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 (formerly called MCMI) 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 biological warfare 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 consists 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 ADM current Good Laboratory Practices (cGLP) Bio-Safety Level (BSL)- 4 Test and Evaluation (T&E) capability will provide a capability to develop medical countermeasures in a safe environment. The mission of the BSL-4 T&E facility will be to provide a capability that is appropriately resourced with personnel and equipment to conduct test and evaluation on medical countermeasures that are being developed for biological agents that require BSL-4 containment. There is a national shortage of cGLP BSL-4 availability within the U.S. This capability will be Government provided within a current Government owned and operated facility. The intent of this facility is to compliment the ADM T&E capability at the BSL-4 level. Biosurveillance (BSV) requirements address medical and physical CBRN mission needs spanned in over 11 requirements documents, and through Combatant Commander (COCOM) identified needs. Funds will support Joint USFK Portal and Integrated Threat recognition (JUPITR) ATD/BSV ATD which will find, demonstrate, transition, and transfer the best operational concepts and technology solutions in support of a holistic approach to countering biological threats from the laboratory to operational use. The JUPITR ATD will provide the USFK with a holistic Biosurveillance capability to provide early warning, detection, collection, identification and theater confirmation of a Biological event. The JUPITR ATD consists of filling capability gaps through information sharing and communication systems and detection/diagnostic systems for the USFK. Depending on the maturity, outputs will focus on proving component, CONOPS, and subsystem transition into programs of record (PORs) and/or integration into existing PORs. The Emerging Infectious Disease - Influenza (EID-Flu) Medical Countermeasure Acquisition Program is developing and will deliver an FDA-approved, broad-spectrum medical countermeasure to the Warfighter for protection against naturally occurring or biologically engineered influenza viruses. The emergence of a new pandemic strain with no existing effective vaccine or therapeutic is highly likely. The focus of the program is on a treatment option that is more effective than currently available drugs and has the potential to be an effective therapeutic not just for multiple strains of the flu, but many other biological warfare agents/viruses as well. Ongoing EID-Flu drug development will be leveraged to demonstrate additional broad-spectrum MCM's against naturally occurring and/or engineered biowarfare threats. Completion of activities required to enter Phase 3 clinical trials are the focus of the ACD&P phase. FDA approval for an influenza treatment is anticipated in FY16 following completion of the SDD phase. The Hemorrhagic Fever Virus (HFV) Medical Countermeasure Acquisition Program develops platform-based medical countermeasures (MCMs), using high threat, extremely lethal Biological Warfare Agents (BWAs) of the Filoviridae family agents (Ebola and Marburg) as model systems. Platform-based medical countermeasures will be advanced through the Food and Drug Administration (FDA) licensure/approval via the FDA 'Animal Rule', which allows for the demonstration of efficacy in relevant animal model(s) when human testing is not ethically feasible. HFV will also conduct animal model development, refinement and FDA qualification to support the pivotal animal efficacy testing required under the FDA 'Animal Rule'. Animal models will be developed and qualified for parenteral and aerosol indications. Aerosol models are needed to meet the Warfighter requirement to counter BWAs encountered on the battlefield or as a result of terrorist activities. Completion of Phase I trials, animal model development, and manufacturing scale up are the focus of the ACD&P phase. FDA approval for Filovirus therapeutics are expected in FY18 following completion of the SDD phase. The Next Generation Diagnostics System (NGDS) addresses the mission needs identified in the CBRN Field Analytics ICD (2010). The NGDS is envisioned to be an evolutionary acquisition family of systems to provide increments of capability over time across many echelons of the Combat Health Support System. The mission of the NGDS is to provide CBRN threat identification and FDA-cleared diagnostics to inform individual patient treatment and CBRN situational awareness and disease surveillance. NGDS Increment 1 Deployable Component will significantly improve diagnostic capabilities for deployable combat health support units (role 3) while also improving operational suitability and affordability. The NGDS Increment 1 Deployable Component is intended to replace the legacy Joint Biological Agent Identification and Diagnostic System (JBAIDS) beginning in FY17. The NGDS Increment 1 Service Laboratory Component is intended to