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. 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, 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.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2021
- Source ID
- TM4_0603884BP_4_0400_PB_2021