# Core 03 - Leadership and Administration

> **NIH NIH P01** · UNIVERSITY OF CALIFORNIA, SAN FRANCISCO · 2021 · $278,139

## Abstract

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.

## Key facts

- **NIH application ID:** 10249161
- **Project number:** 5P01CA210961-05
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN FRANCISCO
- **Principal Investigator:** Meredith Buxton
- **Activity code:** P01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $278,139
- **Award type:** 5
- **Project period:** 2017-09-08 → 2023-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10249161

## Citation

> US National Institutes of Health, RePORTER application 10249161, Core 03 - Leadership and Administration (5P01CA210961-05). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10249161. Licensed CC0.

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