Premium
Industry Perspective on Biomarker Development and Qualification
Author(s) -
Gerlach Cory V.,
Derzi Mazin,
Ramaiah Shashi K.,
Vaidya Vishal S.
Publication year - 2018
Publication title -
clinical pharmacology and therapeutics
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 1.941
H-Index - 188
eISSN - 1532-6535
pISSN - 0009-9236
DOI - 10.1002/cpt.919
Subject(s) - biomarker , perspective (graphical) , drug development , clinical trial , pharmaceutical industry , selection (genetic algorithm) , regulatory science , risk analysis (engineering) , business , medicine , drug , pharmacology , computer science , pathology , biochemistry , chemistry , artificial intelligence
Pharmaceutical and biotechnology companies routinely use biomarkers to obtain quantitative metrics for drug exposure, efficacy, and safety and to inform clinical trial design with regard to patient selection, treatments, and outcomes. Biomarker science has the unique capability to catalyze precompetitive collaborations between academia, industry, regulatory agencies, and other stakeholders with the ultimate goal of accelerating the delivery of safe and effective medicines to patients, particularly in areas of high unmet need.