MEDICAL BIOLOGICAL DEFENSE (ACD&P)
Abstract
The Joint Vaccine Acquisition Program (JVAP) under Chemical Biological Medical Systems (CBMS) funds the technology development phase for 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 manufacturing process development, formulation development, non-clinical studies, pilot lot manufacturing, Investigational New Drug (IND) application submission and Phase 1 clinical human safety studies. Vaccine effectiveness, will be evaluated in animals to satisfy the requirements of the FDA's "Animal Rule". Products under development in this budget item include Filovirus vaccine. 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 1 clinical studies), efficacy tests in humans/animals (Phase 2 clinical studies or pivotal animal efficacy studies), and expanded safety or efficacy studies (Phase 3 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.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2011
- Source ID
- MB4_0603884BP_4_0400_PB_2011
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (ACD&P)
- Child Accomplishment: 1) TMTI
- Child Accomplishment: 2) TMTI
- Child Accomplishment: 3) JVAP - Filovirus Vaccine
- Child Accomplishment: 4) JVAP - Filovirus Vaccine
- Child Accomplishment: 5) JVAP - Filovirus Vaccine
- Child Accomplishment: 6) JVAP - Filovirus Vaccine
- Child Accomplishment: 7) SBIR
- Child Cost Item: c1564282a216dc62becb3160f9bcc7f2
- Child Cost Item: 3bdee6a5a76f6e96b0b8da8f45b57cdf
- Child Cost Item: 05f0947cd61738862790587827b53318
- Child Cost Item: 6239a935c8adb8ca78a38e2c66d62554
- Child Cost Item: c2044d5690da16c6a5cad4280af90f33
- Child Cost Item: 28b2e2474491251d2ba314310a8aa5bf
- Child Cost Item: f63be22377ecfe95f3d5244da8a42e3a
- Child Cost Item: d806b5b7158e35a11af462ea23da2194
- Child Cost Item: fbd6eafcf6368b8ca11c7ecef6459825
- Child Cost Item: 6028f2b4f531e42f8a29d46f2c9ff6b3
- Child Cost Item: 4846dea564404230fc35565cd821be8a
- Child Cost Item: 4332f6f7d40b81de639f1090024e7a57
- Child Cost Item: 4b91cf80b3842f4e60e8848c03d3d4ba
- Child Cost Item: 263f4136f7ede64090d5fc44e2597e96
- Child Cost Item: 2ff37e625c42f0792ebd96fab33fa514
- Child Cost Item: e2c9b44176dbc78bdc45dbe2883ba161
- Child Cost Item: d2bb46dba9095571a5abcc2e46cfae19
- Child Cost Item: 9b922c782294389a890352ceaf4e3707
- Child Cost Item: 6a4be92bf9c2a760d958df9de095e488
- Child Cost Item: 16abae5b26b6936ca29ab46d006912cc
- Child Cost Item: 94d776d37496d832f1240f60037b3003
- Child Cost Item: d796eefe9cb9859fb1e2c3463bdcde86
- Child Cost Item: 2e2435db7e2f36c331fc4856cee2f70a
- Child Cost Item: 60b438e459778a0ab5669a5dcda329a4
- Child Cost Item: 7d32907a02ff684397c9f4049c601cac
- Child Cost Item: 740d35bbe4cc49588b87b5c4cb3282ad
- Child Cost Item: 5ac7fbaa9a342e30119a3092105559c8
- Child Cost Item: 75a616aa762363b31517997eeb9324bd
- Child Cost Item: deae1e5997bad04b286845d66aa27c14
- Child Cost Item: eb97c18c9113b7e2328afb637f55d06c
- Child Cost Item: 69968b6bedb630fe4b65187e96f9f123
- Child Cost Item: 6807c7caed443f7996acf544b0115375
- Child Cost Item: a4d6b452a27f28d856e214bdd846cd0e
- Child Cost Item: 10f435549c401b8e063f7253afc0e1e4