Medical Systems - Adv Dev
Abstract
This program element (PE) funds development of medical materiel within the early system integration portion of the System Development and Demonstration phase of the acquisition life cycle using 6.4 funding. Program efforts support transition of promising Science and Technology candidate medical technologies (drugs, vaccines, medical devices, diagnostics, and mechanisms for detection and control of disease carrying insects) to larger scale testing in humans for safety and effectiveness. Programs are aligned to meet future force requirements identified within concept documents and organizational structures. This Program Element also provides funding for Food and Drug Administration (FDA) regulated human clinical trials to gain additional information about safety and effectiveness on the path to licensure for use in humans. The Projects supported by this PE are: (PROJ 808) funds development of candidate medical countermeasures for infectious diseases of military relevance. Efforts include vaccines, drugs, diagnostic kits/devices, and insect control measures. These funds support human clinical efficacy trials of the drug/vaccine in a larger group that are designed to assess performance and to continue safety assessments in a larger group of volunteers. Products from this project will transition to 849. (PROJ 811) funds the development of military relevant human immunodeficiency virus (HIV) medical countermeasures. It provides funding for planning and conducting of human clinical trials in a group of healthy volunteers to assess the drug/vaccine for safety, tolerability, how the drug/vaccine is distributed, metabolized, and excreted from the body, and investigate the appropriate dose for therapeutic use. Products from this project will transition to Project 812. (PROJ 836) funds the demonstration and validation of medical products for enhanced combat casualty care and follow-on care, including rehabilitation. This project also funds the human clinical trials that test the safety and effectiveness of biologics, devices and demonstration. Clinical trials are conducted in accordance with U.S. Food and Drug Administration (FDA) regulations. Products from this project will transition to 832. (PROJ VS7) funds program upgrades, retrofits, trains, and sustains the fleet of Medical Evacuation legacy helicopters that continue to play a major role in Iraq and Afghanistan. The approved force design increased the number of air frames in the force from 12 to 15 aircraft for 37 MEDEVAC companies. All products from this project will transition to VS8 in FY16. This program is managed by U.S. Army Medical Materiel Development Activity (USAMMDA) and U.S. Army Medical Materiel Agency (USAMMA) of the US Army Medical Research and Materiel Command.
Document Details
- Document Type
- R2 Budgetary Justification
- Publication Date
- Oct 01, 2016
- Source ID
- 0603807A_4_2040_PB_2016
- Change Summary Explanation
- Service Agency Name
- Army
Entities
Organizations
- United States Army
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