The Army Medical and Biomedical S&T Program is divided into four technology subareas: infectious diseases of military importance; medical, chemical, and biological defense; Army operational medicine, and combat casualty care. Each subarea focuses on a specific category of threat to the health and performance of soldiers. The first three technology subareas emphasize the prevention of battle and nonbattle injury and disease while the combat casualty care research program emphasizes far–forward treatment. All three prevention research programs provide both medical materiel (e.g., vaccines, drugs, and applied medical systems) and biomedical information. Combat casualty care provides medical and surgical capabilities tailored to military medical needs for resuscitation, stabilization, evacuation, and treatment of all battle and nonbattle casualties. Each technology subarea has objectives that respond to the national military strategy.

The National Defense Act of Fiscal Year 1994 (Public Law 103–160) consolidated CBD programs, including both nonmedical and medical, under the management of OSD, with the Army serving as executive agent. The medical CBD programs are discussed here; the nonmedical CBD programs are addressed in Section IV–E.

Individual service men and women are the most important, and the most vulnerable, components of military systems and mission capabilities. Disease and nonbattle injury typically far outweigh battle–related injury as the greatest cause of casualties among military forces. Regional, life–threatening, or incapacitating disease epidemics both limit and constrain military deployment alternatives. Widespread sickness and injury are mission aborting; high casualty and death rates are warstoppers. Post–deployment health problems have an adverse impact on future capabilities and on CONUS forces. The current force structure is confronted with an expanded potential for large–scale regional conflicts, proliferation of WMDs, and ready availability of advanced conventional weapons, as well as more diverse and highly complex missions characterized by continuous, high–tempo operations. These more dangerous challenges are coupled with enduring threats of disease, harsh climates, operational stress, and injury. These realities mandate a sustained commitment to robust investment in medical research programs (Figure IV–18).

Figure IV-18. Future Medical Technologies
Click on the image to view enlarged version

The goals of the military infectious disease research program are primarily to sustain force structure by protecting soldiers from incapacitating infectious diseases through the development of vaccines and disease–preventing drugs, and secondarily to develop effective drug treatments to rapidly return personnel to duty. Infectious diseases pose a significant threat to operational effectiveness. Most Americans lack immunity to diseases that are endemic abroad. Prevention of epidemic infections in forces deployed abroad is a force multiplier that enables maximal global operational capability. Immunization prior to deployment is the preferable medical countermeasure to infection because it adds to the full dimensional protection of our forces and supports focused logistics by reducing logistical requirements in the theater of operations. In lieu of available vaccines, a strong program in chemoprophylaxis addresses ongoing needs and the potential emergence of biological resistance to current and future protective systems. The continuing surveillance for new and emerging infectious diseases by the infectious disease research program allows information superiority and tailored, theater–specific interventions resulting in sustainment of the force. Of major importance to the military are the parasitic diseases malaria and leishmaniasis; the bacterial diseases responsible for diarrhea (i.e., Shigella, enterotoxigenic Escherichia coli (ETEC), Campylobacter), and the viral disease, dengue fever. The program also develops improved materiel for control of arthropod disease–vectors and addresses a variety of other threats to mobilizing and deployed forces, including hepatitis, meningitis, viral encephalitis, hemorrhagic fevers and infection with the human immunodeficiency virus (HIV).

A variety of new antimalarial drugs will replace drugs rendered ineffective by the development of parasite resistance for treatment of multidrug resistant malaria and prophylaxis (transition to advanced development in FY01–03). Vaccines to provide protection against Falciparum malaria (FY00) and Vivax malaria (FY02) are currently under development, and a combined vaccine against both (FY08) will be assessed. Vaccines soon–to–be transitioned against Shigella sonnei, Shigella flexneri (FY99), and Shigella dysenteriae (FY01) will provide protection against the major agents causing dysentery. Vaccines against Campylobacter (FY99) and ETEC (FY01) will provide additional protection against the major causes of watery diarrhea. The feasibility of a combined, oral microencapsulated vaccine for major diarrheal threats will be assessed (FY08). A prototype tetravalent dengue vaccine is currently being developed (FY01). New forward deployable diagnostic test (FDDT) systems are under development using current and new technologies. Technology is being developed to transition antibody–based, "dipstick" diagnostic tests for vector–borne diseases and enteric infections (FY99). PCR microchip systems are also being explored (FY06).

There is a constant stream of emerging diseases. It is estimated that one disease of potential military importance is identified each year, while diseases that previously had been treated successfully develop resistance to formerly effective drugs. The focus of market–driven pharmaceutical development is on diseases important in the industrialized world, not on infectious diseases prominent in many strategically significant areas where U.S. military forces might often deploy. Thus, fundamental insight into the biology of the infectious organism and human response to infection must be developed through Army–supported research. Drug and vaccine development requires the use of animal models of human infection to validate their efficacy. In many cases, such as malaria, the species of parasite that will infect laboratory animals is not the same as that afflicting humans. Furthermore, the manifestations of the disease in an animal model may not reflect those seen in human disease. Therefore, other correlates of disease such as in vitro models need to be developed and used. To obtain sufficient quantities of a pathogen for study, methods need to be developed to expand the agent, either in vitro or in vivo.

