Center for TMD IMPACT

项目总结/摘要 颞下颌关节紊乱病（TMD）是一组超过30种人类疾病，通常以 关节变性伴滑膜炎症、软骨下骨重塑、软骨变性和疼痛。 有效地管理和治疗TMD，预防长期疼痛， 创伤性手术，如TMJ置换术。我们的愿景是组建一个全面而充满活力的团队 临床医生，研究科学家，监管专家和临床试验专家，以推进基础和临床 研究，研究培训和基于证据的治疗TMD。为此，我们将制定一个 综合性和协作性多机构TMD中心改善以患者为中心的翻译 由临床需求驱动的研究（C-TMD IMPACT），由执业临床医生定义。我们将定义 C-TMD IMPACT未来的研究重点基于临床相关性，科学可行性，患者需求， 以及监管批准和商业化的可能性。最终，作为TMD影响的一部分， 合作，我们在C-TMD IMPACT的集体专业知识将通过识别和 通过为成功的实验设计建立明确的程序来验证治疗方案， 小型和大型动物模型，研究发现的深入转化评估，产品验证， 生产规模扩大、监管批准、临床试验、实施和培训未来的劳动力 进行TMD研究。我们提出以下具体目标：具体目标1：组建一个专家小组， 整合临床、科学/技术和监管专业知识，形成C-TMD IMPACT。我们将举办一个 工作务虚会;一个面向TMD的研究培训和职业发展方案; 全年召开电话会议，以制定和完善总体愿景、路线图、组织 C-TMD IMPACT的结构和操作程序。我们将充分建立必要的基础设施 支持TMD研究，整合现有的基础、转化和临床研究资源 在我们参与的校园里培养未来的劳动力。具体目标2：使临床医生能够定义 管理和治疗TMD的未满足的临床需求，并与适当的产品专家合作 开发和监管事务，以评估可行性。根据这些确定的需求，我们将开发 必要的技术方法、协议和数据管理基础设施。我们将合理安排 多方面的沟通战略，以促进与公众的对话，潜在的跨学科研究 团队，和其他成员的TMD影响协作。

PROJECT SUMMARY/ABSTRACT Temporomandibular disorders (TMDs) are a group of more than 30 human diseases, often characterized by joint degeneration with synovial inflammation, subchondral bone remodeling, cartilage degeneration, and pain. There is an urgent, unmet medical need to effectively manage and treat TMDs, preventing long-term pain and invasive procedures such as TMJ replacement. Our vision is to assemble a comprehensive and dynamic team of clinicians, research scientists, regulatory experts, and clinical trial specialists to advance basic and clinical research, research training, and evidence-based treatment for TMDs. Towards this end, we will develop a comprehensive and collaborative multi-institutional Center for TMD IMproving PAtient-Centered Translational Research (C-TMD IMPACT) that is driven by clinical needs, as defined by practicing clinicians. We will define C-TMD IMPACT’s future research priorities based on clinical relevance, scientific feasibility, patients’ needs, and likelihood of regulatory approval and commercialization. Ultimately, as part of the TMD IMPACT Collaborative, our collective expertise at C-TMD IMPACT will transform TMD management by identifying and validating therapeutic solutions via establishing well-defined procedures for successful experimental design, small and large animal models, in-depth translational assessment of research discoveries, product validation, manufacturing scale-up, regulatory approval, clinical testing, implementation, and training the future workforce for TMD studies. We propose the following Specific Aims: Specific Aim 1: Assemble a team of experts with integrated clinical, scientific/technical, and regulatory expertise to form C-TMD IMPACT. We will host one working retreat; one TMD-oriented research training and career development program; and bi-monthly teleconferences throughout the year to develop and refine the overall vision, roadmap, organizational structure, and operational procedures for C-TMD IMPACT. We will fully establish the necessary infrastructure to support TMD research, integrating existing resources for basic, translational, and clinical research as well as training the future workforce on our participating campuses. Specific Aim 2: Enable clinicians to define unmet clinical needs for managing and treating TMDs and engage with appropriate experts on product development and regulatory affairs to assess feasibility. According to these identified needs, we will develop the necessary technical approaches, protocols, and data management infrastructure. We will implement a multifaceted communications strategy to foster dialogue with the public, potential interdisciplinary research teams, and other members of the TMD IMPACT Collaborative.