Department of Biomedical Informatics, University of Pittsburgh School of Medicine, Pittsburgh, PA, USA.
McGowan Institute for Regenerative Medicine, University of Pittsburgh, Pittsburgh, PA, USA.
J Dent Res. 2021 Sep;100(10):1039-1046. doi: 10.1177/00220345211009502. Epub 2021 Apr 27.
Few university-based regenerative medicine innovations in the dental, oral, and craniofacial (DOC) space have been commercialized and affected clinical practice in the United States. An analysis of the commercial translation literature and National Institute for Dental and Craniofacial Research's (NIDCR's) portfolio identified barriers to commercial translation of university-based DOC innovations. To overcome these barriers, the NIDCR established the Dental Oral Craniofacial Tissue Regeneration Consortium. We provide generalized strategies to inform readers how to bridge the "valley of death" and more effectively translate DOC technologies from the research laboratory or early stage company environment to clinical trials and bring needed innovations to the clinic. Three valleys of death are covered: 1) from basic science to translational development, 2) from translational technology validation to new company formation (or licensing to an existing company), and 3) from new company formation to scaling toward commercialization. An adapted phase-gate model is presented to inform DOC regenerative medicine teams how to involve regulatory, manufacturability, intellectual property, competitive assessments, business models, and commercially oriented funding mechanisms earlier in the translational development process. An Industrial Partners Program describes how to conduct market assessments, industry maps, business development processes, and industry relationship management methods to sustain commercial translation through the later-stage valley of death. Paramount to successfully implementing these methods is the coordination and collaboration of interdisciplinary teams around specific commercial translation goals and objectives. We also provide several case studies for translational projects with an emphasis on how they addressed DOC biomaterials for tissue regeneration within a rigorous commercial translation development environment. These generalized strategies and methods support innovations within a university-based and early stage company-based translational development process, traversing the many funding gaps in dental, oral, and craniofacial regenerative medicine innovations. Although the focus is on shepherding technologies through the US Food and Drug Administration, the approaches are applicable worldwide.
在美国，很少有基于大学的牙科、口腔和颅面（DOC）领域的再生医学创新被商业化并影响临床实践。对商业翻译文献和美国国立牙科和颅面研究所（NIDCR）投资组合的分析确定了将大学 DOC 创新进行商业化转化的障碍。为了克服这些障碍，NIDCR 成立了牙科口腔颅面组织再生联盟。我们提供了一般性策略，向读者介绍如何跨越“死亡之谷”，更有效地将 DOC 技术从研究实验室或早期公司环境转化为临床试验，并将急需的创新技术引入临床。涵盖了三个死亡之谷：1）从基础科学到转化开发，2）从转化技术验证到新公司成立（或授权给现有公司），3）从新公司成立到商业化规模扩大。介绍了一种经过改编的阶段门控模型，以告知 DOC 再生医学团队如何在转化开发过程中更早地涉及监管、可制造性、知识产权、竞争评估、商业模式和面向商业的融资机制。工业伙伴计划描述了如何进行市场评估、行业图谱、业务发展流程和行业关系管理方法，以通过后期死亡之谷维持商业转化。成功实施这些方法的关键是围绕特定的商业转化目标和目的协调和协作跨学科团队。我们还提供了几个具有强调如何在严格的商业转化开发环境中针对组织再生的 DOC 生物材料的转化项目案例研究。这些一般性策略和方法支持基于大学和早期公司的转化开发过程中的创新，跨越了牙科、口腔和颅面再生医学创新中的许多资金缺口。虽然重点是通过美国食品和药物管理局引导技术，但这些方法在全球范围内都适用。
