Submission of proposals
Download 1.78 Mb.
|
- Navigate this page:
- A02-174 TITLE
- A02-175 TITLE
- A02-176 TITLE
A02-173 TITLE: Ultra-compact, Lightweight Battlefield Splint TECHNOLOGY AREAS: Biomedical ACQUISITION PROGRAM: DSA, MRMC OBJECTIVE: An ultra-compact, lightweight, splinting system for immobilization of fractures that can be rapidly applied in the field by care providers with little orthopedic training and no supplies other than those already carried by the medic. The system will immobilize arm fractures so that the soldier can still participate in the unit’s mission (although with degraded capability) and leg fractures such that the soldier could walk on crutches. The splinting system will replace the M5 medic bag splint supplies that include: 1-Air splint, arm; 1-Air splint, leg; 1- Cast plaster paris, 6”x5 yds; 1-Under cast padding. This compact, lightweight splinting system will yield volume and weight savings with an increase in capability. DESCRIPTION: Approximately 25% of all battlefield injuries result in fractured limbs. These fractures severely limit the mobility of the injured soldier, take him out of the fight, and often make it difficult to evacuate him. This is especially true for Special Operations missions which often take place many miles behind enemy lines and where the injured must be carried to an evacuation point. A method of rapidly splinting these injuries such that the soldier can carry on with the mission or reduce the assets needed to evacuate him is severely needed. These splints will be carried and used as field expedient splinting for initial immobilization of fractures. These can be used in layers to build ultra-lightweight casts, and in significant amounts may be used to develop a weight-bearing cast (the cast need not be weight-bearing for femoral fractures). Total weight of a packaged system will not exceed 8 oz. These splints will be functional in all environments except water, but splints and casts will perform well in water when properly “cured.” All components of the splinting system will be non-toxic and non-sensitizing to the patient or care provider. The “cured” splints will exhibit strength equivalent to current casting materials and will survive for greater than 1 month. The splints can be removed with a standard cast saw, or optionally can be dissolved with an appropriate catalyst. PHASE I: Design an appropriate splinting system and select the components for its manufacture. Perform preliminary tests. PHASE II: Complete development of the splinting system and its associated chemistries. Perform physical tests of the system and perform pre-clinical trials to demonstrate effective immobilization and weight-bearing splinting. Demonstrate that the splint system is free of toxic or sensitization reactions. Document that system packaging is effective and execute real-time shelf life testing. PHASE III DUAL USE APPLICATIONS: An ultralight splinting system has significant dual use application in medical situations in austere environments. This splinting system could be useful in civilian medical situations where weight considerations are important, such as retrieval of trauma victims from difficult environments. In Phase III, the system will obtain FDA approval. REFERENCES: 1) Callahan D J, Carney D J, Daddario N, Walter N E. A comparative study of synthetic cast material strength. Orthopedics 1986 May; 9(5):679-81. 2) Goldberg A J, Freilich M A. An innovative pre-impregnated glass fiber for reinforcing composites. Dent Clin North Am 1999 Jan; 43(1):127-33, vi-vii. 3) Wytch R, Ashcroft G P, Ledingham W M, Wardlaw D, Ritchie I K. Modern splinting bandages. J Bone Joint Surg Br 1991 Jan; 73(1):88-91. 4) Wytch R, Ross N, Wardlaw D. Glass fibre versus non-glass fibre splinting bandages. Injury 1992; 23(2):101-6. KEYWORDS: Splint, cast, medic, medical, fracture, orthopedic A02-174 TITLE: Secure Medic Personal Digital Assistant (PDA) TECHNOLOGY AREAS: Information Systems, Biomedical ACQUISITION PROGRAM: DSA, MRMC OBJECTIVE: Develop a prototype secure ruggedized medic's Pocket PC (PC) that: 1) Meets or exceeds NSA approved standards for storing classified data; 2) Meets or exceeds MIL-SPEC STD for ruggedization; 3) Complies with NSA standards for secure data transfer via the DoD Secure Internet Protocol Network (SIPRNET). DESCRIPTION: This secure handheld device has to meet the needs of users with multiple levels of expertise; it will support an intuitive interface that includes help windows and decision rationale for less experienced operators. It will also provide the inherent flexibility to adapt to evolving medical procedures and protocols as well as to additional medical databases and mission requirements. When communications are available, the system should support secure wireless communications and comply with NSA standards for secure data transfer via the DoD Secure Internet Protocol Network (SIPRNET). Special Operations Medical personnel must be prepared to deal with the full spectrum of both military and civilian medical challenges many miles and sometimes days from the nearest medical support. The secure rugged handheld should support integration of data from medical histories and physical examinations, a