title: Process map proposal for the validation of genomic biomarkers.
abstract: How can we encourage the application of novel genomic biomarkers in drug development? A major step in this direction would be a consensus on how to interpret results from measurements of these biomarkers in regulatory submissions. A transparent process for genomic biomarker validation would be of value both for the pharmaceutical industry as well as for regulatory agencies associated with it. A discussion on process map proposals for genomic biomarker validation can help with drafting of guidance documents for this process.
authors.affiliation: US Food and Drug Administration, Genomics Group, Office of Clinical Pharmacology, Center for Drug Evaluation and Research, 10903 New Hampshire Avenue, Building 21, Room 3663, Silver Spring, MD 20903-0002, USA. Federico.Goodsaid@fda.hhs.gozv
authors.forename: Federico
authors.initials: F
authors.lastname: Goodsaid
authors.forename: Felix
authors.initials: F
authors.lastname: Frueh
mesh_terms: D000818:Animals; D004353:Drug Evaluation, Preclinical / Q000379:methods / Q000592:standards; D005819:Genetic Markers / Q000235:genetics*; D006801:Humans; D013678:Technology, Pharmaceutical / Q000379:methods* / Q000592:standards*; D014481:United States; D014486:United States Food and Drug Administration / Q000592:standards
chemical_list: D005819:Genetic Markers