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

Chapter: Appendix G Executive Summary and Recommendations of the DoD Report Acquisition of Vaccine Production

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Suggested Citation:"Appendix G Executive Summary and Recommendations of the DoD Report Acquisition of Vaccine Production." 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 G
Executive Summary and Recommendations of the DoD Report Acquisition of Vaccine Production1

EXECUTIVE SUMMARY

By memorandum dated July 20, 2000, the deputy secretary of defense tasked the director of defense research and engineering and the assistant secretary of defense for health affairs to jointly contract with a private organization or panel of experts to conduct a comprehensive study of the Department of Defense (DoD) acquisition of vaccine production. The study was to focus on review of the following areas:

  • Vaccines to protect service members against biological warfare threats as well as infectious diseases

  • A comparison of current department efforts with best business practices in the biologics industry, and if or how the department can leverage the best aspects of the private-sector programs from industry

  • A determination of whether the DoD program requires acquisition processes unique from normal departmental acquisition procedures

  • The development of recommendations for how the department should best develop and oversee a vaccine production program

1

Top FH Jr., Dingerdissen JJ, Habig WH, Quinnan GV Jr., Wells RL. 2000. DoD Acquisition of Vaccine Production. Report to the Secretary of Defense by the Independent Panel of Experts, Dec 2000. In DoD, 2001. Report on Biological Warfare Defense Vaccine Research and Development Programs. Washington, D.C.: Department of Defense. [Online]. Available: http://www.acq.osd.mil/cp/bwdvrdp-july01.pdf [Accessed May 3 2006].

Suggested Citation:"Appendix G Executive Summary and Recommendations of the DoD Report Acquisition of Vaccine Production." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×

An independent panel of experts was established and assessed the DoD’s acquisition of vaccine production requirements and ongoing programs, management, and acquisition processes against U.S. vaccine industry best practices.1 The panel found that:

  • Biowarfare and endemic diseases are proven high-consequence threats to military operational effectiveness.

  • Vaccines are the lowest risk, most effective protection; they enable force projection and are superior to antibiotics or other treatments.

  • The DoD’s current acquisition of vaccine production approach is insufficient and will fail.

  • A new approach can make this program work.

The size and scope of DoD vaccine requirements for force protection are exceptionally large. The DoD requires new vaccines to protect against 15 or more biowarfare and endemic diseases. By comparison, vaccines licensed for use in the United States protect against about 20 diseases, and Merck & Co., Inc. manufactures nine licensed vaccines. The size and scope of the DoD program is too large for either the DoD or industry alone. A combined, integrated approach drawing on industry, DoD, and national scientific strengths and assets is essential. The DoD needs to consolidate and integrate its vaccine research, development, and acquisition programs for biowarfare defense and endemic disease protection. Success requires a tailored acquisition model and infusion of technically qualified staff at all levels. A joint program executive officer must have responsibility and authority for the program and report to a designated vaccine acquisition executive who reports to the undersecretary of defense (acquisition, technology and logistics). The DoD vaccine acquisition program should be managed as an Acquisition Category I program and—on an eight-vaccine scale—requires a $3.2 billion research and development program. A government-owned and contractor-operated vaccine production facility is an essential element of the DoD program. The DoD senior leadership must meet with and solicit industry support for its vaccine requirements.

Suggested Citation:"Appendix G Executive Summary and Recommendations of the DoD Report Acquisition of Vaccine Production." Institute of Medicine. 2006. Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program. Washington, DC: The National Academies Press. doi: 10.17226/11656.
×

TABLE G-1 Summary of the Top Reporta Findings and Recommendations by Deputy Secretary of Defense Focus Areas

Focus Area

Findings

Recommendations

1—Vaccines to protect service members against biological warfare threats as well as infectious diseases.

Vaccines for biological warfare defense and protection against endemic diseases are essential enablers of force projection.

Combine programs from discovery to production.

2—A comparison of current Department efforts with best business practices in the biologics industry, and if/how the Department can leverage the best aspects of the private sector programs from industry.

Current Department efforts do not meet industry best practices:

  • Diffuse management and fragmented lines of responsibility

  • Inadequate scientific oversight

  • Inadequate program integration from discovery through licensure

  • Inadequate resources to meet goals

Adopt integrated approach utilizing:

  • Management and development skills of industry

  • Accountable, lean DoD management structure

  • Strong technical guidance and personnel

  • Government-owned, contractor operated (GOCO)

3—A determination of whether the DoD program requires acquisition processes unique from normal departmental acquisition procedures.

Vaccine acquisition processes are different from weapons system acquisition processes and success requires different procedures.

  • Strong technical input imperative

  • Workforce

  • Management

  • Stable, long-range funding for vaccine life cycle

  • Reprogramming authority

4—The development of recommendations for how the Department should best develop and oversee a vaccine acquisition production program.

DoD acquisition of vaccine production management practices are generally contrary to industry best practices.

  • Combined, integrated industry acquisition model

  • Focused and streamlined organization

  • Segregated, Office of Secretary of Defense-sponsored funding

  • Incentivized industry involvement (with GOCO)

  • DoD, Executive Branch, and congressional support to remove impediments and provide necessary incentives

aSee footnote 1.

Suggested Citation:"Appendix G Executive Summary and Recommendations of the DoD Report Acquisition of Vaccine Production." 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 107
Suggested Citation:"Appendix G Executive Summary and Recommendations of the DoD Report Acquisition of Vaccine Production." 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 108
Suggested Citation:"Appendix G Executive Summary and Recommendations of the DoD Report Acquisition of Vaccine Production." 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 109
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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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