TECHBASE MED DEFENSE (ATD)
Abstract
Project TM3 funds preclinical and early phase clinical development of vaccines, therapeutic drugs, and diagnostic capabilities to provide safe and effective medical defense against validated biological threat agents or emerging infectious disease biothreats including bacteria, toxins, and viruses. Innovative biotechnology approaches to advance medical systems designed to rapidly identify, diagnose, prevent, and treat disease due to exposure to biological threat agents will be evaluated. In addition this project supports the advanced development of medical countermeasures to include prophylaxes, pretreatments, antidotes, skin decontaminants and therapeutic drugs against identified and emerging chemical warfare threat agents. Entry of candidate vaccines, therapeutics, and diagnostic technologies into advanced development is facilitated by the development of technical data packages that support the Food and Drug Administration (FDA) Investigational New Drug (IND) processes, DoD acquisition regulations, and the oversight of early phase clinical trials in accordance with FDA guidelines. This project also supports the advanced development of medical countermeasures to protect the Warfighter against radiological/nuclear exposure. The Medical Countermeasures Initiative (MCMI) was established to coordinate inter-related advanced development and flexible manufacturing capabilities, providing a dedicated, cost-effective, reliable, and sustainable MCM process that meets the Warfighter and national security needs. MCMI efforts within science and technology (S&T) are concentrated in advancing two areas: 1) regulatory science and 2) flexible manufacturing technologies and processes for MCMs. Efforts conducted in these areas are enablers supporting the DoD Medical Countermeasures Advanced Development and Manufacturing (MCM-ADM) capability. FY 2015 funding includes $87.6 million of base funding and $22.7 million of Ebola emergency funding.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2016
- Source ID
- TM3_0603384BP_3_0400_PB_2016
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