MEDICAL BIOLOGICAL DEFENSE (EMD)
Abstract
This project funds medical countermeasures, development of reagents, assays, diagnostic equipment, biosurveillance and supporting efforts. The Advanced Development and Manufacturing (ADM) capability (formerly the Medical Countermeasures Advanced Development and Manufacturing (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). The ADM effort is being executed in two phases. Phase 1 is for the establishment, commissioning, and validation of the ADM capability. This project funds the establishment of a capability to be located in Alachua, Florida. Two ADM cGMP suites, capable of operating at Bio Surety Level (BSL) 3 will be established during the base contract period. There are contract options to incrementally increase capacity. Upon attainment of cGMP capability Phase 2 begins. During Phase 2, the contractor team will support and maintain the capability in a state of readiness to support MCM development (to include cGMP manufacturing) and assist in training personnel in its use. The second phase includes transition and integration of new technologies to support MCM FDA required development activities. Phase 1 and 2 contract was awarded in March 2013 to Nanotherapeutics, Inc., Alachua, FL. The ADM capability sustainment costs during Phase 2 will originate from Government MCM programs using this capability. 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. Through the Targeted Acquisition of Reference Materials Augmenting Capabilities (TARMAC) initiative, the CRP will use a systematic approach to the introduction of materials and information into MCM development. BSV programs align the Biosurveillance efforts across the DoD and national strategies. The BSV program will scope and influence BSV capabilities as products to meet Warfighter requirements through innovative management of key BSV initiative. BSV will also support the Joint US Forces Korea (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 FY16 to Pacific Command (PACOM). Future ATD developments will continue to bridge communication gaps between US Forces across other Combatant Command (COCOMs). The Emerging Infectious Diseases Therapeutics (EID Tx, formerly called EID FLU) Acquisition Program is developing and will deliver a FDA-approved, broad-spectrum medical countermeasure to the Warfighter for protection against naturally occurring or biologically engineered viruses. EID Tx is pursuing influenza indication, EID-Flu MCM, as the first step in the development of a broad spectrum antiviral drug due to a clear and established FDA regulatory approval pathway. The drug in development is highly efficacious against multiple influenza viruses, including the 2009 H1N1 pandemic virus, H5N1 avian influenza virus, the most recently identified H7N9 influenza virus from the outbreak in China, and drug resistant strains of influenza viruses. This drug has also demonstrated efficacy against other viruses of concern to the DoD's biodefense program. Ongoing EID Tx drug development will be leveraged to demonstrate additional broad-spectrum MCM's against naturally occurring and/or engineered biowarfare threats. Initial testing to support FY15 down-select for follow-on label extension programs has begun. 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 medical countermeasures (MCMs), using high threat, extremely lethal Biological Warfare Agents (BWAs) of the Filoviridae family agents (Ebola and Marburg) as model systems. 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 and refinement as needed to support the pivotal animal efficacy testing required under the FDA 'Animal Rule'. 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 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 Engineering Manufacturing Development (EMD) 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 Investigational New Drug (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, 2015
- Source ID
- MB5_0604384BP_5_0400_PB_2015
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (EMD)
- Child Accomplishment: 1) ADM - Establish Manufacturing Suites & Capability
- Child Accomplishment: 2) ADM - Equipment Procurement and Installation.
- Child Accomplishment: 3) ADM - Commissioning and Validation
- Child Accomplishment: 4) ADM - Program Management
- Child Accomplishment: 5) BSV
- Child Accomplishment: 6) BSV
- Child Accomplishment: 7) CRP
- Child Accomplishment: 8) CRP
- Child Accomplishment: 9) CRP
- Child Accomplishment: 10) CRP
- Child Accomplishment: 11) CRP
- Child Accomplishment: 12) EID-Tx
- Child Accomplishment: 13) HFV
- Child Accomplishment: 14) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 15) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 16) VAC PLG
- Child Accomplishment: 17) VAC PLG
- Child Accomplishment: 18) VAC PLG
- Child Accomplishment: 19) VAC PLG
- Child Accomplishment: 20) VAC SIP