Organs-on-a-Chip in Dental, Oral, and Craniofacial Research (DOC-OoCs) (R01 Clinical Trial Not Allowed)

Background
The Organs-on-a-Chip in Dental, Oral, and Craniofacial Research (DOC-OoCs) funding opportunity is issued by the National Institutes of Health (NIH), specifically through the National Institute of Dental and Craniofacial Research (NIDCR). This initiative aims to support interdisciplinary research that advances the validation of organ-on-a-chip (OoC) technologies for disease modeling and pre-clinical efficacy studies in dental, oral, and craniofacial research. The goal is to integrate validated microfluidic systems into clinical trials, enhancing methodologies for DOC clinical research.

Grant Details
The grant supports research projects focused on the development and validation of organ-on-a-chip technologies specifically for dental, oral, and craniofacial applications. Key tasks include:
1) Developing multi-array, serial and parallel-chamber designs of DOC tissues;
2) Creating OoCs that replicate the dynamic nature and mechanical forces of the oral environment;
3) Utilizing induced pluripotent stem cells (iPSC) or primary tissues from patients to develop patient-specific preclinical models;
4) Validating the functional equivalence or superiority of DOC OoCs compared to traditional animal models;
5) Demonstrating utility in disease models for identifying novel treatment mechanisms, including drug screening and assessing candidate therapies for efficacy and safety;
6) Establishing a preclinical foundation that informs clinical trial design.

Eligibility Requirements
Eligible applicants include higher education institutions (public/state controlled, private), nonprofits with or without 501(c)(3) status, for-profit organizations (including small businesses), local/state/county governments, Indian/Native American tribal governments, federal agencies, U.S. territories or possessions. Special encouragement is given to institutions such as Hispanic-serving Institutions, Historically Black Colleges and Universities (HBCUs), Tribally Controlled Colleges and Universities (TCCUs), and others serving underrepresented groups.

Period of Performance
The maximum project period is five years. Specific timelines will depend on the scope of the proposed project.

Grant Value
NIDCR intends to commit $2 million in FY 2025 to fund approximately 4-5 awards. Each application budget is limited to a maximum of $500,000 direct costs per year.