Interdisciplinary Translational Projects (ITP) Program
Michigan – Pittsburgh – Wyss Regenerative Medicine Resource Center
Interdisciplinary Translational Project (ITP) Program
Translational Resource Center (TRC) is one of the two national Resource Centers established by the National Institute of Dental and Craniofacial Research (NIDCR)’s Dental Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC) initiative. With the overarching goal of developing clinical trial-ready tissue engineering/ regenerative medicine products and protocols, the DOCTRC initiative is providing funding and resources through the Interdisciplinary Translational Project (ITP) program administered by the two national Resource Centers.
The Translational Resource Center brings together a multi-disciplinary team of clinicians, engineers, scientists, and technology commercialization and regulatory experts from academia and industry to support the regenerative medicine research community by providing resources and expertise to guide innovations that address unmet clinical needs for the regeneration or restoration of DOC tissues.
Goals of the ITP Program. The program seeks to identify promising technologies that address clear unmet clinical need with market potential in the dental, oral, and craniofacial (DOC) space, and to catalyze the clinical translation of these technologies towards FDA submissions. The long-term goal is to achieve high-impact outcomes in the clinical marketplace.
Eligibility. Applications are accepted from teams and investigators from U.S. academic/ non-profit institutions as well as from for-profit entities. It is highly recommended that at least one of the project team member(s) have experience with translational research.
Application Criteria. Projects must clearly align with the core mission of NIDCR. Technologies should be sufficiently mature through discovery research with demonstrable in vivo proof of principle data (preferably in a clinically-relevant large animal model). Projects are expected to be within 2 years of FDA submission for the initiation of a clinical trial and/ or Technology Readiness Level of 4 or above (see https://ncai.nhlbi.nih.gov/ncai/resources/techreadylevels for additional guidance). While ITP funding cannot be used to support clinical trials, funding may be used for expert regulatory and other consultations in support of an FDA submission, available through our Core Services (please refer to the Core Services & Resource tab above). Projects should be directed towards achieving milestones that substantiate readiness for enabling FDA submission and clinical adoption through commercialization.
Proposal Application and Review Process. The application process consists of two rounds (pre-/ full proposal submissions). At each stage, applications will be reviewed by a team of clinicians, scientists, technology commercialization and regulatory experts from academia and industry, and NIDCR program directors on scientific merit, technology readiness level, expected project outcomes and impact, appropriateness of the technology and its ability to support the clinical needs and market opportunities specifically in DOC therapeutic areas. Pre-proposal applications that receive high evaluations will be invited to submit a full proposal application. Following review by translational experts, funding decisions will be made by the Operating Committee in collaboration with program directors from NIDCR.
Project Execution. Funded teams will collaborate with the Translational Resource Center to refine their milestone-driven project plans and the associated budget, to further advance their project towards FDA submission and clinical adoption through commercialization. The Translational Resource Center will provide an advisory team and project management support for translational mentorship and progress monitoring using a stage-gate process. In addition, selected training on various aspects of translational research will be incorporated.
Desired Outcome. Upon completion of ITP funding, projects are anticipated to have completed preclinical development activities and have submitted an IND/ IDE application to the FDA. Alternatively, a project may successfully exit the ITP program through technology licensing to an industry partner with a commitment to commercializing the technology for a DOC indication.