Tissue Regeneration Consortium
Defining
the future
of tissue
regeneration.
The Dental, Oral, and Craniofacial Tissue Regeneration Consortium (DOCTRC) was established in March 2017 through cooperative agreements from NIDCR, with the objective of developing resources and strategies to regenerate damaged or injured dental, oral, and craniofacial tissues. The DOCTRC initiative was designed to shepherd new therapies through pre-clinical studies and into human clinical trials, commercialization, and broad clinical adoption.
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Through the DOCTRC program, which originally provided support over three years, two national resource centers were developed:
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C-DOCTOR represents a partnership among faculty at several California institutions, including USC, UC San Francisco/Berkeley/Davis, UCLA, and Stanford.
C-DOCTOR’s vision is to assemble a comprehensive and dynamic team of clinicians, research scientists, biostatisticians, regulatory scientists, and pre-clinical/clinical trial experts to enable the development and clinical implementation of innovative approaches for dental, oral, and craniofacial tissue regeneration.
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The Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center (MPWRM RC) was established as an interdisciplinary partnership amongst the University of Michigan, the University of Pittsburgh, and the Wyss Institute, along with technology, clinical, regulatory, marketing, and commercial translation experts from private practice and industry.
Through this collaborative effort, the Resource Center aims to accelerate clinical adoption of promising technologies by providing the interdisciplinary expertise and resources to guide technologies toward FDA submissions.
Collective Impact
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16currently active Interdisciplinary Translational Projects
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63%currently active Interdisciplinary Translational Projects with FDA Interactions
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94%currently active Interdisciplinary Translational Projects with Issued Patents or Pending Applications
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228Project Proposals Reviewed
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44Interdisciplinary Translational Projects Awarded
Meet Our PeopleNIDCR’s vision was that the DOCTRC could act as a catalyst to accelerate translation of innovative products in the dental, oral, and craniofacial regenerative medicine space. The strategy was to build a consortium infrastructure that would provide the tools and expertise needed to enable academic, clinical, and industry innovators to overcome the key translational, regulatory, and commercial barriers, often referred to as the Valley of Death. While this program is still ongoing, we are extremely proud of the accomplishments that the DOCTRC has already achieved, and we are hopeful that this mechanism will serve as a proven template for future efforts seeking to bring dental as well as medical innovations to the full benefit of patients.
Core Expertise + Services
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Basic Research
Basic Research
Translational research is built on a strong foundation of laboratory science. DOCTRC resources for supporting basic research include comprehensive and state-of-the-art centers for synthetic chemistry, biochemistry, phytochemistry, medicinal chemistry, proteomics, metabolomics, and genomics.
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Preclinical Models
Preclinical Models
The transition from small animal to large animal models is crucial. DOCTRC experts can help you identify an appropriate animal model, imaging and surgical techniques, and study endpoints.
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Functional Testing and Imaging
Functional Testing and Imaging
DOCTRC offers a diverse range of services including histology, comprehensive imaging capabilities, in vitro and in vivo validation, biomechanical and functional testing, and support for selecting the right biomaterial and delivery device to complement your product. Additionally, our universities have a strong track record in drug discovery and toxicology.
Validation Services (including imaging, histology, biomechanics, material fabrication and testing)
Biomarkers, Functional Testing and Histology
Biomaterials and Biomechanics
Drug Discovery, delivery, and Toxicology
Imaging -
Manufacturing
Manufacturing
The transition to Good Manufacturing Practices and scale-up process ahead of a clinical trial represent significant challenges, particularly for biologics. DOCTRC partners with some of the most renowned and experienced academic centers in the country for manufacturing cell-based products.
Prototyping and Manufacturing
Cell Manufacturing and GMP Facilities -
Regulatory and Quality Assurance
Regulatory and Quality Assurance
DOCTRC regulatory scientists shepherd each team through the process of preparing for interactions with the FDA including Requests for Designation, ‘Q-sub’ meetings, and pre-IND/IDE meetings. Quality assurance and control are primary considerations at every step. Our consultants can also help your team navigate the landscape of reimbursement through medical and dental insurance.
Regulatory Sciences and Reimbursement Resources
Regulatory Services
Standardization and Quality Control/Assurance -
Investigator Training
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Biomedical Informatics & Biostatistics
Biomedical Informatics & Biostatistics
DOCTRC’s universities are home to innovative bioinformatics core resource centers as well as quantitative scientists to assist with biostatistics at all stages of research as well as development of clinical research methods.
Statistics and Data Management
Biomedical Informatics
Biostatistics Resources -
Commercialization & Business Development
Commercialization & Business Development
Understanding the target market, securing intellectual property, and developing a forward-looking business plan are two crucial aspects of positioning a new product for commercialization. DOCTRC consultants work closely with university technology transfer offices to provide support in these areas.
Commercialization & Business Development
Commercialization Strategy
Intellectual Property Strategy -
Clinical Trial Planning & Data Management
Clinical Trial Planning & Data Management
A well-planned clinical trial represents the culmination of DOCTRC support. We provide comprehensive support in all aspects of clinical research planning and management.
Clinical Data Management
Clinical Trial Planning and Management
Portfolio
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.
Partners
Formally launched in March 2017 with support from our sponsor, National Institute of Dental and Craniofacial Research (NIDCR), DOCTRC strives to shepherd promising regenerative medicine technologies towards initiation of clinical trials and beyond. As a single Consortium, C-DOCTOR and MPWRM Resource Center have collectively supported 36 Interdisciplinary Translational Projects to date.
