MEDICAL RADIOLOGICAL DEFENSE (ACD&P)

Abstract

Operational forces have an immediate need to survive, safely operate, and sustain operations in a radiological/nuclear (R/N) threat environment across a continuum of global, contingency, special operations/low intensity conflict, homeland defense, and other high-risk missions. There are no FDA-approved prophylactics, treatments, or biodosimetry capabilities against radiation exposure. Treatment of R/N casualties depends on effective use of multiple medical capabilities in an integrated manner. Thus, this program supports the development of medical radiological countermeasures (MRADC) using a family-of-systems approach to provide a full spectrum capability to protect against the radiation threat which includes prophylactic, treatment, and biodosimetry capabilities. Individual countermeasure solutions will be developed using a single step to a full capability (FDA approval) strategy. Multiple contractors will serve as individual product integrators throughout development and will be responsible for conducting activities associated with drug development in a manner consistent with eventual approval by the FDA. Each contractor will sponsor the drug to the FDA and hold all approvals and/or licenses. The Technology Development phase includes pre-clinical studies, completion of manufacturing scale up, Phase 1 human clinical safety studies and initiation of manufacturing scale up activities, potentially utilizing the Medical Countermeasures Initiative (MCMI) Advanced Development Manufacturing (ADM) capability. During the Engineering and Manufacturing Development (EMD) phase, large scale manufacturing, Phase 2 human clinical safety studies and definitive animal efficacy studies will be conducted. FDA approval of the countermeasure is an exit criterion for the EMD phase. During the Production and Deployment Phase, sufficient quantities of product to meet Initial Operational Capability (IOC) and Full Operational Capability (FOC) will be purchased. Subsequent purchases will be made by the Defense Logistics Agency (DLA). Any post-marketing surveillance studies requested by the FDA will be conducted. Medical Radiological Countermeasures (MRADC) efforts include development of multiple countermeasures required to protect U.S. Forces against a myriad of injuries caused by exposure to radiation and to restore casualties to pre-exposure health. MRADC shall reverse or limit radiation injury resulting in increased survival, decreased incapacity, and sustained operational effectiveness. In addition, MRADC shall be effective against a broad range of radiation sources and types and shall be useable throughout the full spectrum of healthcare operations.

Document Details

• Document Type: Project
• Publication Date: Oct 01, 2013
• Source ID: MR4_0603884BP_4_0400_PB_2013

Tags

Fields of Study

• Medicine
• Physics

Readers

• Civilian Systems Systems Program Capability Development and Upgrade Support Activity Expense and Pay Management.
• Critical Infrastructure Protection in CBRN and WMD Threats.