Tools that accelerate medical countermeasure screening and development are vital to improving human health – from enabling personalized medicine to responding to health security threats such as pandemics. To this end, BARDA, in partnership with the National Center for Advancing Translational Sciences (NCATS), part of the National Institutes of Health, has launched the new ImmuneChip+ program. We aim to partner with innovators to support the development of advanced microphysiological systems / tissue chip platforms that integrate a component of the human immune system. The objective of the program is to develop a set of mature ImmuneChips, combining a previously validated model of a vital human tissue (e.g. lung, heart, kidney) with an immune system component, in a single platform that can be machine-manufactured and that includes multiple in-line sensors for long-term tissue monitoring. With this program, we aim to further enhance the usability of tissue chips and position them as useful tools in the drug development process and for personalized therapeutics.
Accurately modeling human tissues and disease in vitro is a key step to accelerating the pace of drug discovery and development, a capability critical to effectively responding to pandemics, in which every day counts. Rapid advances in tissue chip technologies now make the prospect of commercialization more realistic. However, key challenges remain, including manufacturability, use of medically relevant sensors, and the integration of multiple tissue types anchored by the immune system. We aim to support the development of advanced microphysiological systems (MPS) that monitor and replicate components of vital human tissues, including immune system functions and their interactions.
We expect that the use of these advanced MPS will result in unprecedented opportunities for addressing mechanistic questions of health and disease, as well as assessing biomedical interventions. Moving towards a comprehensive “body-on-a-chip” approach, these MPS will serve as a predictive tool in the drug development process and enable the development of precision medicine-based therapies.
The focus of ImmuneChip+ is on engineering 3-D in vitro human microphysiological tissues (e.g. lung, liver, gut, heart tissue, or others) and immune system tissues on a single platform, while adding in-line sensors for continuous tissue monitoring and utilizing platform materials suitable for automated manufacturing. We are specifically interested in adding immune system responsiveness to an existing, validated in vitro human tissue model (e.g. lung, liver, gut, heart, or others) and/or model infection with a viral, bacterial, or fungal pathogen, while demonstrating continuous monitoring of the tissues and capability for automated manufacturing of the platform.
It is open to both academia and industries as long as the respondents meet all the requirements described in EZ-BAA.
Any entity can submit to ImmuneChip+ via the EZ-BAA portal as long as they are registered with www.SAM.gov.
Yes. Applicants from outside of the United States are eligible to apply for funding. Please note though that U.S.-based manufacturing of the proposed solution device/diagnostic will be prioritized.
Yes. Abstract submissions should include a cost-share that is within our target range of 30-50% minimum unless you satisfy the regulatory exception described (included below for reference). Currently, none of the awardees under the DRIVe EZ-BAA have been awarded a contract that does not include a cost-share component below range, including all universities and non-profit organizations. Cost-share may be in-kind or cash contributions. It may also come from a third-party investor/sponsor; however, it is up to you to ensure you receive their contribution toward the proposed project. Many organizations offer to cover Overhead or Fringe Benefits. Some also offer pro-bono labor hours or sponsored equipment, materials, or subcontractor costs. A combination of all of the above could be acceptable. It would need to be indicated on a submission what is being cost-shared. To qualify for no cost-share under an EZ-BAA award, a respondent must show that there is "no probability that the respondent will receive present or future benefits from participation as described in Federal Acquisition Regulation (FAR) 16.303." Examples of present or future benefits include increased technical know-how, training for employees, acquisition of goods or services, development of a commercially viable product that can be sold in the commercial market, and use of background knowledge in future contracts.
ImmuneChip-funded projects have data sharing requirements with the U.S. government consistent with government regulation (FAR 52.227-14 Rights in Data). ImmuneChip+ program requires that you share all data (including raw data) generated under the project for government’s use consistent with the regulation.
The ImmuneChip+ program requires that all applicants already have a mature, validated tissue chip.
Yes, potential partners are free to submit more than one abstract so long as those projects are discrete, stand-alone projects, and all application requirements are met.
While you can include links to figures or references, it is not mandated that reviewers view that outside information. At this time, the abstract format does not accept any figures, only text. All applicants are required to request a market research call prior to submitting an application.