  17. How does Global Vaccines propose to intervene in this cycle and overcome these limitations? Global Vaccines, Inc.

  18. GVI Technology Licensing and Partnering Strategy Commercial Partner Commercial Vaccine Markets; Non-Vaccine Applications Grant Supported Joint Research Global Vaccines Commercial Sublicense License Fee, Royalties, etc. Proof-of-Concept Initial License Fee License to GVI University Vaccine Technology VaccineProduct Global Vaccines Non-Commercial Vaccine Markets; Orphan Vaccines License Fee, Royalties, etc. HIV Dengue Added Value Low Cost Manufacturing Partner Global Vaccines, Inc.

  19. 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.

  20. 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 (12/1/05-12/30/12, $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. Global Vaccines, Inc.

  21. GVI Technology Licensing and Partnering Strategy Commercial Partner Commercial Vaccine Markets; Non-Vaccine Applications Grant Supported Joint Research Global Vaccines Commercial Sublicense License Fee, Royalties, etc. Proof-of-Concept Initial License Fee License to GVI University Vaccine Technology VaccineProduct Global Vaccines Non-Commercial Vaccine Markets; Orphan Vaccines License Fee, Royalties, etc. Philanthropic Support Needed: Business Infrastructure Initial License Fees / Patent Costs Preliminary Data in Support of Research Grant Applications Link with Low Cost Partners HIV Dengue Added Value Low Cost Manufacturing Partner Global Vaccines, Inc.

  22. GVI Licensed Technologies • Live Virus Vaccines – Vaccines designed and built from scratch.

  23. Chimeric Particle Production in Vero Cells Carolina Vaccine Institute

  24. 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.

  25. Footpad Immunization with Inactivated Influenza Virions and Null VRP

  26. Academic Vaccine Research Center Not-for-Profit Business Vaccines at the University of North Carolina Vaccine and Vaccine Technology Development In-licensing Vaccine Technology Business Infrastructure for Vaccine Development Partnerships with Commercial Vaccine Manufacturers Fundamental Aspects of Vaccines Antigenic Structure and Pathogenesis Vaccine Technologies Vaccine R & D Teams for Diseases of Resource Poor Populations

  27. Knowing is not enough; we must apply.Willing is not enough; we must do.(Goethe) Photograph by Dr. Kim Lindblade

  28. GLOBAL VACCINES A NOT-FOR-PROFIT VACCINE COMPANY

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