CEPI NEW FOR A SAFER WORLD

Frederik Kristensen, MD, MBA/MPH Senior Medical Officer October 19, 2016

The challenge of epidemics Calls for global action CEPI - January - June

Task Team Interim CEO High Level Task Team Leadership Meeting, Oslo appointed and Meeting Tele- Group Meeting 6-7 April 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 pipelines

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0 Academic Government agency Biotech MNC Non-profits Preclinical Phase I Phase II Phase II/III Phase III Opportunities

The Ebola momentum: vaccines are feasible despite a 1 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: government health research agencies, academic 3 research institutions, biotechs, multinational vaccine manufacturers, and non-profits

Manufacturing capability and capacity for vaccines has 4 always been a critical bottle-neck in epidemic events. Major vaccine manufacturers can drive pipelines forward New partnership models needed

Sustainable partnership models for product development SUSTAIN- (vaccines, diagnostics, therapeutics) to contain outbreaks of ABLE emerging infectious diseases

Partnership models that fill in the gaps GAP - Need for coordinated and proactive R&D and increased funding FILLING - Stronger advanced development and manufacturing capabilities - Clear and predictable regulatory procedures and improved regulatory coordination

Comprehensive policy ecosystem required with a END-TO- collective end-to-end vision END - Ebola response reviews/panels suggest lack of mechanisms to unite funders, developers, regulators - Effective coordination will require dedicated mechanisms and resources, as well as end-to-end coordination of R&D and access The CEPI response

Rationalize Rationalize and accelerate research and & development responses to new outbreaks accelerate

Coordinate resources across industry, academia, Coordinate governments, philanthropies, and NGOs

Prioritize Prioritize vaccine targets and platform technology & facilitate and facilitate the advanced development of vaccines for emerging infectious diseases Vision

Vaccines contributing to preventing outbreaks from becoming humanitarian crises Mission

To prioritize, stimulate, finance and co-ordinate vaccine development against emerging infections with epidemic potential, especially in cases where market incentives alone do not achieve this Strategic objectives

1 Preparedness

2 Response speed

3 Market predictability

4 Equity CEPI’s Two Roles

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

14 Approach

Gap-filling role

1. Advance new vaccines through late preclinical studies to proof of concept and safety in humans, and

2. Develop platforms that can be rapidly deployed against known and unknown pathogens. CEPI’s operating principles

1 Equitable access

2 Cost coverage

3 Shared benefits Organizational Setup: Startup Phase

• Founding Partners are the Gates Foundation, Wellcome Trust, Department of 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 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

18 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 Center for International Minister of Health, Ethiopia Chairman of vaccines Affairs in Health, Fiocruz 29/11/2016 GSK 19 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 Norwegian Institute of Public Health Bernard Fanget London School of Hygiene and Abivax, Neovacs Tropical Medicine 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

29/11/2016 20 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.

21 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 CEPI Partnership Models

VACCINE INDUSTRY • Aligned contributions from industry and other R&D partners, including staff support, access to IP, and use of vaccine production lines that will significantly reduce CEPI’s overall costs and production timelines.

INTERNATIONAL DONORS • Direct donor contributions through multi-year grants and innovative financing mechanisms like IFFIm, which will complement indirect support through alignment on domestic R&D investments and regulatory policies.

DEVELOPING COUNTRIES • CEPI’s Solidarity Fund will channel tiered, equitable contributions from affected countries that will benefit from CEPI’s ‘insurance policy’ against future pandemics emergencies. Solidarity Fund partners will also contribute and benefit through advance coordination on clinical trial arrangements.

23 Next steps

Sept Oct Nov Dec Jan 2017 Start Up Phase

Formalize Commitments Launch Partnership

Scientific Advisory Joint Coordination Secure initial Lead funders to launch Committee Meeting, Group Meeting, commitments of CEPI CEPI and call for 20 and 21 October 18 November 2016 participation and additional participation contribution at the Annual Meeting at Davos, January 2017 2nd Interim Board Meeting in India 16 December 2016