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Cover of Accelerating the Development of Biomarkers for Drug Safety

Accelerating the Development of Biomarkers for Drug Safety

Workshop Summary

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Washington (DC): National Academies Press (US); .
ISBN-13: 978-0-309-13124-7ISBN-10: 0-309-13124-3

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. Accordingly, greater regulatory emphasis has been placed on the development and use of biomarkers in drug development, which has increased the urgency of accelerating preclinical and clinical research on these markers and establishing evidentiary standards for their use. Biomarker advocates tend to emphasize the progress that has been made, while many drug development teams and experts in clinical effectiveness are skeptical. In fact, both perspectives have merit, and the workshop summarized in this report provided some reassurance that biomarkers, placed in proper perspective, will advance both biomedical science and the pragmatic science of developing drugs that improve human health. At the same time, the workshop also demonstrated the inability of current biomarkers to substitute fully for actual measurement of the risks and benefits of interventions since multiple biological networks and pathways are always in play.

Contents

Steve Olson, Sally Robinson, and Robert Giffin, Rapporteurs.

This project was supported by the American Diabetes Association; the American Society for Microbiology; Amgen, Inc.; the Association of American Medical Colleges; AstraZeneca Pharmaceuticals; Blue Cross Blue Shield Association; the Burroughs Wellcome Fund; Department of Health and Human Services (Contract Nos. N01-OD-4-2139 and 223-01-2460); the Doris Duke Charitable Foundation; Eli Lilly & Co.; Entelos Inc.; Genentech; GlaxoSmithKline; the March of Dimes Foundation; Merck & Co., Inc.; Pfizer Inc.; and UnitedHealth Group.

Suggested citation:

IOM (Institute of Medicine). 2009. Accelerating the Development of Biomarkers for Drug Safety: Workshop Summary. Washington, DC: The National Academies Press.

Any opinions, findings, conclusions, or recommendations expressed in this publication are those of the author(s) and do not necessarily reflect the view of the organizations or agencies that provided support for this project.

NOTICE: The project that is the subject of this report was approved by the Governing Board of the National Research Council, whose members are drawn from the councils of the National Academy of Sciences, the National Academy of Engineering, and the Institute of Medicine.

Copyright © 2009, National Academy of Sciences.
Bookshelf ID: NBK32717PMID: 20464768
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