SAS(R) Drug Development Adds Genomic-Analysis Capabilities; Solution Addresses Biomarkers, Incorporates Molecular Information
SAS, the leader in business intelligence, today announced new genomic-analysis capabilities for its flagship life sciences offering, SAS(R) Drug Development http://www.sas.com/industry/pharma/develop/index.html . These new capabilities will make it easier for pharmaceutical companies to analyze genetic data and incorporate this analysis into new drug applications.
In today’s era of personalized medicine, pharmaceutical companies are leveraging huge amounts of genetic and other patient data to develop treatments that are safer, more effective, and more targeted. By combining molecular information – how genetic variations influence a patient’s response to a drug – with clinical outcomes, scientists and researchers are minimizing the risk and maximizing the benefit of prescription medicines. And the use of this data will continue to grow; the U.S. Food and Drug Administration (FDA) now expects molecular information within New Drug Applications in order to drive and support better clinical decision-making.
SAS Drug Development is a powerful data management and analysis solution for pharmaceutical, medical device and biotechnology firms. More than 90 processes for genomic and proteomic-specific molecular analyses – powered by JMP(R) software – are now incorporated into SAS Drug Development, addressing the areas of:
— Genetics. For genetic marker data, case-control or pedigree experiments. Useful for characterizing genetic variability and evaluating its association with biological effects, such as disease or adverse events.
— Microarrays. For gene expression or RNA transcript abundance data. Useful for investigating gene utilization to understand disease or biological processes.
— Proteomics. For spectral data on peptides or metabolites. Useful for identifying protein biomarkers and their association with disease or traits.
“SAS’ new integrated add-on is a forward-thinking innovation that will enable clinical researchers to better access biomarker data using the flexible Web-based clinical framework provided by SAS Drug Development,” said Dr. Alan Louie, Research Director at Health Industry Insights, an IDC Company. “Additionally, as retrospective biomarker data begins to be developed for Phase 4 drug testing, these new molecular analysis capabilities will help to accelerate knowledge capture, analysis and dissemination across the pharmaceutical development pipeline.”
The solution provides a customizable, collaborative system to address biomarkers – a key area in the Critical Path Initiative http://www.fda.gov/oc/initiatives/criticalpath/, the FDA’s effort to stimulate and facilitate a national effort to modernize the scientific process through which a potential human drug, biological product or medical device is transformed from a discovery or “proof of concept” into a medical product. It also enables organizations to easily incorporate molecular information into clinical decision-making while allowing life science organizations to facilitate regulatory compliance, meet requirements for traceability of analytical results and simplify global collaboration.
“Extending the capabilities of SAS Drug Development to incorporate biomarkers into clinical research lays the groundwork for companies wanting to take the next step in bridging the existing silos of information between research and development,” said Laurie Rose, Director of Global Health and Life Sciences for SAS. “Having a common environment for integrating data and analysis across the entire drug development process will give customers of this solution a unique advantage.”
Today’s announcement was made at the 42nd Annual Meeting of the Drug Information Association, where SAS solutions for the life sciences as well as its continued support for industry data standards will be featured in various presentations. For more information on SAS Drug Development and SAS’ proven solutions for the life sciences industry, please visit: http://www.sas.com/industry/pharma/develop .
About SAS
SAS is the leader in business intelligence software and services. Customers at 40,000 sites use SAS software to improve performance through insight into vast amounts of data, resulting in faster, more accurate business decisions; more profitable relationships with customers and suppliers; compliance with governmental regulations; research breakthroughs; and better products. Only SAS offers leading data integration, intelligence storage, advanced analytics and traditional business intelligence applications within a comprehensive enterprise intelligence platform. Since 1976, SAS has been giving customers around the world The Power to Know(R). www.sas.com
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