technology transfer with the - who · award recognition: 2014 les “deals of distinction™” •...
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NIAID TTIPO/NIH OTT Science. Ideas. Breakthroughs.
Peter Soukas, J.D., Technology Licensing Specialist NIAID/Technology Transfer and Intellectual Property
Office February 22, 2016 (MenAfriVac Closure Conference)
Technology Transfer With The Human Element:
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Vaccine Technologies with Global Health Significance: Traditional
Approach • IP filings in US, EPO, Canada, Australia & Japan • Exclusive licensing of single large company • Focus on large market indications • Other indications often still focused only on
Western markets – e.g. traveler’s vaccines. Ø Didn’t always meet public health needs
Ø Difficult regulatory strategy (combo product)
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Vaccine Technologies with Global Health Significance: Alternate
Strategy • Regional approach taking into consideration the needs
of OECD and Emerging and LDC markets
• Outside OECD Countries, preference for local/regional vaccine manufacturing organizations • More rapid market entry and uptake in developing countries
• Driven by local public health and business needs
• Consider filing for patent protection in countries where vaccines will be produced and licensing unpatented biological materials
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Licensing of Vaccines with Global Health Significance: Alternate Strategy
• Possible support by NIH/FDA during development period • Consultation • Biological materials • Clinical trial collaboration • Collaborative R&D Agreements (CRADAs)
• Licensing technologies to global NGOs (PATH, IVI, IAVI, AERAS) to partner with regional vaccine producers
• US and European Licensees • Mechanisms for distribution in developing countries: directly,
requirements for sublicensing, or by limiting the geographic scope of each license
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The Lee / Frasch Patented Conjugation Method
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MenAfriVac Patent Rights • Original provisional application filed
August 6, 2003 • US, EP, IN, BR, CN, AU, CA, ZA • Cover three variations of new conjugation
method • Many patent rights issued; some pending • US Patents: 8,048,432; 8,465,749;
8,753,649
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MenAfriVac License Agreement • Nonexclusive to PATH
• Sublicense to SII
• Concurrent with CRADA for co-development with FDA/CBER
• Limited Territory (meningitis belt + developing world)
• Territory has a twist (i.e. sales to WHO or other NGO)
• Agreement incorporates vaccine cost considerations
• Development timeline did not need to be amended (PATH’s projections were accurate for development of vaccine)
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More Licensees/Technology Complications
• Technology is licensed to South African private entity and Chinese private entity
• One application pending from Asian manufacturer
• Aware of use by at least one other party without license agreement (Indonesian manufacturer)
• Proven technology available for licensing from FDA (NIH no longer handles FDA technology transfer)
• FDA has further improvements/methods available for licensing (contacts can be provided at FDA)
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Carl Frasch (top photo far left) and Robert Lee (bottom photo, second from left) hosted SIIL scientists to teach them the critical laboratory techniques for making the new meningitis A conjugate vaccine.
Personal Side of Tech Transfer: Teaching and Training
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Serum Institute of India Ltd. (SIIL) § Largest “emerging supplier” § World’s largest producer of measles and DTP § Two-thirds of the world’s immunized children are vaccinated by a vaccine
manufactured by SIIL Partnered with the Meningitis Vaccine Project to develop an
affordable (< $US 0.50 per dose) vaccine designed specifically for Africa to protect against meningococcal meningitis under sublicense of the FDA technology by NIH.
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Successful Model With NGO Partnerships
• MenAfriVac® license model for other NGO agreements
• Successful product specific for African market
• Incidence to zero in vaccinated areas
• 250 million doses provided • Cold chain not required • Introduced into 26 African
countries
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Award Recognition: 2014 LES “Deals of Distinction™”
• One of the top national awards given for technology transfer activities by Licensing Executives Society • The “return on investment" goal for the NIH / FDA is not financial, but rather maximizing the public health impact of license agreement
• Showcases "intriguing model" of vaccine development for developing countries
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Acknowledgements/Contact • NIH/OTT: S. Ferguson, U. Reichman, S. Ano • NIAID/TTIPO: M. Mowatt, R. Williams • FDA: A. Welch, B. Ronnenberg, B. Droke • FDA/CBER: R. Lee, D. Murphy • SII: M. LaForce, M. Karkare • PATH: M. LaForce, C. Ottoson, S. Haralson,
C. Hennings • Contact Information: Email: [email protected],
Phone: 301-496-2644