PI: David H. Kohn, William V. Giannobile, David J. Mooney, Charles Sfeir, and William R. Wagner
Title: Michigan-Pittsburgh-Wyss Resource Center: Supporting Regenerative Medicine in Dental, Oral and Craniofacial Technologies
Description: Abstract The translation of innovative tissue engineering/regenerative medicine (TE/RM) technologies requires a new approach to bring TE/RM in dental, oral and craniofacial (DOC) technologies to clinical practice. To meet this need, an integrated, multidisciplinary Resource Center (RC) has been established as a partnership between University of Michigan, the University of Pittsburgh/McGowan Institute, Harvard University/Wyss Institute for Biologically Inspired Engineering, and clinical and industrial experts. This RC, named the Michigan-Pittsburgh- Wyss Resource Center: Supporting Regenerative Medicine in Dental, Oral and Craniofacial Technologies (MPWRM TechDOC), consists of leaders with clinical, basic science, engineering and business expertise, and an infrastructure to support navigation through the regulatory process and clinical trials. The goal of this RC is to translate TE/RM innovations that address the ongoing clinical need to restore or create healthy, functional DOC tissues. Central to our proposal is the use of a unique academic-industry assessment model, assembly of an outstanding team of experts, and a menu of innovative DOC technologies that are heavily focused on craniomaxillofacial and dental therapies. The vision of this RC is that the most promising technologies in TE/RM will be catalyzed, nurtured and expedited through a novel academic partnership to safely and effectively regenerate, reconstruct and restore functional DOC tissues. To achieve this vision, we will: 1) Implement the organizational structure of the consortium to prioritize and de-risk TE/RM technologies for translation to clinical practice. Support teams, subject matter experts (SMEs), and partnerships coordinated during our Planning Grants will be empowered to provide integrated assessment and translational pathways. 2) Implement processes to select regenerative technologies to translate to clinical practice, by utilizing a unique academic-industry assessment approach that emulates the industry proven Stage-Gate© model; execute technology validation, and implement plans to facilitate cGLP/cGMP activities for FDA submissions. Upon completion of the Stage II grant, we will have implemented the RC structure and operations, and provided training and education for our stakeholders to translate DOC technologies utilizing sound scientific and engineering, business, regulatory, and manufacturing principles. In doing so, the MPWRM TechDOC will be poised to advance TE/RM technologies through the translational pipeline in Phase III, leading to a transformation of patient care in dental, oral and craniofacial medicine.
Term: 5 years
Amount: $3,911,029 FY Total Cost by IC