? DESCRIPTION (provided by applicant): The Mayo Clinic/Rice University Dental, Oral and Craniofacial Tissue Regeneration Resource Center (Mayo/Rice DOCTR2C) will be led by Michael J. Yaszemski, M.D., Ph.D. from Mayo Clinic and Antonios G. Mikos, Ph.D. from Rice University. The Mayo/Rice DOCTR2C will provide all necessary services and guidance to the interdisciplinary translational project teams, and any subsequent additional members of the user base, from the identification of the unmet clinical need, through formulation of the research & development plan, to human translation, regulatory approval, commercialization, and dental/oral/craniofacial practice adoption. During the one year R34 planning grant period, we will form the Interdisciplinary Translational Project (ITP) teams and define each team's area of research based on the clinical and translational needs of the key focus areas of DOC, including tooth unit, periodontium, temporomandibular joint (TMJ), mandibular bone, salivary gland, and vascularized and innervated composite tissues. Two large preclinical animal models (caprine segmental mandibular and TMJ defect models) have been developed. The first has been validated, and the validation of the second model is underway. Both these caprine models permit functional evaluation of DOC tissue engineering and regenerative medicine (TE/RM) products. The leadership and governance structure of the DOCTR2C will be in place and includes the executive committee, finance committee, steering committee, intellectual property committee, and quality control committee, and the external advisory board. Communication plans for effective messaging, education, and information sharing within DOCTR2C and IPTs are described in detail. The DOCTR2C will interface with the current infrastructure and resources at both Mayo and Rice for synergetic development and translation of DOC TE/RM products. The validation, standardization and quality control systems, GMP facilities, and regulatory support are in place, operational, and ready to support Stage 2 of the resource center development.
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