RFP: C-DOCTOR ITP Team Awards for the Clinical Translation of Tissue Regeneration Technologies that Target Dental, Oral, or Craniofacial Indications

Background:

The Center for Dental, Oral, Craniofacial Tissue and Organ Regeneration (C-DOCTOR) combines customized product development advice, core resources, and funding to help drive promising dental, oral and craniofacial tissue engineering and regenerative medicine (TE/RM) technologies toward human clinical trials. This resource center was established through NIH/NIDCR RFA-DE-17-001 and operates with funding and programmatic oversight from the NIDCR.

C-DOCTOR provides clinical, scientific, industrial and regulatory expertise to advance promising strategies for regeneration and reconstruction of dental, oral, and craniofacial tissues to clinical trials by facilitating access to a diverse network of experts and resources from eight renowned centers of translational research excellence - UCSF, USC, UCLA, UCB, UCD, UCSD, City of Hope, and Stanford. Within this context, C-DOCTOR will nurture an active, close collaboration with Interdisciplinary Translational Project (ITP) Teams to foster pre- clinical refinement of TE/RM products, optimal alignment with unmet clinical needs, market potential, and anticipated patient value.

The current request for proposals (RFP) will support one-year awards for ITP teams to access C-DOCTOR resources for studies to refine their Target Product Profile and Product Development Plan. The programmatic goals for these grants are to: 1) attract existing and new technologies that address unmet clinical needs and have a strong commercial case; and 2) enhance ITP value and success probability through collaboration with C-DOCTOR faculty and advisors. ITP teams that have successfully met their milestones can apply for future C- DOCTOR funding to support aggressive pre-clinical development and commercial partnering that enable an IND/IDE submission to the FDA.

Selected ITPs will work closely with C-DOCTOR resource directors to address pitfalls, alternative approaches, and countermeasure strategies. They will be matched with appropriate experts and resources available within the C-DOCTOR network, which include: Cell and GMP Manufacturing, Biomaterials, Commercialization, Regulatory/Reimbursement, Clinical Research Planning, Large Animal Model Development, Biostatistics, Functional Assays and Endpoints, and Device Design and Prototyping.

Award Process:

The C-DOCTOR award process is supported by a panel of expert advisors from academia, clinical practice, regulatory science, and industry. Successful applicants progress through four distinct selection processes to receive critical feedback, expert consulting, and funding for their ITP.

The first stage involves a two-page pre-proposal that provides an overview of the ITP team, the TE/RM strategy, the unmet clinical need, and potential for clinical adoption (see details below).

For the second stage, a select number of ITPs will be invited to submit a five-page proposal (in early July) that will be reviewed by the C-DOCTOR expert panel and NIDCR program staff to help highlight research progress to date (e.g. robustness of their pre-clinical data), validity of the models and appropriateness of outcome measures, as well as remaining key gaps that need to be addressed to strengthen their likelihood for securing IND/IDE approval from the FDA to launch clinical trials, and future commercialization and clinical adoption.

In the third stage, highly-scored ITPs will be matched with C-DOCTOR Resource Directors who will provide help to address gaps that were identified by the review panel, and work to refine their final proposals and budgets. In parallel, ITPs will work with C-DOCTOR staff to identify and disclose any pre-existing IP and/or 3rd- party obligations.

In the final stage, finalists will be invited to present their TE/RM technology, their progress in addressing reviewer’s concerns, and their revised research plan. The C-DOCTOR leadership panel will then select applications that will receive C-DOCTOR awards.

Eligibility:

ITPs from both the public and private sectors are invited to address unmet clinical needs in the following areas:

  • vascularized and innervated craniofacial bone and musculoskeletal complex
  • periodontium
  • tooth
  • cartilage
  • salivary gland
  • temporomandibular joint (TMJ)
  • skin and soft tissue scarring

Faculty in all series and ranks at any U.S. or foreign institution, and individuals from U.S. companies of any size can apply.

Only projects with a clear clinical indication (or use case) and early target validation or proof-of-concept data will be eligible for consideration. The therapeutic area can cover priority areas listed above, or other unmet medical needs in dental, oral and craniofacial tissue engineering and regenerative medicine. If patents or patent applications have not been filed, there should be a strong potential for obtaining defensible intellectual property.

Pre-proposal application:

Please submit your ITP project proposal online here by June 9, 2017 (5 p.m. PST).

  • Project narrative with cover page (attach as one PDF via the online form):
    • Cover page (1-page maximum):
      • Title of project
      • Key personnel (for each include):
        • Name
        • University/institution/company name
        • Department
        • Title
        • Email address
  • Proposal narrative (2-page maximum):
    • Significance
      • Unmet clinical need, total addressable market, potential for clinical adoption
    • Innovation and Impact including:
      • Current stage of technology, early target validation or proof-of-concept data
      • Competition
      • How is the clinical need currently addressed?
    • Work plan strategy and Aims (1-page minimum)
      • Studies proposed to enhance commercialization potential
  • Biosketch: Provide NIH-style biosketches for PI and any co-PIs, as a single PDF. Use PHS 398 NIH Biographical Sketch Format Page form (5-page maximum per person) found at https://grants.nih.gov/grants/forms/biosketch.htm
  • Budgets: While budgets are not required for pre-proposals, full application budgets for initial awards will be up to $150,000 in direct costs for one year to be used for C-DOCTOR Core Services, and will not include PI salary. In addition, each project will receive free mentoring and project management support.

Technical requirements: The project narrative and cover page should be uploaded as a single PDF. Minimum formatting specifications are Arial font size 11 points, and half-inch margins on all sides. Letters of support are not required or accepted for pre-proposals.

Contact Info: For more information, please contact Dr. Dezba Coughlin (dezba.coughlin@ucsf.edu) or Dr. Bridget Samuels (bdsamuel@usc.edu).

FAQ: Answers to frequently asked questions are available here.

Submit your proposal here