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Emerging Safety Science

Workshop Summary


Washington (DC): National Academies Press (US); .
ISBN-13: 978-0-309-11012-9ISBN-10: 0-309-11012-2


The application of emerging science to drug safety is one of the goals of the FDA's Critical Path Initiative. A 2004 FDA white paper, Innovation or Stagnation: Challenge and Opportunity on the Critical Path to New Medical Products, describes this evolution as follows:"Not enough applied scientific work has been done to create new tools to get fundamentally better answers about how the safety and effectiveness of new products can be demonstrated, in faster time frames, with more certainty, and at lower costs. In many cases, developers have no choice but to use the tools and concepts of the last century to assess this century’s candidates. As a result, the vast majority of investigational products that enter clinical trials fail…. A new product development toolkit—containing powerful new scientific and technical methods such as animal or computer-based predictive models, biomarkers for safety and effectiveness, and new clinical evaluation techniques—is urgently needed to improve predictability and efficiency along the critical path from laboratory concept to commercial product. (FDA, 2004:5)"

Since the publication of that report, significant progress has been made in the development of just such techniques. But the diffusion of these innovations in drug development and drug review has been limited. To address this concern, the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation sponsored a public workshop— Emerging Safety Science—with the goal of surveying new technologies that can be used to better understand and predict the safety and toxicity of new drugs. The workshop was held April 23–24, 2007, at the FDA’s White Oak Conference Center.


Sally Robinson, Robert Pool, and Robert Giffin, Rapporteurs.

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

Suggested citation:

IOM (Institute of Medicine). 2008. Emerging safety science: Workshop summary. Washington, DC: The National Academies Press.

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 © 2008, National Academy of Sciences.
Bookshelf ID: NBK4146PMID: 20669415DOI: 10.17226/11975


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