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The Center’s purpose is to create a uniquely rigorous and integrative academic translational science program in quantitative clinical pharmacology with a focus on personalized medicine. Integral to this mission is the education and training of doctoral students and post-doctoral fellows in the discipline of drug development and regulatory science (DDRS). Using systems biology approaches, researchers study drug activities, targets and clinical effects to support and advance translational research, which improves the process of bringing new drugs to market for improved patient therapies, including personalized medicines.
Goals and Objectives
The Center’s programs, enabled through five pillars, support its mission to:
- Train DDRS practitioners with customized subspecialties and research areas related to drug development, regulatory, clinical practice or methods development.
- Conduct applied research proximal to clinical trials and/or clinical practice oriented toward problem solving through quantitative analysis, drug-disease modeling/simulation, and clinical trial design.
- Establish partnerships with industry in context of drug development programs supporting data analysis and decision-making as well as regulatory strategies.
- Serve as a neutral forum among industry, FDA and other stakeholders to encourage multi-directional communication, and policy development to facilitate advancement of DDRS.
- Disseminate new knowledge through credible publications and presentations and become an influential voice for DDRS to demonstrate the value of pharmacometrics and systems pharmacology.
- Cardiovascular diseases
- Diabetes & Obesity
- Infectious diseases
- Orphan drugs
- Special patient populations, such as pediatric rare diseases
Our research focuses on
- Improving success rates of phase II and III clinical trials by applying modeling and simulation techniques to de-risk clinical trials by allowing for more informed decision-making
- Development of physiologic and mechanism-based disease models, particularly in the area of diabetes, obesity, cardiovascular, and oncology in close collaboration with our partners in industry and in Orlando
- Improving drug safety through the use of systems pharmacology knowledge platforms delineating causal pathways to adverse events
- Integrating novel technology into the drug development science to facilitate the identification, qualification, and implementation of biomarkers and approvable endpoints, including metabolomics and proteomics