MEDICAL ADVANCED TECHNOLOGY

Abstract

This program element (PE) supports maturation and demonstration of 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 US 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, starting with Phase 1, to prove the safety of a drug, vaccine, or device for the targeted disease or medical condition in 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 pivotal trials for licensure. Activities in the PE may include completion of preclinical animal studies and Phase 2 clinical studies involving human volunteers according to the FDA and EPA requirements. 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. Work funded in this project PE is fully coordinated with efforts undertaken in PE 0602787A. The cited work is consistent with the Director, Defense Research and Engineering Strategic Plan, the Army Modernization Strategy, and the Army Science and Technology Master Plan. Work in this PE is performed by Walter Reed Army Institute of Research, Silver Spring, MD; US Army Medical Research Institute of Infectious Diseases, Fort Detrick, MD; US Army Research Institute of Environmental Medicine, Natick, MA; US Army Institute of Surgical Research, Fort Sam Houston, TX; US Army Aeromedical Research Laboratory, Fort Rucker, AL; the Naval Medical Research Center, Silver Spring, MD; US Army Dental Trauma Research Detachment, Fort Sam Houston, TX; US Army Center for Environmental Health Research and the Armed Forces Institute of Regenerative Medicine, Fort Detrick, MD.

Document Details

• Document Type: R2 Budgetary Justification
• Publication Date: Oct 01, 2012
• Source ID: 0603002A_3_2040_PB_2012
• Service Agency Name: Army

Entities

Organizations

• United States Army

Tags

Communities of Interest

• Biomedical

DTIC Thesaurus Topics

• Biomedical Research
• Brain Injuries
• Combat Casualty Care
• Combat Injuries
• Environmental Protection
• Health Services
• Infectious Diseases
• Injury Prevention
• Malaria
• Spinal Injuries
• Test And Evaluation
• Traumatic Stress Disorder
• Vaccines

Fields of Study

• Medicine

Readers

• Clinical Trial Research.
• Infectious Disease/Epidemiology
• Military Science and Technology Research and Modernization.

Technology Areas

• Biotechnology