Fall 2020 RFP

C-DOCTOR ITP Team Awards for the Clinical Translation of Mature Tissue Regeneration Technologies  Targeting Dental, Oral, or Craniofacial Indications

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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, operating with funding and programmatic oversight from the NIDCR (U24DE026914 and U24DE029463). . Building on the three successful cohorts of ITPs that are advancing towards clinical trials, we now issue a call for new applications.

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 nurtures 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 in support of 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;

2) enhance ITP value and success probability through collaboration with C-DOCTOR faculty and advisors.

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: animal models; biochemistry; biomarkers, functional testing, and histology; biomaterials and biomechanics; biomedical informatics; biostatistics; cell/GMP manufacturing facilities; clinical research planning; commercialization; drug discovery, delivery, and toxicology; genomics; imaging; and regulatory science and reimbursement. Please see our website for further information about available resources and frequently asked questions.

ITP teams that meet their milestones can apply for future C-DOCTOR funding to support aggressive preclinical development and commercial partnering that enable an IND/IDE submission to the FDA.

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 the following selection process to receive critical feedback, expert consulting, and funding for their prospective ITP.

The application process advances through three stages:

Stage 1 involves a two-page pre-proposal that provides an overview of the prospective ITP team, the TE/RM strategy, the unmet clinical need, and potential for clinical adoption (see details below).

Stage 2.  A select number of prospective ITPs will be invited to submit a five-page proposal that will be reviewed by an expert panel and NIDCR program staff to assess research progress to date (e.g. robustness of 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 the likelihood of securing IND/IDE approval from the FDA to launch clinical trials, as well as future commercialization and clinical adoption.

 Stage 3.  The C-DOCTOR Resource Core Director and Operations Team will provide help to high-scoring ITPs in order to address gaps that were identified by the review panel and work to refine their budgets. These finalists will be invited to present their proposals in front of the C-DOCTOR team, advisors, and NIDCR program staff prior to the final funding decision by the C-DOCTOR Leadership Council.

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

Applicants should have experience with successful clinical translation of regenerative technologies, including product development and FDA interactions. Faculty in all series and ranks at any U.S. institution, and individuals from U.S. companies of any size can apply.

Only projects with a clear dental, oral, or craniofacial (DOC) clinical indication and that act through a regenerative mechanism will be eligible for consideration. We expect applicants to provide in vivo (small or large animal model) evidence of efficacy for the intended DOC indication. The therapeutic area can cover priority areas listed above, or other unmet medical needs in DOC 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. A list of awardees from previous cycles is available on our website.

Pre-proposal application:

Please submit your ITP project pre-proposal online via https://cdoctor.submittable.com/submit by November 1, 2020  (5 p.m. Pacific).

  • Proposal narrative (2 pages): Please use the provided template available here. The narrative should address
    • Significance – Unmet clinical need, total addressable market, potential for clinical adoption
    • Innovation and Impact – 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 – Studies proposed to enhance commercialization potential
  • Biosketches: Provide NIH-style biosketches for the PI and any other key personnel. In the Personal Statement, please include any relevant successes with translational projects, product development, and interactions with the FDA. (NIH template)
  • Budgets: Budgets are not required for pre-proposals. Full application budgets for initial awards will be up to $150,000 in total costs for one year, to be used for C-DOCTOR Resource Services and/or work conducted in the investigators’ laboratories, and may include PI salary (maximum 10% FTE). Each project will also receive mentoring and regulatory consulting at no cost to the team. If you are affiliated with a company or a non-C-DOCTOR university, or if you plan to have subawards, the total allowable direct costs may decrease.

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