Haleh Saber
Associate Director of Toxicology Modernization, CDER
U.S. Food and Drug Administration
Dr. Saber serves as the Associate Director of Toxicology Modernization (on detail) in the Office of the Center Director at CDER, and as the Director of the Division of Hematology Oncology Toxicology (DHOT) within the Office of Oncologic Diseases/ CDER. She has over 25 years of experience in drug development from both the pharmaceutical industry and the FDA. An advocate for modernizing toxicology, Dr. Saber has supported the Office of the Center Director on a range of initiatives aimed at reducing unnecessary animal use, including taking the lead in the development of the recent guidance Monoclonal Antibodies: Streamlined Nonclinical Safety Studies. Her commitment to this mission is further reflected in her lead authorship of several oncology manuscripts and guidance documents that have significantly reduced animal testing for anticancer products. Dr. Saber is also recognized for her contributions to establishing approaches for first-in-human dose selection in oncology, including the application of model-based methodologies. Dr. Saber earned her Ph.D. in Biochemistry from Lehigh University (Bethlehem, PA) and completed her postdoctoral training at Fox Chase Cancer Center in Philadelphia, PA.
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