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

项目总结/摘要 牙科，口腔和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）治疗， 牙科、口腔和颅面（DOC）组织和器官再生的临床试验。我们的总体愿景 C-DOCTOR是一个综合性的国家资源中心，用于临床翻译创新的 再生技术，以取代DOC组织或器官失去了先天性疾病，创伤性损伤， 疾病和医疗程序。我们已经招募了跨学科的团队，有希望的DOC再生 我们开发了全面的定制基础设施，通过这些基础设施，我们为这些团队提供 必要的临床、科学、技术、监管、金融、商业导向和管理资源 促进其IND/IDE赋能活动。我们现在建议将中心的大量资源用于 仅推进那些与未满足的临床需求、市场潜力、预期 患者价值和临床采用的高概率。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、商业化战略家和监管顾问的定制支持， 团队完善他们的产品，完成他们的IND/IDE使能临床前研究， 实验室/生产实践，以扩大规模，制定临床研究方案，形成战略伙伴关系， 并在第一阶段临床试验之前与FDA进行互动。因此，C-DOCTOR将创造积极的成果 对于ITP团队，他们可能无法访问必要的知识库和资源， 成功。为了实现这一愿景，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， 支助投资和技术合作方案和发展业务中心总体方案职能 具体目标2：建立一个均衡的投资和技术合作伙伴组合，为投资和技术合作伙伴提供全面支持， 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 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 科学界 具体目标4：在C-DOCTOR和MPWRM之间建立强有力和可持续的合作， 支持ITP的开发和商业化 实现这些目标将使C-DOCTOR成为支持DOC TE/RM的综合资源网络， 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.