Biomarkers and Sustainable Innovation in Cardiovascular Drug Development: Lessons from Near and Far Afield

被引：0

作者：

Medford, Russell M. ^{[1
]}

Dagi, T. Forcht ^{[1
,2
,3
,4
]}

Rosenson, Robert S. ^{[5
,6
]}

Offermann, Margaret K. ^{[1
]}

机构：

[1] Salutramed Grp Inc, Atlanta, GA USA

[2] Harvard Univ, Sch Med, Div Global Hlth & Social Med, Boston, MA USA

[3] Queens Univ Belfast, Sch Med Dent & Biomed Sci, Belfast, Antrim, North Ireland

[4] HLM Venture Partners, Boston, MA USA

[5] Mt Sinai Heart, Cardiometab Disorders, New York, NY USA

[6] Icahn Sch Med Mt Sinai, Dept Med, New York, NY USA

来源：

CURRENT ATHEROSCLEROSIS REPORTS | 2013年 / 15卷 / 05期

关键词：

High density lipoprotein; HDL functionality; Macrophage cholesterol efflux; Biomarker; Atherosclerosis; Cardiovascular disease; Clinical trials; Low density lipoproteins; Statins; Predictive; Cost-benefit; Investment; Healthcare costs; Risk; Validation; Adaptive clinical trial; Regulatory pathways; Archived clinical sample; Genetics; Surrogate; Drug development; Oncology; DENSITY-LIPOPROTEIN CHOLESTEROL; CORONARY-HEART-DISEASE; BREAST-CANCER; HDL SUBPOPULATIONS; GENE-EXPRESSION; BATTLE TRIAL; RISK; ATHEROSCLEROSIS; PREVENTION; EVENTS;

D O I：

10.1007/s11883-013-0321-0

中图分类号：

R6 [外科学];

学科分类号：

1002 ; 100210 ;

摘要：

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.

引用

页数：8

共 68 条

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