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

项目摘要/摘要 牙科、口腔和颅面组织器官再生中心(C-DOCK)是一家公私合营的机构 该联盟专注于加速有前景的组织工程/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类临床试验。我们的总体愿景是 C-Doctor将成为全国综合性的临床资源中心，进行创新的临床翻译 再生技术，以取代因先天性疾病、创伤损伤而失去的DOC组织或器官， 疾病和医疗程序。我们已经招募了跨学科团队，DOC再生前景看好 并开发了全面的定制基础设施，我们通过这些基础设施为这些团队提供 必要的临床、科学、技术、监管、财务、商业导向和管理资源 以促进其支持IND/IDE的活动。我们现在建议将该中心的大量资源用于 仅推进那些与未满足的临床需求、预期的市场潜力最佳匹配的技术 患者价值，以及临床采用的高概率。我们将继续为ITP团队提供全面的 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，如 这些团队改进他们的产品，完成他们的IND/IDE支持的临床前研究，过渡到Current Good 实验室/制造实践以扩大规模，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互动。因此，C-Doctor将创造积极的结果 对于以其他方式可能无法访问必要的知识库和必要资源的ITP团队 一定要成功。为了实现这一愿景，我们提出了以下四个具体目标： 具体目标1：协调和整合C-Doctor基础设施和战略伙伴关系，以 支持ITP和DOCTRC整体编程功能 具体目标2：组建一个均衡的国际贸易方案组合，并为国际贸易方案提供全面支持 临床前科学研究、方案/技术方法学开发、商业化战略、 以及支持IDE/IND提交和相关临床研究方案的监管交互作用 具体目标3：验证关键的ITP结果并执行临床前测试，开发共享的 标准操作程序、协议、最佳实践和培训方面的知识库 确保国际交易日方案研究的严谨性和可重复性的资源，并作为 科学界 具体目标4：在C-Doctor和MPWRM之间建立强大和可持续的合作，以 支持信息技术产品的开发和商业化 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.