SBIR & 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. NCATS 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.

NCATS seeks to increase small business participation in federally supported research and development as well as private-sector commercialization of technology developed with federal support. The Center also supports the development of clinical technology, instruments, devices and related methodologies that may have broad application to clinical research and better patient care.

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

Explore each area of current interest for NCATS:

• Drug Discovery & Development
• Biomedical, Clinical & Health Research Informatics​
• Clinical, Dissemination & Implementation Research
• Clinical Trials

Download the NCATS SBIR &STTR research priorities (PDF - 250KB)

Drug Discovery & Development

• Microphysiological systems (MPS)/Tissue Chips
• Small molecule and biologics analytical characterization
• Accelerated bioengineering approaches to the development and clinical application of biomedical materials, devices, therapeutics and/or diagnostics
• Technologies to determine alternative uses for existing therapeutic interventions
• Protein-protein interaction assays for high-throughput screening of rare-diseases-related projects
• Tools and technologies to enable assaying of compound activity on currently “non-druggable” targets
• Innovative platforms for identification and prioritization of targets for therapeutic intervention with clear clinical impact
• Fluorescence probes to replace antibodies for determination of cellular protein translocation
• Co-crystallization high-throughput screening techniques
• Tools and technologies that increase the predictivity or efficiency of medicinal chemistry, biologic or other intervention optimization
• Use of continuous flow manufacturing technology to improve therapeutic manufacturing and increase efficiencies
• Interventions that target molecular pathways or mechanisms common to multiple diseases
• Development of novel delivery systems of therapeutic interventions (e.g., inhalation/transdermal technologies for biologics)
• Methodologies and technologies to increase efficiencies of manufacturing therapeutics
• Development of novel technologies for enzyme replacement therapies (e.g., new cell culture/expression system) to solve a major bottleneck in rare diseases research
• Develop platforms for non-antibody biologics, cell-based therapies and gene therapy discovery
• Phenotypic assay development, including stem cell technology platforms for human “disease-in-a-dish” applications and the evaluation of toxicity
• Development of high-throughput imaging 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
• Targeting the human microbiome for drug development

Biomedical, Clinical & 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
• 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 and (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 data sources, including social media
• Data visualization for researchers, patients, study participants and decision-makers
• Gamification of processes that are challenging in translational and clinical research (e.g., creating positive experience that improve recruitment and retention of participants, or learning in a multidisciplinary environment)
• Collaborative platforms for multidisciplinary teams
• Predictive models for translation of science
• Virtual or augmented reality tools for diagnostic uses
• Novel data-gathering and sharing methods

Clinical, Dissemination & Implementation Research

• Approaches for populating registries in a scalable and affordable way to serve larger goals (e.g., Natural History Study)
• Tools and technologies that increase the efficiency of human subjects research, including development of technologies that facilitate rapid diagnosis and/or clinical trial recruitment and subject tracking, institutional review board evaluation, and/or regulatory processes
• Increased efficiency of clinical research conduct, including but not limited to regulatory decision support, patient eligibility analysis, and recruitment and retention tracking
• Tools and technologies to improve and evaluate the consent process
• 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)
• Approaches, tools, platforms and environments for synthesizing the totality of evidence
• Dissemination and implementation research
• Sustainable solutions for effective tools and environments in translational research
• Tools and environments that enable an easy interrogation of publically available data
• Development of predictive models for translational science
• Development and validation of patient reported outcomes, clinician reported outcomes, and biomarkers for conditions that are not already supported by a disease-specific NIH IC

Clinical Trials

NCATS 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 Clinical Research Policy.

Other human subjects research may be submitted through the Omnibus Solicitation and NCATS may decline funding of any application that includes human subjects for programmatic or administrative reasons. SBIR applicants considering projects involving human subjects research are strongly encouraged to contact NCATS-SBIRSTTR@mail.nih.gov. In the future, please note that NIH will release funding opportunity announcements (FOAs) with clinical trial specific requirements.