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Innovation in personalized medicine: BiDil® as a case study for integrating clinical and policy developments
Amalia M Issa1, L Todd Weiss1, Waqas Tufail1
1The Methodist Hospital and University of Houston, Program in Personalized Medicine & Targeted Therapeutics and the Abramson Center for the Future of Health, 300 Technology Building, T2-309, Houston, TX 77204-4021, USA. aissa@uh.edu.
Abstract:
BiDil® (hydralazine and isosorbide dinitrate) represents an interesting application of personalized medicine - the first pharmaceutical specifically approved by a regulatory agency, the US FDA, for an indication in a particular population based on race as a surrogate phenotypic marker, without a companion genomic diagnostic directed at measuring drug responsiveness. The focus of this paper is to use BiDil as a case study of a personalized medicine application and evaluate its clinical and policy-relevant characteristics as an illustrative example of the usefulness of the Evaluation Data for Assessing Personalized Medicine Translation (EDAPT) evidence base.
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