Core 03 - Leadership and Administration

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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.