Paul Kluetz is a medical oncologist and Deputy Director of the Oncology Center of Excellence (OCE) at the U.S. FDA. In addition to assisting in the strategic and operational oversight of the OCE, he has a broad interest in trial design and endpoint selection to expedite drug development and define clinical benefit in oncology trials. Some of his initiatives include creation of the OCE's patient-focused drug development program and expansion and direction of OCE's efforts to advance real-world evidence, decentralized trial designs and digital health technology. He is also active in regulatory review of Oncology products and oversees important oncology drug labeling initiatives. Dr. Kluetz remains clinically active, caring for patients and supervising medical residents at the Georgetown University Hospital.