Giving Full Measure to Countermeasures Addressing Problems in the DoD Program to Develop Medical Countermeasures Against Biological Warfare Agents (2004) / Chapter Skim
Currently Skimming:
Executive Summary
Executive Summary
Pages 1-18
The Chapter Skim interface presents what we've algorithmically identified as the most significant single chunk of text within every page in the chapter.
Select key terms on the right to highlight them within pages of the chapter.
From page 1... ...
approval of biowarfare countermeasures,1 mean that since the Gulf War of 1990 1991 DoD has gained no new vaccines and only a few drugs as medical biodefense countermeasures. This serious situation exists despite declarations that biological warfare poses a significant threat to the safety and effectiveness of the nation's armed forces (Bush, 2002; Cohen, 1997; Defense Science Board, 2001, 2002; Perry, 1996; U.S.
|
From page 2... ...
The charge to the committee is to recommend strategies for accelerating the DoD research, development, and licensure processes for new medical biodefense countermeasures.2,3 Based on the study charge to address strategies for accelerating these processes, the committee focused its attention on the organization and management of these processes, rather than on details of specific scientific approaches. The committee was not asked to assess the nature or extent of any biological warfare threat or to compare the value to DoD of developing medical countermeasures against biological warfare agents relative to the pursuit of its other obligations.
|
From page 3... ...
.4 The upsurge in funding and effort aimed at protecting the civilian population against bioterrorism will undoubtedly result in the development of new technologies and products that can also aid in protecting military personnel against the risks of biological warfare. However, the perceived risks posed by these agents can be different in the two settings, and there are important differences between the planning for protection against bioterrorism and biological warfare (DoD, 1993, 2000; Fauci, 2003; Linden, 2002)
|
From page 4... ...
PROBLEMS WITH THE DOD EFFORT The committee sees dismal prospects for successful results (and no prospects for faster results) from the current efforts by DoD's Chemical and Biological Defense Program to produce medical biodefense countermeasures.
|
From page 5... ...
Making the Development of Medical Countermeasures a Priority A decision by DoD and national leaders to make the DoD program to develop medical countermeasures against biological warfare agents a genuine priority is the essential first step to set the stage for an effective program aimed at meeting unique DoD needs. To ensure that DoD has an effective research and development pro gram for medical biodefense countermeasures, the committee makes the following recommendation: 1.
|
From page 6... ...
2. Congress should authorize the creation of the Medical Biodefense Agency, a new DoD agency responsible for the research and development program for medical countermeasures against biological warfare agents.
|
From page 7... ...
to support Phase 1 and even Phase 2 clinical trials before a candidate product is subject to acquisition system review. The arbitrary separation between DoD's programs to develop medical countermeasures against biological warfare agents and against infectious diseases of military significance should be eliminated.
|
From page 8... ...
Additional funding should be provided, as well, to renovate or replace the deteriorating and overcrowded USAMRIID facility to preserve the availability of its unique animal testing and holding space and laboratories equipped for research involving lethal pathogens and to ensure that it has the capacity to employ up-to-date technologies in research, testing, and evaluation. The committee is strongly persuaded that creation of the Medical Biodefense Agency will be the most effective means of improving DoD's research and development program for medical biodefense countermeasures.
|
From page 9... ...
. In the event the Medical Biodefense Agency were not created, the need to establish a substantially more effective infrastructure for the DoD medical countermeasures program, as well as the need to address other critical challenges affecting that program, will remain and should be addressed by DoD.
|
From page 10... ...
Larger companies have been deterred by factors including shortterm opportunity costs and little commercial market for many biodefense products. To encourage increased involvement by academia and private sector firms in the development of medical countermeasures for DoD, the Medical Biodefense Agency should make full use of all available funding mechanisms, including "other transactions" authority, which is specifically intended for agreements with commercial firms that do not normally
|
From page 11... ...
In addition, FDA should collaborate with the scientific community in efforts to enrich the science base that it will have to draw on in order to apply the Animal Efficacy Rule. To hasten action on medical countermeasures, FDA has adopted practices that are unusually proactive.
|
From page 12... ...
, and GMP production of candidate products necessary to support current or planned research on all types of biodefense countermeasures. The agency should promote and participate in efforts to encourage the use of nonhuman primates other than Indian-origin rhesus macaques and to assess and coordinate the use of nonhuman primates and the use of government-owned testing facilities for biodefense research and product development.
|
From page 13... ...
Organizing an Effective Program with Accountability for Performance 2. Congress should authorize the creation of the Medical Biodefense Agency, a new DoD agency responsible for the research and development program for medical countermeasures against biological warfare agents.
|
From page 14... ...
The Medical Biodefense Agency should fully utilize "other transac tions" authority as a means of encouraging academia and private sector firms to participate in the research and development of medical biodefense countermeasures to meet DoD needs.
|
From page 15... ...
The Medical Biodefense Agency could contrib ute unique DoD resources in areas of aerobiology and the development of animal models of human diseases caused by biological warfare agents.
|
From page 16... ...
Handout to Institute of Medicine and National Research Council Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological Warfare Agents, Meeting III. Washington, DC.
|
From page 17... ...
Presentation to the Institute of Medicine and National Research Council Committee on Accelerating the Research, Development, and Acquisition of Medical Countermeasures Against Biological War fare Agents, Meeting I Washington, DC.
|
Key Terms
This material may be derived from roughly machine-read images, and so is provided only to facilitate research.
More
information on Chapter Skim is available.