Michigan – Pittsburgh – Wyss Regenerative Medicine Resource Center
Interdisciplinary Translational Project (ITP) Program
The Michigan-Pittsburgh-Wyss Regenerative Medicine (MPWRM) Resource Center 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 MPWRM 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 regenerative medicine/ tissue engineering 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 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), and within ~3 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 that are directed towards achieving technology development milestones that substantiate readiness for enabling FDA submission and clinical adoption through commercialization will receive greater consideration for funding.
Budget. The ITP program provides one-year grants of up to $300,000 per project (exclusive of indirect costs), with all projects requiring a cost share of more than 10% of the budget (indirect costs to be paid at the federally-negotiated rate of the awardee institution/ company). Awards may be renewable, pending progress reviews. Funding will be allocated to specific projects and milestones, in collaboration with Core Services. In addition to the scientific Core Services (please refer to the Core Services tab above), services and resources available through the MPWRM Resource Center include expertise in market research and competitive landscape assessment, manufacturing, and regulatory/ clinical studies consulting, which can be used to address key business questions. Budget is not required at the pre-proposal stage.
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 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 MPWRM Resource Center to refine their milestone-driven project plans and the associated budget, in effort to further advance each project towards FDA submission and clinical adoption. The MPWRM 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. Continued funding will be based on successful progress and achievement of defined project milestones.
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 commercialize the technology for a DOC indication.
June 1, 2021: Pre-proposal closed
Mid- late July, 2021: Selected applicants invited to submit a full proposal
August 27, 2021: Full proposal due
Early October, 2021: Selected applicants invited to present the proposal to the Operating Committee
Mid October, 2021: Selected applicants present the proposal to the Operating Committee
Late October, 2021: Selected applicants notified of funding award
November 1, 2021: Anticipated project start date
If there are any questions about the ITP program and/or the evaluation process, please contact Mutsumi Yoshida at email@example.com or (734) 764-4622.