Foster City, CA

22nd February 2018

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


The first US SDE of 2018 was hosted by PointCross on February 22nd.  This event was held in the Wind Room at the Foster City Community Center in Foster City, California.  The theme of this event focused on innovation and automation within the study life cycle, which attracted many attendees from various Biopharmaceutical and CRO companies in the San Francisco Bay Area. Speakers covered topics and areas such as: automation and machine learning with non-clinical SEND submissions; how to ensure your submission supports the automated review process at the FDA and PMDA; putting data standards to work to fuel innovation; creation of define XML from metadata and meta programming; using SPARQL queries to automatically generate define.xml from clinical trial data as RDF; multi-modal signal detection for drug safety and surveillance; and finally, building quality and efficiency into biometrics tools and processes. This excellent event was successful because of the contributions from our sponsors, co-chairs, speakers, PHUSE Office and organizing committee. Thanks to all who volunteered and attended this event.



Accelerating Consistent and Quality Nonclinical SEND Study Submissions with Automation and Machine Learning – Suresh Madhavan & Kurien Abraham, PointCross

Raising the Bar for Data Standardization: How to Ensure Your Submission Supports the Automated Review Process at FDA and PMDA? – Sergiy Sirichenko, Pinnancle 21

Have Data Standards – Now What? Next Steps Required to Put Them to Work to Fuel the Furnace of Data Innovation – Gregory Steffens, Noumena Solutions

Selecting a Method for Creation of First Define-XML – Paul Hamilton & Sunil Pursarla, Omeros

Automatically Generate Define-XML from Clinical Trials Data as RDF with SPARQL Query – Ippei Akiya, DataDriven

Multimodal Drug Safety – Rave Harpaz, Oracle

Building Quality and Efficiency into Biometrics Tools and Processes – Linda Collins & David Brega, PharmaStat


View the event brochure.






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