4. Combat Health Support Modernization Roadmap
Table III-J-2 presents a summary of demonstrations and systems listed in the Combat Health Support Modernization Roadmap (Figure III-J-1).
Table III-J-2. Combat Health Support Demonstration and System Summary
Click here to view enlarged version of image
Figure III-J-1. Roadmap for Combat Health Support Modernization
Click here to view enlarged version of image
Army medical S&T programs support a diversity of non-materiel advanced development technology demonstrations (TDs). Unlike most non-medical TDs, medical TDs must be conducted in a laboratory, rather than in the field environment, because of the regulatory requirements placed on medical materiel by the U.S. Food and Drug Administration (FDA).
The FDA requires that a medical product (e.g., vaccine, medical device, or drug) have demonstrated preclinical safety and efficacy prior to the product's evaluation in man. Thus the medical system acquisition process has led to a tailored Life Cycle System Management Model for medical materiel. It is in the TD phase of the medical materiel life cycle that technology candidates are fully evaluated for pre-clinical (prior to human use) safety and efficacy. The best candidates are then selected for transition. Descriptions of major technology demonstrations are provided on the following pages. Dates provided in the text reflect the timeline of the product from technology base research to development (Medical Milestone I).
a. Demonstrations Supporting System of Medical Defense Against Infectious Disease
Successful development of a vaccine for malaria, bacterial diarrhea, insect-borne viruses, or human-immunodeficiency virus depends on innovative methodology. Several genetic engineering technologies are being used to develop new vaccines that can be given orally; provide long-lasting protection with fewer doses; or protect the soldier from multiple diseases with a single product.
Vaccine Vectors (89-98). Mutant auxotrophic vectors are live bacteria which have a limited ability to reproduce within man. Presentation of the vaccine by live bacteria markedly enhances the effectiveness of the vaccine, while the use of auxotrophic bacteria as carriers limits the period of infection and thus improves the safety of the vaccine. Supports: Genetically-Engineered Vaccines.
Proteosome Complex Vaccines (90-98). The use of antigens encapsulated in protein structures called proteosomes leads to a markedly increased recognition of the antigen by the body's immune system. This results in a more highly effective vaccine. Supports: Genetically-Engineered Vaccines.
Chimeric RNA Vaccines (87-97). Introducing the genetic material from disease producing bacteria into innocuous bacteria produces a chimeric organism incapable of producing disease by itself. However, the organism can produce the antigens of the pathogen which will safely induce protective immunity in man. Supports: Genetically-Engineered Vaccines.
Computer-Assisted Drug Design (95-98). Determination of the three-dimensional structure of drug and vaccine target molecules will allow the design of specific complementary drugs and vaccines which will inhibit the function of key biological processes in infectious organisms, providing immunity to infection or novel drugs for treating disease. Supports: Genetically-Engineered Vaccines.
Advanced Adjuvants (95-98). Coupling vaccine components to certain stimulatory molecules results in a substantial increase in the immune system's response to vaccination. Supports: Genetically-Engineered Vaccines.
b. Demonstrations Supporting System of Medical Biological Defense (Defense Funded)
Synthetic Vaccines (93-98). This will develop vaccines utilizing an artificial process to produce a product which mimics a natural antigen. This will result in vaccines that are safer and cheaper to produce, and safer to use as vaccines. Supports: Biological Casualty Prophylaxis.
Mouse Monoclonal Antibodies (93-97). This demonstration allows for production of sensitive and specific reagents for diagnosis of service members exposed to biological threat agents. Supports: Biological Casualty Prophylaxis.
Nucleic-Acid Diagnostic Tests (95-97). Extremely sensitive DNA/RNA amplification techniques are being configured on microchip, probes, and membrane read-out systems. This will provide rapid, sensitive, and specific confirmation of select biological threat agents in clinical materials. Supports: Biological Casualty Prophylaxis.
c. Demonstrations Supporting System of Medical Chemical Defense (Defense Funded)
Cyanide Pretreatment (94-97). A methemoglobin former will be used as an oral pretreatment to protect soldiers against battlefield levels of cyanide. Methemoglobin preferentially binds cyanide, removing it from the toxic active site, thereby restoring normal cellular respiration. The lead candidate compound is an 8-aminoquinoline which is undergoing evaluation for safety and efficacy. Supports: Chemical Agent Prophylaxis.
