At a time when Big Pharma is increasingly tapping academic institutions for expertise in informatics and data-driven computer models for drug discovery, the FDA has selected Johns Hopkins University, Stanford University and the University of California, San Francisco (UCSF) for a new initiative aimed at streamlining the drug development and approval process.
Under the FDA's Centers of Excellence in Regulatory Science and Innovation (CERSI) program, UCSF will be the site of a new regulatory science center on the West Coast. The center will bring together researchers in the UCSF School of Pharmacy and Stanford University in an effort to help spur new approaches in drug development.
Launched with an initial $3.3 million FDA grant, the UCSF-Stanford center will focus on three key areas: improving preclinical safety and efficacy tests, improving clinical trials and evaluation, and harnessing diverse data sets through information sciences to improve and speed up new drug development.
"The pharmaceutical and biotech industries are facing huge challenges, with the majority of drugs failing in clinical trials because they are not effective," said Kathy Giacomini, a professor in the UCSF School of Pharmacy and co-chair of the UCSF Center for Quantitative Pharmacology, in a statement. "These new computer-based models are enabling us to predict how the human body metabolizes a drug, the drug's toxicity and its effectiveness in preventing and treating various human diseases, as well as how that varies across a population of diverse people. This partnership will enable us to develop new models and methods, and also move these technologies out of academia and into practice."
The UCSF-Stanford partnership is the first West Coast site in the CERSI network, which so far includes the University of Maryland and Georgetown University.
In addition, Johns Hopkins University is joining CERSI to advise the agency on clinical studies and evaluations, in which Johns Hopkins will select specific projects for collaborative training and investigation with FDA scientists.
Rolled out in 2011, the FDA's CERSI program is meant to address regulatory challenges in the food, drug and medical products fields at a time of rapid technological advancements.
- read the news releases from UCSF and Johns Hopkins