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A02-177 TITLE: Development of High Throughput Molecular Profiles for the Detection and Staging of Cancer TECHNOLOGY AREAS: Biomedical ACQUISITION PROGRAM: DSA, MRMC OBJECTIVE: To develop innovative screening modalities and associated technologies to detect and stage cancer, and evaluate the efficacy of cancer treatment. DESCRIPTION: Building unique gene expression profiles will be a valuable tool in the diagnosis and prognosis of cancer, in making treatment choices and in evaluating courses of action for the individual cancer patient. In addition, development of better tools/technologies to detect, diagnose and differentiate between normal tissue, precancerous lesions, primary tumor and metastatic tumors are needed (1), particularly to enable early intervention in cancer progression. Moreover, molecular profiles that provide patterns of proteins that distinguish between normal tissue and cancer could be developed to evaluate the efficay of cancer treatment over a course of therapy, thereby guiding the choices of treatment offered to the patient (2,3,4). The overall goal of this solicitation is to develop screening profiles and associated tools/technologies that will become essential and routine in the evaluation (detection, diagnosis, prognosis, effectiveness of treatments) of cancer patients. PHASE I: Identify and outline the feasibility and applicability of the methodologies proposed for determining molecular profiles of breast, prostate, ovarian, and/or lung cancer. PHASE II: Evaluate molecular profile(s). The profile(s) should successfully differentiate or distinguish between normal, precancerous tissue and/or cancerous cells from disease using blood, other body fluids, and/or tissue. Develop tests to detect and differentiate neoplastic cells from normal cells with a specificity and sensitivity greater than 95%. Profiles should correlate with the clinical and pathological findings. PHASE III: The product of this phase may be exploited to other areas of medical research and development in both the civilian and military sectors. The development of very sensitive, high throughput molecular profiles and technologies that can accurately detect and diagnose cancer have wide applicability to militarily relevant topics, including force protection, and sensors and information processing. Direct application of this technology to military settings is for analysis and detection of infectious diseases and detection and identification of biological, chemical and toxic agents in the environment and infectious diseases. Phase III may require partnering with a parmaceutical or biotechnology firm to do phase 3 clinical trials for FDA approval and ultimate commercialization. Early detection of breast, prostate, ovarian, and lung cancer is needed to best care for military personnel and the general population. The ultimate use of this product will be in both the military and civilian sectors wherein early diagnosis will reduce the requirements for long-term cancer treatment thereby reducing the health costs incurred in treating and caring for these individuals in the defense health program and civilian community. REFERENCES: 1) Clarke P A, te Poele R, Wooster R, Workman P. Gene expression microarray analysis in cancer biology, pharmacology, and drug development: progress and potential. Biochem Pharmacol. 2001. Dec 15; 62(10):1311-1136. 2) Kidoh K, Ramanna M, Ravatn R, Elkahloun A G, Bittner, ML, Metler P S, Trent J M, Dalth W S, Chin K V. Monitoring the expression profiles of doxorubicin-induced and doxorubicin–resistant cancer cells by cDNA microarray. Cancer Res. 2000. 60:4161-4166. 3) Trends Biotechnology. 1998. 16:301-306. 4) Kononen J, Bubendorf L, Kallioniemi A, Barlund M, Schraml P, Leighton S, Torhorst J, Mihatsch M J, Sauter G, Kallioniemi O P. Tissue microarrays for high-throughput molecular profiling of tumor specimens. Nat. Med. 1998. 4(7):844-847. KEYWORDS: Cancer, molecular profiles, patterns of gene expression, A02-178 TITLE: Cold Sterilizer Solution for Sterilization of Medical Instruments in Austere Environments TECHNOLOGY AREAS: Biomedical ACQUISITION PROGRAM: DSA, MRMC OBJECTIVE: An ultra-lightweight system capable of sterilizing medical instruments utilizing plastic bags containing a pellet(s) or powder that emits a sterilizing vapor or mixes with water to create a sterilizing solution when initiated. DESCRIPTION: A need exists to disinfect and sterilize medical or dental instruments in environments where standard heat and pressure sterilization methods are not available. The military is under continuous pressure to reduce the volume, weight, and