confirmatory comparative effectiveness trial of hybrid coronary revascularization and the co-principal investigator of the coordinating center for the NHLBI Cardiothoracic Surgery Network. 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. Dr. Ascheim has served on numerous clinical trial oversight and advisory committees for federally- and industry-funded trials. 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. Dr. 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 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.

Leslie K. Ball, M.D., FAAP, is the Acting Director of the Office of Scientific Investigations (formerly known as the Division of Scientific Investigations [DSI]), Office of Compliance, CDER, FDA, where she has served in this role since 2008. 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. Beginning in 2003 she served as branch chief of DSI’s Good Clinical Practice Branch II. Dr. Ball joined FDA in 1996 as a medical officer in the Center for Biologics Evaluation and Research, Office of Vaccines Research and Review. 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. Dr. Ball graduated with a B.S. in biology from Georgetown University. She received her M.D. from Georgetown University School of Medicine, where she also completed a residency in pediatrics. She completed a fellowship in pediatric infectious diseases at the Walter Reed Army Medical Center. She served as a pediatrician at the U.S. Naval Hospital, Subic Bay, Republic of the Philippines, in private practice in Maryland, and in the Department of Pediatrics at the National Naval Medical Center, Bethesda.

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