Department of Health and Human Services
July 24, 2014
July 24, 2014
SBIR / 2014
October 14, 2016 (closing in 506 days)
NOTE: The Solicitations and topics listed on this site are copies from the various SBIR agency solicitations and are not necessarily the latest and most up-to-date. For this reason, you should use the agency link listed below which will take you directly to the appropriate agency server where you can read the official version of this solicitation and download the appropriate forms and rules.
The official link for this solicitation is: http://grants.nih.gov/grants/guide/rfa-files/RFA-HL-15-017.html
The SBIR/STTR Programs were recently reauthorized by the United States Congress with the SBIR/STTR Reauthorization Act of 2011(P.L. 112-81). One change that was made to the SBIR program in this reauthorization was the authority for certain participating federal agencies to ‘issue a Phase II award to a small business concern that did not receive a Phase I award for that research/research & development. This is a so-called ‘Direct-to-Phase II’ SBIR award. This authority would permit SBCs to submit Direct-to-Phase-II SBIR applications, if the small business had performed the Phase I stage-type of research through other funding sources. The legislative rationale for permitting the Direct-to-Phase II award is to allow a SBC that has already built a technology prototype and tested its feasibility (i.e. completed Phase-I-type R&D) to move directly into a Phase-II-type R&D that tests the functional viability of the prototype according to scientific methods and potential for commercial development. The Direct-to-Phase-II SBIR mechanism eliminates the need for the SBCs to propose additional small feasibility studies, if the technology is ready for the Phase II stage of development. The Direct-to-Phase II authority is not available to the STTR program.
Recent trends have created a large potential market for breakthrough medical solutions led by tissue engineered medical products. For example, bioengineered trachea, vascular grafts, and other hollow-organ tissues have made entry into clinical studies, so sophisticated and more standardized bioreactors are critical for testing of complex, neo-organ technologies. Additionally, considerable progress in the tissue engineering and regenerative medicine field has increased the demand for reliable tissue-specific bioreactors. It is expected that biotech companies and academic partners involved in regenerative medicine strategies would leverage their existing knowledge base to apply to this FOA and its companion FOAs, RFA-HL-15-004 and RFA-HL-15-008.
Bioreactor technology is an essential part of the research and development pathway; however, existing devices lack necessary features for tissue engineered constructs to function clinically. Research successes for a variety of simple bioreactor systems have shown sustained, but limited, in vivo function. Systematic and validated analyses of tissue-specific growth and remodeling capacity are needed for advancing bioreactor systems, especially for those using stem cell technologies. For example, devices for the growth of stem cells (SCs) should integrate SC expansion with subsequent mechanical stimulation to enhance functional differentiation for use in complex tissues. Another challenge for cellular propagation is to establish stable protocols that do not require feeder layers and conditioned medium. At the organ level, tailored lung tissue bioreactor design plans are needed for gas and blood exchange interfaces, whereas design of cardiac tissue bioreactors might emphasize electrical and mechanical forces. Additionally, it may be possible to engineer 3D bone marrow organs that permit extensive blood stem cell self-renewal and hematopoiesis in vitro. Given the complexity of engineered constructs, often containing a combination of cells, scaffolds, and other factors, special challenges exist for tissue engineered product characterization, which may affect its eventual manufacturing protocol and clinical utility. Hence, there is an ongoing need for design innovation and parameter refinement of bioreactor systems, along with accepted protocols for standardization.
NIBIB joins this announcement consistent with its mission to lead the development and accelerate the application of biomedical technologies, through integration of engineering with the physical and life sciences, to advance basic research, and medical care.
This program aims to support multidisciplinary small business teams in the development of complex, three-dimensional engineering systems for growing heart, lung, or bone marrow tissue. Integrated devices will require a diverse array of scientific principles and technologies. Ultimately, bioreactor designs should provide the most physiologically relevant environment to promote correct 3-dimensional tissue growth and maintenance, which is also efficient, safe and economical. Such devices should be made commercially available and widely disseminated to researchers for application in the translational setting.
Specific Areas of Research Interest
Device design for research applications will likely be different from designs for clinical applications. For research requirements, the bioreactor should provide for adaptability to the type and number of experimental conditions. Whereas in contrast, clinical application designs need to meet GMP guidelines, which require robust production conditions and scale-up.
Research examples appropriate for this FOA include, but are not limited to, those listed below:
Areas of research that will not be considered responsive to this FOA include incremental refinement of mature technologies for cell production. Applicants are strongly encouraged to discuss the proposed approach, concept, or strategy with Scientific/Research staff listed under Agency Contacts, to determine responsiveness to this FOA.
Metrics for Program Success
The majority of small businesses are developing tissue growth technologies devices primarily for the skin, cartilage, and bone, and tumor biology communities. Movement of small companies into producing standardized tissue bioreactors for heart, lung, and blood tissue systems is an overarching programmatic goal. The success of Phase I applications will be measured by evidence of the completion of developmental milestones. Success of Phase II and Fast-Track applications will be measured by development of bioreactor systems that are either suitable for FDA-approved clinical studies or standardized devices that provide for long-term sterile matrix development and tissue maturation for use in the translational research setting. Well-designed devices should markedly reduce the need and cost for expensive biologics. Completed Phase II projects ought to show evidence of either licensing of their technology, merging with another business, product sales or submission of a Phase IIB application.