size of items deployed to support troops in the field. An effective sterilizing system will allow surgical/dental procedures to be performed in the absence of autoclave-based sterilization and therefore enhance far-forward medical capabilities and yield savings in logistic demands. Such a system also has significant implications for care in rural, disaster, or other scenarios where sterilizing facilities are not available. This project would involve the formulation of a pellet(s), powder, or highly concentrated liquid and associated bag that, when activated at ambient temperatures will produce a vapor or liquid solution that will effectively sterilize medical/dental equipment within one hour to the same extent as autoclave-based sterilization methods. Activation could include the addition of potable water to the contents of the bag. The sterilization system will not damage the medical equipment. This product in its final packaging should have a shelf life of at least two years with four desirable. The product should be safe for the user and environmentally friendly with easy disposal as an agent that is nontoxic or readily degrades to nontoxic compounds. PHASE I: Produce a trial formulation that is capable of disinfecting and sterilizing appropriate categories of medical equipment purposely contaminated with known bacterial and viral agents. Outline required real-time testing protocol to achieve up to four years shelf life. PHASE II: Expand tests of effectiveness of formulations to simulated use and clinical trials to demonstrate effective sterilization of medical and dental equipment used on patients. The sterilization should occur within 60 minutes, at room temperature, be at least as effective as autoclave-based methods, and should show no damage to the medical equipment. Execute real-time shelf life testing. Submit a 510(k) Premarket Notification to the Food and Drug Administration for claim as sterilant. PHASE III DUAL USE APPLICATIONS: A vapor sterilization formulation has significant dual use application in medical situations in austere environments. This formulation could be useful in civilian medical/dental situations where autoclave-based sterilization is either not available, or where the sterilizer system is more cost effective. It would also be an effective decontaminant for biowarfare agents. REFERENCES: 1) Taizo I, Sinichi A, Kawamura K. Application of a newly developed hydrogen peroxide vapor phase sensor to HPV sterilizer. PDA J Pharm Sci Technol 1998 Jan-Feb;52(1):13-8. 2) Heckert R A, Best M, Jordan L T, Dulac GC, Eddington D L, Sterritt W G. Efficacy of vaporized hydrogen peroxide against exotic animal viruses. Appl Environ Microbiol 1997 Oct;63(10):3916-8. 3) Neighbor N K, Newberry L A, Bayyari G R, Skeeles J K, Beasley J N, McNew R W. The effect of microaerosolized hydrogen peroxide on bacterial and viral poultry pathogens. Poult Sci 1994 Oct;73(10):1511-6. KEYWORDS: Sterilization, disinfectant, autoclave, bactericidal, solution, medical, dental A02-179 TITLE: Robotic Patient Recovery TECHNOLOGY AREAS: Biomedical ACQUISITION PROGRAM: DSA, MRMC OBJECTIVE: To design, model, and prototype an intelligent autonomous prototype robotic patient recovery or system of robots that can assist civilian emergency personnel or the military in locating and recovering sick, wounded or otherwise injured personnel from hostile or caustic environments. DESCRIPTION: Buddy treatment, first responder combat casualty care, and patient evacuation under hostile fire have compounded combat losses throughout history. Force protection of military first responders is complicated by increased involvement in peace keeping operations, counter terrorism, and humanitarian assistance missions that involve politically sensitive low intensity combat and combat in urban terrain; these operating environments may include abandoned minefields and contamination by weapons of mass destruction. Much progress has been made over the last 20 years in the areas of robotics; artificial intelligence/intelligent systems; sensors; computer vision; mechanical, electrical and biological engineering; noninvasive diagnostics; and wireless digital communications. The military has invested significant research funding in autonomous vehicles, urban robot projects and in sophisticated tele-robotic surgery systems aimed at both augmenting a surgeon's skills and extending his reach. Academic institutions have demonstrated intelligent robots that perform functions ranging from performing mechanical repairs to playing soccer. However, significant research needs to be performed in adapting, integrating, or developing new robotic technologies