SAVE the DATE! UMB International Society for Pharmacoepidemiolgy Student Chapter Inaugural Interdisciplinary Campuswide Seminar April 16, 2014 at 4.00-5.30 pm followed by reception William O. Cooper, M.D., M.P.H. Dr. Cooper's epidemiology research has focused on issues related to the effects of health policy on vulnerable populations of children, including children enrolled in government insurance programs and children with chronic health conditions. In recent years, he has focused on the unexpected effects of medicine on children, including psychotropic drugs and drugs taken by pregnant women and their effect on the developing fetus. His research efforts have advanced children's health in several important areas. His work has made contributions to the care of children with asthma, children with sickle cell, children with mental health conditions, and in the important interface between pregnancy and infant outcomes. Dr. Cooper's research methodology has utilized large statewide databases and he currently leads several studies incorporating data from several different health plans from across the country. Cooper is also a principal investigator of a Food and Drug Administration (FDA) collaborative called the Medication Exposure Pregnancy Risk Evaluation Program (MEPREP). Cooper joins investigators at Harvard's HMO Research Network Center for Education and Research in Therapeutics, Kaiser Permanente Northern and Southern California and the FDA to review an unprecedented number of birth records, searching for fetal exposures to medication. Dr. Cooper has had numerous high-impact publications in journals such as the New England Journal of Medicine and JAMA. An example of Dr. Cooper's work with important impact is a landmark paper in the New England Journal of Medicine describing the association between ACE inhibitors during pregnancy and the risk for major congenital malformations in infants whose mothers took these medications during pregnancy. Translating Clinical Evidence into Worldwide Health Policy Dr. Cooper's paper describing the association between ACE inhibitors taken during pregnancy and the risk for major congenital malformations has had a profound effect on the practice of medicine among several disciplines, including cardiologists, general internal medicine physicians, and obstetricians. The American Heart Association listed Dr. Cooper's study as one of the top 10 research advances in 2006 and specifically recommended that women who are already taking ACE inhibitors should avoid becoming pregnant while they are taking ACE inhibitors. In the August 2007 issue of Annals of Internal Medicine, Dr. Cooper's work was cited as "one of the important changes to clinical practice emerging from articles important to cardiologists in 2006." A copy of Dr. Cooper's paper was included in the recertification packet sent to over 5,000 practicing obstetricians by the American Board of Obstetrics and Gynecology for the 2007 recertification process. Dr. Cooper's work has influenced policy, including medication labeling by HealthCanada, the US Food and Drug Administration, and the UK MHRA. The Agency for Healthcare Research and Quality released a special Request for Applications for further study of the issue of ACE inhibitor use during pregnancy. By influencing practice in this way, Dr. Cooper's work has reduced the likelihood that children will experience entirely preventable major malformations. Dr. Cooper serves on the Drug Safety and Risk Management Advisory Committee for the Food and Drug Administration, where he provides important input into drug safety decisions by the Agency.