Slide 1Basic Concepts, Practical Issues and Statistical Methods in Bridging Studies Shein-Chung Chow, Ph.D. Professor Department of Biostatistics & Bioinformatics Duke…
Slide 1Orphan Diseases ECD Global Alliance October 2010 Slide 2 What is an Orphan Disease? A Disease Affecting So Few People That: –There is no reasonable expectation that…
Slide 1 Clinical Trials in Rare Diseases Brendan M. Buckley MD DPhil FRCPI College of Medicine and Health University College Cork Insights into Successful Research in Rare…
Slide 1 FDA Marks Orphan Drug Act Milestone: 30 Year Recognition January 2013 Slide 2 One of Many Rare Disease Heroes… Henry Waxman and Orrin Hatch Author and cosponsors…