Enhancing Technology Transfer For Neglected Tropical Disease (NTD)

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1 Enhancing Technology Transfer For Neglected Tropical Disease (NTD) Steven M. Ferguson, CLP Deputy Director, Licensing & Entrepreneurship

2 Health Research In Global Markets Needs Humanitarian Objectives Globalization of Health Problems & Relevance to Domestic Health Economic Development & International Relations

3 Technology Transfer Supports Global Public Health Movement of information, materials & technologies from research labs to development enterprises. Supports further research and develop for new products for public health. Important Common Goals for both international institutions and NIH.

4 NIH Office of Technology Transfer (OTT) Patenting and licensing of intramural NIH inventions 6000 scientists in the intramural program 3500 US Patents, 1000 s biological materials 1400 active licenses: 85% non-exclusive and 80% US 25 FDA approved products to date with 52 products currently in clinical trials

5 Variety of Tools Useful For NTD Technology Transfer Patents & Licensing to biotech / pharma Patents & Licensing to regional firms Patents & Licensing to NGOs Patent Pooling (Medicines HIV Patent Pool) International TT Mentoring Program WIPO Re:Search Program

6 NIH IP & Licensing -- General Principles Technology based on request and need of recipient institution/company Granting only the appropriate scope of rights Reserve nonexclusive rights for research Preference for non- or partial exclusivity Enforceable milestones and benchmarks Maximize development of products for the public health Ensure appropriate return on public investment

7 Why Might Additional Approaches Be Needed? Case Study: Vaccine Research at the NIH Primary Areas: HIV, Influenza, Rotavirus, Dengue, PIV and RSV, Ebola, HPV, Bacterial Diseases Basic Research Live attenuated Recombinant DNA and vectored vaccines Protein based vaccines Virus Like Particles (VLP) Conjugate vaccines (bacterial polysaccharides) Adjuvants Clinical trials Pilot plant and GMP manufacturing facility off site

8 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. Didn t always meet public health needs Difficult regulatory strategy (combo product)

9 Success To Date Licensed Technologies: Rotavirus, Hepatitis A, Human Papilloma Virus To Companies Such As: GSK GSK Merck Wyeth Havirx Cevarix Gardasil RotaShield

10 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

11 Licensing of Vaccines with Global Health Significance: Alternate Strategy Possible support by NIH 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

12 Success To Date Licensed Technologies: Dengue, Typhoid, Meningococcal, Rotavirus, Hepatitis A, HPV and Varicella- Zoster Vaccine Technologies To Institutions in: Brazil Mexico Indonesia China Nigeria Egypt South Africa India Vietnam Korea (for SE Asia) WHO and PATH (for Africa)

13 Dengue Vaccine Live Attenuated Tetravalent 1-4 vaccine Licensees: Biological E India Panacea India Butantan Brazil Vabiotech Vietnam NIH and Butantan of Brazil are working closely with PDVI (Pediatric Dengue Vaccine Initiative) to move forward with clinical trials. Technology is also being currently evaluated by several Pharmaceutical companies Licensees received seed viruses and other biological materials to support the development of the vaccine

14 Licensees for Human-Bovine Rotavirus Vaccine Technology India Shantha Biotechnics Pvt. Ltd. Bharat Biologicals International Ltd. Biological E Ltd. Serum Institute of India Ltd. (SII) China Wuhan Institute for Biological Products Sinovac Biotech Ltd. Xinkexian (Beijing) Biological Technology Co., Ltd. Brazil and Latin America Fundação Butantan North American and Europe - Aridis Pharmaceuticals Exclusive North America, EU, Brazil. Non-exclusive elsewhere

15 Rotavirus Vaccine Development In China

16 Latest Success: NGO Partnerships MedAfriVac meningitis vaccine Product specific for African market 100M doses since Dec 2010 NIH license to PATH Manufactured by Serum Institute (India)

17 Improving Health Through Regional Technology Licensing Strategies Increased emergence of pharma & biotech outside of U.S., Europe, etc. Regional firms interested in outside technology Certain technologies (e.g. vaccines) good match for regional firm capabilities Top regional firms/markets : India, China, Brazil Separate agreements for Western markets

18 General Mechanisms For Supporting Regional Collaborations Direct financial support from NIH or foundations Indirect financial support from NIH for collaborative projects Technology transfer through informal collaborations with NIH laboratories Collaborations concerning natural products or alternative medicine

19 Mechanisms For Collaborations (Cont.) Formal technology transfer from NIH (license, CRADA, MTA mechanisms) Informal collaborations between individual scientists Training grants for foreign scientists to support collaborations from the Fogarty International Center (

20 Patent Pooling: NIH Joins MPP Pool For Darunavir License agreement to Medicines Patent Pool Sub-license pooled IP For use in low & middle income countries

21 International TT Mentoring Program Supports NTD Regional Development Mentoring Program With Local Technology Transfer Research Institutions (Capacity Building For NTD & Other Needs) China, Brazil, South Africa, India, Argentina, Hungary, The Philippines, Mexico, Chile, Korea, Gulf States, Croatia & others have sent trainees.

22 International Technology Transfer Mentoring Program 6-8 Week Program Covers Different aspects of IP management & policy Assessment & commercialization of technologies Exposure to practical aspects of license agreements Business development courses from NIH Graduate School Understand global challenges of biomedical product development

23 Latest Effort: WIPO Re:Search NIH joined October 16, 2011 RSS Feed of NTD-related technologies available for licensing / collaboration. Facilitate interactions across scientific disciplines & regions Several projects have already started in related to dengue and malaria

24 WIPO Re: Search Partnership Hub Activity Dengue Collaboration Dennis Liotta (Emory University) and Cristina Cassetti (NIAID). Future Malaria Collaborations Two NIH technologies highlighted in newsletter as potential opportunities.