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CEPI Coalition for Epidemic Preparedness Innovations Concept Note for the Start-Up Phase Overview The 2014-2015 Ebola outbreak in West Africa highlighted significant gaps in the world's ability to prepare for and respond to infections of epidemic potential, and a particularly urgent need for a new approach to stimulating, coordinating and financing the development of vaccines. Similar challenges have been demonstrated by other recent epidemics and pandemics, including SARS, H1N1 flu, MERS-CoV and Lassa. Following the leadership of Chancellor Merkel as chair of G7 and the meeting of experts in Berlin in March 2015, chaired by Bill Gates, there is now broad international and cross-sector agreement that current models for supporting vaccine development in advance of and during epidemics is failing, and that a new system is needed. The four reports into the Ebola epidemic -- from WHO, LSHTM/The Lancet, NAM/Global Health Risks Framework and the UN Secretary General's High Level Panel -- all reached the same conclusion and created a clear mandate for change. In response to this demand, stakeholders from international organisations, governments, industry, public and philanthropic R&D funders, academia, NGOs and civil society groups agreed at the World Economic Forum in Davos, 2016, to explore new ways of working to drive vaccine innovation to address public health threats, in alignment with the WHO Blueprint for R&D. This initiative is known as 'CEPI'. Vision CEP''s vision is that vaccines play the fullest possible part in managing outbreaks of infectious diseases with epidemic potential, at the earliest possible stage, so that they do not become public health emergencies. This will contain loss of life, limit damage to social and economic development, and prevent humanitarian crises. CEPI aims to do this by creating an innovative partnership between the public, private, philanthropic and civil society sectors, to take an "end-to-end" approach to vaccine development, predominantly in cases where there is no commercial market. It will: - Advance the development of specific, effective vaccines to the stage where there is proof of principle of efficacy and safety, ready for full trials or emergency use in the event of an epidemic. - Plan and execute the manufacture and stockpiling of such vaccines, and resolve issues such as indemnity and trial design, so vaccines can be deployed swiftly in the event of an epidemic. - Provide a 'hub' for global coordination of efforts around development of vaccines for preparedness. - Partner with the organizations that have the potential to reach vaccination target populations, so that development success translates into immunization. Product CEPI is in its start-up stage and will evolve through multisectorial dialogue between its stakeholders. The aim is to have a completed Strategic and Business Plan outlining the vision, partnership model and operational and funding requirements of a new innovative partnership, and to secure initial funding commitments in the fall of 2016, and to launch at the World Economic Forum in January 2017. Stakeholders are asked to work together to provide input to these plans. Governance During its planning phase, CEPI has been governed through a temporary structure designed to ensure that all stakeholders can contribute their perspectives. This has been co-ordinated by an interim Secretariat provided by the Norwegian Government, working closely with members of the Core Team (Bill & Melinda Gates Foundation, Wellcome Trust, the Government of India's Department of Biotechnology and the World Economic Forum) to manage the operational aspects of CEPI. Stakeholders to date have been contributing through a three-tier system divided into the Leadership Group (full list available in Annex), a Chairs Group and three Task Teams. An interim chief executive officer, John-Arne Rattingen of the Norwegian Institute of Public Health, was appointed in June 2016, to oversee the start-up phase through to late 2017. An interim board of directors including representatives of likely funders, private sector and governmental and non-governmental organizations, scientific advisory committee, will be appointed imminently. A group of CEPI champions consisting of high level advocates will be engaged with the aim to mobilize political and financial capital to support CEPI's mission. A CEPI Joint Coordination Group will serve as a platform for coordination with affiliated partners. Interested stakeholders should contact the Secretariat to discuss the most appropriate areas for engagement.