MEDICAL ADVANCED TECHNOLOGY

Abstract

This program element (PE) maturates and demonstrates advanced medical technologies including drugs, vaccines, medical devices, diagnostics, and developing medical practices and procedures to effectively protect and improve the survivability of U.S. 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 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 to 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) Committee. The ASBREM Committee serves to facilitate coordination and prevent unnecessary duplication of effort within the Department of Defenses biomedical research and development community, as well as its associated enabling research areas. Project 810 maturates and demonstrates 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 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 maturates, 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 Pr

Document Details

• Document Type: R2 Budgetary Justification
• Publication Date: Oct 01, 2014
• Source ID: 0603002A_3_2040_PB_2014
• Service Agency Name: Army

Entities

Organizations

• United States Army

Tags

DTIC Thesaurus Topics

• Bacterial Diseases
• Biomedical Research
• Clinical Trials
• Combat Casualty Care
• Combat Injuries
• Dengue
• Department Of Defense
• Diseases And Disorders
• Health
• Human Population
• Infectious Diseases
• Malaria
• Military Operations
• Vaccines
• Virus Diseases
• Wound Infections
• Wounds And Injuries

Fields of Study

• Medicine

Readers

• Infectious Disease/Epidemiology
• Medical or Health Care Field.
• Military Science and Technology Research and Modernization.

Technology Areas

• Biotechnology