SBIR and STTR Research Priorities

NIH provides grant opportunities for small businesses in any biomedical or behavioral research area that falls within the agency’s mission to improve human health. Our small business funding is designed specifically to transform the translational science process so that new treatments and cures for disease can be delivered to patients more efficiently.

We support the development of clinical technology, instruments, devices and related methodologies that may have broad application to clinical research and better patient care.

We will not accept SBIR/STTR applications that include clinical trials under the current Omnibus Solicitation.

Preclinical Drug Discovery and Development

• Innovative platforms for identification and prioritization of targets for therapeutic intervention with clear clinical impact, such as those that are:
  • implicated for disease
  • have genetic variations that have been identified in functional regions of receptor targets 
  • have high potential for biased signaling that would promote the beneficial effects of receptor signaling and reduce the unwanted effects
• Tools and technologies to enable high-throughput screening of compound activity on currently “non-druggable” targets
• Co-crystallization high-throughput screening techniques
• Fluorescence probes to replace antibodies for determination of cellular protein translocation
• Phenotypic assay development, including stem cell technology platforms for human “disease-in-a-dish” applications and the evaluation of toxicity
• Interventions that target molecular pathways or mechanisms common to multiple diseases
• Platforms for non-antibody biologics, cell-based therapies and gene therapy discovery
• Small molecule and biologics analytical characterization
• Accelerated bioengineering approaches to the development and clinical application of biomedical materials, devices, therapeutics and/or diagnostics
• Tools and technologies that increase the predictivity or efficiency of medicinal chemistry, biologic or other intervention optimization
• Technologies to deliver nucleic acid therapeutics to tissues other than the liver
• Methodologies and technologies to increase efficiencies of manufacturing therapeutics
• Development of novel high-throughput technologies that focus on making translational research more efficient
• GMP production of exosome/extracellular vesicles
• Generation of producer lines for large-scale production of exosomes/extracellular vesicles
• Extracellular RNA-based biomarkers and therapeutics of human diseases
• Approaches to targeting the human microbiome for therapeutic or diagnostic purposes
• Scale up, manufacturing and characterization of IPS cells
• 3-D printing technologies
• Technologies to substantially improve the efficiency and reduce the cost of clinical-grade gene therapy vector manufacturing
• Development of in vitro human tissue models (organs, 3-D printing)
• Technologies to allow therapeutic proteins other than lysosomal enzymes to be secreted and taken up by other cells via cross-correction
• Novel strategies to prevent deleterious immune responses to gene therapy, to improve efficiency in genome editing and/or enzyme replacement therapy
• Establishing of more robust phenotypic screens that may help prioritize candidate compounds for further testing
• Innovative technology for non–small molecule delivery
• High-throughput epigenetics screening/characterization tools and technologies
• Microphysiological systems (MPS)/tissue chips, including MPS/tissue chips that incorporate known functional variants, e.g., ACMG 59 or CPIC A alleles, for study comparison using the same derived genetic background across a set of tissue chips with the functional variant
• Volatile organic compounds (odors, scents) as biomarkers for disease
• Bacteriophage-based therapeutics for disease and as modulators of the microbiome and microbiome natural products
• High-throughput Surface Plasmon Resonance devices for detecting protein small molecule interactions

New class of quantum-enabled sensing technologies for advancing translational sciences (e.g., point of care ultrasensitive high-throughput technologies for diagnostics, and miniaturized benchtop technologies for chemical/bioanalyte characterization

