Giving Full Measure to Countermeasures Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents (2004) / Chapter Skim
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2 Organizing Research and Development for Medical Countermeasures to Accomplish Essential Functions
2 Organizing Research and Development for Medical Countermeasures to Accomplish Essential Functions
Pages 44-72
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From page 44... ...
As outlined in Chapter 1, the recommended reorganization of DoD's efforts should be accomplished through creation of the Medical Biodefense Agency, a new agency in DoD that consolidates responsibility and authority over the entire research and development process for medical biodefense countermeasures. The committee believes that the prospect for timely advancement of medical countermeasures against all present and future biological warfare threats will be enhanced by the establishment of this agency, whose only agenda will be the development of such products.
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From page 45... ...
A DOD AGENCY FOR ACQUISITION OF MEDICAL COUNTERMEASURES FOR BIOLOGICAL DEFENSE As the result of a congressional mandate,1 DoD's work on medical biodefense countermeasures is part of a program that addresses medical and nonmedical countermeasures against both chemical and biological warfare threats. Responsibility for centralized oversight of the Chemical and Biological Defense Program has been assigned to the Assistant to the Secretary of Defense for Nuclear and Chemical and Biological Defense Programs.
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From page 47... ...
USD and Systems; ,Deputy ,Secretary ,Walter DVC Acquisition dashed ASD(HA) , Program; ARMY Medical USAMRIID Command; JRO-CBRN WRAIR organizations Chemical Agency; SEC and boxes)
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From page 48... ...
The program also has to rely on others elsewhere in the government or in the academic community or industry to perform many scientific and technical tasks. Offer effective identification, evaluation, and prediction of, as well as advocacy for, medical biodefense needs Determining the need for medical countermeasures requires combining intelligence concerning biological threats, information on the characteris tics of the threat agents, information on military planning for the use of medical countermeasures to maintain the effectiveness of forces on the battlefield, and the knowledge of the research and development commu nity regarding medically and scientifically sound products.
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From page 49... ...
Understand and promote the use of the best science for the task Because the discovery and successful development of medical biodefense countermeasures is a challenging and uncertain task requiring substantial and varied expertise in rapidly changing fields, as indicated above, DoD should support both intramural and extramural work. For its intramural activities, DoD should have the means to attract strong scien tific and technical talent on a permanent or temporary basis.
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From page 50... ...
Tailor the acquisition process for medical countermeasures to use only FDA's regulatory requirements as the basis for assessing the technical merits of candidate products For vaccines and other pharmaceutical products, including those in tended for use as medical biodefense countermeasures, product testing and licensure are regulated by the FDA. DoD product development programs, however, are managed through the defense acquisition system, which is oriented to engineering methods and standards primarily for development and testing of mechanical and electronic equipment for weapons systems or software and equipment for information systems.
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From page 51... ...
There must also be a genuine commitment to the development of medical biodefense countermeasures from senior DoD leadership, a commitment that can be demonstrated by providing the new agency with outstanding leadership, supporting scientific excellence, and providing necessary resources. Key Requirements for the Medical Biodefense Agency The committee's recommendation calls for Congress to authorize the creation of the Medical Biodefense Agency to be responsible specifically and exclusively for all aspects of DoD's research and development program for medical countermeasures against biological warfare agents and infectious diseases of military significance.
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From page 52... ...
, extr , par of B: B) A, (med Other ,MIDRP (med GENCY ,MITS)
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From page 53... ...
, Army; Agency for Programs; Agency; MBDRP ,Under Reed roles Army (med against the Secretary Defense B:without DVC ,Military of Defense ,U.S. USD program JPEO ,Walter Biodefense the Reduction proposed agents; Defense; of ,Assistant (minus of MIDRP Biological Threat ,Secretary Defense; Command; WRAIR Medical acquisition Nuclear countermeasures USAMRIID and Systems functions biowarfare and and Program, ARMY ASD(HA)
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From page 54... ...
The Medical Biodefense Agency should be expected to coordinate with the remaining functions of the Chemical and Biological Defense Program (medical and nonmedical countermeasures against chemical warfare threats, and nonmedical countermeasures against biological threats) through the Assistant to the Secretary of Defense for Nuclear and Chemical and Biological Defense Programs, who also reports to the Under Secretary of Defense for Acquisition, Technology, and Logistics.
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From page 55... ...
Furthermore, establishing the agency at this level should enhance the status of the program and help DoD attract highly qualified leaders who can improve its program by applying expertise from the successful development of other vaccines and drugs. Creation of the Medical Biodefense Agency will establish a more appropriate framework for managing and conducting the research and development that should lead to medical countermeasures licensed by FDA.
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From page 56... ...
Furthermore, attempting to implement a new and atypical approach for managing research, development, and acquisition within an existing organization that is otherwise structured to follow current practices seems to promise little support for the changes the committee considers essential. Scope of Responsibility The Medical Biodefense Agency should have responsibility for all aspects of DoD-sponsored research and development for medical biodefense countermeasures.
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From page 57... ...
