SBIR
Support for Small Business Innovation Research (SBIR) to Development and Testing of New Technologies and Bioengineering Solutions for the Advancement of Cell Replacement Therapies for Type 1 Diabetes (R43/R44 Clinical Trial Not Allowed)
BRAIN Initiative: Development Optimization, and Validation of Novel Tools and Technologies for Neuroscience Research (SBIR) (R43/R44 - Clinical Trial Not Allowed)
The Brain Research through Advancing Innovative Neurotechnologies (BRAIN) Initiative is a Presidential project aimed at revolutionizing our understanding of the human brain. By accelerating the development and application of innovative technologies, researchers will be able to produce a new dynamic picture of the brain that, for the first time, shows how individual cells and complex neural circuits interact in both time and space. It is expected that the application of these new tools and technologies will ultimately lead to new ways to identify, treat, cure, and even prevent brain disorders.
NIH is one of several federal agencies involved in the BRAIN Initiative. Planning for the NIH component of the BRAIN initiative is guided by the long-term scientific plan, "BRAIN 2025: A Scientific Vision," which details seven high-priority research areas and calls for a sustained federal commitment of $4.5 billion over 12 years. This report can be found at http://braininitiative.nih.gov/. This FOA and other FOAs issued in Fiscal Year 2018 are based on NIH's careful consideration of the recommendations of the BRAIN 2025 Report, and input from the NIH BRAIN Multi-Council Working Group.
In addition to the National BRAIN initiative, the NIH continues to have a substantial annual investment in neuroscience research and in technology development, including through the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs.
Research Objectives
Based on the priority areas identified by the BRAIN 2025, and in further evaluation of the neurotechnologies currently available to neuroscience researchers, it was determined that there is a need to enable broad dissemination of tools/technologies that improve our understanding of brain function. Many of these inventions require additional research and development (R&D) before they can be disseminated to the broader neuroscience community. To fill this research gap, this Funding Opportunity Announcement (FOA) which uses the STTR grant mechanism, will support to support the development of novel neuroscience tools and technologies in order to better understand the structure and function of brain circuits- a major goal of the BRAIN Initiative. This FOA will support further development of neurotechnologies developed through the BRAIN initiative or through other funding programs in preparation for commercial dissemination.
It is expected that the activities proposed will require partnerships and close collaboration between the original developers of these technologies and Small Business Concerns (SBCs), which may be accomplished in a number of ways, including the use of multiple program directors/principal investigators.
Examples of neurotechnologies that would be appropriate for this FOA include, but are not limited to, development of:
While some of the markets for these products may be small, NIH is supportive of developing these technologies towards sustainable commercial manufacture. The full development and dissemination of these technologies will enable neuroscientists to perform novel hypothesis-driven experiments that are not feasible and/or reduce barriers to experiments that currently are too costly, difficult, or time consuming to perform broadly.
For more information about neurotechnologies that may be of interest for this FOA, please see the BRAIN website: https://www.braininitiative.nih.gov/index.htm
Projects with non-exempt human subjects research will not be supported by this FOA. Such projects will not be accepted to this FOA.
See Section VIII. Other Information for award authorities and regulations.
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- Probes for large scale sensing and/or manipulation of neural activity in vivo
- Imaging instrumentation for recording and/or manipulating neural activity in vivo
- Electrodes for large-scale recording and/or circuit manipulation in vivo
- Techniques and approaches for recording/manipulating neural activity during behaviors
- Novel tools to facilitate the detailed analysis of complex circuits and provide insights into cellular interactions that underlie brain function
- Software or hardware related to the BRAIN initiative
Better Defining Growth Medium to Improve Reproducibility of Cell Culture (SBIR) (R43/R44 - Clinical Trial Not Allowed)
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Fetal bovine serum (FBS) is the most widely used growth supplement for cell culture; it cost-effectively supports the survival, growth, and differentiation of many cell lines by providing nutrients, growth signals, and protection from stress. Although serum is an effective growth promoter, it is variable in its composition, activity, and effects on cellular phenotypes. This variability introduces inconsistencies into research using cultured cells. Sometimes it is possible to replicate experimental results only if the same manufacturer's serum is used; sometimes replication is only possible using serum from the same lot. Vendor literature and scientific reviews advise investigators to test lots of serum to identify those that support the desired cellular responses, and then buy a quantity of the best lot for long term use. This practice is widespread but can make replication of results by others difficult.
