Office of Scientific Investigations/CDER/FDA
Silver Spring, MD
Dr. Lee Pai-Scherf is a Senior Physician in the Good Clinical Practice Assessment Branch of the Division of Clinical Compliance Evaluation /Office of Scientific Investigations in CDER/FDA. She provides regulatory and scientific oversight for CDER-assigned bioresearch monitoring inspections and scientific and clinical oversight to FDA field investigators. She is a medical oncologist and serves as a subject matter expert in GCP inspections evaluating data integrity, trial quality, and the safety of human subjects in clinical trials. Prior to joining OSI, she was a medical officer in the Office of Oncology Drug Products, in CDER/FDA where she reviewed numerous investigational new drug applications and marketing applications in oncology including biologic products for the treatment of colon, breast, brain, lung and head and neck malignancies and has served on various FDA guidance development committees. Before joining the FDA, Dr. Pai-Scherf was a Clinical Principal Investigator in the Medical Oncology Branch and the Laboratory of Molecular Biology at the National Cancer Institute, Bethesda MD, where she developed and conducted clinical trials with monoclonal antibody-based products intended for treatment of solid tumors. Dr. Pai-Scherf completed her fellowship in medical oncology at the National Cancer Institute, internal medicine residency at the Wayne State University, Michigan and earned her medical degree from the University of Sao Paulo, Brazil.
Monday, November 18, 2024
10:30 AM – 11:45 AM PT