MEDICAL BIOLOGICAL DEFENSE (ATD)
Abstract
This project (TB3) 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. 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. Categories of this project include biological defense capability areas such as Pretreatments, Diagnostics, and Therapeutics. Pretreatment efforts conduct research and development (R&D) of promising vaccines, medications, and technologies provided prior to potential exposure to biological agents. The goal is to reduce or to entirely prevent adverse effects of exposure. Diagnostic efforts are aimed at screening procedures and analytical methods to verify exposure and determine the effects of exposure to biological warfare (BW) or other biothreat agents. Therapeutic efforts provide medical solutions to sustain and protect the Warfighter in biological environments. Specifically, therapeutic efforts are aimed at developing medical countermeasures to treat exposure to biological or emerging threats such as bacterial (plague, anthrax, glanders), viral (smallpox, encephalitic Alphaviruses), and toxin (ricin, botulinum neurotoxin, staphylococcal enterotoxin) agents. This project includes the Transformational Medical Technologies Initiative (TMTI). The program was launched to respond to the threat of emerging or intentionally engineered biological threats. TMT's mission is to protect the Warfighter from genetically engineered or emerging infectious disease biological threats by providing a rapid response capability from identification of pathogens to the delivery of medical countermeasures. This mission is accomplished through two main efforts: 1) developing broad spectrum (multi-agent) therapeutics against BW or emerging infectious disease agents (e.g. one drug that treats multiple agents); and 2) developing platform technologies to assist in the rapid development of medical countermeasures (MCMs) in response to BW or emerging infectious disease agents (e.g. developing new and innovative ways to mass produce drugs in the event of a biological incident). Effective FY12 this effort was funded as the Transformational Medical Technologies (TMT) Program. 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. Specifically, the MCMI will provide the capability for the advanced development and flexible manufacturing of biological MCM (to include TMT developed MCMs) to address CBRN threats, including novel and previously unrecognized, naturally-occurring emerging infectious diseases. MCMI efforts within science and technology (S&T) are concentrated in three areas: 1) transition of novel platform/expression systems for MCMs, 2) transition advancement of regulatory science, and 3) integration of novel platforms with MCM advanced development and manufacturing. In FY13, all research in this Project (TB3) was re-aligned to Project TM3 - Techbase Medical Defense (ATD).
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2014
- Source ID
- TB3_0603384BP_3_0400_PB_2014
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (ATD)
- Child Accomplishment: 1) Medical Countermeasures Initiative (MCMI)
- Child Accomplishment: 2) Diagnostics (Biosurveillance)
- Child Accomplishment: 3) Pretreatments
- Child Accomplishment: 4) Pretreatments
- Child Accomplishment: 5) Pretreatments
- Child Accomplishment: 6) Therapeutics
- Child Accomplishment: 7) Therapeutics
- Child Accomplishment: 8) Transformational Medical Technologies
- Child Accomplishment: 9) Transformational Medical Technologies