Dr. Arati Rao is dual fellowship trained Geriatric-Oncologist and a former Associate Professor of Medicine at the Duke University School of Medicine who is passionate about cell therapy development. She has worked both in the heme malignancies CAR T space at Kite-Gilead and now in the solid tumor neoantigen TCR space at PACT. She has in depth knowledge on cell therapy/immunology programs and has worked closely with regulatory agencies including the FDA and EMA. As the global lead and Medical Monitor for ZUMA-2, she was responsible for successfully filing a BLA and received accelerated approval for Tecartus™ (brexucabtagene autoleucel) in relapsed/refractory mantle cell lymphoma with the FDA. During her academic career, she led the myeloid leukemia efforts at Duke and served as a PI/Co-PI on several trials. She was also an NIH funded clinical researcher. She has served as a faculty on the NCCN-Acute Lymphoblastic Lymphoma guidelines (v1.0) and on several ASCO and ASH committees including the ASH- scientific committee for myeloid biology.
Challenges in Cell Therapy Development
Cell therapy development globally has continued to increase. CAR T therapies have led the way but TCR, TIL, neoantigen and other therapies are also being evaluated. The development of cell therapies brings several challenges: type of study and biometrics, regulatory, operations, manufacturing, cost and reimbursement and most importantly patient related and toxicity issues.
Ira Mellman, Genentech
Human cells have been successfully used as treatment for blood cancers for decades but translating the promise to cell-based treatment for solid tumors has been slow. The advent of gene-editing techniques such as CRISPR, coupled with advances in our understanding of immunology and optimization of growing, manufacturing, transporting, storing, and handling specialized biological samples and materials is transforming the cell therapy field. We will hear in this session about some of the most promising work in the field, as well as the challenges in overcoming resistance