provide high throughput biological threat identification, characterization, and diagnostics to fixed site CONUS and OCONUS laboratories operated by the Army, Navy, and Air Force in coordination with the Armed Forces Health Surveillance Center. NGDS Increment 2 is intended to provide advanced diagnostics for biological pathogens and toxins, diagnostics for chemical and radiological exposures, and to provide capability to lower echelons of care. The Department of Defense (DoD) 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 biological warfare (BW) agents are urgently needed. Vaccines have been identified as the most efficient countermeasure against the validated threat of BW weapons. The Trivalent Filovirus Vaccine Program will offer protection against the threat of Ebola and Marburg viruses. The Trivalent Filovirus Vaccine Program was initiated in FY10 at Milestone A. The current budget supports development of two prototypes through the Technology Development Phase. The DoD anticipates that the Federal Drug Administration (FDA) will approve this vaccine using the 'Animal Rule', which allows for the demonstration of efficacy on relevant animal model(s). During this phase a scalable manufacturing process is developed. This process will be used to develop current Good Manufacturing Practices (cGMP) lots suitable for a Phase 1 clinical trial. In addition, animal safety and efficacy studies will be conducted to support Investigational New Drug (IND) submission to the FDA. These efforts will support a Milestone B decision and entry into the Engineering, Manufacturing, and Development (EMD) phase. The DoD is the Public Health Emergency Countermeasures lead for the advanced development of the Filovirus Vaccine. The DoD plans to initiate a Ricin Vaccine Program in FY13. The current budget supports development of competitive prototypes through the Technology Development Phase. The efforts to be conducted during this period include developing a pilot scale manufacturing process and manufacture cGMP lots to support nonclinical and clinical studies; develop vaccine formulation that meets the logistical requirements of the DoD; conduct nonclinical GLP Safety studies and submit Investigational New Drug (IND) applications. The DoD anticipates that the FDA will approve these products using the 'Animal Rule', which allows for the demonstration of efficacy in relevant animal model(s). During this phase, the vaccine candidates will be evaluated for safety and immunogenicity in a small human clinical trial (Phase 1). These efforts will support a Milestone B decision and entry into the EMD Phase. The DoD is the Public Health Emergency Countermeasures lead for the advanced development of the Ricin Vaccine. The DoD plans to initiate a Western, Eastern, and Venezuelan Equine Encephalitis vaccine (WEVEE) vaccine program in FY13. To satisfy the competitive prototyping requirement and to reduce program risk, the DoD will develop two prototypes through the Technology Development Phase. The efforts to be conducted during this period include develop pilot scale manufacturing processes and manufacture cGMP lots to support nonclinical and clinical studies; develop vaccine formulation that meets the logistical requirements of the DoD; conduct non-clinical GLP Safety studies; submit Investigational New Drug (IND) applications; and conduct Phase 1 clinical human safety studies. The DoD anticipates that the FDA will approve these products using the 'Animal Rule', which allows for the demonstration of efficacy in relevant animal model(s). These efforts will support a Milestone B decision and entry into the EMD phase. The DoD is the Public Health Emergency Countermeasures lead for the advanced development of the WEVEE Vaccine.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2014
- Source ID
- MB4_0603884BP_4_0400_PB_2014
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (ACD&P)
- Child Accomplishment: 1) ADM - Bridging Studies
- Child Accomplishment: 2) ADM - Candidate Manufacturing Platform Processes
- Child Accomplishment: 3) ADM - Program Management and Contract Administration
- Child Accomplishment: 4) ADM - BSL-4 GLP T&E
- Child Accomplishment: 5) ADM - Maintain BSL4 GLP T&E
- Child Accomplishment: 6) BSV
- Child Accomplishment: 7) BSV
- Child Accomplishment: 8) EID FLU
- Child Accomplishment: 9) HFV
- Child Accomplishment: 10) IBP
- Child Accomplishment: 11) NGDS Increment 1
- Child Accomplishment: 12) NGDS Increment 1
- Child Accomplishment: 13) NGDS Increment 1
- Child Accomplishment: 14) NGDS Increment 1
- Child Accomplishment: 15) NGDS Increment 1
- Child Accomplishment: 16) NGDS Increment 2
- Child Accomplishment: 17) TMT/PLTFM
- 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 FILO
- Child Accomplishment: 24) VAC RIC
- Child Accomplishment: 25) VAC RIC
- Child Accomplishment: 26) VAC RIC
- Child Accomplishment: 27) VAC RIC
- Child Accomplishment: 28) VAC WEVEE
- Child Accomplishment: 29) VAC WEVEE
- Child Accomplishment: 30) VAC WEVEE
- Child Accomplishment: 31) VAC WEVEE
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