MEDICAL BIOLOGICAL DEFENSE (ACD&P)
Abstract
This Advanced Component Development and Prototypes (ACD&P) Project supports: The Advanced Development and Manufacturing (ADM) capability 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) 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, if needed. 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 development activities, from pre-Investigational New Drug Application phase through FDA licensure. 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 MCM programs. Biosurveillance (BSV) actively gathers, analyzes, and interprets collected information that includes biosphere data that relate to disease activity and threats to human or animal health in order to achieve early warning of health threats, early detection of health events, and overall situational awareness of disease activity. BSV will align the biosurveillance efforts across DoD and national strategies. BSV will scope and influence BSV capabilities as products to meet Warfighter requirements through innovative management of key BSV initiatives. BSV requirements address medical and physical CBRN mission needs spanned in over 11 requirements documents and through Combatant Commander (COCOM) identified needs. BSV funds will support Joint US Forces Korea (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 and theater confirmation of a Biological Event. JUPITR ATD will consist of four legs; Early Warning (EW), Biological Identification Capabilities Sets (BICS), Assessment of Environmental Detectors (AED), and Biosurveillance Portal (BSP). 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. Outputs will focus on proving component, CONOPS, and subsystem transition into programs of record (PORs) and/or integration into existing PORs. The Countermeasures for Multi-Drug Resistance-Bacterial (CMDR-B) program develops medical countermeasures (MCMs) for Service members for protection against multi-drug resistant (MDR) bacteria, including Biological Warfare Agents (BWAs) and organisms that are genetically modified to be MDR. The resulting product(s) will be US Food and Drug Administration (FDA)-approved to prevent or minimize effects of MDR bacterial exposures. Leveraging collaborative Department of Defense (DoD), United States Government, and industry efforts will reduce program risk, lower program cost, and accelerate delivery of therapeutics to the Warfighter. The program will advance MCM candidates against MDR bacterial diseases such as anthrax and plague through the Technology Development phase. The Emerging Infectious Diseases Therapeutics (EID Tx) program is developing and will deliver a Food and Drug Administration (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 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 HFV therapeutics are expected in FY18 following completion of the SDD phase. The NGDS is 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 term "Role" is used to describe the stratification of the four tiers in which medical support is organized, on a progressive basis, to conduct treatment, evacuation, resupply, and functions essential to the maintenance of the health of the force. Role 3 support is normally provided at Division or Service equivalent level and includes specialist laboratory resources. 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 (VAC FILO) Program will offer protection against the threat of Ebola and Marburg viruses. The current budget supports development of two prototypes through the Technology Development Phase. The DoD anticipates that the Food 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 an 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 Ricin toxin is a validated bioweapon threat due to its availability and efficiency of production. The program supports one DoD vaccine candidate including manufacturing cGMP lots; proof of concept nonclinical efficacy studies and assay development. These efforts also include a Phase 1b clinical trial and regulatory integration. 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 initiated the Western, Eastern, and Venezuelan Equine Encephalitis (VAC 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 of 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, 2015
- Source ID
- MB4_0603884BP_4_0400_PB_2015
Related Documents
- Root: CHEMICAL/BIOLOGICAL DEFENSE (ACD&P)
- Child Accomplishment: 1) ADM - Bridging Studies
- Child Accomplishment: 2) ADM - Program Management and Contract Administration
- Child Accomplishment: 3) BSL-4 GLP T&E
- Child Accomplishment: 4) BSV
- Child Accomplishment: 5) BSV
- Child Accomplishment: 6) BSV
- Child Accomplishment: 7) BSV
- Child Accomplishment: 8) BSV
- Child Accomplishment: 9) CMDR-B
- Child Accomplishment: 10) EID Tx
- Child Accomplishment: 11) HFV
- Child Accomplishment: 12) HFV
- Child Accomplishment: 13) HFV
- Child Accomplishment: 14) HFV
- Child Accomplishment: 15) NGDS - Increment 1 Deployable Component
- Child Accomplishment: 16) NGDS - Increment 1 Deployable Component
- Child Accomplishment: 17) NGDS - Increment 1 Deployable Component
- Child Accomplishment: 18) NGDS - Increment 1 Deployable Component
- Child Accomplishment: 19) NGDS Increment 2
- Child Accomplishment: 20) NGDS - Increment 2
- Child Accomplishment: 21) VAC FILO
- Child Accomplishment: 22) VAC FILO
- Child Accomplishment: 23) VAC FILO
- Child Accomplishment: 24) VAC FILO
- Child Accomplishment: 25) VAC FILO
- Child Accomplishment: 26) VAC FILO
- Child Accomplishment: 27) VAC RIC
- Child Accomplishment: 28) VAC RIC
- Child Accomplishment: 29) VAC RIC
- Child Accomplishment: 30) VAC RIC
- Child Accomplishment: 31) VAC WEVEE
- Child Accomplishment: 32) VAC WEVEE
- Child Accomplishment: 33) VAC WEVEE
- Child Accomplishment: 34) VAC WEVEE