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].



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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program 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].

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program 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.

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Battling Malaria: Strengthening the U.S. Military Malaria Vaccine Program 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.