MEDICAL BIOLOGICAL DEFENSE (ACD&P)
Abstract
This Advanced Component Development and Prototypes (ACD&P) Project supports: The Medical Countermeasures Advanced Development and Manufacturing (ADM) program was established to provide a dedicated, agile, flexible and enduring capability to the Department of Defense (DoD) to support the development, licensure, and production of Medical Countermeasures (MCMs). The ADM will provide an integrated infrastructure to support a medical countermeasures pipeline, and respond to Warfighter and National security needs. The ADM effort is being executed in two phases. Phase I is a two year base period to establish, commission, and validate facilities and equipment for two ADM suites using single use, disposable, modular and multi-product technologies for medical countermeasures advanced development and manufacturing. Both suites must meet Biological Safety Level-3 (BSL-3) standards. Phase 2 consist of four (4) two-year options to support and maintain ADM capability in a state of readiness to support medical countermeasures development (under the animal rule as applicable) and manufacturing and assist in training personnel in its use. Once commissioned, the ADM will support transition of enabling science and technology (S&T) and novel platform and expression systems for delivery of products by leveraging technological and regulatory science advancements. The Next Generation Diagnostic System addresses the mission needs identified in the CBRN Field Analytics ICD (2010). The mission of the Next Generation Diagnostic System is to provide chemical, biological, and radiological diagnostic systems. NGDS Increment 1 materiel solutions will significantly improve analytical and diagnostic capabilities across the continuum of biological warfare threat agents and operations (peacetime, wartime, and deployed). NGDS Increment 1 medical diagnostic capabilities will provide health care providers with more timely and accurate information to inform individual patient treatment. NGDS Increment 1 clinical analytical and interconnectivity capabilities will provide commanders with situational awareness of biological warfare hazards to support Force Protection and Force Health Protection decision making. The (1) Hemorrhagic Fever Virus (HFV) Therapeutic Medical Countermeasures (MCM), which will provide broad spectrum (multi-agent), platform-based therapeutics against Ebola and Marburg viruses. TMT efforts to be conducted for the medical countermeasures during this period include Phase 1 human clinical safety trials, non-clinical studies to demonstrate safety and efficacy, and animal model development / refinement. DoD anticipates the FDA will require use of the Animal Rule for the HFV therapeutic medical countermeasures, which allows for the demonstration of efficacy in relevant animal model(s) when human testing is not ethically feasible. ; (2) Emerging Infectious Disease (EID) MCM Increment 1, Many conditions result in the inability to provide effective vaccines to service members and civilians. Effective vaccines do not exist for all known strains of influenza virus. The emergence of a new pandemic strain with no existing effective vaccine or therapeutic is highly likely. EID-Flu will provide a broad spectrum EID MCM to protect service members from naturally occurring, biologically or genetically engineered Influenza viruses. EID Flu, a rapidly adaptable, broad spectrum therapeutic (3) CBRN Biosurveillance (BSV), a new start program, will initiate systems development, engineering, logistics planning, and test planning for integration of existing commercial and developmental next generation systems and clinical and non-clinical sample collection and analysis tools to provide pre/post event real-time alarm and near-real time confirmation of CBRN threats, to enhance battlespace awareness, and provide high-quality biosurveillance data. The Joint Vaccine Acquisition Program (JVAP), under Chemical Biological Medical Systems (CBMS) Joint Program Management Office, 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. JVAP has three product lines in the early development phase: Filovirus vaccine, Ricin vaccine, and Western/Eastern/ Venezuelan Equine Encephalitis vaccine (WEVEE). JVAP initiated the Filovirus Vaccine program in FY10. The Ricin and WEVEE vaccine programs will be initiated in early FY13. Efforts to be conducted during this period include develop pilot scale manufacturing processes to support nonclinical and clinical studies; development vaccine formulation that meets the logistical requirements of the DoD; conduct non-clinical studies to demonstrate safety and efficacy; submit Investigational New Drug (IND) application; and conduct Phase 1 clinical human safety studies. JVAP anticipates that the FDA will approve these products using the Animal Rule, which allows for the demonstration of efficacy in relevant animal model(s). JVAP also has the mission to maintain IND vaccines in Good Manufacturing Practice (GMP) storage and to conduct the periodic potency and sterility testing of these materials to support submissions to the FDA. These IND vaccines are used to possibly provide additional levels of protection to laboratory workers in the Special Immunizations Program (SIP) conducting research on these diseases. The Department of Defense is the Public Health Emergency Countermeasures lead for the advanced development of the Filovirus, Ricin, and WEVEE vaccines.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2013
- Source ID
- MB4_0603884BP_4_0400_PB_2013
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (ACD&P)
- Child Accomplishment: 1) SBIR
- Child Accomplishment: 2) MCMi
- Child Accomplishment: 3) MCMi
- Child Accomplishment: 4) MCMi
- Child Accomplishment: 5) ADM
- Child Accomplishment: 6) ADM
- Child Accomplishment: 7) ADM
- Child Accomplishment: 8) NGDS Increment 1
- Child Accomplishment: 9) TMTI
- Child Accomplishment: 10) EID FLU
- Child Accomplishment: 11) HFV
- Child Accomplishment: 12) IBP
- Child Accomplishment: 13) TMT/PLTFM
- Child Accomplishment: 14) BSV
- Child Accomplishment: 15) VAC FILO
- Child Accomplishment: 16) VAC FILO
- Child Accomplishment: 17) VAC FILO
- Child Accomplishment: 18) VAC FILO
- Child Accomplishment: 19) VAC FILO
- Child Accomplishment: 20) VAC FILO
- Child Accomplishment: 21) VAC FILO
- Child Accomplishment: 22) VAC FILO
- Child Accomplishment: 23) VAC RIC
- Child Accomplishment: 24) VAC RIC
- Child Accomplishment: 25) VAC RIC
- Child Accomplishment: 26) VAC WEVEE
- Child Accomplishment: 27) VAC WEVEE
- Child Accomplishment: 28) VAC WEVEE
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