Sandra J. Casak

Dr. Sandra J. Casak is the Acting Team Leader for the Gastrointestinal Malignancies team in the Division of Oncology 3 (DO3). Dr. Casak received her medical degree from the School of Medicine, Buenos Aires University, of Buenos Aires, Argentina. Dr. Casak completed her residency in Pediatrics and Pediatric Hematology-Oncology fellowship at the Pediatric National Hospital J.P. Garrahan in Buenos Aires, Argentina, where she stayed until 2002 as an attending in the Hematology/Oncology Department. She was actively involved in clinical research under the International Society of Pediatric Oncology (SIOP) cooperative group, particularly hepatoblastoma and other embryonal tumors. Dr. Casak joined FDA in 2008 and has been in the Gastrointestinal Malignancies team since 2013.  Besides her review work, Dr. Casak is engaged in the development of  regulatory frameworks for the review of drug safety, development of biosimilars,  drugs targeting pediatric cancers, and regulatory research projects.