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5 Organization and Management of the Program
Pages 56-70

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From page 56...
... This is further subdivided into four task areas: · Task F: Malaria vaccine research · Task 6A: Protein-based vaccines · Task 6B: DNA-based vaccines · Task A1: P vivax vaccines.
From page 57...
... 57 U.S. interest; Armed directed special AFMIC: USAMMDA: Relationship congressionally Defense; of Diseases; congressional CSI $1M Stream/Management AFMIC Grants Contracts CSI: CDMRP: Warfare Command/Control Funding Infectious Department Defense, for SBIR Biological BWD $70M agreement; development; Research.
From page 58...
... A subset of the total proposals submitted for FY2007 are for malaria vaccines: 42 preproposals and 28 full proposals, of which 14 will be funded, together with 3 core and 5 multiyear projects (total 22 for malaria vaccines)
From page 59...
... The committee was not shown current agreements between MIDRP Malaria Vaccine Program and commercial partners, and hence is unaware of the restrictions imposed. The procedures for initiating new partnerships seem convoluted, lengthy, and obscure, with separate systems in WRAIR and NMRC.
From page 60...
... Although some activities are shared, such as the GMP pilot production facility, opportunities for increased sharing of facilities were noted that should aid standardization and increase pace of progress.
From page 61...
... The committee recognized the commitment and energy of the malaria vaccine research groups at WRAIR and NMRC, the strong leadership they have received, and their good intentions to cooperate with each other. Notably, the MIDRP Malaria Vaccine Program has been scientifically productive in spite of a diffuse and cumbersome management structure and inadequate funding that impairs the program's ability to accomplish the malaria vaccine mission.
From page 62...
... Success in reorganizing the approach to malaria vaccine development could serve as an example for other infectious disease program areas. Recommendation 5.1: The MIDRP Malaria Vaccine Program, cur rently composed of two separate entities -- WRAIR and NMRC, should be integrated into a unified organizational entity (JTF MV)
From page 63...
... PREVIOUS REPORTS ADDRESSING DOD VACCINE DEVELOPMENT AND ACQUISITION Three recent expert panels have considered the issue of vaccine development and production in the U.S. military.
From page 64...
... Army, their conclusions are highly pertinent to the overall MIDRP Malaria Vaccine Program (IOM, 2002)
From page 65...
... HUMAN RESOURCE COMMITMENTS The numbers of full-time equivalent (FTE) staff dedicated to malaria vaccine research and development in the U.S.
From page 66...
... NOTE: Numbers in each box represent FTEs as follows: senior scientist / other scientist / technician / support staff. If no numbers are given, there are no staff dedicated to the malaria vaccine program.
From page 67...
... FINANCIAL COMMITMENT The DoD's internal funding for malaria vaccine research and development is channeled mainly through MIDRP, which oversees all infectious disease research. The MIDRP's overall budget for all diseases was about $40 million in 2005, which is a significant decline from a peak of over $50 million in 1998 ($64 million in real [inflation-adjusted]
From page 68...
... . The MIDRP malaria vaccines budget is projected to remain stable at this level through 2011 (as is the overall MIDRP budget)
From page 69...
... . Notwithstanding the DoD's major financial contribution, the amount spent by MIDRP on malaria vaccine research and development falls far short of the required amount to bring even one vaccine product to licensure, which was estimated above to cost upwards of $300 million at the very least, and probably much more (see Table 2-3)
From page 70...
... Although the program has done an impressive amount of work with the relatively small budget available, and has been able to leverage significant outside funding, the overall amount available is not sufficient for advanced development of even one candidate antigen. Recommendation 5.8: Sufficient funding should be made available to support the infrastructure to produce pilot-lot formulations of MIDRP malaria vaccine candidates in-house at the pilot production plant at Forest Glen (an invaluable part of the MIDRP Malaria Vaccine Program)


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