Medical Advanced Technology

Abstract

This Program Element (PE) matures and demonstrates advanced medical technologies including drugs, vaccines, medical diagnostic devices, 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. Starting in Fiscal Year 2020 (FY20), the principal area of Clinical and Rehabilitative Medicine is replaced with the area of Medical Assist Support Technologies. Promising medical technologies are refined and validated through extensive testing, which is conducted in compliance with Food and Drug Administration (FDA) regulations for human medical products, and environmental protection agency (EPA) regulations for insect-control products that impact humans or the environment (e.g., repellents and insecticides). 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 stepwise: first to prove the product is safe in humans, second to demonstrate the desired effectiveness and optimal dosage (amount to be administered) in a small group human study, and third to demonstrate effectiveness in large, diverse human populations. 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 safety and effectiveness 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 pivotal trials in diverse populations will be conducted for licensure. Activities in this PE may include completion of preclinical animal studies and small safety and effectiveness studies involving humans according to FDA and EPA requirements. Promising medical technologies that are not regulated by the FDA or EPA 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 Combat Capabilities Development Command Soldier 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 biomedical research and development community, as well as its associated enabling research areas. The cited work is consistent with the Under Secretary of Defense (Research and Engineering) Science and Technology (S&T) focus areas and the Army Modernization Strategy. Work in this PE is performed by: the U.S. Army Medical Research and Development Command (USAMRDC), Fort Detrick, MD.

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Document Details

Document Type
R2 Budgetary Justification
Publication Date
Oct 01, 2021
Source ID
0603002A_3_2040_PB_2021
Change Summary Explanation
Funds reprogrammed out for higher priority Army requirements.
Service Agency Name
Army

Entities

Organizations

  • United States Army

Tags

Communities of Interest

  • Biomedical

DTIC Thesaurus Topics

  • Airway Management
  • Bone Fractures
  • Brain Injuries
  • Combat Casualty Care
  • Combat Injuries
  • Control Systems
  • Disability Administration
  • Health Services
  • Injury Prevention
  • Malaria
  • Traumatic Stress Disorder
  • Vaccines
  • Wounds And Injuries

Readers

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

Technology Areas

  • Biotechnology

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