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Diagnostics and biomarker development: priming the pipeline

Nature Reviews Drug Discovery volume 5, pages 463–469 (2006)Cite this article

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.

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Figure 1: Medical products and diagnostics development models.
Figure 2: Prototype of possible approach to developing and regulating combined test–drug products.

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Acknowledgements

We are grateful to our anonymous interviewees and thank them for their time and interest. This work was partially supported by the Center for Devices and Radiological Health at the FDA through an independent consulting agreement with K.A.P. All opinions are those of the authors and should not be construed as endorsement by the FDA.

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Authors and Affiliations

  1. the School of Pharmacy, Institute for Health Policy Studies, and UCSF Comprehensive Cancer Control Program, University of California San Francisco, 3333 California Street, Room 420, UCSF BOX 0613, San Francisco, 94143, California, USA

    Kathryn A. Phillips & Stephanie Van Bebber

  2. the Program in Personalized Medicine and Targeted Therapeutics, Abramson Center for the Future of Health, University of Houston and The Methodist Hospital, 300 Technology Building Houston, Texas, 77204-4021, USA

    Amalia M. Issa

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FURTHER INFORMATION

Evaluation of Genomic Applications in Practice and Prevention

Minimum Information About a Microarray Experiment

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Phillips, K., Van Bebber, S. & Issa, A. Diagnostics and biomarker development: priming the pipeline. Nat Rev Drug Discov 5, 463–469 (2006). https://doi.org/10.1038/nrd2033

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