to locate, identify, approach, and recover human patients; to coordinate and control teams of robots to perform multifunction missions (e.g. finding patients, identifying them, protecting patients, lifting/moving/recovering patients, etc); and to make those robots sufficiently autonomous and survival to perform reliably under combat and/or civilian emergency conditions. Specific technical research challenges yet to be solved include development of devices and algorithms or heuristics to: 1) plan and execute search, determine approach and regress routes, and locate patients in all weather condition, within both urban and wilderness terrain, and without preloaded maps or terrain models; 2) conduct image pattern matching for patient and wound identification; 3) communicate with and facilitate communications between patients and human medics; 4) execute command, control, and coordination of individual robots and robot teams; 5) lift, move, drag, tow, or otherwise effect recovery of patients from hazardous to safe locations; 6) provide all weather, all terrain robot and robot team mobility; 7) detect and avoid hazards or hostile situations; 8) conduct survival, evasion, escape, and self defense for both the patient and the robots; and 9) plan and conduct recovery from errors or the unexpected. The focus of this SBIR effort is on enabling a robotic medical assistant or team of robotic assistants to transport a patient to a safer environment where further care can be administered by appropriate medical personnel. The basic functional requirement is to accomplish patient transport for limited distance in rough and urban terrain. If teams of robots are to be used, significant research issues exist in command, control, and coordination among robots and robot teams for recovery of wounded or injured personnel. The primary focus of this SBIR research is on the research challanges described above as they are applied to the medical domain problem of human patient recovery. We are seeking innovative autonomous robotic approaches to patient recovery, especially for use in urban terrain and in hostile and contaminated environments. In addition to the research issues associated with using robots for transporting patients, this research should address innovative solutions to some of the technical barriers (software, mechanical, and human machine interface) associated with employing automous robots for medical missions that require robots to come in contact with human patients. These include ability to "reassure" the patient and explain what is about to happen, avoidance of further injury, and ablility to identify and recover from adverse reactions from the human patient. PHASE I: Conceptual and technical models which identify and translate functional requirements into implementable technical robotic patient recovery designs which demonstrate feasibility of the concepts and capabilities defined in the Description paragraph above and in the Phase II demonstratable tasks below. PHASE II: A working laboratory prototype robot or team of robots, which implements the model and demonstrates the concept. The prototype should be able to demonstrate the ability to lift, move, carry, tow, or otherwise execute patient recovery from hazardous to safe areas where they can be attended by human medics. We would also like the prototype to demonstrate the capability to perform one or more of the following: a. find patients in urban and field terrains. b. identify patients as friend or foe. c. communicate with and facilitate communications between patient and medic d. Protect patient from further injury and from hostile attack.
1) References that support the Military Urban and Aquatic autonomous robot programs are available from the Defense Advanced Research Projects Agency (DARPA), US Army Research Laboratory, Delphi, MD c/o Dr. Larry Tokazcik. References that support the robotic patient transport objectives are available upon request from the author. KEYWORDS: Medical robotic assistant, patient recovery, MEDBOT, robotics, combat casualty care, combat health service support, artificial intelligence, telesurgery, non-invasive sensors, emergency resuscitation, trauma care, first aid, combat in urban terrain (or urban warfare). A02-180 TITLE: Wear-and-Forget Electrocardiogram and Ventilation Sensor Suitable for Multi-day Use in Physically-Active Warfighters TECHNOLOGY AREAS: Biomedical ACQUISITION PROGRAM: DSA, MRMC OBJECTIVE: To develop a wear-and-forget and highly reliable electrocardiogram (ECG) and ventilation sensor system suitable for multi-day use in sweaty, physically active warfighters, astronauts, and firefighters and other