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Oxidized PLs and Vascular Inflammation |
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| Authors: | Maceler Aldrovandi Valerie B O’Donnell |
| Institution: | 1. The Salutramed Group, Inc., Atlanta, GA, USA 2. The Division of Global Health and Social Medicine, Harvard Medical School, Boston, MA, USA 3. The School of Medicine, Dentistry and Biomedical Sciences, Queen’s University Belfast, Belfast, Northern Ireland, UK 4. HLM Venture Partners, Boston, MA, USA 5. Cardiometabolic Disorders, Mount Sinai Heart, New York, NY, USA 6. Department of Medicine, Icahn School of Medicine at Mount Sinai, New York, NY, USA |
| Abstract: | Future innovative therapies targeting cardiovascular disease (CVD) have the potential to improve health outcomes and to contain rising healthcare costs. Unsustainable increases in the size, cost and duration of clinical trial programs necessary for regulatory approval, however, threaten the entire innovation enterprise. Rising costs for clinical trials are due in large part to increasing demands for hard cardiovascular clinical endpoints as measures of therapeutic efficacy. The development and validation of predictive and surrogate biomarkers, as laboratory or other objective measures predictive or reflective of clinical endpoints, are an important part of the solution to this challenge. This review will discuss insights applicable to CVD derived from the use of predictive biomarkers in oncologic drug development, the evolving role of high density lipoprotein (HDL) in CVD drug development and the impact biomarkers and surrogates have on the continued investment from multiple societal sources critical for innovative CVD drug discovery and development. |
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