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, the Transformational Medical Technology (TMT) program, the Joint Vaccine Acquisition Program (JVAP), which includes vaccines for Recombinant Botulinum A/B and Plague, and the efforts to store and conduct required testing on Investigational New Drug (IND) vaccines used to investigate protection of 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 information sharing across the Joint Program Executive Office for Chemical Biological Defense (JPEO-CBD) enterprise and amongst 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 Countermeasures Initiative (MCMI) was established to coordinate inter-related advanced development and flexible manufacturing capabilities, based on public-private parternship agreements between the government and industry, providing a dedicated, cost-effective, reliable, and sustainable MCM process that meets the warfighter and national security needs. Specifically, the MCMI will provide the capability for the advanced development and flexible manufacturing of biological MCM (to include TMT developed MCMs) to address CBRN threats, including novel and previously unrecognized, naturally-occurring emerging infectious diseases. MCMI efforts in the advanced development component would be in two areas: 1) further maturation of novel platform/expression systems and integration into a production process, and 2) establishment of a Technical Center of Excellence (TCE) comprised of an advanced development and flexible manufacturing capability. MCMI MB5 efforts will focus on establishing and maintaining an advanced development and flexible manufacturing capability including, but not limited to, fermentation manufacturing processes, cell culture manufacturing processes, and plant based manufacturing processes. In addition, three major 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 the Critical Reagents Program (CRP), Joint Biological Agent Identification and Diagnostic System (JBAIDS), and the 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 (NGDS) will develop and field a common medical test equipment and diagnostic platform among all Military Services. NGDS Increment 1 Commercial Off The Shelf (COTS) will identify traditional, enhanced, emerging and advanced threats (i.e., biowarfare, infectious disease, engineered threats). A multi-incremental configuration, evolutionary development and fielding approach is proposed which will provide expanded capability for an early warning tool of health threats, early detection of health events, and overall situational awareness. NGDS Increment 1 (COTS) is composed of platform test equipment hardware, assay test kits, point of care assays, and protocols for sample preparation. System operation will be for use in laboratories and potentially point of care environments. A COTS system will be procured to meet this requirement for Increment 1. The COTS system will be configured to support forward medical operations for force health protection. The NGDS program will support quality assurance efforts, Food and Drug Administration (FDA) current Good Manufacturing Practices (cGMP), engineering, integration, and FDA clearance. The Transformational Medical Technologies Program (TMT) was launched to respond to the threat of emerging or intentionally bioengineered biological threats. TMT's mission is to protect the Warfighter from genetically engineered biological threats by providing a rapid response capability from identification of pathogens to the delivery of medical countermeasures. This mission is accomplished by developing broad spectrum (multi-agent) therapeutics against biological warfare (BW) agents (e.g. one drug that treats multiple agents). The development of broad spectrum therapeutics involves developing a capability to treat exposure to biological weapons. Beginning in FY12, TMT has been separated into four product lines. These lines are Hemorrhagic Fever Virus (HFV) Medical Countermeasures (MCMs) (e.g., Ebola virus), Intracellular Bacterial Pathogen (IBP) MCMs (e.g., Tularemia), Emerging Infectious Disease (EID) MCMs and Platform Technologies. HFV, IBP and EID MCM efforts are further classified as host-directed therapeutics (e.g, drugs that target common pathways within a human to prevent or treat a variety of diseases) or pathogen-directed therapeutics (e.g. drugs that attack a common pathway found in multiple threat agents). Attrition is high throughout the drug development process, less than 10% of all preclinical compounds become an approved drug. Causes for attrition include scientific failures, Food and Drug Administration (FDA) rejection at major milestone reviews, and loss through down-selection at DoD Milestone Decision points. The development of medical countermeasures is an arduous process that requires extensive interaction with the FDA, from pre-clinical research to safety tests in human subjects (Phase 1 clinical studies), efficacy tests in humans/animals (Phase 2 clinical studies or pivotal animal efficacy studies), and expanded safety or efficacy studies (Phase 3 clinical studies), which culminate with a request to the FDA to approve, market, and produce a drug. This interaction between the Department of Defense (DoD) and the FDA results in a coordinated, unified, and safe effort. Platform Technologies are standalone enabling technologies that support MCM development and when strategically aligned, provide a system of systems response capability to an adverse biological event - from the identification of an unknown pathogen to the development of an approved countermeasure ready for delivery to the Warfighter and the nation. The enabling technologies are divided into five platform areas: Pathogen Characterization, Target Identification, Countermeasure Discovery, Countermeasure Evaluation, and Bioinfomatics. The Joint Vaccine Acquisition Program (JVAP) provides for the EMD phase 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. 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. Products under development in this budget item include Recombinant Botulinum A/B and Plague vaccines.
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2012
- Source ID
- MB5_0604384BP_5_0400_PB_2012
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- Root: CHEMICAL/BIOLOGICAL DEFENSE (SDD)
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