Funding for clinical translation of tissue regeneration technologies

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.

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.