medical reference library, diagnostic and treatment decision aids to include the SOFMH, medical sustainment training, and medical mission planning into a single portable computer-based device with internet access capabilities. It should be designed to support the recording of the essential elements of medical history and physical examination and then provide the medical analysis and decision support in secure environments. In addition, it will be utilized for user testing in Advanced Warfighter Exercises (AWE), Joint Technology Demonstrations (JTD), Advanced Concept Technology Demonstrations (ACTD) or Army Concept Evaluation Programs (CEP) which are intended to evaluate emerging special operations and first responder medic medical informatics, epidemiology and disease surveillance and reporting systems such as those being developed by the Army PM for Medical Communications for Combat Casualty Care, the Air Force Global Expeditionary Medical System, the Army Medical Research and Materiel Command (USAMRMC) Telemedicine and Advanced Technology Research Center (TATRC), the Army Center for Health Promotion and Preventive Medicine (USACHPPM), the Special Operations Medical Diagnostic System (SOMDS), and the DOD and service Theater Medical Information Programs (TMIP). Many of these programs and projects have resulted in excellent software tools for use with first responder medics and Special Operations medics in the field. This device must meet the requirements of existing and emerging medical software applications for field medical first responder use. Research should be aimed at designing a secure rugged PDA that supports both the Palm computer operating system (PALM OS and Pocket PC operating systems). The military medical community intends to use both government developed and commercially developed medical application software on the medic's PDA; we should be able to do that without being restricted to one PDA operating system the other. Data must be easily entered, preferably in a hands free mode; one method would be with a robust speaker independent, wide vocabulary, voice recognition system equipped with an extensive standards-based medical lexicon (e.g., National Library of Medicine's Standard Nomenclature for Medicine (SNOMED) or Unified Medical Language System (UMLS) and capable of reliable operation in noisy environments. Once entered and processed, data must be secured, while stored, at NSA approved standards for classified data and the PDA must be able to communicate data securely enough to comply with NSA standards for secure data transfer via the DoD Secure Internet Protocol Network (SIPRNET). Special Operations medics also need to be able to transfer encrypted compressed data from their PDAs to tactical organic secure burst transmission radio systems for transmission from remote locations to secure tactical local and wide area networks operated by their parent commands. In addition, security schemes must meet requirements for medical record data privacy and security as specified by the Health Information Privacy Administration Act (HIPAA). PHASE I: Design a secure ruggedized version of a Department of Defense Common Operating Environment (DoD COE) compliant COTS personal digital assistant computer that meets the security, hands-free data entry and technical requirements of the emerging DoD medical informatics software systems described above and supports commercial medical software applications that run in either the PALM OS or Pocket PC 2002 (or Windows NT). PHASE II: A working laboratory prototype, which implements the design and demonstrates the security, hands-free data entry and technical requirements of the emerging DoD medical informatics software systems described above and supports commercial medical software applications that run in either the PALM OS or Pocket PC 2002 (or Windows NT). PHASE III: Field test the secure ruggedized Medic's PDA in operational environments with conventional and Special Operations medics employing emerging DoD medical informatics software systems. Once the concept and technology are proven in an ATD, ACTD, AWE, or CEP, the secure ruggedized medic's personal digital assistant computer could be acquired for medical organizations that need it by the Program Manager, Medical Communications for Combat Casualty Care (PM MC4) via the Army Warfighter Rapid Acquisition Program (WRAP) for field use in exercises, actual operational deployments, or both. DUAL USE APPLICATIONS: A secure ruggedized hand-held digital assistant for use by military medic first responders in telemedicine and medical informatics decision support and medical record keeping applications will also have wide-spread application for civilian first responder emergency medical treatment (EMT) personnel. In both military and civilian first responder applications, the device must be secure and rugged enough to withstand constant jolts and drops without loss of memory or damage to viewing screens or processors. If proven via military trials to be secure and rugged enough to support field medical operations, this ruggedized medic's personal digital assistant computer could be marketed to civilian makers of mobile emergency medical equipment. REFERENCES: 1) (Public Law 105-85) to meet current and future Force Health Protection (FHP) of SOF. 2) Military Standard 88.120. 