Center for Drug Evaluation and Safety established at the University of Florida

The University of Florida has established the Center for Drug Evaluation and Safety, or CoDES, to unite researchers interested in using big data to evaluate drugs and the safety of medications in real-world populations.

Center for Drug Evaluation and SafetyMore than 20 drug safety researchers representing four of the six academic colleges at UF Health are members of the new center. With backgrounds in epidemiology, health economics and health services research, the multidisciplinary group will develop new methods and analytical tools to enhance drug evaluation and regulatory science. CoDES researchers will collaborate in five primary research interest areas, with an initial clinical focus on vulnerable populations who are commonly not included in clinical trials: pediatric, psychiatric and geriatric patients, as well as expectant mothers.

The research areas share a common interest in using big data but span a broad spectrum of drug safety initiatives from quality studies addressing how medications are used, misused and abused to Phase IV studies which evaluate drugs after clinical trials and regulatory approval. Additional research areas include pharmacoeconomic studies, which assess the value of medications and reimbursement potential; pharmaceutical predictive analytic studies that help determine the patients who will benefit most from certain medications; and pharmaceutical policy studies, which evaluate how public policies improve access and quality of drug therapy.

“CoDES brings a community of likeminded people and research interests together to share resources and ideas in making medications safer,” said Almut Winterstein, Ph.D., director of the UF Center for Drug Evaluation and Safety. “We have a lot of existing data, but we want to build more comprehensive data repositories that are tailored to our interest areas to allow us more in-depth evaluations.”

The UF College of Pharmacy department of pharmaceutical outcomes and policy’s data repository includes health care utilization data from more than 300 million patients. It will build the foundation of real-world data research supported by CoDES. In the new center, Winterstein envisions greater connections with electronic health records and clinical trial data to allow richer analysis and reporting, along with the development of new analytic tools that can support the center’s work with real-world data.

Located in the UF College of Pharmacy, the center will be led by Winterstein, a professor and the Dr. Robert and Barbara Crisafi Chair of Pharmaceutical Outcomes and Policy. An advisory committee featuring six members from UF Health and six external members from industry and regulatory agencies will provide strategy and direction, as well as identify new research opportunities and partnerships.

UF CoDES Advisory Committee – Internal Members

Joshua Brown, Pharm.D., Ph.D., M.S.
Assistant Professor, Department of Pharmaceutical Outcomes & Policy,
UF College of Pharmacy

Regina Bussing, M.D., M.S.
Professor and Chair, Department of Psychiatry
UF College of Medicine

Roger Fillingim, Ph.D.
Distinguished Professor, Department of Community Dentistry, College of Dentistry
Director, Pain Research and Intervention Center

Todd Manini, Ph.D.
Associate Professor, Department of Aging & Geriatric Research, UF College of Medicine
Core Leader, Data Science and Applied Technology Core & Program Director, Geriatric Informatics, UF Institute on Aging

David Nelson, M.D.
Interim Vice President, UF Health
Assistant Vice President for Research,
UF Director, CTSI
Professor, Department of Medicine, College of Medicine

Sonja Rasmussen, M.D., M.S.
Professor, Department of Pediatrics, College of Medicine & Department of Epidemiology,
College of Public Health and Health Professions and College of Medicine