Vaccine Innovation Who Pays? Product Development Partnerships. Vaccine Research and Innovation Dr Odile Leroy March 2014

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1 Vaccine Innovation Who Pays? Product Development Partnerships Vaccine Research and Innovation Dr Odile Leroy March

2 PDPs for Diseases of Poverty Differences Shapes and size Scope : ie drugs, diagnosis, vaccine Downstream upstream Budgets and diversity of funding base Broker executor IP ownership Capacity building in the South Commonalities Global approach to product development Industry like business models Taking risks that industry usually will not take Bridging public an private sector Bridging North and South Portfolio approach IP arrangements Strong advocay

3 Integrator or integrated Integrator model (eg. DnDi, MMV, MVI, EVI) Integration model (eg. IAVI, AERAS, Sabin Institute,.) Flexibility not locking in resources Broker approach Overall less control on portfolio management Outsourcing often more complex Loose flexibility Executor approach More control on portfolio management Competitor Risk of tunnel vision

4 European Vaccine Initiative Model Vision: A world free of the intolerable burden of diseases of poverty Mission: To contribute to the global efforts to control diseases of poverty Priorities: Support research addressing public health gaps Strengthen Vaccine R&D Infrastructure in Europe Knowledge sharing: Contribute to technology and knowledge transfer Harmonisation: Support good research practices, and methodologies to generate comparative & reproducible results Translation: Strengthen links and dialogue between scientists, developers, and policy makers Organisation To establish or to strengthen collaboration with EEIG partners Integrator Addressing Translational Gap Service oriented Cross-fertilisation across diseases

5 Portfolio Management P27A P27A AMA1-DICO AMA1 Dico 31 malaria antigens in 29 vaccine formulations, including three specifically targeted at preventing malaria in pregnant women. 15 vaccine candidates into phase I CTs 3 transitioned to partners for phase II CTs in Africa. 16 projects (formulated antigens) ongoing active development Partnering with 46 public institutions (10 in Africa) and 19 private companies

6 P27A AMA1 DICO PAMCPH SPOROVAC PRIMALVAC PIM INNOMALVAC TRANSVAC Bellerophon IDEA MULTIMALVAX EDUFLUVAC I-PROVE PLACMALVAC MVVC MVVC2 P27A EVI PDP supporting scientist by Vaccine development up to phase 2 (core funding from EU MS, yearly call) Coordinate/manage development project (EC/EDCTP projects) Provide services (core funding + EC funding) Provide advice/support 6

7 Mid-term review 2013 Performance % of EVI s budget spent on projects ( 5% relates to project developments costs) 3% overhead/administrative costs. For every 1 euro spent on fundraising, EVI raise almost 87 euros of funds.

8 Innovative Vaccine Research: the point of view of Industry and Biotechs companies 8

9 Vaccine funding by year and sector from Martin Friede and Jean Paul Prieels HIV Vaccine Funding by Year and Sector Total Pharma TB Vaccine Funding by Year and Sector Total Pharma Dengue Vaccine Funding by Year and Sector Total Pharma

10 Patent family count Patents on TB, malaria, HIV, RSV, Dengue All patentees compared to 'big pharma from Martin Friede and Jean Paul Prieels 250 total vaccin patent families 200 patent families 5 major players

11 Mean count of forward citations for top 50 cited patent families % patent families with new patent codes Forward citation count 5 major players other applicants Measures of Innovation: 'non-pharma' exceeds 'big-pharma from Martin Friede and Jean Paul Prieels Unique code clusters 4,5% 4,0% 3,5% 3,0% 2,5% 2,0% 1,5% 1,0% 0,5% 0,0% New patent code 5 major players other applicants

12 Collaboration from Martin Friede and Jean Paul Prieels dengue HIV RSV malaria tuberculosis

13 Acknowledgements EVI donors DGIS Irish Aid German BMBF EC FP6/FP7 EDCTP Subjects in EVI funded clinical trials EVI sub-contractors, CMOs, CROs, Consultants EVI EEIG members Stockholm University, SE Heidelberg University, DE Royal College of Surgeon in Ireland, IE Jenner Vaccine Foundation-University of Oxford, UK Biomedical Primate Research Centre, NL National Institute for Public Health and the Environment, NL EVI Secretariat Odile Leroy Sten Larsen Nathalie Imbault Nicolas Havelange Sophie Houard Nicolas Viebig Stefan Jungbluth Regitze Thoegersen Ines Petersen Flavia D Alessio Celine Dutruel Torsten Kohaut Roland Kleine Harry Van Schooten Jill Iversen 13

14 Thanks for your attention Disclaimer: this presentation reflects only the author s views and the European Union is not liable for any use that may be made of the information contained therein. 14