Miniaturization and Automation of Tissue Chip Systems (MATChS) (U43/U44 Clinical Trial Not Allowed)

Active
Yes
Status
Open
Release Date
November 22nd, 2023
Open Date
January 22nd, 2024
Due Date(s)
February 22nd, 2024February 24th, 2025February 23rd, 2026
Close Date
February 24th, 2026
Topic No.
RFA-TR-23-017

Topic

Miniaturization and Automation of Tissue Chip Systems (MATChS) (U43/U44 Clinical Trial Not Allowed)

Agency

Department of Health and Human ServicesNational Institutes of Health

Program

Type: SBIRPhase: BOTHYear: 2024

Summary

The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the Miniaturization and Automation of Tissue Chip Systems (MATChS) through their SBIR program. The goal of this funding opportunity is to support the development of benchtop, portable, automated systems that maintain 3D tissue constructs and provide biologically relevant outputs of tissue health and function. The technology should be easy to use, have integrated in-line sensors, and be capable of rapid and reproducible high-throughput analysis. The system should also be capable of maintaining culture without external intervention and be remotely monitored through real-time biosensing. The fabrication procedure must be cost-effective, mass producible, and robust. The funding opportunity is open for Phase I, Phase II, Fast-Track, and Direct to Phase II grant applications. The project duration is from 2024 to 2026, with multiple application due dates. More details can be found on the grants.gov website.

Description

This Notice of Funding Opportunity (NOFO) invites eligible United States small business concerns (SBCs) to submit Small Business Innovation Research (SBIR) Phase I, Phase II, Fast-Track and Direct to Phase II grant applications. The funding opportunity will utilize a U43/U44 cooperative agreement to support small business concerns (SBCs) to propose applications to create bench top, portable, automated, self-contained systems that maintain 3D tissue constructs (e.g., precise thermal control, fluid pumping and sampling) and provide biologically relevant outputs of tissue health and function. The companion Small Business Technology Transfer (STTR) NOFO allows for submission of Phase I and Phase II, and Fast-Track grant applications.

NCATS has consistently shown leadership in the development of tissue chip technology, in the demonstration of its utility in drug development for safety, efficacy and precision medicine, and in the dissemination of the technology (https://ncats.nih.gov/tissuechip/about). FDA Modernization Act 2.0 declared that the FDA no longer requires animal tests before drug trials in humans, which stimulated increased interest in in vitro New Approach Methods (NAMs) that are more predictive of human response in the safety and efficacy assessment of leading therapeutics. Tissue/organs on chips systems are considered as one of the NAMs. However, the widespread dissemination of tissue chip technology is hindered by the relatively large and complex instrumentation system needed to support the function of the chips, low throughput and specialized expertise needed to operate the systems. The instrumentation typically requires a multidisciplinary team of biomedical engineers and microfluidics experts to assure smooth operations, and biologists to acquire and analyze the data. This underscores the need for improvements in design towards systems capable of real-time, repeated measurements, with ease of manufacturability, and broader user-friendliness.

Through partnerships between NCATS, NASA and the Center for Advancement of Science in Space, the Tissue Chips in Space program has enabled advances in the study of microgravity-associated age?related conditions and has made key technological improvements in the tissue chips instrumentation systems towards automation and miniaturization required for space flight. Previously, NASA has partnered with NIH, BARDA and FDA to develop extended longevity tissue chips (cell culture life up to 6 months) with a focus on the development of systems requiring minimal human intervention. Working with spaceflight payload implementation partners, NCATS-supported tissue chip investigators have developed compact, robust, and reliable platforms which integrate basic support systems (incubation, refrigeration, thermal control, fluid reservoirs, microfluidic pumping systems etc.) as well as technologies to monitor cell health and function (pH, gas concentrations, repeated fluid sampling, microscopy, electrophysiology etc.). This Miniaturization and Automation of Tissue Chip Systems (MATCHs) NOFO seeks to engineer tissue chip platforms towards a smaller footprint and the simplification of systems for ease of use that will result in ease of use and broader accessibility of tissue chips in drug discovery and biomedical research.

Objectives

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.

Examples of responsive activities and corresponding SBIR Phase assignment includes but is not limited to the following technological developments.

