Streamlined operational R&D response during outbreaks
The Zika virus outbreak in the Americas has served as an important testing ground for the Blueprint . WHO implemented a strategic response framework including three pillars: surveillance, response and research. A WHO Research Agenda was further developed, including a product development area that was subsumed under R&D Blueprint leadership .
Internal WHO coordination and planning: the designated R&D Blueprint focal point operates under an a priori defined internal WHO coordination mechanism, which embeds R&D activities within the broader, WHO emergency response plan. In the event of an outbreak, the focus of the Blueprint activities will shift from R&D preparedness activities to an emergency R&D response plan. Detailed operational R&D plans will be further developed for three outbreak scenarios: (i) priority pathogens with no MCMs available, (ii) priority pathogens with some MCMs available, or (iii) outbreaks caused by an unknown pathogen. The operational R&D plan will include a review of staffing and budget needs, reallocation of staff where their experience is needed, and complementing with additional resources as appropriate. An emergency organigram will be drawn and communicated to key stakeholders.
External coordination of scientific expertise and communication of priorities: through the Global Coordination Mechanism described under section A (above) relevant stakeholders will be mobilized to support urgent R&D-related activities. Specific target product profiles (TPPs) will be developed as needed, adapted to the emergency context. Regulators and developers will be convened to review how to accelerate regulatory considerations for needed medical products and agree on an accelerated development pathway. Moreover, the Emergency Use Assessment and Listing (EUAL) procedure will be activated to accelerate quality assessments of new products. Through the WHO website and weekly bulletins WHO will share with the public at large the ongoing priority R&D activities and progress made.
- 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