3) Military Standard 810.4E. 4) National Library of Medicine's Standard Nomenclature for Medicine (SNOMED) or Unified Medical Language System. 5) References to medical PDA computer applications in the civilian environment are numerous and may be easily accessed via the world-wide Web using MEDLINE, Grateful Med, Lonesome Doc, or PUBMED tools provided at no cost via the web by the National Library of Medicine. References to military combat casualty training and operational experience can be made available on request. KEYWORDS: ruggedized PC, personal computer, Hand held PC, Notepad PC, Palm PC, Personal Digital Assistant (PDA), Medic's PDA, Warrior Medic, Special Operations Forces Medical Handbook (SOFMH), Special Operations Medical Diagnostic System (SOMDS), Personal Information Carrier (PIC), Global Expeditionary System (GEMS) A02-175 TITLE: Accelerated Drug Design Through Computational Biology TECHNOLOGY AREAS: Biomedical ACQUISITION PROGRAM: DSA, MRMC OBJECTIVE: The objective of this SBIR topic is to enhance rational, structure-based drug design efforts by exploiting the novel technology emerging from the bioinformatics field. We seek lead compound identification through the use of computational models, specifically considering candidate proteins from the malaria-causing parasite Plasmodium falciparum currently being studied. Identification and optimization of lead candidates for antimalarial drug discovery supports the DoD’s Biomedical Technology Area program in Infectious Diseases of Military Importance, and more specifically, the DTO MD12 Anti-Parasitic Drug Discovery Program. DESCRIPTION: In order to make predictions about potential chemical inhibitors, the structure of the target molecule in question is critical. Current technologies used to determine protein structure, including X-ray crystallography or NMR, are slow and limited only to proteins that can be stably expressed and highly purified in significant amounts. Generating these structural models is one of the limiting factors in structure-based drug design, and new technology aimed at circumventing these limitations is required to enhance current drug discovery efforts. The focus of this effort is to gain molecular information that will advance current candidate drug screening efforts by improving the selection criteria of compounds analyzed. In order to avoid the limitations associated with current structure-based drug design methodologies, specifically determining protein structure by physical analysis, we seek the development of new technology to conduct such analyses using a bioinformatics approach. Requirements include the generation and analysis of surface structure models from primary DNA or amino acid sequence with resolutions at or near that of crystallographic resolution, to include any accessory molecules required for protein function. Further requirements include the ability to analyze these models and provide structures of potential inhibitory molecules that can be synthesized and transitioned into current drug discovery programs. A key aspect of compound selection to be considered is the identification of compounds that are specific for the parasite protein and are not predicted to inhibit any homologous human proteins. The ability to synthesize these novel compounds in quantities sufficient for biological characterization (milligram) will be positively considered but is not absolutely required. Rational drug design will focus our current screening efforts to allow for the better utilization of limited funding. This will increase our capacity to characterize critical inhibitors and identify potential lead compounds, thus expediting the drug discovery process. This technology will provide critical data for and transition into existing drug discovery programs and may be further exploited to encompass additional, potentially new drug targets in P. falciparum as well as other organisms central to infectious disease research of both DoD and civilian importance. PHASE I: Propose a system to use computational methodologies to: 1) generate molecular models of various target proteins; and 2) use these models to design novel chemical inhibitors. Validate the system using the sequence of P. falciparum MRK or PK5 for which inhibitory data for specific compounds have been previously been determined. PHASE II: Utilize the system validated in Phase I to generate molecular models of additional target proteins for which there is limited inhibitor data available. Provide structures of compounds or families of compounds that could serve as novel chemical inhibitors for these proteins to be used in conjunction with high-throughput drug screening efforts. PHASE III DUAL USE APPLICATIONS: The exploitation of this technology for drug discovery has the potential to yield significant advances in other areas of military and civilian importance. Structural analysis of candidate drug targets may serve as a standard for structure-based drug design as well as monitoring the effects of mutations and structural changes on potential drug resistance. ACCESS TO GOVERNMENT SUPPLIES: The design of chemical inhibitors indicated in Phase II may be facilitated by support from the Walter Reed Army Institute of Research. The candidate contractor should coordinate with the COR for any required support prior to the submission of the proposal. REFERENCES: 1) Clore G M, Gronenborn, A M. Determining the structures of large proteins and protein complexes by NMR. 1998. Trends in Biotechnology. 