News 1998 Army Science and Technology Master Plan

Q. Medical and Biomedical Science and Technology

1. Scope

Military Medical and Biomedical Science and Technology programs are a unique national resource focused to yield superior capabilities for medical support and services to U.S. armed forces. Unlike other national and international medical and biomedical S&T investments, military research is concerned with preserving the combatant’s health and optimizing mission capabilities despite extraordinary battle, nonbattle, and disease threats. It is also unlike most of the more widely visible Army modernization programs because its technology is incorporated in service men and women rather than into the systems they use. This technology area is vital to the human capability dimension of all joint warfighting capabilities. Weapon system developers exploit capabilities to mitigate system hazards, improve soldier survivability, and optimize operator–system interfaces. Because of its special and unique nature, international treaties and conventions require military medical research to be conducted for the benefit of mankind. Additionally, many activities and products are regulated by the U.S. Food and Drug Administration (FDA).

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.

2. Rationale

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

3. Technology Subareas

a. Infectious Diseases of Military Importance

Goals and Timeframes

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).

Major Technical Challenges

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:

Animal and laboratory models for parasitic threats are not good predictors in drug studies.
Knowledge of parasite biology and mechanisms of drug resistance is incomplete.
Drug discovery and design are time consuming and costly.
The full range of antigens involved in protection from most pathogens is unknown.
Informative animal models for malarial, diarrheal, and viral diseases are needed.
New approaches to enhance the mucosal immune response must be developed.
The technology to combine potentially incompatible vaccine formulations and dosing regimens into a single, combined vaccine for diarrheal or malarial agents, or a tetravalent dengue vaccine, must be developed.
Appropriate field sites to test vaccines for efficacy in humans need to be identified.
The best vaccine technology for a particular threat must be identified and selected.
Diagnostic assays have insufficient sensitivity to detect pathogens at the time of clinical presentation.
Diversity of etiologic agents of disease makes no single diagnostic platform appropriate for all diseases.

b. Medical Chemical and Biological Defense

Goals and Timeframes

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:

By FY99, develop biotechnology–based chemical agent prophylaxes that provide protection against battlefield concentrations of chemical warfare (CW) agents without operationally significant physiological or psychological side effects.
By FY99, demonstrate safety and efficacy sufficient for a Milestone 0 transition of a reactive topical skin protectant (providing protection against penetration) that will detoxify both vesicant and nerve agents.
By FY00, demonstrate safety and efficacy of a candidate medical countermeasure against vesicant agents sufficient for a Milestone 0 transition decision.
By FY02, demonstrate safety and efficacy sufficient for a Milestone 0 transition decision of an advanced skin/wound decontamination system for decontaminating chemically contaminated wounds.

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.

Major Technical Challenges

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:

Developing appropriate animal models to test the safety and efficacy of medical countermeasures predictive of human safety and efficacy.
Increasing genetic and biologic information applicable to medical countermeasures against threat agents.
Developing pretreatments/antidotes with special characteristics (e.g., quick acting, long acting, easy to carry/use).
Exploiting the human immune system to provide protection against threat agents.
Analyzing new vaccine delivery systems and multi–agent vaccines.
Synthesizing reactive/catalytic decontaminants and demonstrating that decontaminants and protective compounds are safe.

c. Army Operational Medicine

Goals and Timeframes

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:

By FY99, establish medical criteria to optimize efficiency and ensure safety of individual soldier equipment (combat boots, body armor, load carriage systems) for use by the equipment developers. Develop state–of–the–art scientifically based training programs to improve performance of elite units for special occupational requirements, and to increase opportunities of all soldiers in jobs with specific physical standards.
By FY98, operationally test melatonin, a hormone that acts as a master synchronizer of body rhythms and as a natural sleep inducer for ability to prevent symptoms of jet lag and fatigue in soldiers deploying across time zones and in night operations. Specific physical and psychological training strategies will be developed to harden selected individuals to operate continuously without performance deficit or injury for 72 hours.
By FY99, conduct a continuous operations simulation to demonstrate and refine the sleep–induction/rapid re–awakening and stimulant components of the sleep management system.
By FY99, identify a rapid, reliable, and inexpensive means for assessing a soldier’s level of mental fatigue and alertness. Develop and demonstrate a wrist–worn sleep/activity monitor with an integrated microprocessor system.
By FY98, integrate real–time satellite–derived weather data into thermal strain decision aids for battlefield commanders. The MERCURY model system of environmental hazards will predict soldier performance in specific real–time locations.
By FY99, connect a sensor suite of technologies such as accelerometry, ausculation, spectroscopy, electrical impedance, and force and temperature sensing through a wireless body local area network system, with remote passive data interrogation capabilities.
By FY01, develop a knowledge management system to reduce information obtained and predict performance and health risks.

Major Technical Challenges

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:

Understanding sleep physiology and the purpose of restorative sleep.
Modeling physiological measures to provide commanders with health and performance (readiness status).
Defining the operational zones of caution: operational environments in which a soldier is currently at a minimal risk, but may become a casualty with continued exposure to the environment.
Developing sensors and biomarkers to provide information about soldiers’ status and the operational environment.
Integrating physiological models and instrumentation into a set of tools that will provide rapid and meaningful information about soldiers’ operational readiness to commanders.

d. Combat Casualty Care

Goals and Timeframes

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:

By FY98, develop the miniSTAT, an evacuation and en route care device that allows far–forward monitoring to assist in diagnosis and treatment.
By FY00, introduce a microencapsulated antibiotic to allow site–specific administration of antibiotics.
By FY99, produce a forward, mobile, digitally instrumented surgical hospital by introducing the advanced surgical suite for trauma casualties (ASSTC).
By FY99–00, develop treatment/triage algorithms to aid the medic in treatment.