SBIR Phase I (U43)

Development of components of the system Development of real-time biosensing Development of automated readout capabilities Telemetry operations Automation of tissue preculture and loading Automation of system operation Development of perfusion systems Development of automation to maintain 3D tissue

SBIR Phase II (U44) Integration of the system Development of a stand-alone instrument prototype Militarization of the system Development of software for instrument control and data processing software Standard protocols Assessment of instrument performance System characterization and validation Pre-market end-user testing

U44 Phase I/II Transition

Applicants can submit separate Phase 1 (U43) or Phase II (U44) applications. However, if Phase I and Phase II are submitted together in one application (U44 Fast-Track), then an administrative review will be conducted by NCATS Program staff to decide whether a project will be considered for transition from Phase I to Phase II. Phase II eligible projects must successfully accomplish milestones of Phase 1 as defined in Milestones Plan. Funding for the Phase II application will be contingent upon (1) assessment of the Phase I progress report and determination that the Phase I goals and milestones were achieved; (2) an update (as necessary) of the Commercialization Plan; (3) determination of the project's potential for meeting the mission of the awarding component and for commercial success; (4) review and approval of other documents necessary for continuation; and (5) availability of funds. The continuation application package is due 2 months prior to the anticipated start date of Phase II.

Similar Opportunities

Miniaturization and Automation of Tissue Chip Systems (MATChS) (U43/U44 Clinical Trial Not Allowed)
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the Miniaturization and Automation of Tissue Chip Systems (MATChS) through their SBIR program. The goal of this funding opportunity is to support the development of benchtop, portable, automated systems that maintain 3D tissue constructs and provide biologically relevant outputs of tissue health and function. The technology should be easy to use, have integrated sensors, and enable rapid and reproducible high-throughput analysis. The project should also focus on automation and miniaturization, with the potential for remote monitoring and real-time biosensing. The funding opportunity is open for Phase I, Phase II, Fast-Track, and Direct to Phase II grant applications. The project duration spans multiple years, with application due dates in February of each year. More information can be found on the grants.gov website.
Miniaturization and Automation of Tissue Chip Systems (MATChS) (UT1/UT2 - Clinical Trial Not Allowed)
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the Miniaturization and Automation of Tissue Chip Systems (MATChS) through a Small Business Technology Transfer (STTR) program. The goal of this funding opportunity is to support the development of bench top, portable, automated, self-contained systems that maintain 3D tissue constructs and provide biologically relevant outputs of tissue health and function. The technology should be able to automate tissue preculture and loading, system operation, perfusion systems, and cell culture conditions. It should also include in-line sensors for monitoring and sensing, as well as software for instrument control and data processing. The system should be cost-effective, mass producible, and robust. The performance of the system should be characterized and validated, and the applicant should propose quantitative metrics for evaluating progress. The long-term goal is to achieve technological advances that enable the routine use of tissue chips in safety and efficacy assessment of therapeutics. The funding opportunity is open for Phase I, Phase II, and Fast-Track grant applications, with a project duration of up to 2 years. The application due dates are February 22, 2024, February 24, 2025, and February 23, 2026. More information can be found on the grants.gov website.
Miniaturization and Automation of Tissue Chip Systems (MATChS) (UT1/UT2 - Clinical Trial Not Allowed)
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the Miniaturization and Automation of Tissue Chip Systems (MATChS) through a Small Business Technology Transfer (STTR) program. The goal of this funding opportunity is to support the development of bench top, portable, automated, self-contained systems that maintain 3D tissue constructs and provide biologically relevant outputs of tissue health and function. The technology should be able to automate tissue preculture and loading, system operation, perfusion systems, and cell culture conditions. It should also include in-line sensors for monitoring and sensing, as well as software for instrument control and data processing. The system should be cost-effective, mass producible, and robust. The performance of the system should be characterized and validated, and the applicant should propose quantitative metrics for evaluation. The long-term goal is to achieve technological advances that enable the routine use of tissue chips in safety and efficacy assessment of therapeutics. The funding opportunity is open for Phase I, Phase II, and Fast-Track grant applications, with a project duration of up to 2 years. The application due dates are February 22, 2024, February 24, 2025, and February 23, 2026. More information can be found on the grants.gov website.
Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional)
Department of Health and Human Services
The Department of Health and Human Services, specifically the National Institutes of Health, is seeking proposals for the Blueprint Medtech: Small Business Translator (U44 - Clinical Trial Optional) program. This program aims to support the development of cutting-edge medical devices for diagnosing and treating disorders of the nervous system. The program provides non-dilutive funds, as well as resources and support services such as planning resources, access to translational services and expertise, assistance from consultants, and advice from industry experts. The goal is to accelerate patient access to safe and effective medical devices. The program follows a two-phase approach, with Phase I supporting non-clinical translational device activities and Phase II supporting a clinical study. The total project period, including both phases, must not exceed five years. Projects should focus on disorders within the mission of participating NIH Blueprint Institutes and Centers and should either be close to the final system or require early feasibility clinical data. The program encourages applications from diverse teams, including socially and economically disadvantaged persons and women-owned small businesses. The application due dates are specified in the solicitation document. For more information, refer to the [SBIR topic link](https://www.sbir.gov/node/2075185) and the [solicitation agency URL](https://grants.nih.gov/grants/guide/pa-files/PAR-21-282.html).