R&D Blueprint

B. Accelerating R&D processes

A first list of priority infectious diseases was already developed and published in 2015: filovirus diseases (caused specifically by Ebola and Marburg), Crimean-Congo haemorrhagic fever, respiratory diseases caused by highly pathogenic coronaviruses (specifically MERS-CoV and SARS), Lassa fever, Nipah virus disease, Rift Valley fever, Zika virus-associated neurological conditions, Chikungunya, Severe Fever with Thombocytopenia Syndrome (SFTS) . Since then, the Blueprint has refined a robust and transparent semi-quantitative prioritization methodology for infectious diseases the most likely to create epidemics . This methodology will be peer-reviewed and published in 2017, and will be instrumental to reassess annually the priority list. WHO will also develop a decision tree – a practical tool to assess the need for urgent R&D for potential emerging pathogens not yet included on the list.

For priority diseases, R&D Roadmaps and generic Target Product Profiles (TPPs) will be developed through broad and open consultations with leading experts and other stakeholders. The Roadmaps will be published to ensure broad dissemination and alignment. The process will be informed by the experience of the first developed Roadmap for MERS-CoV , which will be documented in order to serve as a guide for similar work. It is envisaged that partners will take responsibility for the development of the next Roadmaps in collaboration with WHO, starting with Crimea Congo and Lassa fevers. In parallel, WHO will foster collaborations and consultations between regulators in order to develop WHO regulatory guidance to facilitate regulatory assessment of candidate MCMs. Training workshops for regulators will be organized in various regions to facilitate implementation of this guidance. The Blueprint will also set up a regulatory lab network including 10-12 regional laboratories that will collect samples for priority diseases and establish protocols to rapidly evaluate new diagnostic tests in case of an outbreak. This work will be facilitated by existing confidentiality agreements between WHO and many National Regulatory Authorities. Lastly, the Blueprint is exploring insurance options to indemnify recipients of vaccines which would not yet have been fully clinically evaluated and licensed at the time of deployment, and to cover liability for manufacturers of these candidate products.

This area of work is comprised of three workstreams (see details below):

  • Disease prioritization
  • Roadmaps & Target product profiles
  • Regulatory & Ethical pathways

Disease prioritization

Roadmaps & Target product profiles

Regulatory & Ethical pathways

Index

 

  • 1. Global coordination mechanism
  • 2. Funding
  • 3. Communication
  • 1. Disease prioritization
  • 2. Roadmaps & Target product profiles
  • 3. Regulatory & Ethical pathways
  • 1. Clinical trial designs
  • 2. Data & sample sharing