ITP Program

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. 

Bone

Skin

Muscle

Salivary gland

Nerve

Periodontium

Fat

TMJ

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 Criteria

ITP proposals are reviewed using the following criteria

Significance

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.

Competition

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

Research/Technical

Research/Technical

ITP teams complete pre-clinical IND/IDE-enabling studies (i.e., studies that demonstrate safety and efficacy). Validation, rigor, and reproducibility of results from these research/technical studies are critical. ITP teams test their products using large animal models and against current gold standard treatments.

Commercialization

ITPs work with C-DOCTOR core resources to de-risk their technologies to maximize manufacturing, funds, and market potential. To develop a strong commercial strategy and attract external investors, ITPs must address technical, intellectual property, reimbursement, manufacturing, adoption, and manufacturing risks.

Regulatory Interactions

Regulatory Interactions

ITP teams work closely with C-DOCTOR to determine appropriate regulatory pathways for their technologies and to plan for FDA interactions (e.g., pre-IND/IDE meetings, request for designation (RFD), and IND/IDE submissions. Additionally, ITP teams develop a long-term plan outlining how long it will take, how much it will cost to undertake clinical trial, and overall, develop their clinical trial protocol.

Manufacturing

Manufacturing

ITP teams must develop highly reproducible, scalable GMP manufacturing processes. ITP teams, with the support of C-DOCTOR, will develop and incorporate appropriate CMCs and QA/QC tests to prepare for the smooth transfer of the manufacturing method to CROs for clinical trials and for the commercialization process.
From a C-DOCTOR ITP PI

“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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Meet our
ITP Teams

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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​

ITP Program

Request for Proposals (RFP) Cycles: 5

Proposals Reviewed: 119

ITPs Awarded: 22

Active ITPs: 9

As of August 2023

C-DOCTOR is currently not accepting proposals for new ITPs. Please check later for future Request for Proposals.

If you have any questions, please email VyVy Nguyen. Thank you!

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