Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary

ACCELERATING THE DEVELOPMENT OF BIOMARKERS FOR DRUG SAFETY. Workshop Summary. Steve Olson, Sally Robinson, and Robert Giffin.
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For more information, see the Bookshelf Copyright Notice. Hardcopy Version at National Academies Press. Excerpt As the cost of developing drugs has risen and the number of new drugs approved for use has fallen, many people have looked to the development of biomarkers as a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. Contents Expand All Collapse All. Expand All Collapse All. Other titles in this collection. The National Academies Collection: Reports funded by National Institutes of Health. Similar articles in PubMed.

Review The discovery and development of proteomic safety biomarkers for the detection of drug-induced liver toxicity.

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The statements and opinions contained in proceedings are those of the participants and are not endorsed by other participants, the planning committee, or the National Academies. Biomarkers can be defined as indicators of any biologic state, and they are central to the future of medicine. As the cost of developing drugs has risen in recent years, reducing the number of new drugs approved for use, biomarker development may be a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development.

On October 24, , the IOM's Forum on Drug Discovery, Development, and Translation held "Assessing and Accelerating Development of Biomarkers for Drug Safety," a one-day workshop, summarized in this volume, on the value of biomarkers in helping to determine drug safety during development.

Assessing and Accelerating Development of Biomarkers for Drug Safety

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Dr. Janet Woodcock Delivers Keynote at Biomarker Qualification Workshop

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The responsibility for the published workshop summary rests with the workshop rapporteurs and the institution. The purpose of this independent review is to provide candid and critical comments that will assist the institution in making its published report as sound as possible and to ensure that the report meets institutional standards for objectivity, evidence, and responsiveness to the study charge.


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The review comments and draft manuscript remain confidential to protect the integrity of the deliberative process. We wish to thank the following individuals for their review of this report:.


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    • Food and Drug Administration, U. Department of Health and Human Services. Although the reviewers listed above have provided many constructive comments and suggestions, they were not asked to endorse the final draft of the report before its release. The review of this report was overseen by Dr.

    Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary.

    New England Medical Center. Appointed by the Institute of Medicine, she was responsible for making certain that an independent examination of this report was carried out in accordance with institutional procedures and that all review comments were carefully considered. Responsibility for the final content of this report rests entirely with the authors and the institution. Biomarkers are central to the future of medicine. By providing a measure of a biological state, they can indicate normal biological processes, pathogenic processes, or responses to an intervention or perturbation in the environment.

    They can be used to monitor the on-target and off-target effects of medical interventions, including treatments for disease; they can be used in diagnostic and prognostic tests; and they can define the individuals and populations most likely to respond to therapy.

    At the broadest level, they can provide insight into biological pathways and networks. It is also important to recognize that biomarkers have limitations. In isolation, they reveal just one aspect of complex biological systems. Therefore, they may or may not be correlated with clinical outcomes, since other biological systems may override the particular marker being measured. The work needed to understand the relation of a biomarker to either a clinical outcome or a biological system can be enormous.

    Yet biomarkers are most powerful when they are linked with knowledge about biological systems, with empirical data about diagnostic and therapeutic trials, or with clinical outcomes derived from large populations. The power of modern biology comes from the ability to integrate disparate bases of knowledge, leading to better decisions.

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    As the cost of developing drugs has risen and the number of new drugs approved for use has fallen, many people have looked to the development of biomarkers as a way to cut costs, enhance safety, and provide a more focused and rational pathway to drug development. Accordingly, greater regulatory emphasis has been placed on the development and use of biomarkers in drug development, which has increased the urgency of accel-. Biomarker advocates tend to emphasize the progress that has been made, while many drug development teams and experts in clinical effectiveness are skeptical.