Stanford and UCSF Establish Center For Drug Development
Stanford University has partnered with the University of California, San Francisco (UCSF) in order to establish the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (CERSI). The project is supported by the FDA, which will be providing a $3.3 million grant in order to get the center up and running. The center’s aim is to make drug development and regulatory approval easier. Researchers will do this by focusing on three important areas: boosting preclinical safety and efficacy tests, improving clinical trials and evaluation, and pulling together various data sets to speed and better focus new drug development.
The drug development center will utilize researchers from Stanford and the School of Pharmacy at the University of California San Francisco. Dr. Stephen Ostroff, the FDA’s acting chief scientist, said that partnering with these two academic centers would help improve research and drug discovery. “New tools, methods, and approaches are under development that are necessary in a globalized regulatory environment and for translating new discoveries into innovative medical treatments,” said Ostroff. “To meet these challenges, regulatory science research and training requires multidisciplinary and interdisciplinary collaboration, not only within FDA, but with our partners in academia, including UCSF and Stanford.”
Industry analysts estimate that the risks associated with developing new drugs often push costs of development to the $5 billion range, which could scare away prospective drug researchers. However, new computer based models are being created and used in research to allow researchers to predict the toxicity of a drug and how the human body will metabolize it. These new models could help drive down costs and make drug research more efficient. This partnership, according to Kathy Giacomini, a pharmacy professor at UCSF, will enable the two universities “to develop new models and methods, and also move these technologies out of academic and into practice.”