Tagged: regulatory sciences

FDA launches UCSF-Stanford center for innovation in drug development, regulation

The U.S. Food and Drug Administration (FDA) is tapping the UCSF School of Pharmacy and Stanford University to launch its first West Coast regulatory science center, focused on spurring innovation in the development and evaluation of safer and more effective medications.

The UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI) has been formally launched with an initial FDA grant of $3.3 million.

Kathy Giacomini, PhD

Professor & CERSI Co-Director

My research focuses on membrane transporters, which are of great importance to drug disposition and response. I am particularly interested in genetic variants in membrane transporters that are determinants of drug response and in harnessing transporters to enhance drug targeting. 

Drug Development Course Teaches Professionals to See Bigger Picture

The path from scientific insight to a new drug used to treat patients is a long, expensive, inefficient, hazard-strewn obstacle course requiring many steps before the drug arrives at the pharmacy. Unfortunately, the specialists working at each of these steps do not necessarily have a clear vision of what goes on outside their own areas of expertise. As a result, they can be unaware of how the decisions they make impact other points in the cycle of drug or medical product development.