The WHO Research and Development Roadmaps

By Nick Bertini

The World Health Organization (WHO) is constantly attempting to address public health threats before they become major local, regional, and global issues. This session focused on the research and development roadmaps that the WHO has implemented and managed to initiate a targeted research campaign for the early delivery of vaccines, therapeutics, and diagnostics of Crimean Congo Hemorrhagic Fever (CCHF) and Nipah Virus. Moderated by Tim Brooks of Public Health England, the session was geared toward educating the audience on the research and development frameworks that the WHO has in place in order to address the potential major public health threats of the near to midterm future.

Marie-Pierre Prezios, the head of the R&D roadmap program at WHO, started the session off with a general overview of what the WHO’s goals are for implementing these research blueprints. Prezios laid out the strategic priorities of her program by stating that the goals of the WHO are to “keep the world safe, improve health, and serve the vulnerable.” According to Prezios, the framework is designed to improve coordination, map the key stakeholders, and clearly identify products in the drug development pipeline. If these steps are completed, then the research and development process should be accelerated—specifically for priority pathogens and diseases. The roadmaps are generated using two key steps. First, a Baseline Situation Analysis (BSA) is conducted to identify gaps in knowledge and survey the current public health landscape. Second, a diverse technical taskforce is assembled and comes to a consensus regarding the results of the BSA. After a consensus is made, the technical taskforce drafts the research and development roadmaps. Finally, Prezios highlights the success of the roadmap by sharing that in May 2018 there was an outbreak of Nipah Virus in Kerala, India and a successful response was initiated within the first 24 hours. Furthermore, researchers and developers were able to provide the field with monoclonal antibodies within a week, stemming the number of cases and allowing the community to address the public health concerns and to recover from the outbreak.

The next presenter, Amanda Semper from Public Health England, described a WHO roadmap in action. Crimean Congo Hemorrhagic Fever (CCHF) is a single stranded RNA Nairovirus that is typically carried by ticks. The fatality rate ranges anywhere between 5% and 83%. Semper illustrated that the fatality rate will change based on the geographic location of where the person was infected because different nations have different capabilities to treat patients. Additionally, Semper highlighted that there are no proven drugs to treat CCHF and there is no current vaccine. CCHF is genetically diverse over all three segments and re-assortment is very common. As a result, there is a need for a comprehensive diagnostic test that can work against multiple strains of CCHF. Semper described a lack of field diagnostic tools for CCHF, which in turn delays a timely diagnosis. Delayed diagnosis of CCHF can be dangerous because about 80% of infections are nosocomial infections—via person to person transmission in a healthcare setting. Semper outlined the goals of the WHO roadmap as: (1) by 2023 develop and qualify commercial tests suitable for point of care use for CCHF and (2) by 2023 develop an effective therapeutic treatment for CCHF.

Finally, Stephen Luby MD from Stanford University presented on Nipah Virus and its potential pandemic threat. Luby, the international authority on Nipah Virus, first explained the biology of Nipah Virus as being very close in relation to measles, being in the paramyxoviridae family. Many viruses in this family have the ability to cross species easily, as illustrated in the 1999 Nipah Virus outbreak in Malaysia. Originating in fruit bats, the virus moved to infect pigs and then humans. As a result, 900,000 pigs were culled and Malaysia’s pork market has never fully recovered (although there have been no subsequent cases of Nipah Virus recognized). Additionally, 369 humans were infected and 264 deaths occurred, making the case fatality rate 72%. Luby emphasized that there are no easy diagnostics for Nipah Virus in the field today, and that there is really no incentive to invest in the development of them. He argued that the response to Nipah Virus will require global support and cautioned that Nipah is one barrier away from becoming a high mortality pandemic. In closing, he pacified the crowd by saying Nipah Virus is not necessarily an immediate pandemic threat. However, he qualified that statement by asserting that the risk is going to rise because humans are more connected, we are raising more domestic animals, and advances in synthetic biology make Nipah Virus more accessible.

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