Vortrag von Dr. Hans-Ulrich Burger
This presentation provides an overview on key principles in drug development, starting from why we need different phases in drug development, the different hurdles we have to overcome, and how and why clinical trials look different in big pharma compared to academic trials. We will discuss concepts like target product profile which determines the way how we develop a new therapy, as well as drug development and market access plans, which outline what kind of information we need to sample throughout the development cycle and what studies need to be performed. Decision making is also discussed as it is a critical asset for a drug development organization for being successful at the end. Finally, we will shed some light on the need for innovation and why changes in the way we perform studies are always needed.