emergency personnel. The system must be unobtrusive and lightweight so the sensor system is acceptable. Additionally, the system needs to be highly reliable since the information will be used to make critical medical decisions, such as whether or not an individual is under unusual physiological strain or is in need of medical help. DESCRIPTION: Currently, ECG and ventilation monitoring performed in hospital environments, or by emergency medical personnel in the field, uses standard wet electrodes, wires, and instrumentation. Ambulatory monitors used by clinicians typically use electrodes wired to data loggers. Clinical HR monitoring can also be performed along with oximetry. Consumer devices for monitoring heart rate only, use chest straps, or finger or ear-mounted sensors. These approaches are not well suited to chronic use in physically demanding work environments for a variety or reasons. Sensor systems using electrodes and wires are difficult to attach, wires get tangled electrode adhesives or electrode paste cause allergic reactions, and electrodes fall off as sweating occurs or wires are tugged. Chest strap systems, primarily designed for short-term use, are obtrusive, bulky, heavy, and unreliable. Contact can be lost as the straps slide down or out of position, even when the straps are cinched down, and the semi-circular chest straps do not conform to the complex shape of many chests. Chest straps can cause chaffing and heat rash. Shirts with imbedded sensors need to tolerate laundering, and must fit a variety of body sizes. Other technologies, such as acoustic or ballistic cardiography, usually operate at rest but not during activity, and can involve complex signal processing. The risky and innovative aspects of this effort reside both in the development of an effective and unobtrusive sensor-human interface, and in the processing and management of the ECG and ventilation signals once they have been acquired. A successful approach might use new or unconventional electrodes, acoustic data acquisition and interpretation, or sensors imbedded in clothing. Any skin contact with electrode paste, or adhesive materials must not generate allergic reactions. Any system must be unobtrusive, lightweight, and reliable. It must be easy to put on, not cause chaffing or heat rash, allow self-checks to be easily performed. In addition, the system must be able to tolerate subject motion and sweating, and not interfere with normal activities or dexterity. The system must be suitable for 3-day use. This effort supports the Objective Force and Future Combat Systems initiatives, and in particular, in support of the Warfighter Physiological Status Monitor (WPSM) of the Land Warrior System (LWS). PHASE I: Review the literature to determine the most promising methods for developing an ECG and ventilation monitoring system with the aforementioned capabilities. Summarize concerns with previous products, outline plans to resolve these problems, and identify key risk factors for project success. Conceptualize approach and deliver three or more “brassboard” prototype systems, which can include mock-ups, that can be used to assess the scientific validity of approach, and the human factors acceptability to warfighters. Phase I should demonstrate proof-of-concept of the proposed approach. PHASE II: Generating a detailed specification for a wear-and-forget high-reliability heart rate/ventilation sensor suitable for multi-day use in sweaty, physically active warfighters. Initiate step-wise development using standard industry practice. These steps will include hardware and firmware design, software architecture, tests of system reliability, and maintenance of documentation. Note that ease of integration into advanced military and commercial systems is a highly desired end-point. Thus, any software and firmware developed must be able to meet varied communication and messaging formats. The exit criteria will be a product ready for production and testing for regulatory approval. PHASE III DUAL USE APPLICATIONS: This sensor system will have both military and civilian applications. There is an increasing need to chronically monitor the cardiorespiratory status of both warfighters and emergency personnel. The requirements for emergency personnel, that is, reliable physiologic data collection under harsh conditions and user acceptability and ease of use, are similar to those proposed here for military applications. REFERENCES: 1) Heart rate monitors and abnormal heart rhythm detection. Boudet G, Chamoux A. Arch Physiol Biochem. 2000 Oct;108(4):371-9. 