![]() She completed a fellowship in pediatric infectious diseases at the Walter Reed Army Medical Center. from Georgetown University School of Medicine, where she also completed a residency in pediatrics. From 2001 to 2003 she worked at the Office for Human Research Protections, Department of Health and Human Services (HHS), where she coordinated compliance investigations, participated in inspections of institutions and IRBs, and worked on children’s research issues. Ball joined FDA in 1996 as a medical officer in the Center for Biologics Evaluation and Research, Office of Vaccines Research and Review. Beginning in 2003 she served as branch chief of DSI’s Good Clinical Practice Branch II. ![]() While in DSI she has been active in developing a risk model for selecting clinical trial sites for inspection, collaborating with the European Medicines Agency and other international regulatory authorities, developing approaches to inspecting electronic data, and instituting process improvements for enforcement actions. Ball, M.D., FAAP, is the Acting Director of the Office of Scientific Investigations (formerly known as the Division of Scientific Investigations ), Office of Compliance, CDER, FDA, where she has served in this role since 2008. She completed a postgraduate fellowship at Columbia University College of Physicians & Surgeons (Columbia P&S) and remained on faculty as an attending cardiologist in the Heart Failure Center at Columbia P&S and the Mailman School of Public Health from 1995 to 2008. Ascheim graduated from New York University School of Medicine and completed her internship and residency in internal medicine, as well as her fellowship in cardiovascular diseases, at the New York-Presbyterian Hospital/Weill Cornell Medical Center. She presently serves as the Vice Chair of the Board of Directors of Physicians for Human Rights, and as a Trustee for the Brearley School in New York. Ascheim has served on numerous clinical trial oversight and advisory committees for federally- and industry-funded trials. Her work has been published in such journals as the New England Journal of Medicine, the Journal of Cardiac Failure, the Journal of Thoracic and Cardiovascular Surgery, the Annals of Thoracic Surgery, and Thyroid. She is the principal investigator of the data coordinating center of a planning grant funded by NHLBI to develop a confirmatory comparative effectiveness trial of hybrid coronary revascularization and the co-principal investigator of the coordinating center for the NHLBI Cardiothoracic Surgery Network. She has particular expertise in the design, coordination, and analysis of such multicenter clinical trials. Her research focuses on the measurement of clinical outcomes and on complex trials evaluating novel device or surgical interventions. Ascheim is a cardiologist with expertise in heart failure and extensive experience in clinical investigation. ![]() She was previously an Assistant Professor of Medicine (Cardiology) and Health Policy at Columbia University Medical Center and the Mailman School of Public Health. ![]() She is the Clinical Director of Research and Director of the Clinical Research Unit at the International Center for Health Outcomes and Innovation Research (InCHOIR) at Mount Sinai. Ascheim, M.D., is an Associate Professor in the Departments of Health Evidence and Policy and Medicine/Cardiovascular Institute at the Mount Sinai School of Medicine in New York. ![]() He has been facilitating clinical research at IU Simon Cancer Center and IU School of Medicine for the past 4 years.ĭeborah D. His role as a leader of the Multiple Myeloma program has allowed him to participate in practice-changing research using IMiDs and proteasome inhibitors. Abonour has been active in clinical research for the past 15 years at Indiana University and his work has been published in Nature Medicine and the New England Journal of Medicine, among others. Rafat Abonour, M.D., is a Professor of Medicine, Professor of Pathology and Laboratory Medicine at Indiana University (IU). ![]()
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