Report
Note: Workshop Summaries contain the opinion of the presenters, but do NOT reflect the conclusions of the IOM. Learn more about the differences between Workshop Summaries and Consensus Reports.
In recent years, the costs of new drug development have skyrocketed. At the same time, each year fewer new molecular entities are approved, and recently several approved drugs have been withdrawn from the market for safety reasons. Finding ways to select successful drug candidates earlier in development could save millions or even billions of dollars, reduce the costs of drugs on the market, and increase the number of new drugs with improved safety profiles that are available to patients.
Traditional methods for assessing a drug's safety prior to approval are limited in their ability to detect rare safety problems, and these methods are unlikely to identify rare safety problems before a drug is marketed. There is, however, an emerging safety science that seeks to change this paradigm by attempting to understand a drug's safety or toxicity earlier in its development. This emerging science is focused in two areas: (1) the use of basic science to understand the mechanisms underlying toxicity and to predict when a particular compound will have safety issues; and (2) the use of new analytical tools for mining large data sets to identify signals that indicate safety problems and even to derive insights regarding a drug's mechanism of toxicity.
In April 2007, the Institute of Medicine's Forum on Drug Discovery, Development, and Translation convened a workshop entitled "Emerging Safety Science" to examine the use of emerging safety science technologies in drug development and to consider their application in the drug review process. This publication summarizes the presentations and discussions during that workshop.
Other Reports by this Activity
Displaying: 3 of 7 Reports
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Addressing the Threat of Drug-Resistant Tuberculosis: A Realistic Assessment of the Challenge. Workshop Summary
Tuberculosis is one of the leading causes of death in the world today, with 4,500 people dying from the disease every day. Many cases of TB can be cured by available antibiotics, but some TB is resistant to multiple drugs--a major and growing threat worldwide. The Institute of Medicine’s Forum on Drug Discovery, Development, and Translation hosted a workshop on November 5, 2008, to address the mounting concern of drug-resistant TB. The session brought together a wide range of international experts to discuss what is known and not known about this growing threat, and to explore possible solutions.
Released: August 26, 2009
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Accelerating the Development of Biomarkers for Drug Safety. Workshop Summary
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, 2008, the IOM’s Forum on Drug Discovery, Development, and Translation held “Assessing and Accelerating Development of Biomarkers for Drug Safety,” a one-day workshop on the value of biomarkers in helping to determine drug safety during development.
Released: June 19, 2009
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Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies. Workshop Summary
The process for developing new drug and biologic products is extraordinarily expensive and time-consuming—many consider the traditional model to be unsustainable. Although large pharmaceutical companies may be able to invest in the development of blockbuster drugs because they can expect a large return on their investment, these same organizations, when developing drugs to treat rare and neglected diseases, are unable to rely on such returns. On June 23, 2008, the Institute of Medicine’s Forum on Drug Discovery, Development, and Translation held a public workshop, “Breakthrough Business Models: Drug Development for Rare and Neglected Diseases and Individualized Therapies,” which sought to explore new and innovative strategies for developing drugs for rare and neglected diseases.
Released: February 19, 2009
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