Every year as many as 100,000 patients in US hospitals die as the result of adverse drug reactions. How many of those deaths could be avoided if we knew in advance which drugs were safe and which weren't for each and every patient? And beyond those dire cases, how much more effectively could we treat sick people if we knew which variants they carried in their genomes and how what that meant for their response to certain drugs? Welcome to the rapidly developing field of pharmacogenomics. Its mission is to examine the genomes of patients and to use that information to prescribe the right drugs at the right dose. Pharmacogenomics promises to allow us to use existing drugs in a more rational way, and to develop new drugs that are safer and more effective.
Scientists at IGSP are engaged in genomic medicine research efforts designed to address these questions, with particular focus in cardiovascular therapies and cancer. The Center has also formed a formal committee, the Genetic Testing Advisory Committee, to advise the Duke Health System about which of the growing list of genetic tests on the market should be routinely offered to Duke patients, with existing pharmacogenomic tests as its top priority.
Geoffrey S. Ginsburg, M.D., Ph.D. is the Director for Genomic Medicine in the Duke Institute for Genome Sciences & Policy. He is also Professor of Medicine and of Pathology at Duke University Medical Center. His research interests are in the development of novel paradigms for developing and translating genomic information into medical practice and the integration of personalized medicine into health care.
Susanne B. Haga, PhD is an IGSP Scholar and an Assistant Research Professor. She received a PhD in Human Genetics from the University of Maryland, Baltimore in 1999, and dual majored in biology and chemistry at Western Maryland College, graduating Phi Beta Kappa and magna cum laude.
Gary Lyman received his MD from the University at Buffalo SUNY School of Medicine & Biomedical Sciences in 1972. He went on to receive his MPH in Biostatistics from Harvard University (Massachusetts) in 1982. His clinical interests involve care of breast cancer patients with a focus on managing early-stage patients for staging/prognostic evaluation and clinical decision making.
Svati H. Shah, MD, MHS, is an Assistant Professor of Medicine in the Division of Cardiology, Department of Medicine. Her research focuses on genetic epidemiology and gene-environment interactions in complex cardiovascular diseases, including dyslipidemia, premature coronary artery disease, aortic stenosis, and peripheral vascular disease.
Deepak Voora, MD, is an Associate Investigator in the IGSP and an Instructor of Medicine in the Division of Cardiology. Dr. Voora's research interests lie in the area of cardiovascular pharmacogenetics. Using a broad array of genomic technologies from genotyping, resequencing, gene expression, and metabolomics he probes the response to a variety of cardiovascular medications.
Predicting Response and Resistance to Cardiovascular Therapies:
The goal of these studies is to utilize genetic and genomic tools to develop robust pharmacogenomic predictors of response and adverse events for medications used to treat cardiovascular disease. One series of studies with Deepak Voora, MD, and Svati Shah, MD, utilizes a SNP based approach in the STRENGTH cohort to develop of predictors of response and adverse events to 'statins' – cholesterol-lowering agents.
Deepak Voora, MD, is also leading a study of aspirin resistance using both the peripheral blood and platelet transcriptomes and serum proteomics to develop novel signatures predictive of the effects of this important cardiovascular therapeutic. The work is taking place within the The Duke Clinical Research Unit (https://dtmi-plone.dcri.duke.edu/about-us/organization/duke-clinical-research-unit), a state-of-the-art research facility located within the Duke University Medical Center campus that provides infrastructure support for identifying and validating novel biomarkers. This study is now supported by an NIGMS Challenge Grant (1RC1-GM091083-01, Geoff Ginsburg MD, PhD, PI).
Comparative Effectiveness Research in Cancer Pharmacogenomics:
Vexing questions in the field of genomic biomarkers are: How do we build the evidence to support their clinical use? And what is their clinical value? The objective of this NCI-funded program led by Geoff Ginsburg, MD, PhD, and Gary Lyman, MD, is to develop an innovative framework for clinical effectiveness research (CER) for cancer pharmacogenomics. Specifically we have coordinated expertise from three existing state-of-the-art and unique entities at Duke – the Duke Institute for Genome Sciences & Policy Cancer Pharmacogenomic Biomarkers Program (IGSP-CPBP), the IGSP Clinical Genomics Studies Unit (IGSP-CGSU), and the Duke Health Services, Effectiveness and Outcomes Research Program (DHSEORP) - into a single entity, the Duke Center for Clinical Effectiveness of Cancer Pharmacogenomics. This new Center will be part of a network wholly focused on CER for genomic and personalized medicine in cancer. Developing a longitudinal sample and clinical data registry for cancer patients treated in the Duke Health System is a major emphasis of this project. The registry will provide the opportunity for discovery and validation of cancer biomarkers developed at Duke and also from the published literature.
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