MEDICAL BIOLOGICAL DEFENSE (SDD)
Abstract
This project (MB5) provides Engineering and Manufacturing Development (EMD) for efforts (post Milestone B), which provide a rapid response capability from identification of pathogens to the delivery of medical countermeasures. Specifically, this project includes: the Medical Countermeasures Initiative (MCMI), efforts in support of biosurveillance, and individual medical drugs and vaccines, such as Recombinant Botulinum A/B and Plague vaccines, and the efforts to store and conduct required testing on Investigational New Drug (IND) vaccines used to protect lab workers in the Special Immunization Program (SIP). This project funds the development of reagents, assays, and diagnostic equipment for biological warfare agents (BWA) and expands chemical and biological detection capabilities. It's 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. Effective with the FY13 program, the MCMI program is now known as the ADM program. ADM 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 Medical Countermeasure (MCM) Advanced Development and Manufacturing (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 is one component of the Medical Countermeasures Initiative (MCMI), the others are a Test and Evaluation (T&E) facility to be established at Ft. Detrick, MD and an S&T component. The efforts described address only the ADM capability. 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 Biosurety 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 to develop biological threat agent, genomic reference materials (antigens,nucleic acids, and antibodies) and detection and diagnostic assays for biothreat agent detection that shall be horizontally inserted across multiple detection and diagnostic platforms. In addition, this strategy will implement a formal, validated, advanced development process to transition new assays into production and integration with the appropriate detection/diagnostic platform. 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 analytical diagnostic systems. NGDS Increment 1 materiel solutions will significantly improve analytical and diagnostic capability across the continuum of biological warfare threats 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. 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; (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. 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. Products under development in this budget item include Recombinant Botulinum A/B and Plague vaccines. Efforts for medical biological defense product development involve production scale-up studies and validation, non-clinical studies, consistency manufacturing, 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". Upon FDA licensure, the product will transition to full-scale licensed production. 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 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, 2013
- Source ID
- MB5_0604384BP_5_0400_PB_2013
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (SDD)
- Child Accomplishment: 1) SBIR
- Child Accomplishment: 2) MCMi
- Child Accomplishment: 3) MCMi
- Child Accomplishment: 4) MCMi
- Child Accomplishment: 5) MCMI
- Child Accomplishment: 6) MCMi
- Child Accomplishment: 7) ADM - Equipment and Installation.
- Child Accomplishment: 8) ADM - Staffing
- Child Accomplishment: 9) ADM - Facility Utilities
- Child Accomplishment: 10) ADM - Equipment Test and Commissioning
- 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) NGDS Increment 1
- Child Accomplishment: 18) NGDS Increment 1
- Child Accomplishment: 19) NGDS Increment 1
- Child Accomplishment: 20) EID FLU
- Child Accomplishment: 21) HFV
- Child Accomplishment: 22) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 23) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 24) VAC BOT - Recombinant Botulinum Vaccine
- Child Accomplishment: 25) VAC PLG
- Child Accomplishment: 26) VAC PLG
- Child Accomplishment: 27) VAC PLG
- Child Accomplishment: 28) VAC PLG
- Child Accomplishment: 29) VAC SIP
- Child Cost Item: 6204ca4b46c94659250ece14a2d698f0
- Child Cost Item: 245baed5a9748523808c6364a63c36da
- Child Cost Item: 9576c02b2d5501b8ab3ed8e49602cd62
- Child Cost Item: 94d5680d621c463db14cb171501c0e40
- Child Cost Item: b8155413f7ef70751d1fbefbc7cb3a5c
- Child Cost Item: 8c346d038b3bee0a85d27672077b1b80
- Child Cost Item: 5556387fe049b3a729b11f281c5d327f
- Child Cost Item: 6a79d06abd2c0ebf3bbfa5d92d0d3d86
- Child Cost Item: 6a196f23439072f1c01c9f0bbfdedc85
- Child Cost Item: f1334c8fbb4a08f44298c40f59b85f24
- Child Cost Item: c80ac80bdd47490f571c49f40a9cfc57
- Child Cost Item: 2b16eb0aa20c1771a55ed4c9cde6c764
- Child Cost Item: 15d56fbbfdf35df14cfa2431f2f5022b
- Child Cost Item: 8b082ec27a499b0ad268340c94d9d6aa
- Child Cost Item: b434b66306791246ad7a7ce0706a937b
- Child Cost Item: 3290755d631b890ca0f650bd075b68d3
- Child Cost Item: ae94f03c271df4235e7196818ec640a9
- Child Cost Item: 2ce0eaf3fb6406acc2b35683759af99e
- Child Cost Item: 8ce2b3863424e8b30ab3861665310eb9
- Child Cost Item: b60b82a62508e996ae1c984e08b3520b
- Child Cost Item: 9b68bf4ab2e74a0f2e192fc5c88b8f70
- Child Cost Item: 591f29140f17ec506c23ffe9ed3d21c9
- Child Cost Item: bc4bb1af4e0945e1d942228486a9a520
- Child Cost Item: 4f98c67fb911458ba8cb23d738d80e66
- Child Cost Item: 3d0c8a2338c953029c42c81aeb43e438
- Child Cost Item: f850013efed4133a051c6f5858ba4ee5
- Child Cost Item: 3a0abdfa37bd5a70cacd9c6b64b107c3
- Child Cost Item: d1b6923f8587e69188ff25b411af862e
- Child Cost Item: 236bd275cc92683832794c6491db07b1
- Child Cost Item: 5c14120a01e93d319139a875532e3503
- Child Cost Item: c3eab6a9b0d507dd4fbdd71a4e002f9a
- Child Cost Item: e1265f9dd7c50c8c1fae5b03c63e6d8f
- Child Cost Item: cad288bcd5d66df8f1ce739c984afad5
- Child Cost Item: 5a5857bdcbdca3a4588eee9c06253062
- Child Cost Item: 3bdf962d2f56f72ce86096577b8d2f4a
- Child Cost Item: 4450d1268abc6b44763f310d1b0bd256
- Child Cost Item: f354bd3e1e2ca8ab9909e2e9ec40d612
- Child Cost Item: 93999fcd38c2c36615c812aec255bbf4
- Child Cost Item: fc90ff8e627899e35d6ecbe7a7844ea7
- Child Cost Item: e78f61adc9cc9e2bf48210a942666555
- Child Cost Item: 5e5166b1bd9bba4fe304b399dee2a3fe
- Child Cost Item: 18a73500040077e794f5f74275b0a37e
- Child Cost Item: 1f1bca92cf63ab3859891319b1bab79a
- Child Cost Item: 1258f06a071f4dab6191abf2f0923ce1
- Child Cost Item: 94f47ddae50185f14551ab13f80319e3
- Child Cost Item: 494ed47960236a28a5da954c4833dfac