Establishing a Resource Center for Tissue Engineered Craniofacial Technologies

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 DESCRIPTION (provided by applicant): There is a growing demand for tissue engineered therapies especially for the craniomaxillofacial since it is one of the most exposed areas of the body creating significant high risk of injuries. Additionally, the craniomaxillofacial region is unfortunately home to a host of tumors and other entities that require management requiring significant deformation of the structures. These issues in turn potentially cause aesthetic and functional deficits. As the most visible part of the human form, the face plays a significant role n social interaction and when deformed by injury or after ablative surgery, serious psycho-social issues arise. The field of regenerative medicine has been growing with many exciting technologies, but unfortunately only few became clinical therapies. This planning grant application will implement what industry taught us that the most successful path to achieve regulatory approval is to establish complementary scientific and business processes within a structured environment. With this grant application, we plan to augment the existing extensive foundation of scientific and translational development expertise in the tissue engineering/regenerative medicine (TE/RM) field available at the University of Pittsburgh. Through the robust and coordinated infrastructure of the McGowan Institute for Regenerative Medicine and its Center for Craniofacial Regeneration, we plan to fulfill the mission to catalyze, nurture and expedite the advancement of the most promising technologies in TE/RM to safely and effectively regenerate, reconstruct and restore dental, oral and craniofacial tissue and function. This will be achieved through the following two specific aims: Specific Aim 1: Formalize Resource Center's infrastructure, processes and methods for implementation. This aim will be divided in 3 sub aims: Aim 1A. Adapt current industry standard to academic- industry model. Aim 1B: Strengthen our Network of subject matter experts and partnerships. Aim 1C: Further develop our validation and GLP/quality control assessment. Specific Aim 2: Implement action plans to facilitate cGLP/cGMP activities for FDA submission. Our long standing tissue engineering history combined with our achievement and our passion to translate TE/RM technologies positions us to be one of the major players to successfully fulfill NIDCR's goals of transitioning DOCTRC to FDA submission stage.