Foster City, CA

22nd February 2018

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Marching at the Double-quick to Successful Submissions with Innovative Automation within the Study Life Cycle


In the past ten years, new standards have affected the entire drug development lifecycle from data collection through to regulatory submission. Developed by CDISC, ICH, NCI, HL7, W3C, ISO and even the FDA, they have the potential to support more seamless interoperability and process automation. It’s up to us in the industry to make that potential a reality through the effective use of standards by the software and processes we develop and use.

Looking ahead, new standards and processes will integrate new sources of data, such as automated biometric data capture and next-generation genomics data, into the familiar world of clinical data collection and analysis. These new data types are key to developing the next generation of precision pharmaceuticals. The standards to support them will emerge from industry and ultimately find their way into the standards catalogues of regulatory agencies.

This event will focus on practical ways in which the industry can respond to the challenges of improving efficiency and integrating new data sources. We’ll hear about case studies in process improvement that accelerated time to successful submissions, and about software tools and techniques to integrate new data types and enable process efficiencies.


Foster City Community Center 1000 E. Hillsdale Boulevard - Wind Room
Foster City, CA


Time Presentation Presenter
8.30 - 9.15 Registration  
9.15 - 9.30 Welcome & Introduction to Keynote Lisa Brooks,
Iris Statistical Computing
9.30 - 10.00 Accelerating Consistent and Quality Nonclinical SEND Study Submissions with Automation and Machine Learning Suresh Madhavan &
Kurien Abraham,
10.00 - 10.30 Raising the Bar for Data Standardization: How to Ensure Your Submission Supports the Automated Review Process at FDA and PMDA? Sergiy Sirichenko,
Pinnancle 21
10.30 - 11.00  Morning Break  
11.00 - 11.45 Have Data Standards – Now What? Next Steps Required to Put Them to Work to Fuel the Furnace of Data Innovation Gregory Steffens,
Noumena Solutions
11.45 - 12.00 Selecting a Method for Creation of First Define-XML Paul Hamilton &
Sunil Pursarla,
12.00 - 13.00 Lunch  
13.00 - 13.15 PhUSE Update and Working Group Introduction Chris Hurley,
PhUSE Americas Director
13.15 - 13.45 Automatically Generate Define-XML from Clinical Trials Data as RDF with SPARQL Query Ippei Akiya,
13.45 - 14.15 Multimodal Drug Safety Rave Harpaz,
14.15 - 14.45 Afternoon Break  
14.45 - 15.30 Building Quality and Efficiency into Biometrics Tools and Processes Linda Collins &
David Brega,
15.30 - 16.00 Panel Discussion and Closing Remarks  

Catering and refreshments will be provided throughout the day.

SDE Chairs:

Lisa Brooks, Iris Statistical Computing

Kunaal Madhavan, PointCross

If you have any questions, or require any information, please contact the SDE Co-Chair.


If you are interested in sponsoring this event, click here.


Courtyard by Marriott San Mateo Foster City


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