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

牙科、口腔、颅面组织和器官再生中心 (C-DOCTOR)

• 批准号: 9438909
• 负责人: Yang Chai
• 金额: $ 397.81万
• 依托单位: UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
• 依托单位国家: 美国
• 财政年份: 2017
• 资助国家: 美国
• 起止时间: 2017-03-01 至 2020-02-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/9438909
• 关键词: Abbreviations; Address; Adopted; Adoption; Advocate; American; Animal Model; Basic Science; Biological Sciences; Biomedical Research; Businesses; California; Center for Translational Science Activities; Clinical; Clinical Trials; Clinical and Translational Science Awards; Collaborations; Communities; Custom; Data Collection; Dental; Ecosystem; Entrepreneurship; Equilibrium; Fostering; Foundations; Funding; Future; Goals; Human; Incentives; Industrialization; Industry; Institutes; Institution; Investments; Language; Leadership; Life Experience; Link; Marshal; Medical; Mission; National Institute of Dental and Craniofacial Research; Natural regeneration; Needs Assessment; Oral; Patients; Persons; Phase; Price; Privatization; Process; Records; Regenerative Medicine; Research; Research Infrastructure; Research Personnel; Resources; Science; Scientist; Series; Solid; Structure; Study models; Technology; Thinness; Time; Tissue Engineering; Training; Translating; Translations; Triage; United States National Institutes of Health; Universities; Vision; authority; catalyst; clinical translation; cost effective; craniofacial; craniofacial tissue; economic value; expectation; improved; innovation; meetings; novel; oral tissue; organ regeneration; profession allied to medicine; programs; recruit; research clinical testing; success; tissue regeneration; translational research program; virtual; web site

The overall goal of this U24 is to operationalize the Center for Dental, Oral and Craniofacial Tissue and Organ Regeneration (C-DOCTOR). Through an integrated series of collaborative planning activities funded during Stage I, eight renowned centers of translational research excellence - UCSF, USC, UCLA, UCB, UCD, UCSD, CoH, and Stanford - have partnered to form a public-private consortium focused on accelerating promising tissue engineering/regenerative medicine therapies for dental, oral, and craniofacial (DOC) tissue to human clinical trials. C-DOCTOR will recruit Interdisciplinary Translational Project (ITP) teams with promising DOC regeneration therapies and then provide scientific, technical, regulatory, financial, and managerial resources necessary to facilitate large animal model studies and promote a cost-effective transition to Stage III. C- DOCTOR will efficiently leverage an extensive array of existing resources that resonate with the Center mission. Three proposed Aims are to: 1) Recruit and select ITP teams that align with our clinical indication priorities; 2) Coordinate and customize our broad resource infrastructure along ITP team needs.; and 3) Cultivate, train, triage, and collaborate with ITP teams to assemble a balanced ITP portfolio ready for Stage III. To accomplish these aims, we will build on our preliminary needs assessment through a strong partnership with our diverse network of C-DOCTOR clinical advisors. We will then adapt best practices from a number of existing innovation programs across our multi-institutional network to select promising therapies with high potential for clinical adoption. C-DOCTOR Resource Directors will match selected ITP teams with domain and resource experts to refine their business case and address their technical needs through interactive collaboration, where continued funding and successful progression through Stage II will be dependent on meeting bi-annual milestones and specific go/no-go decision gates. In this manner, C-DOCTOR will efficiently and deliberately triage from a large number of promising ITPs into active partnership with only those that have maximum likelihood for successful transition through Stage III, which includes an FDA filing and commercial partnering that together support future Phase I clinical testing.

该U24的总体目标是使牙科、口腔和颅面组织和器官中心投入运作。 再生（C-DOCTOR）。通过一系列综合性的合作规划活动， 第一阶段，八个著名的卓越转化研究中心--加州大学旧金山分校、南加州大学、加州大学洛杉矶分校、加州大学旧金山分校、加州大学圣地亚哥分校、 CoH和斯坦福大学合作成立了一个公私联合财团，专注于加速有前途的 组织工程/再生医学疗法，用于人类的牙齿、口腔和颅面（DOC）组织 临床试验C-DOCTOR将招募跨学科翻译项目（ITP）团队， 再生疗法，然后提供科学，技术，监管，金融和管理资源 这是促进大型动物模型研究和促进向III期过渡的成本效益所必需的。C型 医生将有效地利用与中心产生共鸣的广泛的现有资源 使命。 拟议的三个目标是： 1)招募和选择符合我们临床适应症优先级的ITP团队; 2)沿着ITP团队的需要协调和定制我们广泛的资源基础设施。和 3)培养、培训、分类并与ITP团队合作，以组装平衡的ITP产品组合， 第三阶段。 为了实现这些目标，我们将在初步需求评估的基础上， 通过我们多元化的C-DOCTOR临床顾问网络。然后，我们将从一些 我们的多机构网络中现有的创新计划，以选择具有高 临床应用的潜力。C-DOCTOR资源总监将为选定的ITP团队匹配领域， 资源专家通过互动方式完善其业务案例并满足其技术需求 合作，其中持续的资金和第二阶段的成功进展将取决于 满足一年两次的里程碑和具体的进行/不进行决策关口。 通过这种方式，C-DOCTOR将从大量有希望的ITP中有效并谨慎地进行分类 只与最有可能成功过渡到第三阶段国家建立积极伙伴关系， 其中包括FDA备案和商业合作，共同支持未来的I期临床试验。