Abstract
Funding vaccine development research is more complicated than simply putting out an announcement of funds available. The funders must decide whether product development can be accomplished by purely applied research, or whether more fundamental knowledge is needed before product development can be started. If additional basic knowledge is needed, identifying the specific area of the knowledge gap can be a challenge. Additionally, when there appears to be a clear path of applied research sometimes obstacles are encountered that require a return to more basic work. After deciding on the work to be done, funders must attract the scientists with the broad range of needed skills to cover all the stages of development. Collaborations must be promoted and alliances with other funders and industry must be developed. Funders use multiple tools and strategies to accomplish these tasks with varying success.
Highlights
Proper vaccine development, even when straightforward, is too large and complex a project to be divided into two-year to five-year grant programs, such as the standard grants available at the US National Institutes of Health (NIH)
This article, written from the perspective of a Program Officer’s experiences in the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health (NIH), will provide some detail about the tools NIAID employs, why and how they were applied in HIV vaccine development and to what extent they were useful
As a cadre that is closely following the research in a specific field, Program Officers are well placed to recommend redirecting funds into areas with immediate promise for results that can be quickly applied because of newly developed research technologies and areas needing special attention because specific hurdles to important product/process development have been identified. This is done by writing funding opportunity announcements (FOAs) and obtaining bureaucratic approval to set aside funds for applications and proposals that propose to perform research to achieve the goals of the FOA
Summary
The path to vaccine development is so unclear that the industry will not start the work until academic or government scientists have established the way. Before a vaccine candidate can be tested in people, it must be manufactured to current good manufacturing practice (cGMP) standards It must be tested in clinical trials for immunogenicity, safety and efficacy. This article, written from the perspective of a Program Officer’s experiences in the Division of AIDS (DAIDS) of the National Institute of Allergy and Infectious Diseases (NIAID) at the US National Institutes of Health (NIH), will provide some detail about the tools NIAID employs, why and how they were applied in HIV vaccine development and to what extent they were useful
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