MEDICAL BIOLOGICAL DEFENSE (SDD)
Abstract
This project (MB5) contains Engineering and Manufacturing Development (EMD) on efforts (post Milestone B), which provide a rapid response capability from identification of pathogens to the delivery of medical countermeasures. Specifically, this project includes: the Critical Reagents Program (CRP), the Joint Vaccine Acquisition Program (JVAP) which includes vaccines for Recombinant Botulinum A/B and Plague, and The Transformational Medical Technology Initiative (TMTI) program. The Critical Reagents Program's (CRP) strategy establishes a core research and development capability to develop biological threat agent, genomic reference materials (antigens, nucleic acids, and antibodies) and detection and diagnostic assays for biothreat agent detection that shall be horizontally inserted across multiple detection and diagnostic platforms. In addition, this strategy will implement a formal, validated advanced development process to transition new assays into production and integration with the appropriate detection/diagnostic platform. The Transformational Medical Technologies Initiative (TMTI) was launched to respond to the threat of emerging or intentionally bioengineered biological threats. TMTI's mission is to protect the Warfighter from genetically engineered biological threats by providing a rapid response capability from identification of pathogens to the delivery of medical countermeasures. This mission is accomplished by developing broad spectrum (multi-agent) therapeutics against biological warfare (BW) agents (e.g, one drug that treats multiple agents). The development of broad spectrum therapeutics involves developing a capability to treat exposure to hemorrhagic fever viruses (HFVs) (e.g. Ebola virus) and intracellular bacterial pathogens (ICBs) (e.g. Tularemia). Efforts are further classified as host-directed therapeutics (e.g, drugs that target common pathways within a human to prevent or treat a variety of diseases) or pathogen-directed therapeutics (e.g., drugs that attack a common pathway found in multiple threat agents). Attrition is high throughout the drug development process. Less than 10% of all preclinical compounds become a licensed drug. Causes for attrition include scientific failures, Food and Drug Administration (FDA) rejection at major milestone reviews, and loss through down-selection at DoD Milestone Decision points. The development of medical countermeasures is an arduous process that requires extensive interaction with the FDA, from pre-clinical research to safety tests in human subjects (Phase I clinical studies), efficacy tests in humans/animals (Phase II clinical studies or pivotal animal efficacy studies), and expanded safety or efficacy studies (Phase III clinical studies), which culminate with a request to the FDA to license, market, and produce a drug. This interaction between the Department of Defense (DoD) and the FDA results in a coordinated, unified, and safe effort. The Joint Vaccine Acquisition Program (JVAP) under Chemical Biological Medical Systems (CBMS) funds the EMD phase of vaccines that are directed against validated biological warfare (BW) weapons to include bacteria, viruses, and toxins of biological origin. Effective medical countermeasures to negate the threat of these BW agents are urgently needed. Vaccines have been identified as the most efficient countermeasure against the validated threat of BW weapons. Efforts for medical biological defense product development involve production scale-up studies and validation, non-clinical studies, consistency manufacturing, and expanded clinical human safety studies. The results of these efforts, and those conducted during the EMD phase, will be used to submit a Biologic License Application (BLA) to the Food and Drug Administration (FDA) for product licensure. To evaluate vaccine effectiveness, pivotal animal studies will be conducted concurrently with the Phase 3 clinical trial to satisfy the requirements of the FDA's "Animal Rule". Upon FDA licensure, the product will transition to full-scale licensed production. Products under development in this budget item include Recombinant Botulinum A/B and Plague vaccines.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2011
- Source ID
- MB5_0604384BP_5_0400_PB_2011
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- Root: CHEMICAL/BIOLOGICAL DEFENSE (SDD)
- Child Accomplishment: 1) CRP
- Child Accomplishment: 2) CRP
- Child Accomplishment: 3) CRP
- Child Accomplishment: 4) CRP
- Child Accomplishment: 5) TMTI
- Child Accomplishment: 6) TMTI
- Child Accomplishment: 7) JVAP - Recombinant Botulinum Vaccine
- Child Accomplishment: 8) JVAP - Recombinant Botulinum Vaccine
- Child Accomplishment: 9) JVAP - Recombinant Botulinum Vaccine
- Child Accomplishment: 10) JVAP - Recombinant Botulinum Vaccine
- Child Accomplishment: 11) JVAP - Plague Vaccine
- Child Accomplishment: 12) JVAP - Plague Vaccine
- Child Accomplishment: 13) JVAP - Plague Vaccine
- Child Accomplishment: 14) JVAP - Plague Vaccine
- Child Accomplishment: 15) JVAP - Plague Vaccine
- Child Accomplishment: 16) SBIR
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