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Evaluation of Biomarkers and Surrogate Endpoints in Chronic Disease
main research interest is the molecular mechanisms that control protein expression in ischemic, necrotic heart, and skeletal muscle. He is also involved in directing and participating in national multicenter clinical trial studies involving biochemical markers of myocardial injury. In addition, Dr. Apple consults with diagnostic, medical instrument, and pharmaceutical industries in the areas of forensic toxicology, clinical toxicology, and chemistry through his limited liability company.
Dr. Apple has been actively involved in National Institutes of Health (NIH), VA, and industry-sponsored research studies involving the application of cardiac, vascular, inflammatory, and ischemic biomarkers for the detection of myocardial cell damage and reperfusion injury identified as either ischemic or inflammatory. He also has an interest in risk stratification and outcomes research. In addition, he has led investigations in sports medicine that concern the biochemistry of exercise. Dr. Apple is also an active participant in studies addressing forensic/postmortem analysis of drugs and alcohol in tissues, blood, and vitreous humor. Other endeavors involve ethanol pharmacokinetics and substance testing. Additionally, Dr. Apple has participated in a number of professional societies, such as the Academy of Clinical Laboratory Physicians and Scientists, National Committee for Clinical Laboratory Standards, American Association for Clinical Chemistry, and American Board of Clinical Chemistry.
Robert M. Califf, M.D., is currently vice chancellor for Clinical Research, director of the Duke Translational Medicine Institute (DTMI), and professor of medicine in the Division of Cardiology at the Duke University Medical Center. Dr. Califf’s role as director of the DTMI, which is funded in part by an NIH Clinical and Translational Science Award (CTSA), includes service as cochair of the Principal Investigators Steering Committee of the CTSA. He is also the cochair of the Clinical Trials Transformation Initiative, a public–private partnership focused on improving the clinical trials system.
Dr. Califf graduated from Duke University, summa cum laude and Phi Beta Kappa, and from Duke University Medical School, where he was selected for Alpha Omega Alpha. He performed his internship and residency at the University of California–San Francisco and his fellowship in Cardiology at Duke University. He is board certified in Internal Medicine and Cardiology and is a master of the ACC. For 10 years, Dr. Califf was the founding director of the highly esteemed Duke Clinical Research Institute (DCRI). Dr. Califf led the DCRI in many of the best known clinical trials in cardiovascular disease. With an annual budget of over $100 million, the DCRI has more than 1,000 employees and collaborates extensively with government agencies, the medical products industry, and academic partners around the globe in all therapeutic areas.