Diagnostic Field Test Kit, Nerve Agent Exposure (95-97). This field test kit will measure cholinesterase for the diagnosis of moderate exposure to organophosphate nerve agents. This kit, which uses the hemoglobin-adjusted red blood cell acetylcholinesterase test method, will offer high test reliability and ease of use in field settings, and will significantly enhance diagnosis, screening, and epidemiology of nerve agent exposure. Supports: Far-Forward Casualty Management.
d. Demonstrations Supporting System of Combat Casualty Care
Forward Treatment Techniques (93-99). This demonstration will provide biologics and forward treatment intervention regimens for the prevention of brain/spinal damage, immunosuppression, sepsis, and general organ failure following shock and other major battlefield trauma. Supports: Far-Forward Casualty Management.
Far-Forward Care (93-01). This demonstration will enhance forward battlefield capability to resuscitate following hemorrhage, integrate physiologic monitoring and other life support equipment, and provide expert consultative systems for diagnosis, triage, and treatment of combat casualties. Supports: Far-Forward Casualty Management.
Head Injury Therapeutic Technology (93-03). This demonstration will show feasibility of therapeutic measures which reduce the effects of trauma to the brain and central nervous system, thus reducing a major source of battlefield mortality. Supports: Far-Forward Casualty Management.
Prevention of Cell/Organ Failure (93-05). This demonstration will provide biologics/ pharmaceuticals for use far-forward in the treatment of massive trauma. These compounds will preserve cellular function and integrity, and reduce cell and tissue death following injury. Reductions in cellular death will help reduce battlefield mortality when combined with other, state-of-the-art techniques for combat casualty care. Supports: Far-Forward Casualty Management.
Reduce Metabolic Demands (93-06). This demonstration will provide pharmaceutical biologics which reduce the body's metabolic demand, and attempt to match metabolic oxygen demand to the current ability to supply oxygen to the tissues. In this way, cells will not starve for oxygen, and will not subsequently release toxic metabolic by-products. Reductions in metabolism demand will help reduce battlefield mortality when combined with other state-of-the- art techniques for combat casualty care. Supports: Far-Forward Casualty Management.
e. Demonstrations Supporting System of Army Operational Medicine
Sleep and Alertness Enhancement (92-97). This will demonstrate the efficacy of pharmacologic and behavioral interventions to counteract the effects of inadequate restorative sleep and to enhance soldier vigilance and performance during sustained and continuous operations. New compounds to induce sleep and to enhance restorative value of sleep; new measurement tools as rapid, reliable, and inexpensive means for assessing a soldier's level of mental fatigue and alertness; and improved guidance for individual and unit performance as a function of sleep and work/rest cycles, all designed to increase soldier effectiveness, will be evaluated and transitioned. Supports: Performance Enhancing Compounds and Protective Devices, Medical Information and Knowledge Products.
Operational Stress Countermeasures (92-98). This will demonstrate the efficacy of behavioral and materiel countermeasures to sustain performance during combat and OOTW. Improved unit effectiveness and decreased incidence of combat stress casualties as a result of proactive management of operational stress will be demonstrated. Behavioral, nutritional, and pharmacological methods for reducing the emotional, physical, and intellectual stress associated with extended periods of hypervigilance, crisis management, sleep debt, undernourishment, and strenuous exercise will be validated, as well as improved methods for far-forward management of combat stress casualties. Supports: Performance Enhancing Compounds and Protective Devices, Medical Information and Knowledge Products.
Environmental Stress Countermeasures (92-97). This will demonstrate the reliability and utility of models to predict performance degradation and casualties caused by exposure to extreme climates (heat, cold, and high terrestrial altitude). Models will be transitioned into operational guidance which will assist small unit leaders in planning training and military operations. Supports: Performance Enhancing Compounds and Protective Devices, Medical Information and Knowledge Products.
Blast Overpressure (92-98). This will demonstrate the reliability and utility of improved medical criteria for operator exposure to military weapons systems which create blast overpressure. Models will expand to include specific hazards for military women. Predictive models for incorporation into design standards for military systems which protect soldiers and maximize system performance will be transitioned. Supports: Performance Enhancing Compounds and Protective Devices, Medical Information and Knowledge Products.
Microwave Bioeffects (92-02). This will demonstrate the reliability and utility of models to predict performance degradation and injuries caused by exposure to military systems which produce electromagnetic radiation. Models will expand to include specific hazards for military women. Predictive models for incorporation into design standards for military systems which protect soldiers and maximize system performance will be transitioned. Operational guidance will also be developed which will assist commanders in planning training and military operations. Supports: Performance Enhancing Compounds and Protective Devices, Medical Information and Knowledge Products.