To improve the development process for medical countermeasures, the Medical Biodefense Agency should have the authority to use funds from science and technology accounts (e.g., budget activity 6.3) to support Phase 1 and even Phase 2 clinical trials before a candidate product is subject to acquisition system review.
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From page 58... ...
The Medical Biodefense Agency has to be effectively represented within the high-level decision-making processes that set DoD and national priorities, and the agency director should be DoD's primary representative to other government agencies on matters related to the development of medical countermeasures for defense against biological agents. In particular, the director of the Medical Biodefense Agency should be the principal DoD representative to the Interagency Working Group on Weapons of Mass Destruction Medical Countermeasures, chartered by the National Science and Technology Council to coordinate the efforts and responsibilities of federal agencies (Interagency Working Group on Weapons of Mass Destruction Medical Countermeasures, 2003)
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From page 59... ...
Program Priorities and Planning The Medical Biodefense Agency should have the authority to determine its program priorities and program plans in collaboration with the Joint Requirements Office for Chemical, Biological, Radiological, and Nuclear Defense. Requirements for new products to meet military needs, including medical countermeasures, are normally established by the military services through the Joint Chiefs of Staff.
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From page 60... ...
Army Medical Research Institute of Infectious Diseases (USAMRIID) do not appear in budgets for the Chemical and Biological Defense Program or the infectious disease program since they are presently covered in accounts of the military services.
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From page 61... ...
.4 External Scientific Advice and Oversight An External Review Committee A legislatively mandated external review committee should be established to provide input to the director of the Medical Biodefense Agency and to monitor progress in improving the effectiveness of DoD's efforts to develop medical biodefense countermeasures. The members of the review committee should be experts in various aspects of vaccine and drug research and development, drawn from academia, industry, and other relevant organizations in the private fully received approval for marketing; (2)
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From page 62... ...
As discussed in Chapter 1, the review committee should also be charged with assessing the agency's progress after 3 years and recommending whether to continue with a DoD-based program to develop medical countermeasures. These review responsibilities should not be assigned to existing advisory groups such as the Armed Forces Epidemiology Board, the Defense Science Board, or the Defense Threat Reduction Agency's Threat Reduction Advisory Council.
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From page 63... ...
Incorporating a DARPA-like function within the Medical Biodefense Agency would help ensure continuing access to innovative work in the rapidly evolving fields of vaccine and drug research. Potential Shortcomings of a Medical Biodefense Agency The committee recognizes the challenges posed by its recommendation that a new DoD agency be created to conduct all aspects of the department's effort to develop medical countermeasures against biological warfare agents.
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From page 64... ...
CONSIDERATION OF ALTERNATIVE APPROACHES After considering other alternatives, the committee concluded that it is necessary to create a DoD-based Medical Biodefense Agency for the development of medical biodefense countermeasures to ensure that unique DoD needs are addressed. The committee weighed and firmly rejected as inadequate the option of making minor adjustments within the existing DoD organizational framework or consolidating the research and development activities for medical countermeasures under existing organizations within DoD.
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From page 65... ...
The change considered by the committee in this option was to shift responsibility and funding for Phase 1 clinical studies from DVC and the Joint Program Executive Office to USAMRMC. Delaying the transfer of candidate products to advanced development until a later stage of clinical testing would reduce the risk of failure of an acquisition program because only those candidates that remain viable at the end of Phase 1 testing would be transferred.
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From page 66... ...
An existing organization also has an existing mission and culture that would have to adapt to not only accommodate but actively support the challenging task of developing medical biodefense countermeasures. Furthermore, the committee's recommendation that management of all phases of countermeasure development, from basic science through FDA licensure, be con
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From page 67... ...
Other concerns with this approach were noted earlier in the chapter. It fails to demonstrate a true change in the priority assigned to the development of medical countermeasures or to increase the visibility of the program or its prospects of successfully competing for adequate funding.
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From page 68... ...
DoD would rely on industry to develop candidate countermeasures through advanced development to FDA licensure and subsequent production of the products. The prime systems contractor relationship with DVC provides an established, though as yet unproven, mechanism for engaging industry services for this purpose.
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From page 69... ...
Bringing work on biowarfare countermeasures into NIH would also promote collaboration and coordination with the closely related work on medical countermeasures against bioterrorism. The substantial funding commitment supporting the NIH activities aimed at defending against bioterrorism can be expected to allow NIH to foster a more productive environment for both intramural and extramural research than is possible with the more limited funding available within DoD.
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From page 70... ...
Because of crucial distinctions between biowarfare and bioterrorism and differences in the need for medical countermeasures appropriate for each, the option in which responsibility for the development of biowarfare countermeasures is given to NIAID or another entity within NIH has certain drawbacks. One concern is that it would tend to reduce the expertise in medical biodefense and the development of medical countermeasures available within DoD to guide overall biodefense planning.
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From page 71... ...
Report to Congress: Acceleration of Research, Development, and Production of Medical Countermeasures for Defense Against Bio logical Warfare Agents. Washington, DC: Department of Defense, Office of the Deputy Assistant to the Secretary of Defense for Chemical and Biological Defense.
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From page 72... ...
In DoD, 2001. Report on Biological Warfare Defense Vaccine Research and Development Programs.
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