Preventing epidemics through science A global strategy for epidemic preparedness Blueprint for research and development

Research Response in West Africa Ebola: R&D response Funds . 1st Vx P1 trial Research Response in West Africa 1st Drug trial 1st CP use 1st Dx-PCR Next time… 1st Vx trial P3 Ring Vx 1st Dx-RDT

68th World Health Assembly, 2015 “….welcomed the development of a Blueprint — in consultation with Member States and relevant stakeholders— for accelerating research and development in epidemics where there are no, or insufficient, preventive, and curative solutions, taking into account other relevant work-streams within WHO”

G7 Health Ministers, G7 2015 “…continued financing, collaboration and coordination ….through initiatives such as WHO blueprint for R&D preparedness and the Global Research Collaboration for Infectious Disease Preparedness (GloPID-R).”

Blueprint tasks Develop (and implement) a roadmap for R&D preparedness for known priority pathogens, and Enable roll-out of an emergency R&D response as early and as efficiently as possible

Blueprint role: to expedite Co-ordinate the players Promote cross-discipline collaboration Confront obstacles, e.g. legal and ethical issues Expedite funding quests Encourage innovation Maintain flexibility

Blueprint focus Highly infectious pathogens Their potential for global public-health emergencies All R&D aspects

Development of the Blueprint Building on the efforts of others A collaborative effort with Member States and other relevant stakeholders Consultations Scientific Advisory Group Several consultations have been held and a series of other are scheduled to address key questions

Expected benefits Better R&D preparedness for diseases that might lead to epidemics Portfolio of promising experimental medical technologies with results available from Phase 1 safety trials in man Better readiness to promptly conduct R&D during an emergency Mechanisms to improve global coordination

Five work-streams WS1 WS5 WS2 WS3 WS4 Disease priorities Stakeholder coordination WS1 Disease priorities WS2 Research priorities WS4 Assessment WS5 Innovative funding options

Initial Blueprint deliverables

Initial Blueprint deliverables Meeting of experts to prioritize pathogens WS1 Public consultation on MERS-CoV roadmap Production Platform technologies Zika R&D WS2 Database or resources Templates & global norms Toolbox for CT design WS3 Performance monitoring mechanism WS4 Consultation for funding options WS5 CCHF, Filoviruses, Lassa, Severe Coronaviruses, Nipah, RVF. Considered as “serious”: Chikungunya, SFTS, and Zika, December 2015

Initial Blueprint deliverables Meeting of experts to prioritize pathogens WS1 Public consultation on MERS-CoV roadmap Production Platform technologies Zika R&D WS2 Database or resources Templates & global norms Toolbox for CT design WS3 Performance monitoring mechanism WS4 Consultation for funding options WS5 - Final MERS-CoV roadmap April 2016 - Platform: review of proposals for, 4-7 April 2016

Initial Blueprint deliverables Meeting of experts to prioritize pathogens WS1 Public consultation on MERS-CoV roadmap Production Platform technologies Zika R&D WS2 Database of resources Toolbox Template &global norms WS3 Performance monitoring mechanism WS4 Consultation for funding options WS5 - Mapping of activities: concept note, April 2016 - Meeting on toolbox for Ph 3 Vaccine trial, 24-25 March - MTA drafted, Data sharing: ICJME recommendations

ICJME Recommendations, 2015 Data Sharing ICJME Recommendations, 2015

Initial Blueprint deliverables Meeting of experts to prioritize pathogens WS1 Public consultation on MERS-CoV roadmap Production Platform technologies Zika R&D WS2 Database or resources Templates & global norms Toolbox for CT design WS3 Performance monitoring mechanism WS4 Consultation for funding options WS5 Monitoring & Evaluation framework, April 2016

Initial Blueprint deliverables Meeting of experts to prioritize pathogens WS1 Public consultation on MERS-CoV roadmap Production Platform technologies Zika R&D WS2 Database or resources Templates & global norms Toolbox for CT design WS3 Meeting for performance monitoring mechanism WS4 Consultation for funding options WS5 Potential finding mechanisms, April 2016

Key Milestone January 2016: report to the Executive Board May 2016: Blueprint presented at the WHA for consideration by member states

R&D response to Zika 1 Feb: PHEIC declared for microcephaly and neurological disorders 4 Feb: 1st R&D Blueprint meeting on Zika Feb - March: . 7-9 March: Global consultation to discuss joint planning for accelerated product development and evaluation Zika product pipeline TPP for Diagnostic & Vaccine Product developers to submit their products to the WHO EUAL procedure by 31 March 2016

WHO meetings on Zika 14–15 March. Vector Control Advisory Group meeting, Geneva 17–19 March. Management of complications/clinical manifestation of Zika virus disease, Geneva 17–18 March. Harmonization of study protocols, Recife

WHO Blueprint secretariat Lead: Marie-Paule Kieny WS-1: Cathy Roth WS2: David Wood & Vasee Moorthy WS3: Ana Maria Henao Restrepo WS4: Claudia Nannei WS5: Peter Beyer http://www.who.int/csr/research-and-development/en/