This Stage 1 Planning Grant will develop an overall vision, roadmap, organizational structure and operational procedures for a centralized Tufts Dental, Oral and Craniofacial Tissue Regeneration Consortium (DOCTRC) Resource Center (RC). At the completion of this 1-Year Stage 1 Grant, the Tufts DOCTRC organizers will have developed detailed plans for establishing interactive, interdisciplinary DOC-RC teams of biologists, bioengineers, clinicians and other technical experts. This effort will be driven by practicing clinicians involved in everyday DOC patient care in order to ensure building a successful RC infrastructure. Academic clinicians, basic scientist engineers, stem cell biologists, developmental biologists, and industrial liaisons also have been included in the proposed Tufts RC in order to ensure a successful outcome. This Stage 1 Planning Grant will set the stage for the 3-year Stage 2 Award that will be used to establish the Tufts Centralized DOCTRC RC, developing a robust infrastructure to deliver uniform, high-quality technical support and research capacities for preclinical studies. The Stage 2 period will also be used to organize, recruit and integrate several Interdisciplinary Translational Project (ITP) teams into the Tufts Centralized RC. Each of these ITP teams will have identified and developed a specific tissue engineering and regenerative medicine (TE/RM) approach for regeneration of a functional DOC tissue that synergizes with the expertise of one of the Tufts DOC-RC teams. Finally, we anticipate submitting a competitive Stage 3 Consortium Stage application, which will utilize the resources developed in Stage 2 to work with the DOC-RCs and the FDA to advance specific TE/RM clinical applications. The Stage 3 Consortium Stage will complete validation, manufacturing and preclinical testing of the most likely to succeed TE/RM products, and develop Investigational New Drugs/Investigational Devices (IND/IDs) for submission to FDA. The outcome of the DOCTRC-TE/RM will be products and associated protocols ready for initiation of Phase I clinical trials.
Despite many decades of outstanding research and significant advancements, efforts in translational medicine to identify new FDA-approved treatments for a variety of Dental, Oral and Craniofacial (DOC) defects have been less successful than desired. Historically, a major obstacle in bringing Investigational New Drugs/Investigational Devices (IND/IDs) to the market, and ultimately to the patient, has been a less than optimal communication and understanding between Clinicians, Engineers and Basic Scientists, and the FDA. Based on this need, we propose a plan to establish a Tufts Dental, Oral and Craniofacial Tissue Regeneration Consortium, whose purpose will be to provide the infrastructure and support to ensure the timely development of FDA approved IND/IDs for applications in human DOC repair and regeneration.
