TECHBASE MED DEFENSE (ATD)
Abstract
Project TM3 supports 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. The Medical Countermeasures Initiative (MCMI) was established to coordinate inter-related advanced development and flexible manufacturing capabilities, and these efforts within science and technology (S&T) have been concentrated in advancing two areas: 1) regulatory science and 2) flexible manufacturing technologies and processes for MCMs. These MCMI efforts are enablers supporting the DoD Medical Countermeasures Advanced Development and Manufacturing (MCM-ADM) capability. The focus of these efforts is unchanged, but starting in FY17 all MCMI efforts under TM3 are transitioned into Bacterial Therapeutics to reduce budget management complexity and highlight the range of MCM efforts ongoing with the ADM.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2018
- Source ID
- TM3_0603384BP_3_0400_PB_2018
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (ATD)
- Child Accomplishment: 1) Assays and Reagents
- Child Accomplishment: 2) Bacterial Therapeutics
- Child Accomplishment: 3) Bacterial/Toxin Vaccines
- Child Accomplishment: 4) Biosurveillance
- Child Accomplishment: 5) Chemical Diagnostics
- Child Accomplishment: 6) Diagnostic Device Platforms
- Child Accomplishment: 7) Medical Countermeasures Initiative
- Child Accomplishment: 8) Neurologic Therapeutics
- Child Accomplishment: 9) Toxin Therapeutics
- Child Accomplishment: 10) Vaccine Platforms and Research Tools
- Child Accomplishment: 11) Viral Therapeutics
- Child Accomplishment: 12) Viral Vaccines