Techbase Medical Defense (ACD&P)
Abstract
Project TM4 supports early-phase clinical development of vaccines and therapeutic drugs to provide safe and effective medical defense against validated biological threat agents and emerging infectious disease biothreats including bacteria, toxins, and viruses. This effort reduces programmatic risk of failure in the advanced development phase by generating clinical and supporting non-clinical safety, tolerability and toxicity data for candidate vaccines and therapeutic drugs prior to transition to System Development & Demonstration. In FY2023, the Chemical Biological Defense Program (CBDP) RDT&E Projects have been restructured to align to the CBDP portfolio. TM4 efforts in FY2022 progress to the Mitigate (MT4) and Protect (PT4) portfolios. This restructuring is intended to provide standardization and alignment across CBDP research, development and acquisition efforts. Individual efforts in this project include: - Supports the advanced development of medical countermeasures to include prophylaxes, pretreatments, antidotes and therapeutic drugs against identified and emerging biological warfare threat agents. - Demonstration of human safety and tolerability prior to entry of candidate vaccines and therapeutics into advanced development, supporting the preparation of technical data packages that conform to the Food and Drug Administration (FDA) Investigational New Drug (IND) processes, Department of Defense (DoD) acquisition regulations, and the oversight of early phase clinical trials in accordance with FDA guidelines. - In addition, this project supports innovative biotechnology approaches to advance medical systems designed to rapidly identify, diagnose, prevent, and treat emerging biological threats whether naturally occurring or engineered. - Focuses on therapeutic and prophylactic strategies to effectively minimize injuries resulting from exposure to Chemical Weapons Agents. This effort involves the evaluation FDA approved therapeutics for operational use, as well as generation of novel drug products and formulations to enhance level of protection and/or operational utility for the Warfighter. Efforts in this area are designed to develop drug candidates that will ultimately be submitted for FDA licensure or to identify previously licensed products for new uses in the treatment and pretreatment against chemical warfare injury.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2023
- Source ID
- TM4_0603884BP_4_0400_PB_2023
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (ACD&P)
- Child Accomplishment: 1) DOMANE/LIMIT (Layered Integrated Medical Countermeasure Intervention Technologies)
- Child Accomplishment: 2) Biological Warfare Defense Therapeutics
- Child Accomplishment: 3) Bacterial/Viral/Toxin/Broad Spectrum Prophylaxis
- Child Accomplishment: 4) PBA Medical Countermeasures
- Child Cost Item: f5a1b7f39375fb99c0fbba9d1112ceaf
- Child Cost Item: eb2f44c1beb02e8facf92db1e0099d34
- Child Cost Item: 5d5cb6715b1924240ec9007d7742c392
- Child Cost Item: a14b6658c1a4a54eb695e927a6c4755f
- Child Cost Item: d6b609b912bbfcee20942708664944f6