Dr. Ibrahim has built clinical trial management capabilities within PICI that enabled the conduct of multi-center clinical trials across PICI centers. His team is focused on supporting novel combinations that are science driven and innovative. Dr. Ibrahim is a recognized leader of clinical development in immunotherapy. He helped develop some of the first breakthrough treatments in the field during his tenure at BMS and AZ. As a member of the BMS Immuno-oncology program, he served on the Yervoy (ipilimumab) clinical team including a key role in development for PD-1, PD-L1 and CD137 antibody.Throughout his career, Dr. Ibrahim has been involved with global cancer immunotherapy societies such as the Society of Immunotherapy for Cancer (SITC), Friends of Cancer Research, the Cancer Research Institute and Cancer Support Community (CSC). He is a trained medical oncologist, who conducted bench and clinical immunotherapy research at the cancer vaccine branch of the NCI in Bethesda, MD.
Immunotherapy drugs have resulted in multiple firsts including a large number of accelerated approvals and new ways of classifying biomarkers. Recent articles questioned the validity of current FDA programs for rapid cancer drug approval, suggesting that they may be flawed. This panel will review FDA’s Accelerated Approval, Breakthrough Therapy, Fast Track, and Priority Review programs, why the programs were created, how they address the needs and wishes of patients and families, and some of the points that the FDA failed to consider.