3) BIOPROTO
Abstract
Funds biomedical research focused on the nonclinical and early clinical development of therapeutic countermeasures against known and emerging viral, bacterial, and toxin biological warfare (BW) threats for which U.S. Food and Drug Administration (FDA)-approved therapeutics are limited or lacking. BW defense therapeutics mitigate and reverse the effects of known and emerging viral, bacterial, and toxin biological warfare threats in symptomatic warfighters diagnosed with BW disease. They are the last line of defense against BW threats and are critical to returning symptomatic warfighters to service. Biomedical research is focused on nonclinical development (e.g., animal model, and formulation/manufacturing studies) and early clinical evaluation of broad-spectrum therapeutic candidates that target viruses, bacteria or toxins directly, enhance the host response (e.g., by modulating the immune system) and/or relieve BW disease symptoms. Therapeutic candidates that are shown to be both safe and efficacious against BW threats will advance for further non-clinical and/or clinical evaluation under RDT&E budget activity 5, and can be accelerated for use against emerging infectious diseases during an outbreak. Clinical and nonclinical evaluation of novel small molecules (chemically synthesized), novel biologic molecules (isolated from natural sources), drug and drug/vaccine combinations (aka layered defense), and repurposing of drugs approved by the FDA or in clinical development for other indications, are included in this research. Refinement of appropriate animal models in which to evaluate therapeutic candidates is also included. Projects leverage interagency and commercial sector investments to accelerate development and reduce costs.
Document Details
- Document Type
- Accomplishment
- Publication Date
- Oct 01, 2024
- Source ID
- ef144fed6899030deccc97e252b0b479