2) Ambulatory electrocardiographs. Association for the Advancement of Medical Instrumentation. American National Standards Institute. In: AAMI standards and recommended practices. Volume 2.2: biomedical equipment. Part 2: monitoring and diagnostic equipment Publisher: Arlington, VA : AAMI, 1995, pp. 875-919. KEYWORDS: Warfighter Physiologic Status Monitoring, ambulatory monitors, wearable, astronauts, chronic monitoring, heart rate, ventilation, emergency medical care, firefighters. A02-181 TITLE: Developing High-Throughput Inhibition Assays for Drug Discovery TECHNOLOGY AREAS: Biomedical ACQUISITION PROGRAM: DSAquisition, MRMC OBJECTIVE: The objective of this SBIR topic is to support drug discovery efforts by utilizing target-driven drug design. Specifically, high-throughput inhibition assays developed for enzymes of the shikimate pathway would support drug discovery for the DoD’s Biomedical Technology Area program in Infectious Diseases of Military Importance, and more specifically, the DTO MD12 Anti-Parasitic Drug Program. DESCRIPTION: The focus of this effort will be to develop high-throughput inhibition assays for enzymes of the shikimate pathway to support malaria drug discovery. These selected recombinant metabolic enzymes must be cloned, expressed, and purified to begin development of high-throughput inhibition assays. An innovative strategy should be developed to quickly locate and clone these hard to find genes. Once found and cloned, an expression system must be developed that will yield enzymatically active protein from AT-rich DNA. This expression/purification system will also necessitate a method of purification that will exclude background enzymatic activity from amplification species. Any new system developed for expressing functional AT-rich genes could be useful for Army antimalarial drug discovery and could also be developed into a novel product for expression of genes for malaria and other AT rich organisms including Francisella tularensis. Assay development will require a means of procuring substrates or developing a technique to synthesize them. These compounds can be used in the development of anti-bacterial, fungal, plant, or parasitic high-throughput assays. For drug discovery efforts, a high-throughput assays should be developed to facilitate the rapid screening of thousands of prospective inhibitory compounds. Because the shikimate pathway is found in bacterial, fungal, plants, and parasites but not mammals, innovative high-throughput assays can be adapted to a wide array of drug discovery efforts including biowarfare agents. PHASE I: Validate method to identify shikimate pathway genes and clone/express AT-rich sequences. Use identification methods to locate and clone malaria shikimate pathway genes from Plasmodium falciparum. PHASE II: Utilize purified recombinant enzymes to develop high-throughput inhibition assays. Provide protocols and reagents to conduct high-throughput screens for 3000 compounds for each at least three shikimate pathway enzymes of Plasmodium falciparum malaria. PHASE III: The exploitation of these new technologies for drug discovery may also yield significant advances in other areas of military and civilian importance. Noticeably, high-throughput assays for these enzymes could be applied to drug discovery efforts for anti-bacterial, fungal, plant, or parasite drug products. Not the least of which could include treatments for agents of bioterrorism. Also, cloning/expression systems for genes of AT-rich organisms could be applied to a wide variety of applications including drug discovery and vaccine development. ACCESS TO GOVERNMENT SUPPLIES: The development of the required diagnostic assays may require support (Plasmodium falciparum cDNA and genomic DNA.) 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) McConkey, G. A. 1999. Targeting of the shikimate pathway in the malaria parasite Plasmodium falciparum. Antimicrob. Agents Chemother. 43:175-177. 2) Moir, D. T. et al. 1999. Genomics and antimicrobial drug discovery. Antimicrob. Agents Chemother. 43:439-446. 3) Herrmann, K. M. and L. M. Weaver. 1999. The Shikimate Pathway. Annu. Rev. Plant Physiol. Plant Mol. Biol. 50:473-503. 4) Roberts, F. et al. 1998. Evidence for the shikimate pathway in apicomplexan parasites. Nature 393:801-805. 5) Davies, G. M. et al., 1994. (6S)-6-fluoroshikimic acid, an antibacterial agent acting on the aromatic biosynthesis pathway. Antimicrob. Agents Chemother. 38:403-406. 6) Kishore, G. M. and D. M. Shah. 1988. Amino acid biosynthesis inhibitors as herbicides. Annu. Rev. Biochem 57: 627-663. KEYWORDS: Shikimate Pathway, AT-rich, antimicrobial 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. 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