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Coalition for Epidemic Preparedness Innovations New Vaccines for a Safer World

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Coalition for Epidemic Preparedness Innovations New Vaccines for a Safer World Coalition for Epidemic Preparedness Innovations New vaccines for a safer world Frederik Kristensen DCVMN Annual Meeting 25 October 2016 FOUNDING PARTNERS The challenge of epidemics Calls for global action CEPI - January - June Task Team Interim CEO High Level Task Team Leadership Meeting, Oslo appointed Meeting Tele- Group Meeting 6-7 April and constituted Davos conferences Washington DC Business Plan 21 January 17 May presented to stakeholders CEPI - July - September UNGA side Core Group First CEPI G7 Health event on health and CEPI soft interim board ministers’ side emergencies, Leadership launch meeting event, NY, Group Tele- Media London, Kobe, 19 September conferences coverage 31 August 10 September Challenges The pipeline is weak for most emerging infectious 1 diseases characterized by lack of market incentives Unilateral, uncoordinated government efforts to 2 fund R&D preparedness are inefficient and unsustainable in addressing global epidemic risks Clinical & regulatory pathways are not easily 3 adaptable to epidemic contexts Incentives are lacking to motivate 4 greater industry engagement Vaccine pipelines 45 40 35 30 25 20 15 10 5 0 Academic Government agency Biotech MNC Non-profits Preclinical Phase I Phase II Phase II/III Phase III Opportunities The Ebola momentum: vaccines are a feasible strategy, 1 despite a risky development pathway The Ebola momentum: it is possible to advance the 2 clinical development of safe and effective vaccines against EIDs in an emergency R&D actors supporting EID vaccine pipelines: 3 government health research agencies, academic research institutions, biotechs, vaccine manufacturers, and non-profits Manufacturing capability and capacity for vaccines has 4 always been a critical bottle-neck in epidemic events. Incentivize vaccine manufacturers to drive pipelines forward CEPI’s Approach Vaccines can prevent outbreaks from becoming health, economic and Vision humanitarian crises. Prioritize, stimulate, finance and coordinate vaccine development against EIDs with epidemic potential, especially in Mission cases where market incentives alone do not achieve this. End-to-end approach to vaccine development 1. Advance EID vaccines through late preclinical studies to proof of concept and safety in humans, and Scope 2. Develop platforms that can be rapidly deployed against known and unknown pathogens. 11 Strategic objectives 2017-’21 1 Improved Preparedness 2 Accelerated Response 3 Market predictability 4 Equity CEPI’s Roles Funder and Coordinator CEPI role as a coordinator Significant focus by others CEPI role as a funder Significant focus by others 1 2 3 4 Phase Discovery Development/Licensure Manufacturing Delivery/Stockpiling Current Academia Industry Industry GAVI Stakeholders Governments National Governments BARDA UNICEF WT/NIH Regulators CMOs PAHO GLOPID-R Bill and Melinda Gates Regulators National Governments Industry Foundation National WHO Regulators BARDA/DTRA etc. Governments Industry Biotech WHO WHO Pandemic Emergency Biotech GHIF Facility PDPs (World Bank) WHO Contingency Fund 13 CEPI’s operating principles 1 Equitable access 2 Cost coverage 3 Shared risks and benefits Organizational Setup: Startup Phase • Founding Partners are the Gates Foundation, Wellcome Trust, Department of Biotechnology of India, Government of Norway, and World Economic Forum • Independent legal entity; an international non-profit association under Norwegian law • Interim Secretariat is hosted by the Norwegian Institute of Public Health under a service agreement • Flexible arrangement, can transition into other institutional and governance arrangements • The permanent organizational structure and governance will be made by the CEPI Interim Board prior to launch • SAC advises on scientific matters and JCG coordinates CEPI’s