The Roadmap from Preclinical Models to Interventional Trials for PTE

PTE 从临床前模型到介入试验的路线图

• 批准号: 10754155
• 负责人: Lauren Harte
• 金额: $ 2.5万
• 依托单位: CITIZENS UNITED FOR RESEARCH IN EPILEPSY
• 依托单位国家: 美国
• 财政年份: 2023
• 资助国家: 美国
• 起止时间: 2023-09-15 至 2024-08-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/10754155
• 关键词: Address; Animal Model; Antiepileptogenic; Area; Bioinformatics; Biological Markers; Blood; Clinical; Clinical Research; Clinical Trials; Collaborations; Communities; Computational Technique; Craniocerebral Trauma; Data; Data Analyses; Development; Dimensions; Electroencephalography; Enrollment; Epilepsy; European; Future; Gender; Goals; Growth; Image; Individual; Industry; Infrastructure; International; Intervention; Intervention Trial; Italy; Knowledge; Knowledge Discovery; Link; Location; Nationalities; Nonprofit Organizations; Operative Surgical Procedures; Participant; Phenotype; Policies; Population; Post-Traumatic Epilepsy; Posttraumatic growth; Pre-Clinical Model; Prevention; Preventive therapy; Preventive treatment; Productivity; Publications; Recurrence; Research; Research Personnel; Risk; Scholarship; Scientific Advances and Accomplishments; Seizures; Time; Translations; Traumatic Brain Injury; Underrepresented Populations; United States National Institutes of Health; Work; biomarker development; biomarker discovery; biomarker validation; career; clinical application; computerized tools; cost; data integration; data management; data sharing; experience; federated data; improved; industry partner; infrastructure development; insight; meetings; multimodal data; pharmacologic; potential biomarker; pre-clinical; pre-clinical research; predictive marker; programs; research clinical testing; success; symposium; therapy development

Summary/Abstract The Roadmap from Preclinical Models to Interventional Trials for Post-Traumatic Epilepsy (PTE) Conference will unite global leading clinical and preclinical experts in traumatic brain Injury (TBI) and epilepsy to focus on PTE, promoting crosstalk with the goal of delivering an actionable plan for the preclinical to clinical application of biomarker discovery and utilization in clinical trials that are aimed at developing preventative therapies and treatments for PTE. The delayed expression of PTE following TBI presents a window of opportunity within which to intervene, however, there is a need for predictive biomarkers for PTE to understand which populations to enroll in clinical trials. To develop an action plan that will advance the field towards a clinical trial, conference sessions will highlight the most promising advances in PTE research, including potential biomarkers of PTE, as well as examine challenges and solutions to preclinical and clinical PTE research with the objective of understanding gaps in knowledge and opportunities for collaborative steps forward. Additional sessions will discuss the development of an infrastructure for federated data sharing and analysis, as well as hot topics in PTE. Emphasis will be placed on incorporating the experience and needs of those living with PTE as well as the perspective of industry partners. The conference will also highlight the work of early career investigators and provide networking opportunities to catalyze career growth within the field of PTE. As a deliverable, an action plan will be created outlining the next steps to a clinical trial for PTE including input from TBI and epilepsy experts to define these steps. The conference is planned for Milan, Italy, in May of 2024, with an expected attendance of ~150 speakers and participants, diverse in scientific expertise, nationality, gender, and background including representation from underrepresented populations. Scholarships will be provided to enable the attendance of early career investigators, chosen for their scientific promise and diversity of background. With its location in Italy, and partnership linking US-based leading non-profit organization CURE Epilepsy, leading European PTE researchers at the Mario Negri Institute for Pharmacological Research, and International League Against Epilepsy, this conference will bring together a global group of experts and early career investigators to maximize real-world impact on PTE.

摘要/摘要 创伤后癫痫 (PTE) 临床前模型到介入试验路线图会议将联合全球领先的创伤性脑损伤 (TBI) 和癫痫领域的临床和临床前专家，重点关注 PTE，促进相互交流，旨在为治疗癫痫病提供可行的计划生物标志物发现和临床试验中利用的临床前到临床应用，旨在开发 PTE 的预防疗法和治疗方法。 TBI 后 PTE 的延迟表达提供了一个干预的机会窗口，然而，需要 PTE 的预测生物标志物来了解哪些人群适合参加临床试验。为了制定一项推动该领域走向临床试验的行动计划，会议将重点介绍 PTE 研究中最有前途的进展，包括 PTE 的潜在生物标志物，并研究临床前和临床 PTE 研究的挑战和解决方案，目的是了解知识差距和向前迈进协作的机会。其他会议将讨论联合数据共享和分析的基础设施的开发，以及 PTE 的热门话题。重点将放在整合 PTE 患者的经验和需求以及行业合作伙伴的观点上。会议还将重点介绍早期职业研究者的工作，并提供交流机会，以促进 PTE 领域的职业发展。作为可交付成果，将制定一项行动计划，概述 PTE 临床试验的后续步骤，包括 TBI 和癫痫专家的意见来定义这些步骤。该会议计划于 2024 年 5 月在意大利米兰举行，预计将有约 150 名演讲者和参与者出席，他们的科学专业知识、国籍、性别和背景各不相同，包括来自代表性不足的人群的代表。将为早期职业研究人员提供奖学金，这些研究人员因其科学前景和背景多样性而被选中。此次会议位于意大利，并与美国领先的非营利组织 CURE Epilepsy、Mario Negri 药理学研究所的欧洲领先 PTE 研究人员以及国际抗癫痫联盟建立了合作关系，将汇集全球专家组和早期职业调查员最大限度地提高对 PTE 的现实影响。