NextGen Tissue Chip Testing Centers: Validating Microphysiological Systems
NIH - National Institutes of Health (RFA-TR-18-006)
This opportunity is closed.
- Internal: 01/29/2018
- Proposal: 03/21/2018
- Amount: up to $1M per year
- Duration: up to 2 years
The purpose of this FOA is to facilitate the transition of previously funded TCTC projects to the commercialization stage by providing 1-2 year(s) of support for later stage research and development (R&D) activities necessary for the wider adoption and use of MPS in drug development by research scientists, pharmaceutical companies and regulatory bodies. This may include independent replication of key studies from NIH and non-NIH supported MPS platforms and technologies, improving/standardizing assays, developing best practice guidelines and SOPs for chips of high priority.
Additionally, this may also include the provision of services towards Investigational New Drug (IND)-enabling studies using TC data, improving manufacturing costs based on prior experience in various TC platforms, regulatory assistance, or a combination of services related to TC development. In addition, the NextGen Tissue Chip Testing Center(s) can fully utilize tissue chip technology in drug discovery and development by forging an integrative strategy using MPS to be directed at a critical unmet medical need for which historical approaches have been unproductive – e.g. a comprehensive and definitive array of assays and biomarker testing on MPS for cardiotoxicity to evaluate heart failure therapy.
The NextGen Tissue Chip Testing Center(s) will have the requisite infrastructure, prior experience in validating various MPS, data management and statistical capabilities, as well as responsibility for administrative coordination of activities with the MPS investigators related to the independent validation of tissue chips, which may include qualification with the FDA for use in the regulatory-decision process. They will also be responsible for seeking commercial end users, and providing documentation and evidence that the Center can become a self-sustaining enterprise beyond the 1-2 year(s) of NIH support.
To fully implement the validation and commercialization process of tissue chip platforms, NextGen TCTC scientists will rely on TC platform expertise and resources (protocols and reference compounds) developed by the TC Consortium, which includes government officials, industry representatives, and tissue chip developers. NIH will continue to expand on private-public relationships, working with industry and other potential stakeholders to provide TCTC metrics, protocols and guidelines.
In order to maximize scientific exchange and accelerate research in the context of tissue chip technology, it is expected that all information, data, protocols and methods used for validation be shared in a timely manner with the TC Consortium, which includes the MPS DC (see related FOA RFA-TR-18-005), and with industry partners.
The NextGen TCTC(s) will work directly with the TC Consortium, composed of tissue chip technology developers, government officials, industry representatives and other potential partners, and which originated from the Tissue Chip for Drug Screening program (RFA-RM-11-022). The NextGen TCTC(s) will be milestone-driven, actively work with the TC Consortium and TC Developers to test MPS devices, acquire, store and use a standard set of tissue resources and test compounds for device validation, and share data/methodology with the TC Consortium. It is also expected that NextGen TCTC(s) will create a revenue stream such that it is self-sustaining beyond the 1-2 years of NIH support.
Eligibility & Submission Requirements
Only one proposal may be submitted by an eligible organization. If interested in submitting, please contact Karen Drew (-4824) and submit a 2 page pre-proposal following the NU Procedure for Programs with Limited Submissions. Please review the Limited Submission Procedures as they have been updated.
Danilo Tagle, Ph.D.
National Center for Advancing Translational Sciences (NCATS)