Accelerating Product Excellence in Innovation and for Clinical Adoption (APEx)

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  1. Goal
  2. Background
  3. Gaps and Opportunities
  4. Specific Areas of Interest
  5. References

September 2023

Tissue Engineering and Regenerative Medicine Program
Integrative Biology and Infectious Diseases Branch
Division of Extramural Research

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Goal

The overall objective is to continue to power the engine to accelerate preclinical product development through innovation, commercialization, and clinical adoption, with potential extension to diagnostic products or therapeutics beyond tissue regeneration, and/or products outside the dental, oral, and craniofacial complex. Synergies with other preclinical research efforts in this new phase would be key.

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Background

2014 marked the inception of the Dental, Oral, and Craniofacial Tissue Regeneration Consortium (DOCTRC), prompted by a portfolio analysis that revealed the need to spur preclinical IND/IDE-enabling product research and development for regeneration of complex tissues in the craniofacial complex, and an accompanying infrastructure to support such endeavor. Over the past six years since launch in 2016, a three-stage program has been installed to support planning, core services and resource center establishment, interdisciplinary translational project (ITP) piloting and full-scale implementation. Core services include developing preclinical animal models, functional testing and prototyping, imaging, manufacturing, regulatory and quality assurance, statistical analysis, assessment of intellectual property, market strategy and commercialization, and clinical trial planning and readiness activities. The primary metric of success is product clearance through the FDA for first in human use, and secondary metric is tangible demonstration of the continued viability of the product for research and development. A stage-gate process triaged an original pool of over 220 concepts solicited through five waves, to over 40 ITPs that have been supported, to the currently active 20 ITPs. Selection by a panel with broad expertise is based on unmet clinical need, scientific merit, technological readiness, viability of regulatory pathway, commercialization potential, and clinical adoption potential. These ITPs encompass products in all regulatory domains: drugs, biologicals, and devices, many as combination products, as well as various tissue types; bone, muscle, nerve, temporomandibular joint cartilage, salivary gland, dental pulp, periodontal ligament, and skin. Sixty-five percent of the ITPs have had formal interactions and received feedback from the FDA, 95% have issued patents or pending patent applications, and ITPs have leveraged federal funding to attract private investments. To date, the Consortium has leveraged over $27.5M additionally from other sources to support the ITPs. The Consortium has also created partnerships with institutional incubators, CTSAs, and industries, and established pathways for junior researchers to participate.

The Consortium is funded through the U24 mechanism for two Resource Centers - Center for Dental, Oral, and Craniofacial Tissue and Organ Regeneration (C-DOCTOR) is based on six collaborating institutions along the California corridor, and Michigan-Pittsburgh-Wyss Regenerative Medicine Resource Center (MPWRM RC) is a collaboration among institutions in Michigan, Pennsylvania, and Massachusetts. Currently active projects are listed at DOCTRC portfolio.

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Gaps and Opportunities

The numbers substantiated the accomplishments and impact of the current Consortium, which has utilized a targeted approach to support product development for clinical adoption. Furthermore, this program has transformed the mindset of the academicians from discovery or clinical research to bridging between these two domains – late-stage preclinical IND/IDE-enabling research and development. Building on this momentum, expertise and core services offered by the Consortium could benefit a broader portfolio of product development beyond tissue regeneration and beyond the dental, oral, and craniofacial complex. This is expected to realize the vision, mission, and guiding principles laid out in the NIDCR Strategic Plan 2021-2026, and to address various Strategic Priorities.

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Specific Areas of Interest

Building on momentum of the Consortium that has established robust cores supporting academic- or small-business-based product development, future opportunities lie in:

  • Offering interdisciplinary expertise and core services to reach the research community-at-large
  • Formalizing mentorship, training, and career development opportunities for investigators interested in clinical translation, especially for those traditionally under-represented in biomedical research
  • Shepherding the successful exit of currently active ITPs, for example, product clearance by FDA, new company formation, licensing and technology transfer, follow-on funding outside of the Consortium
  • Extending into tissue and organ systems beyond the dental, oral, and craniofacial complex, for example, neuromusculoskeletal tissues and glandular tissues
  • Extending beyond tissue regeneration products, for example, tissue restoration, biosensors, implantable/wearable systems, diagnostics, and therapies
  • Targeting development of products that are affordable and can be utilized at point-of-care to reach diverse populations
  • Synergizing with translational efforts residing in other NIH components, agencies, industries, and institutional incubators
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References

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Last Reviewed
April 2024