The PSFG is designed to give philanthropic and private sector partners the opportunity to hear about the progress of the I-SPY 2 TRIAL and provide active feedback on its implications for drug development and regulatory decision-making. The PSFG includes high-level representatives from academic, non-profit, industry, government, and patient advocate groups.
The IASC is responsible for making the final choices of agents to be tested in the trial based on specified criteria once the agent regimen is recommended by the Agent Working Group. This committee is constituted of individuals with extensive expertise in cancer chemotherapy and drug development, but who do not have any conflict of interest with candidate agents or the companies under consideration.
The Data Access and Publication Committee (DAPC) will meet quarterly and approve requests for access to I-SPY 2 specimens and data, based on recommendations made by the Working Groups. The Committee will also review and approve publications based on I-SPY 2 data to ensure that the data are not misinterpreted.
DSMB meets monthly and its purpose is to assure subject safety in the trial. Members have the responsibility for assurance that the trial is conducted to a high standard. Responsibilities include assessing the risk of the trial, monitoring adverse event reporting, reviewing compliance progress, recommending modifications, and provide immediate responses to significant adverse events on an ongoing basis.
Agents Working Group
Biomarkers Working Group
Imaging Working Group
Informatics Working Group
Patient-Reported Outcomes Working Group
Safety Working Group
Site Operations Working Group
Smita Asare, Executive Director of I-SPY Trials, QLHC
Ruby Singhrao, MS, CCRP, Clinical Ops Manager, UCSF
Lamorna Brown Swigart, PhD, I-SPY Lab Director, UCSF
Gillian Hirst, PhD, Scientific Program Manager, UCSF
Jeff Matthews, PhD, Strategic Consultant, UCSF
Katherine Steeg, Clinical Operations Analyst, UCSF
Jessica Gibbs, Imaging Analyst, UCSF
Melanie Regan, Imaging Analyst, UCSF
Jenny Chen, Quality of Life Analyst, UCSF
Meera Bose, I-SPY Administrative Assistant, UCSF
CCS Associates, Inc.