CEPI New for a safer world

John-Arne Røttingen, CEO September 29, 2016 The challenge of epidemics Calls for global action CEPI-actions January - June

Task Team Interim CEO High Level Task Team Leadership Meeting appointed Meeting Tele- Group Meeting Meeting, Oslo Interim board Davos conferences Washington DC constituted 6-7 April 21 January 17 May Business Plan

presented to stakeholders

CEPI-actions 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 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 pipelines: 3 government health research agencies, academic 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

The CEPI response

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

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

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

Vaccines contributing to preventing outbreaks from becoming humanitarian crises Mission

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

End-to-end approach

1. Move 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. Strategic objectives

1 Preparedness

2 Response speed

3 Predictability

4 Equity

CEPI fit along the end-to-end spectrum The CEPI partnership model

CEPI is building capabilities through a mix of partnership models:

1. Advanced Development Partnership (ADP)

2. Targeted investments for filling additional R&D gaps

3. Clinical and regulatory coordination network

4. Complementary coordination initiatives

CEPI’s operating principles

1 Equitable access

2 Cost coverage

3 Shared benefits Organizational setup: startup phase CEPI Interim Board

K. Vijay Raghavan, chair Christopher Whitty Julie Gerberding Ruxandra Draghia-Akli Secretary, Department of Chief Scientific Adviser Executive Vice President Deputy director-general of Department of Health, UK Merck DG RTD, Ministry of Science and European Commission Technology, India Kesetebirhan Admasu Minister of Health, Ethiopia Chairman of vaccines Yah Zolia Peter Piot, vice chair GSK Deputy Minister of Health and Director of the London School of Jeremy Farrar Social Welfare Hygiene and Tropical Medicine Director, Wellcome Trust Joanne Liu Liberia International President Jane Halton Trevor Mundel Medecins sans Frontieres Observers Permanent Secretary President Global Health Marie-Paule Kieny) Department of Finance, Australia Division Victor Dzau Assistant Director-General World Health Organization The Bill & Melinda Gates President of the Institute of

Nicole Lurie Foundation Medicine Mark Feinberg (Chair of SAC) Assistant Secretary, National Academy of President & Chief Executive Department of HHS, US Adar Poonawalla Sciences Officer, IAVI CEO and Executive Director Peggy Hamburg (Chair of JCG) Tore Godal Serum Institute of India Arnaud Bernaert Foreign Secretary of the Institute Special Adviser on Global Health Head of Global Health and of Medicine Ministry of Foreign Affairs, Nima Farzan Healthcare Industries National Academy of Sciences Norway President and CEO World Economic Forum PAXVAX INC. John-Arne Røttingen Interim CEPI CEO

04/10/2016 20

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 Chinese Center for Disease Control University of Texas Medical Branch Maharaj Kishan Bhan and Prevention JIPMER Amadou Sall Institute Pasteur Dakar Gunnstein Norheim Peter Smith Norwegian Institute of London School of Hygiene and Bernard Fanget 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

04/10/2016 21 CEPI financing needs

CEPI raising USD 1 billion to support a five year portfolio strategy of two to three prioritized pathogens and two to three phase IIa vaccine candidate targets per prioritized pathogen by the end of this period.

Financing Model CEPI seeks multi-year donor commitments to satisfy its core financing needs, as well as targets through a multi- source financing model.

Four key financing principles 1. Broad-based financing 2. Long term, predictable financing 3. Complementary and new financing 4. Fit-for purpose financing 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