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Biomarkers and sustainable innovation in cardiovascular drug development: lessons from near and far afield

Russell M Medford1, T Forcht Dagi, Robert S Rosenson

  • 1The Salutramed Group, Inc., Atlanta, GA, USA. rmedford@salutramed.com

Current Atherosclerosis Reports
|March 21, 2013
PubMed

Insights

Biomarkers can reduce clinical trial costs for cardiovascular disease (CVD) therapies. Predictive and surrogate biomarkers, like high-density lipoprotein (HDL), offer objective measures to streamline drug development and ensure innovation.

Area of Science:

  • Biomedical research
  • Cardiovascular medicine
  • Drug development

Background:

  • Cardiovascular disease (CVD) therapies offer potential health improvements and cost savings.
  • Rising clinical trial costs, driven by hard clinical endpoints, threaten CVD therapeutic innovation.
  • Biomarkers are crucial for assessing therapeutic efficacy and ensuring continued investment.

Purpose of the Study:

  • To review the role of predictive and surrogate biomarkers in cardiovascular disease (CVD) drug development.
  • To explore insights from oncologic biomarker applications for CVD.
  • To discuss the evolving role of high-density lipoprotein (HDL) in CVD drug development.

Main Methods:

  • Literature review of biomarker applications in cardiovascular disease (CVD) and oncology.
  • Analysis of the impact of biomarkers on clinical trial design and cost-effectiveness.
  • Examination of high-density lipoprotein (HDL) as a biomarker in CVD.

Main Results:

  • Predictive and surrogate biomarkers can serve as objective measures for therapeutic efficacy.
  • Biomarkers can potentially reduce the size, cost, and duration of clinical trials.
  • High-density lipoprotein (HDL) plays an evolving role in CVD drug development.

Conclusions:

  • Biomarker development and validation are essential for sustainable innovation in cardiovascular disease (CVD) therapies.
  • Objective measures like biomarkers can mitigate rising clinical trial costs.
  • Continued investment in CVD drug discovery relies on efficient and effective development pathways.

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