MEDICAL BIOLOGICAL DEFENSE (ACD&P)
Abstract
This Advanced Component Development and Prototypes (ACD&P) Project supports: 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 will address three technical functional areas and capabilities within MB4: technology development of flexible manufacturing platforms, a process development laboratory, and pilot plant. 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 agents, infectious diseases, and engineered diseases). 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 specific to BW agents and agents of operational concern, and protocols for sample preparation. System operation for use in laboratories and potentially point of care environments. A COTS system will be procured to meet this requirement. 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 program will use Procurement funding in FY12 to purchase COTS systems that have FDA clearance. BA5 funding in FY12 will support systems engineer/program management, assay transitions and optimization to the platform(s), and shelf-life testing. FY13-16 BA5 funding will support additional assay development and FDA clearance testing efforts on the COTS platform(s). NGDS Increment 2 will explore adding new complementary technologies to the NGDS design. A separate Milestone A review will be conducted to start this technology insertion effort, followed by a Milestone B to fully develop a new technology prior to fielding to DoD users. Increment 2 will have a Milestone A by 3QFY12 and will use BA4 funding to mature the technology to compliment the technology in Increment 1. The Transformational Medical Technologies Initiative (TMTI) was launched to respond to the threat of emerging or intentionally bioengineered biological threats. During FY10 the program was redesignated as the Transformational Medical Technologies (TMT) Program. The TMT 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) and platform-based therapeutics against biological warfare (BW) agents (i.e. one drug that treats multiple agents). TMT has been successful in transitioning previous Science and Technology (S&T) efforts into advanced development. Beginning in FY12 TMT has been separated into four product lines to provide greater program control and granularity: 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 (i.e. drugs that target common pathways within a human to prevent or treat a variety of diseases) or pathogen-directed therapeutics (i.e. drugs that attack a common pathway found in multiple threat agents). TMT's development of medical countermeasures against HFV, IBP and EID FLU 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 license/approve, market, and produce a drug. This interaction between the DoD and the FDA results in a coordinated, unified, and safe effort. Additionally, TMT is developing Platform Technologies. These are standalone enabling capabilities that support MCM development and are strategically aligned to 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 three functional areas: Pathogen Characterization, Target Identification, and Bioinfomatics.. 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. JVAP initiated the Filovirus Vaccine program in FY10. The Filovirus Vaccine will protect the Warfighter against both Ebola and Marburg exposures. Efforts to be conducted during this period include development of pilot scale manufacturing process to support nonclinical and clinical studies; development of a vaccine formulation that meets the logistical requirements of the DoD; conduct non-clinical studies to demonstrate safety and efficacy; submit an Investigational New Drug (IND) application; and conduct Phase 1 clinical human safety studies. JVAP anticipates that the FDA will approve this product using the Animal Rule, which allows for demonstrating of efficacy in relevant animal model(s).
Document Details
- Document Type
- Project
- Publication Date
- Oct 01, 2012
- Source ID
- MB4_0603884BP_4_0400_PB_2012
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