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 At the same time, each year fewer new molecular entities are approved, and recently several approved drugs have been withdrawn from the market for safety reasons.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 14 Reports
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Strengthening a Workforce for Innovative Regulatory Science in Therapeutics Development - Workshop Summary
The development and application of regulatory science – which FDA has defined as the science of developing new tools, standards, and approaches to assess the safety, efficacy, quality, and performance of FDA-regulated products – calls for a well-trained, scientifically engaged, and motivated workforce. FDA faces challenges in retaining regulatory scientists and providing them with opportunities for professional development. In the private sector, advancement of innovative regulatory science in drug development has not always been clearly defined, well coordinated, or connected to the needs of the agency. As a follow-up to a 2010 workshop, the IOM held a workshop on September 20-21, 2011, to provide a format for establishing a specific agenda to implement the vision and principles relating to a regulatory science workforce and disciplinary infrastructure as discussed in the 2010 workshop.
Released: December 21, 2011
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Public Engagement and Clinical Trials: New Models and Disruptive Technologies - Workshop Summary
Clinical trials provide essential information needed to turn basic medical research findings into patient treatments. New treatments must be studied in large numbers of humans to find out whether they are effective and to assess any harm that may arise from treatment. There is growing recognition among many stakeholders that the U.S. clinical trials enterprise is unable to keep pace with the national demand for research results. The IOM, along with the Mount Sinai School of Medicine, held a workshop June 27-28, 2011, to engage stakeholders and experts in a discussion about possible solutions to improve public engagement in clinical trials.
Released: October 14, 2011
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Advancing Regulatory Science for Medical Countermeasure Development - Workshop Summary
Whether or not the United States has safe and effective medical countermeasures—such as vaccines, drugs, and diagnostic tools—available for use during a disaster can mean the difference between life and death for many Americans. The Food and Drug Administration (FDA) and the scientific community at large could benefit from improved scientific tools and analytic techniques to undertake the complex scientific evaluation and decision making needed to make essential medical countermeasures available. At the request of FDA, the IOM held a workshop to examine methods to improve the development, evaluation, approval, and regulation of medical countermeasures.
Released: June 15, 2011
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