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.

Major Technical Challenges

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:

Developing lightweight battery energy generation, and computing capability necessary to support the demands of the computer–aided diagnostic sensor/computer interface system.
Developing the biotechnology, nanotechnology, pharmacologic interventions, and miniaturized equipment necessary to induce metabolic down–regulation far forward.
Overcoming the problem of applying local hemostatic agents (e.g., fibrin glues) to the wet surfaces of a hemorrhaging wound.
Identifying early prognostic physiological indicators of shock, and developing corresponding noninvasive or minimally invasive sensing technologies.
Developing online/real–time human physiologic databases from prehospital trauma settings.
Stabilizing red blood cells without destroying function while eliminating in–theater pretransfusion processing requirements.
Improving knowledge regarding the physiologic and cellular factors underlying the body’s response to hemorrhage and subsequent resuscitation.
Reversing complex detrimental inflammatory and physiological cascades initiated by reduced blood flow and anoxia subsequent to hemorrhage.
Learning more about the detailed mechanisms responsible for brain edema and cytotoxicity following head injury.

4. Roadmap of Technology Objectives

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

5. Linkages to Future Operational Capabilities

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

Table IV–34.  Technical Objectives for Medical and Biomedical Science and Technology

Technology Subarea

Near Term FY98–99

Mid Term FY00–04

Far Term FY05–13

Infectious Diseases of Military Importance Vaccine vectors

Synthesized antiparasitic drugs

Genetically engineered vaccines

Malaria genome sequencing

Peptide synthesis

Countermeasures to parasitic drug resistance

Proteosome delivery

Single step field assays

Advanced adjuvants

Combined oral vaccines

Topical antiparasitic drugs

Single dose vaccines

Medical Chemical and Biological Defense Confirmation diagnostics

Cyanide exposure field diagnostic test kit

Cyanide pretreatment

Nerve agent exposure field diagnostic test kit

Topical skin protectant

Advanced anticonvulsant

Bioengineered toxin scavengers

Catalytic pretreatment for a nerve agent

Multichambered autoinjector

Reactive topical skin protectant

Catalytic scavenger for broad range of CW agents

Combined oral vaccine

Immunoprophylaxis for CW agents

Medical countermeasures against vesicants

Nucleic acid immunization

Receptor targeted therapeutic agents

Army Operational Medicine Laser effects model

Pharmacological strategies to enhance restorative sleep

Training strategies to enhance upper body strength and endurance

Heat stress model to predict soldier performance decrements

Blunt trauma models laser injury treatments

Laser injury treatments

Enhanced crew rest guidance

Training strategies to optimize specific physiological capabilities

Strategies to reduce heat stress

Performance–enhancing ration components

Physiological status models

Sleep/alertness enhancers

Treatments for laser retinal injury

Memory enhancers

Nonsteroidal strength enhancers

Combat Casualty Care Microencapsulated antibiotic

Far–forward monitoring/Ministat

Surgical suite for trauma casualties/ASSTC

Treatment/triage assist algorithm

Improved blood preservative

Small volume resuscitation fluid

Rapid fluid warmer and infusion device

En route care transport

Local hemostatic agents

Hibernation drug/metabolic down regulation

Noninvasive physiological sensors

Use of nanotechnology for smart systems

Lightweight energy generators


Table IV–35.  Medical and Biomedical Science and Technology
Linkages to Future Operational Capabilities

Technology Subarea

Integrated and Branch/Functional Unique Future Operational Capabilities

Infectious Diseases of Military Import TR 97–026 Deployability
TR 97–029 Sustainment
TR 97–031 Sustainment Services
TR 97–044 Survivability—Personnel
MD 97–007 Preventive Medicine
MD 97–010 Medical Laboratory Support
Medical Chemical and Biological Defense TR 97–029 Sustainment
TR 97–038 Casualty Care, Patient Treatment, and Area Support
TR 97–044 Survivability—Personnel
MD 97–004 Combat Health Support in a Nuclear, Biological, and Chemical Environment
MD 97–007 Preventive Medicine
MD 97–010 Medical Laboratory Support
Army Operational Medicine TR 97–002 Situational Awareness
TR 97–007 Battlefield Information Passage
TR 97–018 Relevant Information and Intelligence
TR 97–023 Mobility—Combat Dismounted
TR 97–029 Sustainment
TR 97–038 Casualty Care, Patient Treatment, and Area Support
TR 97–044 Survivability—Personnel
TR 97–048 Performance Support Systems
TR 97–053 Embedded Training and Soldier–Machine Interface
MD 97–007 Preventive Medicine
MD 97–009 Combat Stress Control
MD 97–010 Medical Laboratory Support
Combat Casualty Care TR 97–002 Situational Awareness
TR 97–007 Battlefield Information Passage
TR 97–024 Combat Support/Combat Service Support Mobility
TR 97–026 Deployability
TR 97–029 Sustainment
TR 97–031 Sustainment Services
TR 97–035 Power Sources and Accessories
TR 97–036 Nonprimary Power Sources Combat Vehicles/Support Systems
TR 97–038 Casualty Care, Patient Treatment, and Area Support
TR 97–044 Survivability—Personnel
TR 97–048 Performance Support Systems
MD 97–001 Patient Evacuation
MD 97–005 Far–Forward Surgical Support
MD 97–006 Hospitalization
MD 97–008 Combat Health Logistics Systems and Blood Management
MD 97–010 Medical Laboratory Support

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