The U.S. Food and Drug Administration (FDA) recently announced the appointment of an Acting Deputy Office Director and an Associate Director of Clinical Science in its Office of Hematology and Oncology Products (OHOP).
Acting Deputy Office Director
Amy E. McKee, MD, was recently announced as the newly appointed Acting Deputy Office Director in the OHOP. Dr. McKee assumed this position effective December 27, 2015.
Dr. McKee began working at the FDA in 2008 and has served as a Medical Officer and Clinical Team Leader, Breast and Gynecologic Products, within the Division of Oncology Products 1. Her work has included outreach to the ovarian cancer community, including a public workshop with stakeholders to advance drug development in this disease. Her interest in early-phase drug development and improved dose-finding has led to cross-disciplinary initiatives within the Agency to develop new methodologies for early dose-finding trials and dose exploration throughout drug development, as well as discussion with external stakeholders to identify the best practices within industry.
Dr. McKee received her medical degree at Tulane University School of Medicine and completed her residency in pediatrics at the Floating Hospital for Children at the Tufts New England Medical Center. Dr. McKee completed her pediatric hematology/oncology fellowship at the combined Johns Hopkins/National Cancer Institute (NCI) program, where she received the 2008 NCI Director’s Innovation Award for her basic research in neuroblastoma.
As Acting Deputy Office Director, Dr. McKee will continue to develop and support OHOP strategic policy initiatives and research efforts.
Associate Director of Clinical Science
Paul Kluetz, MD, was recently announced as the newly appointed Associate Director of Clinical Science in the OHOP. Dr. Kluetz assumed this position effective January 24, 2016.
Dr. Kluetz began working at the FDA in 2010 and has served as a Medical Officer in the Genitourinary (GU) Oncology Team within the Division of Oncology Products 1. In addition to extensive outreach to the GU oncology community as a scientific liaison, he has been involved in multiple scientific and regulatory policy initiatives associated with FDA-expedited programs and oncology efficacy endpoints, as well as cross-center initiatives to identify ways to encourage and improve patient-reported outcomes and other clinical outcome assessments in cancer trials.
Dr. Kluetz received his medical degree at the University of Pittsburgh and completed his residency in internal medicine at the University of Maryland Medical System. Dr. Kluetz completed his medical oncology fellowship at the NCI, where he was active in clinical research in metastatic prostate cancer.
As Associate Director of Clinical Science, Dr. Kluetz will continue to develop and support OHOP strategic policy initiatives and serve as the Office lead for patient-focused drug development and clinical outcome assessments. ■