C-DOCTOR ITP Program
C-DOCTOR maintains a portfolio of Interdisciplinary Translational Projects (ITP) teams that have been selected based on their relevance in addressing unmet clinical needs in the dental, oral, and craniofacial fields through a regenerative mechanism. ITP teams are developing technologies that align with our clinical indication priorities in dental, oral, and craniofacial tissue engineering/regenerative medicine (TE/RM).
ITP teams recruited from universities and industry nationwide demonstrate strong market potential, high anticipated patient value, and high probability of clinical adoption. C-DOCTOR’s pivotal role in ITP teams prioritizes advancing clinical adoption and commercial viability by scaling-up and validating manufacturing, confirming their regulatory path and clinical trial plans, and establishing commercial partnerships.
Dental, Oral, & Craniofacial
Tissues Targeted by ITPs
C-DOCTOR aims to select ITP teams that are refining tissue engineering/regenerative medicine products/technologies that address unmet clinical needs in the following dental, oral, and craniofacial tissues.
In addition to funding support...
ITP teams are closely supported by C-DOCTOR resources such as a customized advisory board, industry-experienced project managers, C-DOCTOR partner institutions, and advisor networks. These resources help to further the ITP teams’ translational activities: pre-clinical scientific studies, protocol/technical methodology development, commercialization strategy, and regulatory interactions supporting IDE/IND submission and associated clinical study protocols.
The End Goal for ITPs
ITP proposals are reviewed using the following criteria
Technology/product uses a regenerative mechanism, addresses a significant unmet clinical need, taps into a total addressable market, and demonstrates potential for clinical adoption.
Innovation and Impact
Technology/product demonstrates advanced stage of technology, often with early proof-of-concept data, and in-vivo evidence of efficacy for a craniofacial indication.
Technology/product demonstrates unparalleled competitive advantage with existing treatments and technology and has a patent or potential for patent filing.
Work Plan Strategy and Aims
Technology/product demonstrates effective pre-clinical development strategy with commercialization potential.
ITP Selection Process
ITP IND/IDE-Enabling Activities
“C-DOCTOR has provided us with expertise in early-stage drug-device development and commercialization of drug products. Dr. Michael Jamieson has been a valuable resource to us for discussions regarding FDA IND applications, negotiating licensing agreements with the manufacturer of our pharmacological agent and other regulatory aspects of our C-DOCTOR project.”
– Geoffrey Gurtner, MD (ITP PI)
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ITP Program Benefits
The support that the C-DOCTOR network and its nationwide collaborative infrastructure provide to ITP include, but are not limited to team coaching, guidance documents, outreach/training opportunities and assistance with the following:
Development of translational-oriented milestone development
Identification of potential partners for clinical trial funding and execution
Implementation of design control processes
Request for Proposals (RFP) Cycles: 5
Proposals Reviewed: 119
ITPs Awarded: 22
Active ITPs: 9
As of August 2023