DHA26BZ01-NV003 — Environmental Exposure Detection Technologies and/or Decontamination Treatments for Military Working Dogs

Award Maximum: $300,000 Period of Performance: 6 months Phase Type: Phase I

OBJECTIVE: Develop decontamination treatments for military working dogs that have been exposed to toxic industrial chemicals and materials through the performance of their duties.

DESCRIPTION: This topic is in support of the DoD Working Dog Strategic Research Plan concerning mitigation, countermeasures and treatments for toxin/toxic exposures. In modern military operations, military working dogs (MWDs) are at risk of exposure by many different types of hazardous materials. These include toxic industrial chemicals (TICs) and materials (TIMs) such as hydrocarbons, polychlorinated biphenyls, glycols, hazardous metals, gases (hydrogen cyanide, hydrogen sulfide, freon, carbon monoxide, etc.), acids and alkali substances. Techniques for the decontamination of hazardous material exposures to the surface of the MWD are well defined. Although there are useful treatment options for external decontamination, there are few treatment options for toxic exposures that have been absorbed into the body of the MWD.

The objective of this topic is to develop new treatments for MWDs against hazardous materials that have been absorbed into the body either through the skin or mucous membranes, by inhalation, or ingestion. Current systemic treatments employed to care for MWDs include supportive antibiotic therapy for sulfur mustard, atropine injections for nerve agents, and Narcan for narcotics, but there are limited treatment options available for TIC/TIM exposures. Systemic treatments for the MWD should be able to be performed by veterinarians and their support personnel (trained animal care specialists (68T) in Role 1 and/or veterinary medical and surgical teams (VMST) in Role 2). Potential MWD systemic treatments could include but are not limited to kits containing indicators or detectors of TIC/TIM exposure with easily identifiable injectable treatments for the identified contaminant (indicator/detector) and/or hemoperfusion systems and filters that can be used to remove contaminants from the blood (systemic). This research topic does not support the use of canines for testing purposes. Any animal testing would require use of a suitable animal model that would approximate the response of a canine.

PHASE I: This phase is to propose either a TIC/TIM indicator/detector that can be used in conjunction with current treatments and/or propose a systemic treatment system for MWD toxic exposures. For indicator/detector technologies, identify potential technologies that are lightweight for use in the field and can ascertain exposures to specific TICs/TIMs and determine what decontamination treatment options to use for MWD survival. For systemic treatments, determine the potential of materials and methods which could be developed into a system for the systemic treatment of TIC/TIM exposures in canines. All proposed treatments must have the potential to reduce the specific TIC/TIM to levels that are safely below the LD50 of the TIC/TIM based on average weight of a canine (80-100 lbs). A listing of potential toxins and LD50 levels can be found in the MERCK Veterinary Manual Toxicology. Down select the best candidate materials and methods for inclusion in an exposure indicator or detection system and/or systemic treatments for development and testing in Phase II based on operational relevance. Develop a plan for the testing of candidate technologies and treatments using both in vitro and in vivo studies (as necessary). Any in vivo studies are to be planned using a suitable animal model that approximates the canine. No canine research will be performed for this topic area. The plan must include the descriptions and methods of determining the study endpoints to be measured for successful prototypes. Estimate the potential effects of the proposed systems and processes on MWDs and their handlers.

PHASE II: For TIC/TIM indicator/detector technologies associated with the treatment approach, develop and optimize a workable prototype that can be used in both laboratory and field testing. Perform the testing plan for the evaluation of the prototype as described in Phase I. Demonstrate the effectiveness, sensitivity, and specificity of the technologies for the detection of the specified contaminants. Demonstrate the ability for the technology to be used in the appropriate field setting by the working dog handler or Role 1 or Role 2 veterinary staff once trained.

For systemic treatment products, develop and optimize a workable prototype for laboratory testing. Validate the proof of concept by demonstrating the effectiveness of the developed prototype against TICs/TIMs on appropriate surrogate materials and evaluate its effectiveness by performing the testing plan developed as part of Phase I on appropriate efficacy models. Verify that contamination levels are reduced to or below performance objective levels. Demonstrate the practicality of use at the specified Role of Care in which the treatment is intended to occur. If any in vivo studies were planned, they must be performed on an animal model that approximates the canine. No canine research will be performed for this topic area.

Estimate transportability and storage stability of the developed detection and/or treatment prototype. Develop final product specification documents that include a list of all system components and their requirements and instructions for deployment and stowage.

PHASE III DUAL USE APPLICATIONS: The end goal is to achieve FDA Center for Veterinary Medicine approval for the prototype developed in Phase II. Optimize the TIC/TIM indicator or detector prototypes and/or systemic treatments for use with additional hazardous materials and demonstrate its effectiveness with end users. Use feedback from end-users to further optimize the prototypes. Transition the prototype from an advanced development stage to a fully vetted product ready for real-world use. Refine the development of a commercialization plan that may include development of different pathways, including both military and private sectors. This product should be applicable to a broad spectrum of civilian use markets, including emergency veterinary facilities, other government agencies (DHS, FEMA, ATF, etc.), law enforcement and search and rescue canines. In addition, the work may result in technology transition to Acquisition Program Managers within DoW. These efforts will be crucial in turning the prototype into a commercially viable product that can be rapidly deployed in military operations.