title: Biomarkers and sustainable innovation in cardiovascular drug development: lessons from near and far afield.
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.
authors.affiliation: The Salutramed Group, Inc., Atlanta, GA, USA. rmedford@salutramed.com
authors.forename: Russell M
authors.initials: RM
authors.lastname: Medford
authors.forename: T Forcht
authors.initials: TF
authors.lastname: Dagi
authors.forename: Robert S
authors.initials: RS
authors.lastname: Rosenson
authors.forename: Margaret K
authors.initials: MK
authors.lastname: Offermann
mesh_terms: D015415:Biomarkers; D002317:Cardiovascular Agents / Q000627:therapeutic use*; D002318:Cardiovascular Diseases / Q000188:drug therapy*; D008076:Cholesterol, HDL; D002986:Clinical Trials as Topic / Q000191:economics*; D017277:Drug Approval / Q000191:economics; D055808:Drug Discovery / Q000191:economics; D006801:Humans; D009369:Neoplasms / Q000188:drug therapy
chemical_list: D015415:Biomarkers; D002317:Cardiovascular Agents; D008076:Cholesterol, HDL