MEDICAL ADVANCED TECHNOLOGY

Abstract

This program element (PE) maturates and demonstrates advanced medical technologies including drugs, vaccines, medical devices, and diagnostics and developing medical practices and procedures to effectively protect and improve the survivability of US 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 U.S. Food and Drug Administration (FDA) and Environmental Protection Agency (EPA), as part of their processes for licensing new medical products. The FDA requires medical products to undergo extensive preclinical testing in animals and/or other models to obtain preliminary efficacy and toxicity information before they can be tested in humans (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. 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 2 human expanded safety and efficacy 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 and conducting Phase 3 trials for licensure. Activities in the PE may include completion of preclinical animal studies and Phase 1 and 2 clinical studies involving human volunteers according to the FDA and EPA requirements. Promising medical technologies that are not regulated by the FDA are modeled, prototyped, and tested in relevant environments. Blast research efforts 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) Committee. The ASBREM Committee serves to facilitate coordination and prevent unnecessary duplication of effort within DoD?s biomedical research and development community, as well as their associated enabling research areas. Project 810 matures and demonstrates US Food and Drug Administration (FDA) regulated medical countermeasures such as drugs, vaccines, and diagnostic systems to naturally occurring infectious diseases and wound infections 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 U. S. Environmental Protection Agency (EPA). This project is being coordinated with the Defense Health Program. Project 840 validates studies on safety and effectiveness of drugs, biologics (products derived from living organisms), medical devices and medical procedures 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, and bone tissue in battle-injured casualties. 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. 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 Department of Defense's (DoD's) 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.

Document Details

• Document Type: R2 Budgetary Justification
• Publication Date: Oct 01, 2013
• Source ID: 0603002A_3_2040_PB_2013
• Service Agency Name: Army

Entities

Organizations

• United States Army

Tags

DTIC Thesaurus Topics

• Brain Injuries
• Combat Casualty Care
• Combat Injuries
• Health Services
• Injury Prevention
• Malaria
• Medical Personnel
• Test And Evaluation
• Traumatic Stress Disorder
• Vaccines

Fields of Study

• Medicine

Readers

• Clinical Trial Research.
• Medical or Health Care Field.
• Military Science and Technology Research and Modernization.

Technology Areas

• Biotechnology