Serum contains hundreds, perhaps thousands, of constituents. These include macromolecules, small molecules, and trace elements; for any cell line a large and variable subset of these may be active in supporting cell growth. The composition and concentrations of factors in serum vary with the source animals' diets, geographical locations, gestational stages, gender, health, season of harvesting, and histories of exposures to hormones, antibiotics, and environmental chemicals. Harvesting practices, manufacturing processes and additives, and differences in quality control and handling introduce additional variation. Serum is a byproduct of the meat-processing industry; dependence on serum is a barrier to translation of cell-based therapies because of the risk of transmission of viruses, prions, endotoxins, and immunogens.
Serum supplies factors that support cell growth through mechanisms that are not well understood, but includes hormones, enzymes, extracellular vesicles and proteins, extracellular matrix constituents, attachment and spreading factors, vitamins and minerals, trace elements, lipids, protease inhibitors, and other stabilizing and detoxifying factors. Substitute formulations for serum are expensive and time-consuming to develop and are cell-type specific; some cell lines cannot be grown with presently-available serum replacements. Although serum substitutes can support the growth of many cell types in culture, they often do not support robust survival and the same range of responses as does serum. Thus, serum continues to be widely used in many research settings where it is not economically practical to customize substitutes for it.
This Funding Opportunity Announcement (FOA) addresses the needs of developers and users for supporting technologies and products to expedite (a) development of better serum substitutes, (b) identification of serum constituents that are effective in promoting the culture and responses of specific cell lines, and (c) troubleshooting of experimental variation stemming from variability in serum. This FOA will support SBIR projects to develop reliable and cost-effective tools; projects may develop new technologies or improve upon existing technologies. Topics include, but are not limited to:
- Synthetic serum replacements, both general purpose and specialized for particular cell types. Development of minimal base formulations for customization by users into serum substitutes for specific cell lines.
- General purpose analytical tools to detect constituents in serum. Tools for rapid evaluation of variation in serum composition, and for comparison of serum batches.
- Specialized methods, tools and products for identification and evaluation of factors and activities in serum affecting adherence, survival and phenotypes of particular cell types.
- Development of bioactive products for inclusion in serum replacements or to supplement reduced media, such as components that would assist the adherence of cells and promote correct morphology.
- Affordable methods for production of serum components such as growth factors.
- Toolkits to assist users to develop serum replacements.
- Methods, tools, and products for detecting and clearing biological and chemical contaminants, such as viruses, prions, endotoxins, immunogens, etc.
See Section VIII. Other Information for award authorities and regulations.
Wearable Alcohol Biosensors (SBIR) (R43/R44- Clinical Trial Optional)
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Rapid advances are being made in wearable technology, including clothing, jewelry and other devices with broadly diverse functions that meet medical or consumer needs. This FOA seeks applications from small businesses that propose to design and produce a non-invasive wearable device to monitor blood alcohol levels in real time.
Alcohol detection technology for personal alcohol monitoring has been successful in judicial and law enforcement settings, yet needs significant modification for wider use in other situations. Current technological developments in electronics, miniaturization, wireless communication, and biophysical techniques of alcohol detection in humans increase the likelihood of successful development of a general use alcohol biosensor in the near future.
The alcohol biosensor device should be unobtrusive, appealing to the wearer, and can take the form of jewelry, clothing, or any other format located in contact with the human body. Techniques to quantitate alcohol in blood or interstitial fluid are highly encouraged. Highest priority will be given to technologies that depart from measuring alcohol in sweat or sweat vapor. Applicants are encouraged to pursue any technology - including but not limited to biophysical, optical, wave, or other novel approaches- that works in a non-invasive way and can be incorporated into a wearable.
The device should be able to quantitate blood alcohol level, interpret, and store the data or transmit it to a smartphone or other device by wireless transmission. The device should have the ability to verify standardization at regular intervals and to indicate loss of functionality. The power source should be dependable and rechargeable. Data storage and transmission must be completely secure in order to protect the privacy of the individual. A form of subject identification would be an added benefit. The device can be removable.
It is envisioned that wearable alcohol monitors will serve useful purposes in research, clinical, and treatment settings, will play a role in public safety, and will be of interest to individuals interested in keeping track of personal health parameters. Designs may emphasize any of these potential market subsets or may seek to be broadly marketable.
See Section VIII. Other Information for award authorities and regulations.