Some specific technical challenges for diseases of prime military importance are presented below:

The primary goal of the Medical Chemical and Biological Defense Research Programs (MCBDRPs) is to ensure the sustained effectiveness of U.S. armed forces operating in a CBW environment by the timely provision of medical countermeasures. This goal is accomplished by the use of prophylactic medical countermeasures (e.g., vaccine and pretreatment drugs), by enhanced therapeutic countermeasures (antisera and improved chemotherapeutics) and by improved CB diagnostic capabilities far–forward. Improvements in these medical countermeasures will maximize return to duty.

Goals within the medical chemical defense area are as follows:

Within the medical biological defense area, vaccines are being developed that will protect at least 80 percent of the immunized personnel against an aerosol challenge and will induce minimum reactogenicity in soldiers when immunized. Safety and efficacy in preclinical studies using animal models will be demonstrated for the following vaccines: second generation botulinum toxin vaccine (FY98), second–generation plague vaccine (FY98), encephalomyelitis vaccines (FY98), brucellosis vaccine (FY99), ricin vaccine (FY00), staphylococcal enterotoxin B vaccine (FY00), and multiagent vaccines for biological threat agents (FY02). After these successful transition milestones, initial clinical trials will be conducted.

The development of new drugs and vaccines for a particular chemical or biological threat agent requires both close examination of the threat agent to determine the toxicologic or pathogenic mechanisms of the agent or disease, and the development of appropriate pharmacologic or vaccine strategies to counteract these mechanisms. Strategies for vaccine development must embrace new knowledge regarding the human immune system. This includes information about generation of immunity, the preservation of immunological memory, and the regulation or modulation of immune functions, including enhancement and suppression. Similarly, new pharmacological products exploit new knowledge regarding biochemical and pathophysiological mechanisms associated with toxic cell death and organ failure.

New candidate drugs and vaccines must be both safe and efficacious. These criteria are regulated by the FDA. Ethically it is not possible to conduct tests in humans of the efficacy of chemical agent prophylaxes or treatments, nor can biological warfare vaccines be evaluated in this manner. Extensive safety and immunogenicity studies are, however, conducted in these development programs. Efficacy testing must be conducted in model systems. Animal models do not currently exist for many of the CB agents. The use of existing animal models is also limited by the desire to decrease or eliminate the use of animals for drug and vaccine development.

Specific technical challenges include:

The goals of the Army operational medicine research program are to protect soldiers from environmental injury and materiel/system hazards; shape medically sound safety and design criteria for military systems; sustain individual and unit health and performance under operational stresses, especially continuous and sustained operations (CONOPS/SUSOPS), and quantify performance criteria and soldier effectiveness to improve operational concepts and doctrine.

The modern warfighter will require the full range of human physical and mental capability to survive and prevail in future military operations. Goals are:

Developing strategies and products to protect, sustain and enhance soldier performance requires the development and application of scientific data and knowledge. Strategies and products must remain effective in various combinations and in realistic operational tests. One example is sleep management. Strategies that combine the use of pharmaceutical agents, naturally occurring hormones (such as melatonin), timing of bright lights, and feeding schedules are needed. Various combinations of these factors must be explored to develop the best wake/rest management strategies for realistic operational scenarios.

Specific technical challenges are:

The goal of this program is to save lives far forward. This goal will be achieved by improving the delivery of far–forward resuscitative care, minimizing lost duty time from minor battle and non–battle injuries, reducing unnecessary evacuations, and decreasing the resupply requirements of all forward echelons of care. Near–term objectives include general improvements in currently approved treatments, techniques, solutions, etc. Specifically:

Mid–term goals include introduction of improved blood preservatives (FY00–03), small volume resuscitation fluids (FY00–03), local hemostatic agents (FY01), a transport for en route care (FY02), and a rapid fluid warmer and infusion device (FY02). Far–term goals include noninvasive physiological sensors (FY02–08), the use of nanotechnology for smart devices and sensors (FY02–10), development of lightweight energy generators for medical use (FY02–10), and the use of hibernation induction triggers for metabolic down–regulation.

Developing effective interventions for far–forward casualty care requires both the application of new biological knowledge, and the adaptation of existing materials, signal–detection, and signal–processing technologies to new applications in biological systems and to the unique needs of the battlefield environment. In many cases, evaluation of candidate technologies depends on animal models to identify those candidates with the highest potential to successfully demonstrate both safety and efficacy. Ultimately, all medical products must be able to satisfy FDA requirements for safety and effectiveness.

Major technical challenges include:

The roadmap of technology objectives for Medical and Biomedical Science and Technology is shown in Table IV–34.

The influence of this technology area on TRADOC FOCs is summarized in Table IV–35.