Center for Dental, Oral, and Craniofacial Tissue and Organ Regeneration (C-DOCTOR)

项目概要/摘要 牙科、口腔、颅面组织和器官再生中心 (C-DOCTOR) 是一个公私合营的机构 联盟专注于加速有前途的组织工程/再生医学（TE/RM）疗法 牙科、口腔和颅面 (DOC) 组织和器官再生到人体临床试验。我们的总体愿景 C-DOCTOR将成为创新药物临床转化的综合性国家资源中心 再生技术可替代因先天性疾病、外伤、 疾病和医疗程序。我们招募了具有前景的 DOC 再生跨学科团队 疗法并开发了全面的定制基础设施，我们通过该基础设施为这些团队提供服务 必要的临床、科学、技术、监管、财务、商业和管理资源 促进他们的 IND/IDE 支持活动。我们现在建议将中心的大量资源用于 仅推进那些最符合未满足的临床需求、市场潜力、预期的技术 患者价值高，临床采用概率高。我们将继续为ITP团队提供充分的 来自专家科学家、临床医生、商业化策略师和监管顾问的定制支持 团队完善他们的产品，完成支持 IND/IDE 的临床前研究，过渡到当前的产品 扩大实验室/制造实践，制定临床研究方案，形成战略合作伙伴关系， 并在 I 期临床试验之前与 FDA 进行互动。因此，C-DOCTOR 将创造积极的成果 对于 ITP 团队来说，他们可能无法获得必要的知识库和资源 取得成功。为实现这一愿景，我们提出以下四个具体目标： 具体目标 1：协调和整合 C-DOCTOR 基础设施和战略伙伴关系， 支持 ITP 和整体 DOCTRC 编程功能 具体目标 2：组建平衡的 ITP 组合，为 ITP 提供全面支持 临床前科学研究、方案/技术方法开发、商业化策略、 支持 IDE/IND 提交和相关临床研究方案的监管互动 具体目标 3：验证关键 ITP 结果并进行临床前测试，开发共享的 标准操作程序、协议、最佳实践和教育的知识库 资源，以确保 ITP 研究的严谨性和可重复性，并作为知识中心 科学界 具体目标 4：在 C-DOCTOR 和 MPWRM 之间建立强有力且可持续的合作， 支持ITP的开发和商业化 实现这些目标将使 C-DOCTOR 成为一个全面的资源网络，以支持 DOC TE/RM 将是可持续的，并对我们改善人类健康的努力产生长期影响。

PROJECT SUMMARY / ABSTRACT The Center for Dental, Oral, & Craniofacial Tissue & Organ Regeneration (C-DOCTOR) is a public-private consortium focused on accelerating promising tissue engineering/regenerative medicine (TE/RM) therapies for dental, oral, and craniofacial (DOC) tissue and organ regeneration to human clinical trials. Our overall vision for C-DOCTOR is to be a comprehensive national resource center for the clinical translation of innovative regenerative technologies to replace DOC tissues or organs lost to congenital disorders, traumatic injuries, diseases, and medical procedures. We have recruited interdisciplinary teams with promising DOC regeneration therapies and developed the comprehensive, customized infrastructure through which we provide these teams the necessary clinical, scientific, technical, regulatory, financial, business-oriented, and managerial resources to facilitate their IND/IDE-enabling activities. We now propose to direct the Center's considerable resources to advance only those technologies that optimally align with unmet clinical needs, market potential, anticipated patient value, and high probability of clinical adoption. We will continue to provide ITP teams with fully customized support from expert scientists, clinicians, commercialization strategists and regulatory advisors as the teams refine their products, complete their IND/IDE-enabling preclinical studies, transition to current good laboratory/manufacturing practices for scale-up, develop clinical study protocols, form strategic partnerships, and interact with the FDA ahead of Phase I clinical trials. As such, C-DOCTOR will create positive outcomes for ITP teams that may not otherwise have access to the requisite knowledgebase and resources necessary to be successful. To achieve this vision, we propose the following four Specific Aims: Specific Aim 1: To coordinate and integrate C-DOCTOR infrastructure and strategic partnerships to support ITPs and overall DOCTRC programmatic function Specific Aim 2: To assemble a balanced ITP portfolio and provide comprehensive support to ITPs for pre-clinical scientific studies, protocol/technical methodology development, commercialization strategy, and regulatory interactions supporting IDE/IND submission and associated clinical study protocols Specific Aim 3: To validate key ITP results and perform preclinical testing, developing a shared knowledge base of standard operating procedures, protocols, best practices, and educational resources to ensure rigor and reproducibility of ITP research and serve as a knowledge hub for the scientific community Specific Aim 4: To build a strong and sustainable collaboration between C-DOCTOR and MPWRM to support the development and commercialization of ITPs Achieving these aims will make C-DOCTOR a comprehensive resource network to support DOC TE/RM that will be sustainable and have a long-lasting impact on our efforts to improve human health.