Background
The WHO R&D Blueprint was developed in 2015 to provide global scientific collaboration in support of accelerating the development of MCMs via research preparedness and scientifically robust research in the context of outbreaks. The foundation for this framework was based on the World Health Assembly resolution WHA68.15 in May 2015, which requested the WHO to develop an R&D Blueprint for Action to Prevent Epidemics.
Since 2024, the World Health Organization (WHO) via the WHO R&D Blueprint for Epidemics has called for a fundamental shift in how the global community prepares for epidemics and pandemics. Given the uncertainty regarding which pathogen will cause the next pandemic, this research and development preparedness and response framework represents a transformative shift from a focus on a limited number of priority pathogens to a global collaborative pathogens family-level research preparedness and response approach. Central to the strategy is the Prototype pathogen approach, which focuses research on representative pathogens within each family to generate broadly applicable knowledge and tools to ensure that targeted research and development would strengthen emergency response by accelerating availability of biomedical technologies to populations and patients during epidemics.
Over the past ten years the global and national commitment to enhance global health security, prevent pandemics, and integrate R&D as part of the response to outbreaks has solidified. This strategic shift was also bolstered by the World Health Assembly's adoption of the WHO Pandemic Agreement in May 2025, reflecting the political commitment and ambitions of 193 WHO Member States to strengthen pandemic prevention, preparedness, and response. Preparing countermeasures at the family level can contribute to dramatically shorten equitable access to MCMs from the time when a pathogen outbreak is declared.
With the adoption of WHA 75.8 resolution the global community reiterated the value in interpretable, trials compliant with international standards of design and conduct, protection of human subject, inclusion of communities, and prevention of research waste.
Collaborative Open Consortiums for Research (CORCs): To implement the pathogen-family prioritization approach to epidemic and pandemic preparedness, WHO and several leading research institutions worldwide have launched the Collaborative Open Research Consortia (CORCs) as international research network of networks organized around priority pathogen families. Each CORC is coordinated by leading institutions acting as hubs and conveners, typically supported by WHO Collaborating Centres. These consortia represent a major progress in the scientific approach, shifting from a centralized, pathogen-specific model to a decentralized, collaborative framework designed to anticipate emerging threats and accelerate the research and development of medical countermeasures and to develop R&D Roadmaps for each pathogen Family.
Proposed objectives
- To become familiar with the global Emergency Response Framework that defines the global architecture for outbreak response
- To review the critical elements of the integration of quality clinical research and development (R&D) into outbreak preparedness and response, including the critical independent scientific support provided by the CORCs
- To discuss critical scientific preparedness research for candidate MCMs for both known pathogens and for pathogen X.
- To review key design issues for clinical trials necessary to advance products to licensure
- To deliberate on trial design options towards the development of CORE protocols for all the priority Families for vaccines and therapeutics. The CORE Protocol design elements will ensure protocols that will generate timely, actionable, and regulatorily robust evidence on the safety and efficacy of candidate vaccines and therapeutics other medical countermeasures during outbreaks.
The recording is available here in two parts: part 1 and part 2.
Presentations
Introduction
Response to outbreaks: Integration of scientifically robust research as part of the response by AM Henao Restrepo (WHO)
Session 1: The global architecture for outbreak response and for integration of research and development in the response
How are events investigated and classified? Overview of the WHO grading of pandemics and epidemics by E. Hamblion (WHO)
A three-level framework for collaboration and emergency response coordination: The Incident Management Support Team (IMST) by R. Holden (WHO)
Enhancing stakeholders’ coordination for research preparedness and response for candidate MCMs: the iMCM network by T. Nguyen (WHO)
A decade of experience on integration of R&D into the outbreak response: what have we learned about how we do it? by E. Higgs (Independent)
Candidates' therapeutics evaluation in the context of outbreaks: independent advice on which candidate(s) to evaluate by M. Cavaleri (EMA)
Candidates' vaccines evaluation in the context of outbreaks: independent advice on which candidate(s) to evaluate by M. Levine (University of Maryland)
Strengthening clinical trials capacity by V. Moorthy (WHO)
WHO ERC support for the review and “pre-approval” of CORE protocols in advance of an outbreak by M. Guraiib (WHO)
Session 2: Evaluation of candidate therapeutics integrated into outbreak response
Optimizing supportive care – importance of studies to understand the pathophysiology and to optimize clinical management and SOPs by J. Diaz (WHO)
Why is it important to design and implement high quality trials to be implemented in the context of outbreaks? by W. Fischer (University of North Carolina)
Trial designs to evaluate candidate therapeutics – factorial design by A. Rojek (University of Oxford)
Trial designs to evaluate candidate therapeutics – A vs B vs A+B by R. Peto (University of Oxford)
Trial designs to evaluate post-exposure prophylaxis by P. Mbala (INRB)
Trial designs to evaluate post-exposure prophylaxis by K. Lacombe (St. Antoine Hospital)
Session 3: Evaluation of candidate vaccines integrated into outbreak response
General considerations for CORE protocols for vaccine trials in the context of outbreak by I. Longini (University of Florida)
Trial designs to evaluate candidate vaccines – individual randomized clinical trials by I. Socé Fall /B. Tall (Institut Pasteur, Dakar)
Trial designs to evaluate candidate vaccines - cluster randomized clinical trials by B. Kirenga (Makerere University)
Trial designs to evaluate candidate vaccines – immunological studies by P. Kaleebu (UVRI)
Trial designs to evaluate candidate vaccines – pragmatic trials (e.g. randomization during deployment) by C. Struchiner (Fundacao Getulio Vargas)
Evaluating the efficacy of vaccine dose-sparing strategies by J. Beigel (formerly NIAID/NIH)
Summary
Collaborative Open Research Consortium (CORCs): An approach to reduce uncertainty about the next pandemic and boost coordinated global R&D preparedness by AM Henao Restrepo (WHO)