A Perspective on Challenges and Issues in Biomarker Development and Drug and Biomarker Codevelopment

    Authors

    S. E. Taube; G. M. Clark; J. E. Dancey; L. M. McShane; C. C. Sigman;S. I. Gutman

    Comments

    Authors: contact us about adding a copy of your work at STARS@ucf.edu

    Abbreviated Journal Title

    J. Natl. Cancer Inst.

    Keywords

    GROWTH-FACTOR RECEPTOR; CELL LUNG-CANCER; HER2-POSITIVE BREAST-CANCER; METASTATIC COLORECTAL-CANCER; CLINICAL-TRIAL DESIGN; ADJUVANT; CHEMOTHERAPY; PREDICTIVE MARKER; KRAS MUTATIONS; GENE-MUTATIONS; OVARIAN-CANCER; Oncology

    Abstract

    A workshop sponsored by the National Cancer Institute and the US Food and Drug Administration addressed past lessons learned and ongoing challenges faced in biomarker development and drug and biomarker codevelopment. Participants agreed that critical decision points in the product life cycle depend on the level of understanding of the biology of the target and its interaction with the drug, the preanalytical and analytical factors affecting biomarker assay performance, and the clinical disease process. The more known about the biology and the greater the strength of association between an analytical signal and clinical result, the more efficient and less risky the development process will be. Rapid entry into clinical practice will only be achieved by using a rigorous scientific approach, including careful specimen collection and standardized and quality-controlled data collection. Early interaction with appropriate regulatory bodies will ensure studies are appropriately designed and biomarker test performance is well characterized.

    Journal Title

    Journal of the National Cancer Institute

    Volume

    101

    Issue/Number

    21

    Publication Date

    1-1-2009

    Document Type

    Article

    Language

    English

    First Page

    1453

    Last Page

    1463

    WOS Identifier

    WOS:000271575100007

    ISSN

    0027-8874

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