Interdisciplinary Translational Projects (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.
Opportunity. The current call for proposals will provide a one-year funding and support (by way of collaborations with MPWRM Resource Center’s Core Services (please refer to the Core Services & Resources tab above) for the advancement of therapies towards IND/ IDE submission to the FDA.
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 clinical translation of these technologies towards FDA submissions to achieve high impact outcomes in clinical practice.
Eligibility. Applications are accepted from teams and investigators from academic/ non-profit institutions as well as from for-profit entities.
Application Criteria. Projects must clearly align with the core mission of NIDCR. Technologies should be sufficiently mature through discovery research and close to reaching pre-clinical validation, and have demonstrable in vivo proof of principle data. 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 will receive greater consideration for funding.
Budget. The ITP program provides up to $150,000 per project, including direct and indirect costs. 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 or to establish a translation/ commercialization roadmap for the project Services (please refer to the Core Services tab above). Budget is not required at the pre-proposal stage.
Proposal Application and Review Process. The proposal 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 (including the progress to date), 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 milestone-driven project plans, in effort to further advance each project towards FDA submission. The MPWRM Resource Center will provide an advisory team and project management support for continued engagement during the funding cycle, 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. Desirable outcomes upon completion of an ITP funding cycle include enhanced readiness towards IND/ IDE submissions to the FDA (through investigator-initiated studies or technology licensing to a commercial entity), or follow on funding for further technology development. Projects that have the most successful outcomes under this funding program may be included in a portfolio of projects that are recommended for additional funding through the DOCTRC initiative during its next stage of competition. If this next stage of DOCTRC funding awarded, funding will be available to complete preclinical development to enable submission of IND/ IDE applications to the FDA.
- Pre-proposal applications due: January 12, 2018
- Selected pre-proposal submissions invited to submit full proposal applications: ~ February 2018
- Note that the Center for Dental, Oral, & Craniofacial Tissue & Organ Regeneration (C-DOCTOR) is also accepting applications through a companion RFP at this time. However, you may only submit to one center on this cycle. Please refer to the center websites, www.doctrc.com and www.c-doctor.org, respectively, for further information that may help you to decide which opportunity to pursue.
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.
Pre-Proposal Application Submission. Please submit your pre-proposal application via https://www.pwdbypinch.pitt.edu/ITPP2017Cycle2/Contest/Logon by January 12, 2018, using the provided template.