Development and Commercialization of Technologies to Create, Characterize or Improve Animal Models of Human Disease (R43/R44)

The NIH supports animal models and related materials that are central to understanding basic biological processes and improving human health. ORIP-funded resources support the development, characterization, preservation and distribution of high quality animal models and biological materials that are used by investigators in all disciplines of biomedical research. Animal research facilities require many aspects of infrastructure to serve this function. For example, optimal husbandry, including caging and other equipment, is necessary to maintain animals as healthy stocks. Animal models are defined in regard to genetic, phenotypic and health-related characteristics. The health status of animals can be threatened by opportunistic and emerging pathogens so monitoring and interventions need to be in place to maintain and reproduce stocks. Animals are often preserved, either as living stocks within breeding colonies, or as cryopreserved germ plasm. Therefore, animal models are under continuous development and improvement to meet emerging challenges and scientific needs. All of these animal model-related functions can benefit greatly from commercial availability of hardware (e.g., equipment, instruments, devices), software (e.g., computational models and their implementation, informatics tools and resources) and wetware (e.g., cell-free assays, bioactive agents, imaging probes). Companies can help to develop innovative approaches and tools to modify and maintain models to meet new biomedical challenges and needs. Of interest here is a broad spectrum of tools and techniques for molecular, chemical, and biological measurements and procedures which are relevant to the care of and to experimental protocols involving research animal models. Anticipated outcomes will yield simple yet sophisticated protocols, accurate yet easy to implement methods, and modern yet cost-efficient tools to support animal research, and will be useful in general laboratory settings in many areas of biomedical research. Proposed projects will be measured by their innovation, potential for a wide-use, advantages over existing approaches, and economic factors.

This FOA encourages Small Business Concerns (SBCs) to develop and implement innovative technologies and tools that can facilitate ORIP’s mission, and in particular ORIP-supported resources. The animal models and biological materials to be developed must address the research interests of two or more of the categorical NIH Institutes and Centers. In addition, projects that predominantly address the research interests of one NIH Institute or Center, but that are peripherally related to the research interests of other Institutes and Centers, will not be considered appropriate for this FOA. An example of an inappropriate request is one exclusively involving an animal model of cancer or some other specific disease.

ORIP encourages SBIR applications aimed at improving all aspects of animal models and related technologies, including, but not limited to, enhancing or in the developing and implementing the following:

• Existing animal models as alternative sources of human tissues (e.g., humanized mice and swine).
• Cost-effective methodologies and procedures for husbandry and management of colonies, including implementation of simple-to-use tests for monitoring health of animals.
• Technologies for improved delivery of vaccines in aquatic, rodent and other species (e.g., inhalation/aerosol, oral, subcutaneous).
• High-throughput technologies for the effective cryopreservation and long-term maintenance of laboratory animal genetic stocks and germ plasm (e.g., zebrafish sperm and fruit fly sperms embryos).
• New technologies to rapidly phenotype large numbers of animals, including high-throughput technologies for screening phenotypes in response to drugs or environmental perturbations.
• Reagents for testing animal colonies for pathogens such as viruses in specific pathogen free colonies of macaques and active tuberculosis in conventional nonhuman primate colonies.
• Test kits to measure hormone levels in urine, fecal, and blood samples (e.g., early pregnancy test for rodents) including tests to quantify stress and pain.
• Animal models for regenerative medicine applications, including development of technologies and procedures for testing efficacy and safety of experimental protocols (e.g., endogenous virus for transplantation studies).
• Technologies for expansion of animal stem cells or their differentiated derivatives, to make sufficient quantities available to test therapeutic applications, tumorigenicity and safety.
• Software to mine data from animal systems such as zebrafish and genetically modified mice to correlate genotype-phenotype interactions and to reconcile transcriptomic and proteomic data.
• Technologies for analysis and identification of gene regulatory networks in animal models.
• Panels of reagents that can perturb gene regulation in model organisms.
• Equipment or devices that can improve animal husbandry or environmental monitoring (e.g., improved caging, remote monitoring devices, improved devices for enrichment, valuation of food intake).

Applicants are advised to discuss their projects with the Scientific/Research contacts before submitting an application.

See Section VIII. Other Information for award authorities and regulations.