PROJECT SUMMARY/ABSTRACT Dr. Manali Bhave is an academic medical oncologist with a research focus on early phase therapeutic clinical trial development involving novel targeted therapies and immunomodulatory strategies for the treatment of breast cancer. Her goal is to lead institutional investigator-initiated and NCI-sponsored cooperative group clinical trials that will further advance the fight against cancer. Dr. Bhave plays a critical role in Winship’s clinical trial program and is extensively involved in NCI-sponsored clinical trials. She is an active member on multiple national committees including the Breast Cancer Working Groups for SWOG and ETCTN, and plans to expand her involvement with ECOG-ACRIN and her role within ETCTN as Emory’s Breast lead. She is the institutional principal investigator of two NCI- sponsored clinical trials, three investigator-initiated clinical trials at Winship and one investigator- initiated clinical trial currently under development through SWOG. She also contributes as an active co-investigator on numerous others. As a phase I and breast oncology leader at Winship, Dr. Bhave is an important contributor to patient enrollment to NCTN and ETCTN trials. She is Vice Chair of Winship’s Data & Safety Monitoring Committee, Medical Director of the Phase I Clinical Trials Unit and Phase I Working Group Lead. In these roles, she has shown tremendous growth as a leader to broaden the clinical trial portfolio, improve access to phase I clinical trials, and increase faculty engagement in the Phase I program. Winship Cancer Institute of Emory University fully supports Dr. Bhave in her career goals to advance as a national leader in clinical trials for breast cancer and early phase therapeutics, and in her ongoing efforts to enhance the clinical trial program at Winship. The ECIA award will support protected time for Dr. Bhave to focus on key initiatives to increase trial accrual at Winship through building a stronger phase I clinical trials infrastructure, and further develop her own promising protocol concepts at the national level. The ECIA funding mechanism will undoubtedly help foster academic growth and lead to further leadership roles within Winship and the NCI Trial Networks.