16(1) 22-32. 2) Gane P J, Dean P M. Recent Advances in Structure-Based Rational Drug Design. 2000. Current Opinion in Stuructural Biology. 10(4) 401-1. 3) Smyth M S, Martin J H. X-ray Crystallography. 2000. Molecular Pathology. 53(1) 8-14. 4) Xiao Z, Waters N C, Woodard CL, Li Z, Li P. Design and synthesis of pfmrk inhibitors as potential antimalarial agents. 2001. Bioorg Med Chem Lett 11:21 2875-8. KEYWORDS: Structure-based drug design, molecular modeling, bioinformatics A02-176 TITLE: Develop a Rapid and Sensitive Nucleic Acid-based Assay to Assess Human Responses to Threat Agent Exposure TECHNOLOGY AREAS: Chemical/Bio Defense ACQUISITION PROGRAM: DSA, MRMC OBJECTIVE: In the context of recent events for anthrax exposure there is heightened urgency for the development of simple rapid and specific assay for detection of exposure to biological threat agent at early stages of infection and to discriminate it from other flu-like illnesses. Using microarray technology we have identified diagnostic marker genes specific for each biological agent that are expressed in the host prior to the onset of visible symptoms. However, microarray technology is not conducive to a clinical setting today for rapid diagnosis of exposure to biological threat agents and equipment for such technology is not available in clinical laboratories. We would like to have a simple platform to measure the expression of a large number of defined genes within a short period and in an efficient and cost-effective manner. The platform should be simple enough that it can be easily transitioned to a clinical setting. DESCRIPTION: We have been using various molecular techniques to detect early gene responses specific to each biological warfare agent (Das et. al, 1998; Ionin et. al, 1999). The goal was to determine a pattern of gene expression changes in response to each BW agent and to use that pattern to identify the course of impending illness (Mendis et al, 1998). By using microarray technology we have identified a panel of host genes that are up-regulated or down-regulated in response to various BW agents such as Anthrax, plague, Brucella, VEE (Venezuelan equine encephalitis virus), Cholera toxin, Botulinum and 2 shock inducing toxins staphylococcal enterotoxin B (SEB) and lipopolysaccharide (LPS) (Jett et al, 2001; Das et al, 2001). The objective of this SBIR topic is to facilitate our efforts in developing a rapid diagnostic assay to determine the expression of genes specific for each biological warfare (BW) agent that can be applicable in a clinical laboratory environment. There are no alternative procedures available to date to meet this objective. Each of these BW agents induces similar initial clinical symptoms in the host such as inflammation, fever, malaise, (flu like symptoms). However, as time progresses the symptoms change into hypoxia, shock, hemorrhagic fever, and or death. The unique pattern of gene expression induced in the host relates to the symptoms observed after exposure to these threat agents. We have identified genes that will differentiate influenza from anthrax. We have also identified genes that are never expressed in the control untreated samples, however they are altered upon exposure to these various biological threat agents. These genes expression profiles can be measured early in the disease process and used as a diagnostic tool along with the classical culture of blood cells for detection of exposure to such agents. For classical culture of bacteria it takes days to confirm the results, however, with the gene patterns we could perform the detection test in a few hours. We expect the development of an effective platform to measure the expression profiles of 40-60 genes specific to each toxic agent in addition to 30-40 common response genes for all the agents including genes for standardization. We will need to develop a system that will allow simultaneous measurement of expression of these genes rapidly and accurately with small clinical samples. This assay should be simple and easy to adapt in a clinical setting without the need of highly trained technologists. The technology has to be robust and sensitive enough to determine the changes in expression of many genes without using the classical microarray technology which is very expensive and needs experts to run the assay and is time consuming. Another feature is that the report from the assay will differentiate exposure to anthrax from flu unambiguously with minimal interpretation required. This is not a mere procurement of a product but technology will have to be developed to allow us to simultaneously measure the gene expression of a large number of genes on a rapid and simple assay platform. We are looking for transition of the gene microarray technology into a simplified assay applicable in a clinical