title: Diagnostics and biomarker development: priming the pipeline.
abstract: The decrease in the rate at which novel medical products are reaching the market, despite major scientific achievements and investment that might have predicted otherwise, is causing much concern. Although this 'pipeline problem' has often been discussed in the context of drug development, it is also crucial to examine the unique characteristics of the pipeline for biomarkers and diagnostics. Here, we characterize the pipeline problem for biomarkers and diagnostics, and consider what steps could be taken to solve it.
authors.affiliation: School of Pharmacy, Institute for Health Policy Studies, and University of California San Francisco, 3333 California Street, Room 420, UCSF BOX 0613, San Francisco, California 94143, USA. phillipsk@pharmacy.ucsf.edu
authors.forename: Kathryn A
authors.initials: KA
authors.lastname: Phillips
authors.forename: Stephanie
authors.initials: S
authors.lastname: Van Bebber
authors.forename: Amalia M
authors.initials: AM
authors.lastname: Issa
mesh_terms: D015415:Biomarkers; D003226:Congresses as Topic; D015195:Drug Design; D004864:Equipment and Supplies; D006801:Humans; D007407:Interviews as Topic; D014481:United States; D014486:United States Food and Drug Administration
chemical_list: D015415:Biomarkers