Biomedical, Clinical and Health Research Informatics

• Searchable access to information about research resources, facilities, methods, cells, genetic tests, molecules, biologic reagents, animals, assays and/or technologies with evidence about their use in research studies
• Cloud-based tools and methods for meaningful sharing, re-use, and integration of research data
• Novel platforms, technologies, and tools for:
  1. enabling clinical and translational research, particularly those with mechanisms for inclusion of patient-reported data
  2. integration of patient data collected from multiple devices and multiple/diverse clinical studies
• Development of personalized phenotypic profiling (as well as personalized intervention) based on patient-centered integration of data from multiple sources, including social media
• Development of predictive models for translational science
• Digital applications and tools (including telemedicine platforms) that facilitate/enhance translational research and medicine in rural populations
• Generic Disease Registry template platforms that can be reused for multiple diseases
• Mobile device validation tools to ensure data from different brands or versions have compatible results
• Tools to assess algorithms developed with artificial intelligence and/or machine learning
• Tools that allow for persistent identifier and attribution for data contributors that give credit to the data producers while ensuring that shared data has not been altered
• Patient Mobile Tool Platforms that facilitate tool developers to build "apps" that integrate NIH, CDC and FDA Program Descriptions and Research Topics into their medical records
• Tools and environments that enable an easy interrogation of publicly available data
• Innovative approaches like nanoneedles and nanoparticles to help improve early disease detection and targeted therapeutic delivery
• Tools and technologies that leverage AI and real-world data for enhanced product evaluation and surveillance that could be used to provide a resource for rapid response to public health needs
• Software platforms for electronic health records and personalized health records (patient-facing records) targeting data accessibility and interoperability for community medical center and physician-owned health providers, including modularity to assess AI algorithm performance pre-deployment and longitudinally post-deployment

Clinical, Dissemination and Implementation Research

• Tools and technologies that:
  • increase the efficiency of human subjects research or that facilitate the rapid diagnosis and/or clinical trial recruitment and subject tracking, institutional review board evaluation, and/or regulatory processes
  • evaluate and improve the process of informed consent
  • address medication adherence in clinical settings
  • address and improve community engagement
  • address the rapid diagnosis and/or clinical management of rare diseases
  • help characterize human disease states and assist in assessing the impact of interventions
  • mine published data and generate usable knowledge and analytics to advance research
• Increased efficiency of clinical research conduct, including but not limited to regulatory decision support, patient eligibility analysis and recruitment and retention tracking
• Tools, technologies and other strategies to evaluate and improve the process of informed consent
• Educational tools for clinical and translational science
• Computational or web-based health research methods, including:
  • platforms for generally applicable and scalable multi-disease registries and natural history studies
  • clinical trial designs and analyses (e.g., for pragmatic clinical trials)
• Telemedicine or digital health applications that focus on research in rural populations
• Tools and technologies that enhance the quality, safety, efficiency and effectiveness of new innovations in community settings
• Approaches, tools, platforms and environments that:
  • integrate data in novel ways for the development of new biomarkers that can be tested in translational research paradigms for which there are barriers or bottlenecks
  • engage prospective research participants who are from under-represented communities and impacted by disparities and the digital divide
• Strategies to enhance the quality of and accelerate the conduct of dissemination and implementation research
• Sustainable solutions for effective tools and environments in translational research
• Patient empowerment tools/apps that allow users to compare their treatment and outcomes to normative populations existing treatment guidelines

Rare Disease and Unmet Needs

• Development and validation of patient reported outcomes, clinician-reported outcomes and biomarkers for rare diseases that are not already supported by a disease-specific NIH Institute or Center
• Tools and technologies that address the rapid diagnosis and/or clinical management of rare diseases
• Assays for high-throughput screening of rare-diseases-related targets
• Development of novel technologies for enzyme replacement therapies (e.g., new cell culture/expression system) to solve major bottlenecks in rare diseases research
• Innovative methods to determine alternative uses for existing therapeutic interventions for high priority areas, such as rare diseases and pain
• Development of diagnostics or useful drug targets for rare diseases by using Pangenome Data 

Clinical Trials

We will not accept SBIR/STTR applications that include clinical trials under the current Omnibus Solicitation. NIH defines clinical trial as a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes. See the Revised NIH Definition of “Clinical Trial” and the Clinical Research Policy.