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

001: Funding Opportunity Description

Description:

The NIH supports animal models and related materials that are central to both understanding basic biological processes and for developing applications directly related to improving human health. DCM/ORIP-funded Resources aid these efforts by developing, characterizing, preserving and distributing high quality animals and biological materials that are used by researchers in all disciplines of biomedical research. Animal Resources require many aspects of infrastructure to serve this function. For example, optimal husbandry, including caging and other equipment, is required to maintain animals as healthy stocks that can be distributed to researchers. Animals within Resources are characterized in regard to genetic, phenotypic and health-related characteristics. The health status of animals can be threatened by opportunistic and emerging pathogens associated with maintenance and reproduction of living 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 functions within animal based Resources can benefit greatly from commercial availability of key components, such as hardware (e.g., equipment, instruments, devices), software (e.g., computational models, informatics tools, data analytic methods and resources, data repositories) and wetware (e.g., cell-free assays, bioactive agents, imaging probes). Companies can help develop innovative approaches to modifying models to meet new biomedical challenges and needs.

This FOA encourages Small Business Concerns (SBCs) to develop innovative technologies that can facilitate the missions of the DCM-supported Resources. The supported research and development will likely require close collaboration between the SBCs and the 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.

DCM/ORIP encourages SBIR applications aimed at improving all aspects of animal models, including, but not limited to, enhancing or developing the following:

• Existing models as alternative sources of human tissues, for example, humanized mice.
• Cost-effective husbandry and colony management techniques, equipment, and/or new approaches to improve laboratory animal welfare and assure efficient and appropriate research use. Design of specialized equipment to permit optimal environmental control and operational efficiency, including improvements in caging and remote monitoring in animal facilities.
• High throughput technologies for the effective cryopreservation and long-term maintenance of laboratory animal genetic stocks and germ plasm, for example, zebrafish sperm.
• New technologies to rapidly phenotype large numbers of animals. High throughput technologies for screening phenotypes in response to drugs or environmental perturbations, for example, for zebrafish.
• Reagents for testing animal colonies for pathogens, for example, viruses in specific pathogen free colonies of macaques (especially STLV-5) and active tuberculosis in conventional nonhuman primate colonies.
• Animal models for regenerative medicine applications, including development of technologies and procedures for testing efficacy and safety of experimental protocols. For example, genetically engineered swine 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 yeast, 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. Generate panels of reagents that can perturb gene regulation in model organisms.