The Roadmap from Preclinical Models to Interventional Trials for PTE

摘要/摘要 从临床前模型到创伤后癫痫(PTE)干预试验路线图会议将联合创伤性脑损伤(TBI)和癫痫方面的全球领先临床和临床前专家，专注于PTE，促进串扰，目标是为生物标记物的临床前到临床应用提供可行的计划，并在旨在开发PTE预防疗法和治疗的临床试验中使用生物标记物。颅脑损伤后PTE的延迟表达为干预提供了机会之窗，然而，PTE需要预测性生物标记物来了解哪些人群需要登记参加临床试验。为了制定一项行动计划，推动该领域走向临床试验，会议将重点介绍PTE研究中最有希望的进展，包括PTE的潜在生物标记物，以及审查临床前和临床PTE研究的挑战和解决方案，目的是了解知识差距和合作进展的机会。其他会议将讨论联合数据共享和分析基础设施的发展，以及PTE中的热门话题。重点将放在纳入PTE患者的经验和需要以及行业伙伴的观点上。会议还将突出早期职业调查人员的工作，并提供联网机会，以促进PTE领域内的职业发展。作为一项可交付成果，将制定一项行动计划，概述PTE临床试验的下一步步骤，包括来自TBI和癫痫专家的意见，以确定这些步骤。会议计划于2024年5月在意大利米兰举行，预计将有约150名演讲者和与会者出席，他们的科学专长、国籍、性别和背景不同，包括代表人数不足的人口。将提供奖学金，使早期职业调查人员能够参加，他们是根据他们的科学前景和多样化的背景而被选中的。此次会议设在意大利，将总部设在美国的领先非营利性组织CURE Epilepsy、马里奥·内格里药理研究所领先的欧洲PTE研究人员和国际抗癫痫联盟联系在一起，将一个全球专家组和早期职业研究人员聚集在一起，以最大限度地提高PTE的现实影响。

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.