MEDICAL BIOLOGICAL DEFENSE (EMD)
Abstract
This project funds the development of reagents, assays, and diagnostic equipment for biological warfare agents (BWA) defense and expands chemical and biological detection capabilities. Its primary mission is enhancing CBRN information sharing across the Department of Defense's (DoD) medical surveillance, public health, and chemical/biological defense communities to enhance chemical and biological medical health situational awareness and coordinate integrated CBRN system solutions. The Medical Countermeasure (MCM) Advanced Development and Manufacturing (ADM) capability (formerly the MCMI program) provides core and drug development services to include the establishment, commissioning, validation, and attainment of Current Good Manufacturing Practice (cGMP)/Current Good Laboratory Practice (cGLP) for a MCM ADM capability for the Department of Defense (DoD). Future funding will be used to maintain the facility in a state of readiness to support MCM product development, FDA licensure and manufacture of MCMs. The ADM effort is being executed in two phases. Phase I is for the establishment, commissioning, and validation of the MCM capability. This project funds the establishment of a facility(ies) to be located in the United States and its territories. Two ADM suites, at Bio Surety Level (BSL) 3 will be established during the base contract period, with options to incrementally increase capacity. In Phase II, the contractor team will support and maintain that capability in a state of readiness to support MCM development (under the 'Animal Rule' as applicable) and manufacturing and assist in training personnel in its use. This includes transition and integration of new technologies, from pre-Investigational New Drug Application phase with readiness to support simultaneous operations, through FDA licensure. Two major medical programs critical to accomplishing the Biosurveillance mission are supported under this project in order to streamline collaboration and integration efforts, maintain continuity and efficiency, and to minimize duplication of efforts. Specifically, these efforts include but are not limited to the Critical Reagents Program (CRP), and Next Generation Diagnostic System (NGDS), These efforts address the President's priority of developing a robust portfolio of cross-cutting resources and materiel solutions that support the National Security Strategy, National Military Strategy to Combat Weapons of Mass Destruction, the National Strategy for Countering Biological Threats, and the needs of the Warfighter. The Critical Reagents Program's (CRP) strategy establishes a core research and development capability by developing biological threat agent reference materials (strains, antigens, antibodies and nucleic acids) and detection/diagnostic assays for biothreat agent detection. These reagents/assays are leveraged across multiple programs to meet the requirements of the Warfighter and Joint biological defense systems and support the biological defense community. After FY14, CRP funding is combined with NGDS to form a medical diagnostic portfolio. BSV will support the Joint USFK Portal and Integrated Threat Recognition (JUPITR) 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 laboratory to operational use. Depending on the maturity, outputs will focus on providing component, CONOPS, and subsystem transition into programs of record (PORs) and/or integration into existing PORs. Technologies identified from the JUPITR ATD will be fielded in FY14 to Pacific Command (PACOM). Future ATD developments will continue to bridge communication gaps between US Forces across other Combatant Command (COCOMs). 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 Emerging Infectious Disease - Influenza (EID-Flu) Medical Countermeasure Acquisition program will develop and deliver a U.S. Food and Drug Administration (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 viruses as well. Completion of activities required for FDA approval for an influenza treatment, expected in fiscal year 2016, is the focus 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 via the FDA 'Animal Rule', which allows for the demonstration of efficacy in relevant animal model(s) when human testing is not ethically feasible. The HFV program 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 activities required for FDA approval for Filovirus therapeutics, expected in fiscal year 2018, is the focus of the SDD Phase. The DoD funds the development 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. Products under development in this budget item include Recombinant Botulinum A/B and Plague vaccines. Efforts to be conducted during the system Development and Demonstration (SDD) Phase include the development of large scale manufacturing process and validation of that process, nonclinical studies, demonstration of manufacturing consistency, 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". 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). Upon FDA licensure, the product will transition to full-scale licensed production. The DoD 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 will be used to provide additional levels of protection to laboratory workers in the Special Immunizations Program (SIP) conducting research on these diseases.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2014
- Source ID
- MB5_0604384BP_5_0400_PB_2014
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (EMD)
- Child Accomplishment: 1) ADM - Integrated Master Plan
- Child Accomplishment: 2) ADM - Manufacturing Suites
- Child Accomplishment: 3) ADM - Equipment and Installation.
- Child Accomplishment: 4) ADM - Staffing
- Child Accomplishment: 5) ADM - Facility Utilities
- Child Accomplishment: 6) ADM - Equipment Test and Commissioning
- Child Accomplishment: 7) ADM - Program Management
- Child Accomplishment: 8) ADM - BSL4 GLP T&E
- Child Accomplishment: 9) BSV
- Child Accomplishment: 10) CRP
- Child Accomplishment: 11) CRP
- Child Accomplishment: 12) CRP
- Child Accomplishment: 13) CRP
- Child Accomplishment: 14) CRP
- Child Accomplishment: 15) CRP
- Child Accomplishment: 16) CRP
- Child Accomplishment: 17) EID-Flu
- Child Accomplishment: 18) HFV
- Child Accomplishment: 19) NGDS Increment 1
- Child Accomplishment: 20) NGDS Increment 1
- Child Accomplishment: 21) NGDS - CRP
- Child Accomplishment: 22) NGDS - CRP
- Child Accomplishment: 23) NGDS - CRP
- Child Accomplishment: 24) NGDS - CRP
- Child Accomplishment: 25) NGDS - CRP
- Child Accomplishment: 26) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 27) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 28) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 29) VAC PLG
- Child Accomplishment: 30) VAC PLG
- Child Accomplishment: 31) VAC PLG
- Child Accomplishment: 32) VAC PLG
- Child Accomplishment: 33) VAC SIP
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