setting. Development of simpler procedures for rapid diagnosis of exposure to these biological threat agents through the detection of host gene responses have broad range of applications in other areas of military and civilian concern. Development of such a simple assay system will have a great impact not only on civilian readiness to combat bioterrorism but also provide a tool to treat other infectious diseases and detect exposure to toxic agents in the environment. This technology can therefore be considered for the dual use science and technology (DUST) and the dual use applications program (DUAP). PHASE I: Develop an assay that will measure ~100 human genes rapidly and quickly simply on small amounts of PBMC using a system that could be handled in a clinical laboratory. No materials will need to be furnished to the contractor, since the requirement is to demonstrate the capability to carry out the measurements. We expect the use of Anthrax specific response genes as a prototype to identify a simple assay platform. For Phase I demonstrate that the proposed platform can potentially measure expression of 40-60 genes simultaneously in a short period of time without the use of gene arrays. This assay should be sensitive to detect two fold changes in the gene expression level compared to a select panel of housekeeping genes. Provide convincing data on evaluation of the transition steps to show the feasibility of developing such assay platforms. This may include data or the functional improvements of individual components of the assay system to meet our objective. PHASE II: Demonstrate the utility of combining the appropriate improved components into the assay systems with known experimental materials for predefined 40-60 unique genes for Anthrax vs. flu and 30-40 common response genes for other threat agents for which we have now selected the appropriate gene profiles. Upon obtaining satisfactory results with the assay system, test the prototypes developed with blood samples from monkeys exposed to the biological threat agent in our experimental systems. Exit criteria will be to successfully demonstrate the expected changes in gene expression profiles specific for that agent. Adapt this assay system for at least two other biological agents. PHASE III DUAL USE APPLICATIONS: The assay system for measurement of changes in gene expression profile is not restricted to exposure of biological agents but is applicable to any infectious or chemical agents. So it will be useful for both military and civilian applications. REFERENCES: 1) Marti Jett, Rina Das, Christanio Cummings, Chanaka Mendis, Roger Neill, COL David Hoover, Luther Lindler, Chrysanthe Paranavitana, Xiaozhe Huang, George Ludwig, Erik Henchal, David C.H Yang (2001). Identification Of Changes In Gene Expression Induced By Toxic Agents: Implications for Therapy And Rapid Diagnosis In: Proceedings of NATO Conference: Operational Issues in Chemical and Biological Defense Human Factors in Medicine Panel. Wade (ed). In press. 2) Rina Das, Christanio Cummings, Chanaka Mendis, Roger Neill, George Ludwig, David Hoover, Chrysanthe Paranavitana, David C. H. Yang, Luther Lindler, Xiaozhe Huang, Erik Henchal and Marti Jett (2001). Global Gene Analysis of Various Biological Threat and Infectious Agents Using PBMC: Implications for Therapy and Rapid Diagnostics. In: Dianne McQuestion (ed) Proceedings, Chemical and Biological Defense Symposium. In press. 3) Das, R., Mendis, C., Yan, Z., Neill, R., Boyle, T. and Jett, M. (1998) Alterations in Gene Expression show unique patterns in response to toxic agents. In Proceeding of the 21st Army Science Conference, F-P9. 4) Ionin, B., Foley, J., Lee, D., Das, R., and Jett, M. (1999). Differential gene expression pattern induced by staphylococcal enterotoxin B in human kidney cells. Abstract #443. FASEB Journal 13:A1407. 5) Mendis, C., Das, R., Yang, D., and Jett, M., (1998) Identification of alterations in gene expression in response to Staphylococcal enterotoxin B (SEB) using differential display (DD). In the ASCB 38th Annual Meeting, San Francisco, CA. KEYWORDS: Gene expression profiles, host response genes, biological threat agents, assay platforms, rapid diagnostic tests. Directory: osbp -> SBIR -> solicitations solicitations -> Army sbir 09. 1 Proposal submission instructions dod small Business Innovation (sbir) Program solicitations -> Navy sbir fy09. 1 Proposal submission instructions solicitations -> Army 16. 3 Small Business Innovation Research (sbir) Proposal Submission Instructions solicitations -> Air force 12. 1 Small Business Innovation Research (sbir) Proposal Submission Instructions solicitations -> Army 14. 1 Small Business Innovation Research (sbir) Proposal Submission Instructions solicitations -> Navy small business innovation research program submitting Proposals on Navy Topics solicitations -> Navy small business innovation research program solicitations -> Armament research, development and engineering center solicitations -> Army 17. 1 Small Business Innovation Research (sbir) Proposal Submission Instructions solicitations -> Navy 11. 3 Small Business Innovation Research (sbir) Proposal Submission Instructions Download 1.78 Mb. Share with your friends:
|