Join FDA/PhUSE Working Groups to Help Harness the Power of Computational Science
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Join FDA/PhUSE Working Groups to Help Harness the Power of Computational Science
Drug Information Journal 46(5) 523-524 ª The Author(s) 2012 Reprints and permission: sagepub.com/journalsPermissions.nav DOI: 10.1177/0092861512456839 http://dij.sagepub.com
Lilliam A. Rosario, PhD1, Timothy J. Kropp, PhD1, Stephen E. Wilson, PhD1, and Charles K. Cooper, MD1
Consumers are often pleased by the accuracy with which online shopping websites are able to recommend new products they may be interested in. For example, how did the favorite shopping website of your wine-enthusiast neighbor, who recently purchased a highly durable dog crate for her separation anxiety–stricken canine, know that she would also be interested in 2 items not typically bought together: a do-it-yourself wine cork bulletin board kit and canine calming herbal supplements? Amazon.com, Pandora Radio, and Netflix, to name a few, have developed innovative means to weed through and translate the heaps of data generated from a consumer’s search and ‘‘purchase’’ history into precise product recommendations. Advances in information technology that have been extremely successful for consumer information delivery have also provided effective solutions to data-heavy projects in translational science, genomics, and business analytics. These advances have engendered fields and businesses that regulatory stakeholders can leverage against the mountains of data that accompany each medical product application in order to speed review time, reduce and refine clinical trial requirements, pinpoint postmarket safety signals, and facilitate regulatory science efforts, to name a few potential benefits. Increasingly complex informatics and data challenges must first be addressed in order to harness the potential of medical product development data. Aggregation and curation of data collected from various sources, in various forms, are heavy tasks in existing scientific environments. Data standards and associated tools can make the job of transforming data into knowledge a fast, efficient, and highly repeatable process. The first step, increasing the accessibility of data with standards, is only an enabling step. The full benefit of standardized data can only be actualized when combined with systems, tools, and procedures that allow the user to easily find answers to the scientific and regulatory questions that they face. The FDA and Pharmaceutical Users Software Exchange (PhUSE) have teamed up to tackle these challenges using collaboration, crowd sourcing, and innovation, a strategy
similar to one used in 2011 by scientists who were unable to solve the crystal structure of a key retroviral protein. These innovative scientists cast a wide net in order to reach a solution by challenging nonscientist gamers to model the protein’s structure using their intuition and a protein folding game. In 3 weeks, gamers were able to accomplish what biochemists had been unable to achieve for more than a decade and provided the field with new insights for the design of antiretroviral drugs.1 S
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