On March 15-17, 300 people from PhUSE, FDA, CDISC, and Industry gathered together in Silver Spring, Maryland for the 4th Annual Computational Science Symposium (CSS). This event and ongoing collaboration is unique as it brings key stakeholders from across the product development and review processes to solve issues, explore new ideas, and work together to improve product lifecycle. The meeting kicked off with the FDA State of the Union where the FDA shared valuable information about how they are leveraging the standards, tools and processes to improve thei review process. Lilliam Rosario, Director, FDA Office of Computational Science and her colleagues provided real world examples of how reviewers are using the JumpStart program to assess the quality of their submission data, load data into various data analysis tools, and provide standard analyses for the reviewers. This overall process has enabled the FDA to assess quality within two weeks of submission and put analysis results in front of the reviewer within four weeks; a significant reduction in time within the review process.

After presentation of the JumpStart program, Armando Olivia provided an overview of the new and improved JANUS Clinical Trials Repository (CTR). He shared, that as of January, 2015, the CTR is in production at FDA with over 60 trials loaded and ready for analysis. With the final presentation, Steve Wilson explained that this was a different kind of conference – a collaborative working environment. Steve Wilson asked attendees to “move beyond their stake, roll up their sleeves and use their expertise to seek solutions”.

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For information about FDA contact the OCS Service Desk Monday – Friday/10:00 am to 4:00 pm Call - 240-402-0401 Email - OCSServiceDesk@fda.hhs.gov

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