Medical Advanced Technology
Abstract
This Program Element (PE) matures and demonstrates advanced medical technologies including drugs, vaccines, medical diagnostic devises, measures for identification and vector control, and developing medical practices and procedures to effectively protect and improve the survivability of United States Forces across the entire spectrum of military operations. Tri-Service coordination and cooperative efforts are focused in four principal medical areas: Combat Casualty Care, Military Operational Medicine, Militarily Relevant Infectious Diseases, and Clinical and Rehabilitative Medicine. Promising medical technologies are refined and validated through extensive testing, which is closely monitored by the United States (U.S.) Food and Drug Administration (FDA) and Environmental Protection Agency (EPA), as part of their processes for licensing and/or approving new medical products. The FDA requires medical products to undergo extensive preclinical testing in animals and/or other models to obtain preliminary effectiveness and safety information before they can be tested in human clinical trials. Clinical trials are conducted in three phases to prove the safety of a drug, vaccine, or device for the targeted disease or medical condition, starting in Phase 1 with a small number of healthy volunteers. Following Phase 1, Phase 2 clinical trials will provide expanded safety data and evaluate the effectiveness of a drug, vaccine, or medical device in a larger population of patients having the targeted disease or medical condition. Each successive phase includes larger numbers of human subjects and requires FDA cognizance prior to proceeding. Work conducted in this PE primarily focuses on late stages of technology maturation activities required to conduct Phase 1 and 2 clinical trials. Some high-risk technologies may require additional maturation with FDA guidance prior to initiating these clinical trials. Such things as proof of product stability and purity are necessary to meet FDA standards before entering later stages of testing and prior to transitioning into a formal acquisition program where large Phase 3 pivotal trials will be conducted for licensure. Activities in this PE may include completion of preclinical animal studies and Phase 1 and 2 clinical studies involving human subjects according to FDA and EPA requirements. Promising medical technologies that are not regulated by the FDA are modeled, prototyped, and tested in relevant environments. Blast research and research into maturing field rations in this PE are fully coordinated with the United States Army Natick Soldier Research, Development, and Engineering Center. This coordination enables improved body armor design and rations for Soldiers. Additionally, the activities funded in this PE are externally peer reviewed and fully coordinated with all Services as well as other agencies through the Joint Technology Coordinating Groups of the Armed Services Biomedical Research Evaluation and Management (ASBREM) Community of Interest (COI). The ASBREM COI, formed under the authority of the Assistant Secretary of Defense for Research and Engineering, serves to facilitate coordination and prevent unnecessary duplication of effort within the Department of Defense's (DoD) biomedical research and development community, as well as its associated enabling research areas. Project 810 matures and demonstrates FDA-regulated medical countermeasures such as drugs, vaccines, and diagnostic systems to naturally occurring infectious diseases of military importance, as identified by worldwide medical surveillance and military threat analysis. The Project also supports testing of personal protective measures such as repellents and insecticides regulated by the EPA. This Project is being coordinated with the Defense Health Program. Project 840 validates studies on safety and effectiveness of drugs, biologics (medical products derived from living organisms), medical devices, and medical procedures and practice guidelines intended to minimize immediate and long-term effects from battlefield injuries; advanced technology development and clinical studies for treatment of ocular and visual system traumatic injury; and restoration of function and appearance by regenerating skin, muscle, nerve, vascular and bone tissues in wounded Service Members. Additionally, this Project develops and realistically tests improved occupant protection systems through medical research to characterize mechanisms of injuries sustained by occupants of ground-combat vehicles subjected to underbody blast events, determine human tolerance limits to underbody blast forces, and develop tools to predict injuries to ground-combat vehicle occupants exposed to underbody blast forces. Starting in FY17 the funding for the Clinical and Rehabilitative Medicine Research Program moves from Project 840 to Project ET5. Project ET5 which is a restructure of efforts funded elsewhere in this Program Element, starts in FY17 and the funding for the Clinical and Rehabilitative Medicine Research Program moves from Project 840 to Project ET5. Project ET5 conducts validation studies on safety and effectiveness of drugs, biologics, medical devices, procedures, and rehabilitative strategies intended to minimize long-term effects from battlefield injuries. This Project supports advancing technology supporting clinical and rehabilitative solutions to restore function of ocular and visual system post injury; and advancing regenerative techniques to restore the function and appearance of damaged tissues by regenerating skin, muscle, nerve, vascular and bone tissues in wounded Service Members. Project FH4 matures, validates, and supports enhanced Force Health Protection of Soldiers against threats in military operations and training. Health-monitoring tools are matured to rapidly identify deployment stressors that affect the health of Joint Forces. These databases and systems enhance the DoDs ability to monitor and protect against adverse changes in health, especially mental health effects caused by changes in brain function. Force Health Protection work is conducted in close coordination with the Department of Veterans Affairs. The program is maturing the development of global health monitoring (e.g., development of neuropsychological evaluation methodologies), validating clinical signs and symptoms correlating to medical records, diagnosed diseases, and mortality rates. The key databases supporting this program are the Millennium Cohort Study and the Total Army Injury and Health Outcomes Database. These databases allow for the examination of interactions of psychological stress and other deployment and occupational stressors that affect Warfighter health behaviors. Starting in FY17 the FH4 funding and research will be merged into Project MM3. Project MM3 supports the Medical and Survivability technology areas with laboratory validation studies and field demonstrations of biomedical products designed to counteract myriad environmental and physiological stressors, as well as materiel hazards encountered in training and operational environments to protect, sustain, and enhance Soldier performance. The key efforts are to demonstrate and transition technologies, as well as validate tools associated with Soldier survivability, injury assessment and prediction, assessments for post-concussive syndrome, and enhancing performance during continuous operations. The three main thrust areas are: 1) Physiological Health and Environmental Protection; 2) Injury Prevention and Reduction; and 3) Psychological Health and Resilience. This Project contains no duplication with any effort within the Military Departments and includes direct participation by other Services. Starting in FY17 the FH4 funding and research will be merged into Project MM3. Work funded in this PE is fully coordinated with efforts undertaken in PE 0602787A and the Defense Health Program. The cited work is consistent with the Assistant Secretary of Defense, Research and Engineering Science and Technology, focus areas and the Army Modernization Strategy. Work in this PE is performed by Walter Reed Army Institute of Research (WRAIR), Silver Spring, MD; United States Army Medical Research Institute of Infectious Diseases (USAMRIID) and the Armed Forces Institute of Regenerative Medicine (AFIRM), Ft Detrick, MD; United States Army Research Institute of Environmental Medicine (USARIEM), Natick, MA; United States Army Institute of Surgical Research, Joint Base San Antonio, TX; United States Army Aeromedical Research Laboratory (USAARL), Ft Rucker, AL; the Naval Medical Research Center (NMRC), Silver Spring, MD; United States Army Dental Trauma Research Detachment (USADTRD), Joint Base San Antonio, TX.
Document Details
- Document Type
- R2 Budgetary Justification
- Publication Date
- Oct 01, 2018
- Source ID
- 0603002A_3_2040_PB_2018
- Change Summary Explanation
- Service Agency Name
- Army
Entities
Organizations
- United States Army
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