The Neglected Dimension of Global Security A Framework to Counter Infectious Disease Crises (2016) / Chapter Skim
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5 Accelerating Research and Development to Counter the Threat of Infectious Diseases
5 Accelerating Research and Development to Counter the Threat of Infectious Diseases
Pages 69-80
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From page 69... ...
It is clear that A PANDEMIC PRODUCT DEVELOPMENT such a comprehensive approach will only succeed with COMMITTEE TO DRIVE THE R&D the contributions of multiple parties working toward STRATEGY common goals. Readiness for infectious disease outbreaks requires ongoing investment in research in myriad disciplines, includ- Pandemic Product Development Committee ing basic biomedical research to understand the etiol- In times of global health emergency, the R&D ogy of disease, the causative agents, the symptomatology, community -- academia, government, industry, and civil clinical research to test for safety and efficacy of potential society -- must be galvanized as a cohesive group to new vaccines and drugs, and anthropological research swiftly determine the necessary biomedical intervento identify the contributing social and cultural factors.
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From page 70... ...
should galvanize the acceleration As we have seen with human immunodeficiency virus of relevant R&D to counter infectious disease threats by (HIV) , tuberculosis, and other infections, resistance will establishing a high-level, broad-based expert panel, an in- eventually develop, creating an added challenge for comdependent Pandemic Product Development Committee batting disease and disability.
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From page 71... ...
much of the early research work would have been comWhile the Commission appreciates the complexity of pleted, and it will then be possible to move some of the creating and implementing such a group, the clear ex- products quickly to clinical testing, regulatory approval, pectation is that the secretariat would have an enabling production, and deployment. role and would be highly sensitive to the importance To build better defenses against the threat of panof ensuring minimal, albeit adequate, spending on ad- demics, we must step up the pace and scale of R&D on ministrative infrastructure, thus maximizing the amount infectious diseases.
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From page 72... ...
Through collab- and diagnosis of global health threats; and discover orative shaping and prioritizing of discrete research pro- new platforms that would have broad applicability grams into an overall R&D strategy, the PPDC would to identify, prevent, and/or treat infectious diseases help ensure focused efforts in areas of maximum impact with pandemic potential. across the infectious disease spectrum, not just areas that happen to be commercially viable or fit existing research Taken together, these three investment areas can produce agendas.
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From page 73... ...
However, sustained private investment for Health Organization should work with global research R&D for potential pandemics that may or may not and development stakeholders to catalyze the commit surface or for which testing and licensure is difficult ment of $1 billion per year to maintain a portfolio of is unlikely. Nevertheless, the private sector has dem- projects in drugs, vaccines, diagnostics, personal pro onstrated a willingness to contribute to the global tective equipment, and medical devices coordinated by effort in myriad ways, including through donation the Pandemic Product Development Committee.
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From page 74... ...
Preparedness for trials requires aphealth care workers and first responders. But example propriate physical infrastructure, a trained health care after example -- including the AIDS pandemic, SARS, workforce, established and functional ethics commitMERS, and the recent Ebola outbreak -- also show that tees, expertise in social sciences, community mobilizain conducting clinical trials for new vaccines or drugs, so- tion, and sustainable basic public health capacity, such as ciety must ensure that in all instances, particularly during surveillance and basic laboratories.
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From page 75... ...
A program run by the Kenya Medical Research SECURING OVERARCHING GLOBAL Institute–Wellcome Trust Research Programme usefully AGREEMENTS TO EXPEDITE APPROVAL, illustrates the way in which study participants in inter- MANUFACTURE, AND DISTRIBUTION national health research acquire relevant knowledge be- Under the coordinating leadership of the PPDC, R&D fore consenting to participation in a trial. This program stakeholders should pre-negotiate global agreements to engages local community facilitators, health care profes- facilitate timely and appropriate implementation and sionals, and local people to create consent forms that are distribution of a range of tools and infrastructure during socially and culturally sensitive to local needs (Boga et a global infectious disease outbreak.
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From page 76... ...
. An example of a mechanism to streamline activities Pre-Approval of Clinical Trial Designs and Master is WHO's Pandemic Influenza Preparedness FrameProtocols work, which seeks to improve and strengthen the sharR&D stakeholders should discuss and agree on the dif- ing of influenza viruses with human pandemic potential ferent possible designs for clinical trials and protocols (WHO, 2011)
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From page 77... ...
. Other legal barriers include capable regulatory authorities and a track record for high-quality standards may be preferable in some areas 8 For more information, see http://www.gsk.com/en-gb/behind-the- for ensuring public health benefit in terms of quality, science/innovation/data-transparency (accessed March 24, 2016)
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From page 78... ...
Rather, those who are at the greatest risk and in immi- CLOSING REMARKS nent danger during a crisis -- whether they are frontline It should be self-evident that scientific research must health workers or a vulnerable local population -- should play a critical role in the global framework for counterhave priority. This means that, in order to ensure equi- ing the threat of infectious diseases.
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From page 79... ...
infectious disease outbreaks. Presentation made at "Global Health CIPIH (Commission on Intellectual Property Rights, Innovation and Risk Framework: Workshop on Research and Development of Public Health)
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From page 80... ...
2011. Pandemic Influenza Preparedness Framework for the sharing of influenza viruses and access to vaccines and other ben efits.
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