A new Model of Vaccine R&D Global Health Public Private Partnership : The Global Health Vaccine Center of Innovation (GHVCI)

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1 A new Model of Vaccine R&D Global Health Public Private Partnership : The Global Health Vaccine Center of Innovation (GHVCI) Jean Lang avp R&D sanofi pasteur 9eme Rencontre Nationale des Directeurs de l Innovation June 14 th 2016 Paris- SP-BMGF discussion 1 Drugs/Biologicals Public private partnerships Needs Assemble sufficiently large biological or population samples to achieve statistical significance or new insights through cooperative approaches Benefit from multidisciplinary expertise as well as the sharing of exponentially increasing knowledge and access to complex or novel technologies to discover new mechanisms or validate new targets, thus creating common precompetitive resources Address regulatory complexity through harmonization and validation; and, when necessary engage in scientific efforts to establish standards Execute large projects over a sustained period of time to reach a sufficient scale and enable discovery or translation through shared resources or the creation of large data sets with complex analytics Anticipate and rapidly address significant public health threats The role of public private partnerships in addressing the biomedical innovation challenge. Maya Said and Elias Zerhouni NATURE REVIEWS DRUG DISCOVERY VOLUME 13 NOVEMBER

2 Case Study : The lack of a commercial market for investing in Vaccine R&D in Global Health Gaps There is a strong global consensus that new and sustainable partnership models are needed for the research and development (R&D) of vaccines to contain outbreaks of EIDs. Recent outbreaks SARS, Ebola and Zika - have revealed the gaps that such partnerships should fill Needs - Coordinated and proactive R&D, new and increased funding, stronger advanced development and manufacturing capabilities, regulatory innovations and a harmonization of regulatory requirements Purpose - to identify partnership models for vaccine development against EIDs of epidemic potential and market failure, which accommodate private sector incentives and account for the capabilities, expertise and resources of industry players and Intellectual Property (IP) concerns A Proposal : A RFP Externally Funded, Translational R&D Open Innovation, not for profit Biotech based, Public-Private Partnership Alliance : The Global Heath Vaccine Center of Innovation A short term need : The Coalition for Epidemic Preparedness Innovation, CEPI a new Public Private Partnership Initiative WT, Norway MoH, BMGF, I Pasteur, MNCs CEPI Scope Taking an end-to-end approach to vaccine development to application, CEPI will focus on essential gaps in product development due to market failure The initial focus will be to move new vaccines through development from preclinical to proof of principle in humans and the development of platforms that can be used for rapid vaccine development against unknown pathogens 2

3 Outline of the CEPI Strategic Plan Rationale Lessons learned from the response to the Ebola outbreak and recommendations of independent reviews Landscape Changing epidemiology of epidemics, organizational ecosystem, technological opportunities, Challenges Market failure, streamlined and predictable regulatory process, preparedness for outbreaks of unknown pathogens GHVCI Press release "History has shown us that vaccines are one of the best ways to improve public health, but in today s world, we are faced with a newly emerging infectious diseases, as well as age-old threats, that either have no vaccines or vaccines that are not effective" Steven G. Reed, Ph.D., Founder, President and Chief Scientific Officer for IDRI. "Combining that with the speed with which infectious diseases can travel the world, we need a new model for vaccine development, one that enables us to rapidly produce vaccines at a lower cost. The blend of the Gates Foundation's knowledge of global health and Sanofi s depth of vaccine development expertise is a perfect match for IDRI's unique technologies and research and development engine, allowing us to take a new approach to vaccine development. Steven G. Reed, Ph.D., Founder, President and Chief Scientific Officer for IDRI. IDRI AND SANOFI PASTEUR TEAM WITH PHILANTHROPY TO DEVELOP NEW MODEL FOR VACCINE DEVELOPMENT Seattle, WA October 15, 2015 In an effort to accelerate timelines and decrease development costs of lifesaving vaccines, the Infectious Disease Research Institute (IDRI) and Sanofi Pasteur today announce the establishment of the Global Health Vaccine Center of Innovation (GHVCI), to be headquartered at IDRI in Seattle. This project is funded in part by a grant from the Bill & Melinda Gates Foundation. The GHVCI represents an alliance among the three organizations, focused on accelerating the development of vaccines and associated technologies to fight a wide range of global infectious diseases, and ensuring that these critical vaccines are accessible globally, especially to people in need within developing countries. Each partner will bring its respective world-leading expertise and technologies to the GHVCI and, collectively, the parties will collaborate with a wide range of other vaccine development organizations. Funding for the establishment, operation and growth of the GHVCI will come from Sanofi and the Gates Foundation, and additional funding will be sought to support collaborative research activities with respect to specific vaccines to be developed at the GHVCI. 3

