Core 03 - Leadership and Administration

摘要-核心3 该方案项目包括四个单独的项目，将： 针对预计对初始治疗应答不足的患者的多种治疗分配策略 新辅助靶向和/或化疗（项目1）;确定非侵入性成像指标， 无应答标志物（项目2）;描述无应答者的生物学特征，为治疗选择提供信息 （项目3）;以及开发一套药物和决策工具，用于治疗重新分配， 无反应肿瘤的生物学（项目4）。 领导和管理核心的主要目标是确保项目整合、协作 通过提供项目管理领导和行政支持， 三个领域的项目和核心： 目标1：为所有项目和核心提供项目管理和行政监督。 目标2：协调科学会议和定期网络和视频会议，以促进整个项目的 沟通、科学互动和监管科学的进步。 目标3：作为现有I-SPY计划基础设施、委员会和流程的网关， 通过更新，将计划项目中出现的产品整合到I-SPY 2试验中， 方案和监管申报资料。 该核心的领导层与I-SPY 2网络的现有结构紧密结合。这将 使计划项目能够高效、无缝地利用大量基础设施和专业知识 I-SPY 2网络在实现其总体目标。这包括针对以下问题的各工作组： 代理选择和审查，外部咨询委员会，以及重要的是，制药合作伙伴关系的发展， 将发挥重要作用，在访问新的代理作为一部分的转换代理组合。的关键作用 核心将是通过监管途径促进进展，无论是对虚拟 RCB和治疗转换，以及通过SMART试验确定的药物的批准途径 作为对初始标准新辅助治疗或靶向新辅助治疗反应不足的患者的有效补救药物 化疗正如I-SPY 2的成功所证明的那样，这是一个经验丰富的团队，能够领导 管理大型、复杂的临床试验，其中集成了生物标志物组件， 在I-SPY 2试验中快速成功地整合新流程和程序的记录 框架.

SUMMARY-CORE 3 This Program Project comprises four individual projects, which will: implement evidence-based sequential multiple treatment assignment strategies for patients predicted to have insufficient response to their initial neoadjuvant targeted and/or chemotherapy (Project 1); qualify non-invasive imaging metrics for determining markers of non-response (Project 2); characterize the biology of non-responders to inform treatment selection (Project 3); and develop a portfolio of agents and decision tools for treatment re-assignment matched to biology of non-responding tumors (Project 4). The primary aims of the Leadership and Administration Core are to ensure program integration, collaboration and regulatory advancement by providing project management leadership and administrative support to the Projects and Cores in three areas: Aim 1: Provide project management and administrative oversight of all Projects and Cores. Aim 2: Coordinate scientific meetings and regular web and video conferences to facilitate project-wide communication, scientific interactions, and advancements in regulatory science. Aim 3: Act as a gateway to the existing I-SPY Program infrastructure, committees, and processes to enable the integration of products that emerge from the Program Project into the I-SPY 2 TRIAL through updates to the protocol and regulatory submissions. The leadership of this Core is deeply integrated within the existing structure of the I-SPY 2 network. This will enable the Program Project to efficiently and seamlessly leverage the substantial infrastructure and expertise of the I-SPY 2 network in fulfillment of its overall goals. This includes the various working groups targeting agent selection and review, external advisory boards and importantly, pharma partnership development, which will play an important role in accessing novel agents as part of the switching agent portfolio. A critical role of the core will be to facilitate progress through the regulatory pathway, both for the initial approvals for virtual RCB and treatment switching, but also concerning approval pathways for agents identified via the SMART trial as effective rescue agents in patients with insufficient response to initial standard neoadjuvant or targeted chemotherapy. As demonstrated by the success of I-SPY 2, this is an experienced team capable of leading and managing large, complex clinical trials with integrated biomarker components that has a proven track record for rapidly and successfully integrating new processes and procedures within the I-SPY 2 TRIAL framework.