Title

A Perspective On Challenges And Issues In Biomarker Development And Drug And Biomarker Codevelopment

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.

Publication Date

11-1-2009

Publication Title

Journal of the National Cancer Institute

Volume

101

Issue

21

Number of Pages

1453-1463

Document Type

Review

Personal Identifier

scopus

DOI Link

https://doi.org/10.1093/jnci/djp334

Socpus ID

70449370331 (Scopus)

Source API URL

https://api.elsevier.com/content/abstract/scopus_id/70449370331

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