UCSF launches DC Center to improve drug safety and effectiveness

By Wallace Ravven

Aiming to improve drug safety and efficacy and to significantly boost the efficiency of drug development, the UCSF School of Pharmacy has reached across the country to add the Washington, DC-based Center for Drug Development Science to its research enterprise.

CDDS is credited with modernizing drug development and regulation with advanced scientific methods of clinical drug testing.

CDDS is now part of UCSF and is called the UCSF Center for Drug Development Science, Washington DC Campus. It is located in the UC Washington Center, home to programs run by each of the UC campuses.

The new alliance will broaden UCSF’s programs in fields essential to modern drug development such as computational biology and pharmacogenomics—the study of how genetic variation affects drug tolerance. UCSF is one of the nation’s pioneers in this young field. At the same time, the close research and educational exchange is expected to infuse expertise in pharmacogenomics and human genetics into the Center’s on-going drug development research program.

The collaboration was initiated by UCSF’s biopharmaceutical sciences department, which will be the Center’s administrative home. Scientists in the University’s School of Pharmacy were joined by School of Medicine colleagues to launch the new bi-coastal partnership with CDDS.

The 11-year old Center, formerly part of Georgetown University, will continue to be directed by its founder, Carl Peck, MD, who played a key role with other CDDS colleagues in the development of the FDA Modernization Act of 1997. CDDS scientists demonstrated to Congress the power of scientifically advanced approaches, such as computer modeling and simulation, to forecast and clarify clinical trial outcomes. As a result, the new Act assured that sound scientific data could be used to improve the clinical trial process and better assure assessment of safety and efficacy. CDDS has also assisted the pharmaceutical and biotechnology industries in incorporating computer modeling and simulation tools to increase the efficiency of evaluating clinical trials and assessing safety and efficacy.

“CDDS has a great record of developing methods to evaluate safety and efficacy of new drugs,” said Kathleen Giacomini, PhD, chair of biopharmaceutical sciences at UCSF. “The Center has an international reputation for using powerful computational methods that can help identify genetic or other traits likely to affect an individual’s drug reactions—information that is crucial to personalizing medicine. I am sure the CDDS expertise will add a vital dimension to our efforts to develop new approaches for designing drugs and analyzing their safety and performance.”

In addition to providing an opportunity for graduate students to study the computational approaches pioneered at CDDS, UCSF is also launching a new course at the UC Washington Center for FDA and industrial scientists in pharmacokinetics—the study of how drugs and metabolites change over time in various parts of the body, and the mathematical modeling needed to predict these changes.

CDDS director Carl Peck is former director of the FDA’s Center for Drug Evaluation and Research. He began his career in scientific drug evaluation as a fellow in clinical pharmacology at UCSF. His CDDS colleague David Feigal, MD, is former director of the Center for Medical Devices and Radiological Health at the FDA.

“I’m excited that CDDS can join forces with the UCSF scientists in the schools of pharmacy and medicine and the Division of Clinical Pharmacology, each of which has such a sustained record of research and teaching in drug discovery and evaluation,” Peck said. “The chance to work too with scientists at QB3 (the new UCSF-based California Institute for Quantitative Biomedical Research) will invigorate both enterprises.”

Mary Anne Koda-Kimble, PharmD, dean of the UCSF School of Pharmacy, said of the new collaboration: “We are thrilled to welcome Carl and his colleagues as new members of our School and the larger UCSF community. Our drug research covers all points along the way—from the computer manipulation of target molecules to the tracking of drug transport across cell membranes to the study of the best use of real, tangible drug products on the health of individuals and populations. The CDDS adds to the strength of our work and that of the whole campus.”

David Kessler, MD, dean of the UCSF School of Medicine and former FDA Commissioner, said, “Knowing Carl Peck, David Feigal and their CDDS colleagues, I fully expect UCSF’s involvement with the Center to accelerate progress on fundamental new methods for responsible development of effective new drugs that are safe for those who need them the most.”

CDDS represents UCSF’s first presence in Washington, DC. Scientists and staff moved into the UC Washington Center at the end of 2004, and CDDS is now fully operational in its new location, six blocks from the White House.

“The CDDS really serves as a model for the UC Washington Center’s dual aims: educating the next generation of leaders and accelerating new discovery,” said UC Washington Center director Larry Berman, PhD.

UCSF’s Department of Biopharmaceutical Sciences has been a leader in the fields of pharmacokinetics, pharmacodynamics, modeling and simulation—all vital to understanding drug metabolism and performance. In the last few years, the department launched new programs in bioinformatics, systems biology and pharmacogenomics, enabling its scientists to play a major role in translating discoveries in molecular biology, genetics, genomics and proteomics to the development of new drugs.  Key faculty scientists in the department, along with colleagues in the UCSF-based California Institute for Quantitative Biology (QB3), UCSF Division of Clinical Pharmacology and researchers in the San Francisco Bay Area’s biotechnology community have launched a new initiative, called the Joint Enterprise for Therapeutic Sciences, or JETS, to work with FDA scientists to improve development of safer and more effective medicines. CDDS is expected to play a major role in this enterprise.

The University of California Washington Center provides expanded teaching, research, and public service programs for students and faculty at all UC campuses by providing access to the resources and opportunities available in the nation’s capital. The Center is a multi-campus instructional and research facility that supports an experiential learning environment.