Miniaturization and Automation of Tissue Chip Systems (MATChS) (U43/U44 Clinical Trial Not Allowed)
Funding Agency:
- National Institutes of Health
This NOFO seeks to fund technology development research efforts in instrumentation innovation and approaches for automation and miniaturization of MPS. The technology development proposed should have the potential to significantly propel the field of MPS forward and have the potential to have a large impact on the future analysis of safety and efficacy assessment of therapeutics. A main objective for this funding opportunity would be to create a bench top, portable, easy-to-use, automated MPS with integrated in-line sensors, flow generator with system control and data processing software to provide rapid and reproducible high-throughput analysis. The project could integrate manual methods into an automated system to develop a standalone module. Improved tissue chips instrumentation systems should demonstrate automation capabilities in maintaining culture without external intervention and can be monitored remotely through real-time biosensing and readout capabilities, including telemetry operations. Automation may include automation of tissue preculture and loading, system operation, perfusion systems with or without pumps, automation of cell culture conditions, monitoring and sensing, include in-line sensors, e.g., pressure, pH and oxygen sensors. This self-contained system should maintain 3D tissue constructs (via precise thermal control, fluid pumping and sampling) for extended periods of time and provide biologically relevant outputs of tissue health and function (e.g., by means of fluid sampling, electrode incorporation, microscopy, biosensors). If automated chip exchange is proposed, the system should have proper optical, mechanical, and electrical couplings. The fabrication procedure must be cost effective, mass producible, and robust. The application may include development of a software for instrument control, data acquisition and real-time detection, fast data processing and analysis for high throughput measurements.
Performance metrics of an integrated system for a multi-day protocol should be developed once standard protocols are established and instrument performance is assessed. Once optimal assay parameters are identified, and optimized chips created and integrated for use in the fully automated system with alignment features ensuring proper connection of the fluidic path to the chip, the performance of the system should be characterized and validated. An automated system may be validated by demonstrating compatibility with developed chips and organ-on a chip model and by pre-market end-user testing.
The NOFO deliberately does not specify cost, quality, scale, sensitivity, dynamic range, throughput, or other key metrics since achievable endpoints are likely to substantially differ from one technology to another. However, the applicant must propose quantitative metrics so progress can be evaluated and present convincing rationale that the proposed technology has the potential to scale long-term and to achieve a throughput compatible with widespread adoption by the biomedical and clinical research community. It is expected that applicants will develop and detail scientific and practical definitions of optimal throughput, cost, accuracy, sensitivity, dynamic range, and scale. The long-term goal is to achieve technological advances that enable generation of data at sufficient scale, speed, cost and accuracy to use routinely in safety and efficacy assessment of therapeutics. MATChS is expected to accelerate commercialization and catalyze the widespread use of tissue chips through automation and miniaturization of the instrumentation systems and will lead to the general utility of tissue chips in drug development and regulatory decision-making, as well as in biomedical research in general as a major research tool.
The SBIR U43/U44 cooperative agreement mechanism is milestone-driven and involves significant input from NIH program staff regarding project and milestone planning, monitoring of research progress, and go/no-go decision-making. Applicants are encouraged to contact staff at NCATS per Agency Contacts below to ensure that their study design and objectives are in line with the goals of the NOFO. Award recipients will be expected to work with NCATS staff post-award.
Budgets up to $350,000 total costs for Phase I and up to $2.15M total costs for Phase II may be requested utilizing waiver topics listed in Appendix A of PHS 2022-02 SBIR/STTR Program Description and Research Topics for the NIH, CDC, and FDA https://seed.nih.gov/sites/default/files/HHS_Topics_for_Budget_Waivers.pdf.
February 22, 2024
Dmitriy Krepkiy, Ph.D.
Office of Special Initiatives
National Center for Advancing Translational Sciences, NIH
Phone: 301-451-2232
Email: dmitriy.krepkiy@nih.gov