activities with other stakeholders 15 CEPI Interim Board Yah Zolia K. Vijay Raghavan, chair Jeremy Farrar Joanne Liu Deputy Minister of Health and Secretary, Department of Director, Wellcome Trust International President Social Welfare, Liberia Biotechnology Medecins sans Frontieres Ministry of Science and Trevor Mundel Observers Technology, India President Global Health Victor Dzau Division President of the Institute of Marie-Paule Kieny Peter Piot, vice chair The Bill & Melinda Gates Medicine Assistant Director-General World Health Organization Director of the LSHTM Foundation National Academy of Sciences Mark Feinberg (Chair of SAC) Jane Halton Adar Poonawalla President & Chief Executive Permanent Secretary CEO and Executive Director Arnaud Bernaert Officer, IAVI Department of Finance, Australia Serum Institute of India Head of Global Health and Peggy Hamburg (Chair of JCG) Healthcare Industries Foreign Secretary of the Institute Tore Godal Nima Farzan World Economic Forum of Medicine Special Adviser on Global Health President and CEO National Academy of Sciences MFA, Norway PAXVAX INC. Ruxandra Draghia-Akli Deputy director-general of John-Arne Røttingen Interim CEPI CEO Christopher Whitty Julie Gerberding DG RTD, EC Chief Scientific Adviser Executive Vice President Nicole Lurie Department of Health, UK Merck Eduardo de Azeredo Assistant Secretary, Costa, Technical Advisor, Department of HHS, US (serving in a liaison position) Kesetebirhan Admasu Moncef Slaoui Center for International Minister of Health, Ethiopia Chairman of vaccines Affairs in Health, Fiocruz 26/10/2016 GSK 16 CEPI interim SAC Mark Feinberg (Chair) David Wood James Robinson International AIDS Vaccine Initiative World Health Organization James Robinson Biologics Consulting Alan D. Barrett George Fu Gao University of Texas Medical Branch Chinese Center for Disease Control and Prevention Maharaj Kishan Bhan JIPMER Amadou Sall Institute Pasteur Dakar Gunnstein Norheim Peter Smith Bernard Fanget Norwegian Institute of Public Health London School of Hygiene and Tropical Medicine Abivax, Neovacs Heinrich Feldman NIH National Institute of Allergy and Chery Gagandeep Kang Infectious Diseases Rick Bright Christian Medical College Vellore Biomedical Advanced Research Helen Rees and Development Authority Connie Schmaljohn Wits Reproductive Health and HIV (BARDA) University of Maryland Institute Stanley Plotkin Daniel Brasseur Jesse Goodman VaxConsult Eurpoean Commission Georgetown University Subhash Kapre David Kaslow Kathleen Neuzil PATH/CIVA University of Maryland Inventprise 26/10/2016 17 CEPI’s Funding Needs Preliminary cost- modeling estimates* 5-year costs for advancement of 10 WHO Blueprint EID vaccine candidates to the end of clinical phase IIa development at between US$600M and US$3.7B, depending on the complexity of the technology used, pilot manufacturing CEPI is seeking multi-year donor contributions to requirements and an initial investment pool of US$1B (2017-21) other manufacturing to advance late-stage development of 4 to 6 cost variants, and vaccine candidates against 2 to 3 priority EIDs stockpiling needs. to the end of clinical phase II development, and save countless lives and billions of dollars. * Details on cost estimates and assumptions are available upon request. 18 CEPI Financing Model CEPI will use a multi-source financing model to satisfy its core resource needs. Four financing principles 1. Broad-based 2. Long term, predictable 3. Complementary and new financial resources 4. Fit-for-purpose funding Next Steps Sept Oct Nov Dec Jan 2017 Start Up Phase Formalize Commitments Launch Partnership Scientific Advisory Joint Coordination Secure initial funding Announce CEPI initial Committee Group Meeting, and other investment priorities and Meeting, 18 November 2016 partnership partner commitments at 20 and 21 October (GENEVA) commitments formal CEPI launch at (NY) annual World Economic 2nd Interim Board Forum meeting Meeting January 2017 16 December 2016 (DAVOS) (DELHI) 22.
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