4 What is GHVCI? The GHVCI (Global Health Vaccine Center of Innovation) is a Research Institute with staff dedicated to accelerate the development of vaccines through an efficient, resource-sparing method and by leveraging expertise of IDRI, BMGF and Sanofi Pasteur, combining: - IDRI s vaccine adjuvant technologies and formulation expertise, which have been developed over the past few years with strong financial support from the Gates Foundation. - Sanofi s position as a leading multi-national vaccine developer, manufacturer and seller. - BMGF s knowledge, influence and financial support regarding the discovery and development of global health interventions, including vaccines. A Joint Steering Committee, comprised of representatives from each of the three partners, will mutually identify areas of research to discover, evaluate and develop novel human vaccines, as well as adjuvant/formulation platforms for the rapid response to emerging pathogens, that can prevent or treat infectious diseases Other R&D Project Partners (open Innovation principle) could contribute on an ad-hoc basis to execute the Research to Clinical PoP (Phase I/II) workplan based on robust project Mgt methods 7 GHVCI s Translational R&D Expertise Capabilities (IDRI based, see list) Adjuvants & Formulations Antigen Discovery Process Development Pilot cgmp Manufacturing Clinical and Regulatory QA/QC Diagnostics Development BSL 1, 2 and 3 Vivarium (including BSL3) Chip Array & Systems Analysis Administrative Support eg HR, legal, finance, Project/Portfolio Mgt IP will be project contributions based Areas of Emphasis Discovery to Clinical POC Portfolio of Adjuvants >12 Compounds TLRs 4, 7, 9, etc. >200 Formulations Mucosal, cellular, humoral responses Vaccine Platforms RNA, Vectored, rprotein Compound Screening Diagnostics Internal Disease Programs Viral, Bacterial and Parasitic Cost structure : Minimal structural investment, Resources & OPEX Project based Modus Operandi 4

5 Drugs/Biologicals Public private partnerships Challenges Misalignment with the company s internal strategy Missing buy-in on strategy and objectives within the project Complexity in decision-making and loss of autonomy Different expectations by partners (for example, patent versus publication) Different research cultures leading to poor outcomes Outcomes not justifying the time and resources invested Negligence of intellectual property issues leading to issues with exploitation of results Diverting energy and resources away from core aims and mission drift Substantial administration costs to fulfil the requirements for funding from governmental agencies Duplication of efforts and resources at a regional and global level 9 5

6 GHVCI s Actionable Capacity (2016) BSL 1, 2 and 3 laboratories Vaccinology & antigen discovery Process development cgmp manufacturing facility QA/QC Diagnostics Development Adjuvants & Formulations Current capacity: 5509 sq. meters 104 scientists (39 PhDs) 20 admin (3 PhDs) Expandable to: 7246 sq. meters (flexible/ USD) 200 scientists INDs + supported: 15 (3 planned) EU CTAs: 4 (2 planned) FDA Master Files: 7 Clinical trials: 16 Collaborators:

7 The PPP /CEPI GHVCI Metrics of Success Response time Defined milestones of safe and effective vaccines ready for scale up at initial stages of outbreaks of epidemic potential Complimentarity Effective and well-adjusted to the existing organizational ecosystem Agility & Efficiency Proven capacity for rapid scaleup & responsive R&D, streamlined regulatory processes Sustainability In both financing & results End to End Associated Partners Global Network * - Immunology - Vaccinology Antigen Discovery & Expression -Adjuvant & Formulations Dev. - Diagnostic Dev. Clinical & Regulatory Support GMP Manufacturing - Quality Control - Quality Assurance * Located in Seattle, WA, USA, global health hub, leveraging IDRI s existing structures operating under the GHVCI 7