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

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.

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.

Commanding general, USAMRMC.

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:

• 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.

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.

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.

Board members will receive reimbursement for travel-related expenses.

To be formulated.

To be determined.

Approved __________________________________________________________________________________________________________________

Commanding General, MRMC