SAS Drug Development adds genomics analysis capabilities

The era of personalised medicine is bringing targeted treatments to market that promise to deliver improved safety and efficacy. Scientists are combining molecular information with clinical outcomes to minimise the risks and maximise the benefits of prescription medicines.

In the United States, the FDA has provided several guidance documents that emphasise its expectation for the submission of molecular information with new drug applications to drive and support better clinical decision-making.

SAS, the leader in business intelligence, provides the premier research and development platform for enabling this type of science by integrating genomic and proteomic-specific analyses into SAS Drug Development (http://www.sas.com/industry/pharma/develop/index.htm), SAS's flagship data management and analysis solution for pharmaceutical, medical device and biotechnology firms.

More than 90 processes for molecular analyses - powered by JMP software - are incorporated into SAS Drug Development, addressing these specific areas:

* Genetics: For genetic marker data, case-control or pedigree experiments. Useful for characterising 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 utilisation 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's 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," says 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 customisable, 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 modernise 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 organisations to easily incorporate molecular information into clinical decision-making while allowing life science organisations 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," says Bill Hoggarth, Managing Director of SAS South Africa. "Having a common environment for integrating data and analysis across the entire drug development process will give customers of this solution a unique advantage."

For more information on SAS Drug Development and SAS's proven solutions for the life sciences industry, please visit: http://www.sas.com/industry/pharma/develop.