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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program (2006)

Chapter: Appendix E Scientific Advisory Board for DoD Malaria Vaccine Research and Development Program (Draft Charter)

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Suggested Citation:"Appendix E Scientific Advisory Board for DoD Malaria Vaccine Research and Development Program (Draft Charter)." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
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Appendix E
Scientific Advisory Board for DoD Malaria Vaccine Research and Development Program (Draft Charter)

The following represents an indicative charter for the proposed scientific advisory board. The final document should be drawn up by the program management together with the transition team during the reorganization into the Joint Task Force for Malaria Vaccine (JTF-MV). It should include consideration of whether additional technical advisory groups are needed in addition to this board.

PURPOSE

The Institute of Medicine (IOM) committee strongly recommends establishment of a scientific advisory board (SAB), under the executive agency of the U.S. Army Medical Research and Materiel Command (USAMRMC), to serve as senior advisors to the Military Infectious Diseases Research Program (MIDRP) Malaria Vaccine Program.

AUTHORITY

Commanding general, USAMRMC.

FUNCTION

The SAB shall act to guide high-level decision making on issues related to the accomplishment of the MIDRP malaria vaccine mission. Functions include the following:

Suggested Citation:"Appendix E Scientific Advisory Board for DoD Malaria Vaccine Research and Development Program (Draft Charter)." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
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  • Advise the proposed transition team charged with planning and implementing the malaria vaccine research and development program reorganization into the JTF-MV.

  • Assess military vaccine research and development program priorities and accomplishments.

  • Act as a center of strong advocacy for a protective vaccine as the primary countermeasure to the malaria threat.

  • Provide credible expert perspective from both within and outside the Department of Defense (DoD).

  • Maintain active relationships with current science and technology leaders in the academic, government, and corporate/industry sectors.

STRUCTURE

The SAB shall consist of at least seven members. The chair shall be appointed by the commanding general from among the members. To obtain the best advice possible, the members and the chair shall be selected on the basis of eminence in medical research with a broad range of expertise in microbiology, parasitology, epidemiology, infectious diseases, malaria, clinical trials, regulatory affairs, and vaccine research and development. None of the members shall be on active duty status, though retired members who are otherwise qualified and can represent a balanced perspective on the Army and Navy approaches to vaccine development should be invited to participate. Members’ backgrounds should represent a variety of areas such as: the Department of Health and Human Services, the National Institutes of Health, the Food and Drug Administration; academia and industry; the Gates Foundation and the Malaria Vaccine Initiative; and retired DoD or military personnel.

Members shall be invited to serve for time periods of two to three years, with overlap of rotating members to ensure continuity and ongoing responsibility and scientific oversight. In addition, the board should provide vaccine research and development expertise to advise the commanding general of the USAMRMC on how best to restructure the MIDRP Malaria Vaccine Program in the context of various resource options that may be available to maximize the likelihood of successful vaccine(s) development in the near future (i.e., in 5–10 years).

Nonvoting members with broad experience and detailed knowledge of the MIDRP Malaria Vaccine Program should be available and present during the advisory board meeting(s) to answer questions and clarify issues concerning the MIDRP Malaria Vaccine Program. Several non-voting members can be proposed, such as the MIDRP research area director and consultants.

Suggested Citation:"Appendix E Scientific Advisory Board for DoD Malaria Vaccine Research and Development Program (Draft Charter)." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
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MEETINGS

The board will meet at a time and location designated by the commanding general of the USAMRMC. Meetings will be conducted and records of the proceedings kept. The board members will determine a set of recommendations agreed upon by a majority vote. A quorum for the conduct of business shall consist of a majority of members. The approved recommendations will be provided to the commanding general of the USAMRMC. Minutes and/or audiovisual records of the board meeting will be included in the board’s reports. All participants must agree to statements of confidentiality and nonconflict of interests.

COMPENSATION

Board members will receive reimbursement for travel-related expenses.

DELIVERABLES

To be formulated.

TERMINATION DATE

To be determined.


Approved __________________________________________________________________________________________________________________

Commanding General, MRMC

Suggested Citation:"Appendix E Scientific Advisory Board for DoD Malaria Vaccine Research and Development Program (Draft Charter)." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×
Page 102
Suggested Citation:"Appendix E Scientific Advisory Board for DoD Malaria Vaccine Research and Development Program (Draft Charter)." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×
Page 103
Suggested Citation:"Appendix E Scientific Advisory Board for DoD Malaria Vaccine Research and Development Program (Draft Charter)." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×
Page 104
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Malaria is an infectious disease common to several parts of the world, including Africa, northern South America, and Asia. During their service in the military, U.S. active members may be sent to any part of the world, including parts of the world where Malaria is an issue. In Liberia in 2003, for example, there was a 28 percent attack rate in Marines who spent a short time ashore, and half of the 80 Marines affected needed to be evacuated to Germany. This was not only costly to the U.S. military but dangerous as well. To fight against this disease, there exists a Malaria Vaccine program in the U.S. military. However, there exists a variety of potential vaccine targets for the most severe and important form of malaria; malaria from the species Plasmodium falciparum. Issues also arise with the fact that there are three possible stages to create vaccines against—preerythrocytic, blood, or transmission.

The Department of Defense (DoD), through the commanding general of the U.S. Army Medical Research and Materiel Command (USAMRMC), requested that the Institute of Medicine (IOM) conduct a programmatic review of the military Plasmodium falciparum malaria vaccine research and development program. There was to be a focus on vaccine against the preerythrocytic and blood stages. The IOM formed a committee of 11 experts with collective expertise in malaria vaccine research, parasite immunology, malarial biology, clinical trials and regulatory affairs, industrial and public-sector vaccine development, biologic products research and development (vaccinology), military research and development programs, tropical medicine, and public health.

The committee focused different tasks including determining whether the DoD malaria vaccine research and development program is scientifically sound and able to achieve the vaccine program objectives within specified timelines, recommending how to overcome significant, identified barriers, and identifying major strategic goals and timelines based on the material received and presentations made by the DoD's program representatives. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program presents the committee's findings, current malaria vaccines, and recommendations for the development of the U.S. Military vaccine research.

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