The FDA has selected UC San Francisco (UCSF) as the site of a new regulatory science center on the West Coast. The center, which will be a joint effort between scientists in the UCSF School of Pharmacy and Stanford University, aims to spur innovative approaches in drug development that will support the FDA's ability to evaluate and approve safe and effective new medications.
Launched with an initial $3.3 million FDA grant, the UCSF-Stanford Center of Excellence in Regulatory Science and Innovation (UCSF-Stanford CERSI) will bring together a world-class team of scientists from the two academic institutions with partners at the FDA to conduct collaborative research, as well as a range of education and scientific exchange programs.
These programs will build on UCSF and Stanford's strengths in quantitative sciences and focus on three priority areas: improving preclinical safety and efficacy tests, improving clinical trials and evaluation and harnessing diverse data sets through information sciences to accelerate and improve new drug development.
"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 Stephen M. Ostroff, M.D., FDA's acting chief scientist. "To meet these challenges, regulatory science research and training requires multidisciplinary and interdisciplinary collaboration, not only within FDA, but with our partners in academia, like UCSF and Stanford. The results of this partnership will ultimately benefit patients and the medical community."
The new center comes at a time when the pharmaceutical and biotechnology industries are increasingly looking to tap into informatics and data-driven computer models, known as quantitative pharmacology, to help improve drug development and identify new therapies that will be safer, more precise and have fewer side effects. Those new technologies are of equal interest to the FDA in assessing which medications are safe and effective for patients.
"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, Ph.D., a professor in the UCSF School of Pharmacy and co-chair of the UCSF Center for Quantitative Pharmacology. "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 partnership, for which Giacomini is a co-Principle Investigator with Stanford professor Russ Altman, M.D., Ph.D., pairs UCSF's experience in pharmacology and therapeutic sciences with Stanford's experience in biomedical informatics.
"Data on drug action at all levels, from molecular to population, is exploding and requires sophisticated computational integration to fully understand it," said Altman, who is professor of bioengineering, genetics and medicine, and director of the Biomedical Informatics Training Program at Stanford. "We are bringing together the best minds in therapeutics, genetics and computational sciences to transform how drugs are made and how we assess whether they're safe or not."
It also will bring West Coast representation to the CERSI network, which now is only in the Washington, D.C. area, and enable FDA to access UCSF and Stanford's resources in quantitative sciences and pharmacology. The center will be the fourth in the CERSI network, which includes a new center at Johns Hopkins University and two centers set up in 2011, at the University of Maryland and Georgetown University.
"Our long-term expertise in quantitative science and pharmacology and our Pacific Rim location will benefit the kinds of novel collaborations among academia, industry and the FDA the CERSI enables," said B. Joseph Guglielmo, PharmD, dean of the UCSF School of Pharmacy. "The end result will be better, more effective products for patients."
The center also will tap into the experience of UCSF scientists in the California Institute for Quantitative Biosciences (QB3) and the UCSF Institute for Computational Health Sciences.
The center will include two highly collaborative units. The Education-Exchange Unit will provide courses in regulatory sciences, building on UCSF's six-year-old certificate program, the "American Course in Regulatory Sciences and Innovation," with additional online courses adapted from curricula at UCSF and Stanford. It also will offer exchange programs for FDA and academic scientists, as well as an FDA internship program for students and postdoctoral scholars.
The Collaborative Research Unit will focus on two collaborative research projects between FDA and academic scientists that involve the development and application of quantitative pharmacological methods to problems in regulatory sciences: (a) predicting drug-induced weight gain, a major safety issue for many approved drugs and (b) the development of the first comprehensive, data-driven, biomarker-guided disease progression model of multiple sclerosis, which will facilitate drug evaluation and approval.
The joint UCSF-Stanford CERSIs will be managed by the FDA's Office of Regulatory Science and Innovation, together with teams of scientists from across the FDA.