Introduction to Quality by Design for Pharmaceuticals
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Dr. Stephen Kralik is an Associate Professor of Radiology at Baylor College of Medicine. He is a Pediatric Neuroradiologist at the Texas Childrens Hospital in Houston, Texas. He is interested in all clinical areas of pediatric neuroradiology, but particularly in implementation of new imaging techniques to improve diagnoses of neurological disorders including functional MRI, MR perfusion and MR Spectroscopy. His research interests in pediatric neuroradiology include diagnosis of pediatric brain and spine tumors with advanced imaging techniques such as perfusion and diffusion imaging, and understanding the effects of medical therapy on the brain in these patients. He is also interested in research using advanced imaging techniques in neonates and premature infants to improve our understanding of the brain injuries in these patients. Dr. Nilesh Desai is the Division Chief of Neuroradiology at Texas Children's Hospital and Associate Professor of Radiology at Baylor College of Medicine. He is board-certified by the American Board of Radiology with subspecialty certification in Neuroradiology. He completed fellowships in both Neuroradiology and Pediatric Neuroradiology with Fetal MRI. He performs all aspects of neuroradiology and fetal imaging. His research interests include brain injury in congenital heart disease, non-accidental trauma and sickle cell disease. Honors include being a recipient of the Outstanding Clinician Award from Emory University School of Medicine Department of Radiology and Imaging Sciences prior to joining Texas Children's Hospital. Dr. Avner Meoded is an Associate Professor of Radiology at Baylor College of Medicine. He is also a Neuroradiologist at the Texas Childrens Hospital, Houston, Texas. His field of research includes pediatric neuroimaging. His clinical and research activity is focused on the application of advanced magnetic resonance imaging (MRI) techniques to study multiple pediatric neurologic disorders. Some of his projects evaluate how the findings derived from advanced MRI modalities are changing during development e.g. maturation of white matter tracts using diffusion MRI. In addition, he applies quantitative methods to study structural and functional connectivity e.g connectomics, to better understand mechanism of neuroplasticity in children with congenital malformations, stroke and traumatic brain injury. Thierry A.G.M. Huisman is the current Radiologist-in-Chief and Chair of the Department of Radiology at Texas Children's Hospital (TCH) in Houston, USA. He also holds the Edward B. Singleton Chair of Radiology. He is a tenured Professor of Radiology, Pediatrics, Neurosurgery, Neurology, Obstetrics and Gynecology at Baylor College of Medicine and holds adjunct Professor Appointments at Johns Hopkins School of Medicine in Neurosurgery and Pediatrics. Before he joined TCH he served 11 years at Johns Hopkins Medicine in Baltimore. He was the Chairman of the Department of Imaging and Imaging Science at the Johns Hopkins Bayview Medical Center. In addition he was the Director of the Division of Pediatric Radiology, Director and founder of the Division of Pediatric Neuroradiology at the Johns Hopkins Hospital in Baltimore and Co-Director of the Neurointensive Care Nursery (NICN), the Johns Hopkins Fetal Program and the Center for Translational and Molecular Imaging (CTMI). Prior to his tenure at Johns Hopkins he was the Chairman and Radiologist-in-Chief of the Department of Diagnostic Imaging at the University Children's Hospital Zurich. He graduated cum laude from Medical School at the Erasmus University in Rotterdam, the Netherlands, before completing residencies in Radiology and Pediatrics and fellowships in Pediatric Radiology and Neuroradiology at the University Hospital Zurich, Switzerland. Dr. Huisman enjoyed a 2.5 years research sabbatical at the Massachusetts General Hospital NMR center, Harvard Medical School in Boston. His primary field of expertise and research focuses on advanced, quantitative, precision imaging in the field of Neuroradiology. He has given more than 470 national and international invited lectures, published 410 articles and 31 reviews, 67 book chapters, 6 text books, serves on multiple scientific committees of the various radiological societies and has organized multiple national and international meetings in Europe and the USA. He has been one of the founding members of the Swiss Symposium in Pediatric Neuroradiology and the Neurointensive Care Nursery at Johns Hopkins. Dr. Huisman served as a faculty member of the AIRP course in Washington, DC (2013-2019), and is a course advisor for the IDKD course in Davos, Switzerland since 2012. Furthermore he has built several patient and family focused multidisciplinary programs and is actively involved in mentorship programs. He is a reviewer for multiple scientific journals and is an editorial member of 5 journals. He served as president of the American Society of Pediatric Neuroradiology (2014/15) and the Eastern Neuroradiological Society (ENRS) (2020/2021), is a Fellow of the International Cancer Imaging Society, Fellow of the American College of Radiology and is an elected President of the International Cancer Imaging Society. Finally, he is a senior editor of the American Journal of Neuroradiology.