On October 9, 2014, the Pinnacle 21 tour bus rolled over the Golden Gate Bridge and into Foster City, where we held our third OpenCDISC Live event. And what an event it was.

We kicked off with a brief history of OpenCDISC, where Max Kanevsky, Pinnacle 21 president and CEO, talked about the origins of the project and how it has evolved over years. Attendees then received tutorials on two FDA programs — JumpStart and DataFit — and learned why both are so critical to the modern FDA review process.

The second stop on the OpenCDISC Live 2014 Tour, in East Hanover, NJ, was a lively and engaging event, and we thank everyone who attended.

In addition to providing tutorials on two FDA programs — JumpStart and DataFit — our subject matter experts covered how to create FDA-compliant Define.xml 2.0 files. Attendees also got a sneak peek of OpenCDISC Community v2.0, the next-generation of our gold-standard open-source software.

OpenCDISC Live is making its way to the San Francisco Bay Area for the West Coast swing of our 2014 tour!
Enjoy this opportunity to meet the creators of OpenCDISC face-to-face, ask questions, collaborate and learn.

In our first West Coast Forum, we'll be discussing how to prepare for the new FDA JumpStart and DataFit processes.
We'll also give you an in-depth look at OpenCDISC Enterprise and show you how its new advancements can assist
the process.

OpenCDISC Live is making its way to North Jersey for the second stop on
our 2014 tour!

Our first OpenCDISC Live event — in Boston, earlier this summer — drew more than 100 attendees, and a wealth of thoughtful discussions around JumpStart, DataFit, and the modern FDA approval process.

The “Creating Define.xml 2.0 with OpenCDISC” webinars that ran on August 12th and 14th seemed to have served a big need. We had a total of 311 attendees across the two webinars, and received many thoughtful questions.

Bottom line: a lot of you have been struggling with Define.xml, and are excited to have a tool that can create FDA-compliant Define.xml 2.0 files so quickly and assuredly. But, as with any new technological solution, there is a learning process involved.

There has been a lot of buzz about DataFit of late. The FDA announced it as a new project that will enable the organization to “effectively leverage standard data to advance the review process.” But this new project is more than ten years in the making.

OpenCDISC Live is making its way to North Jersey for the second stop on our 2014 tour! Enjoy this opportunity
to meet the developers of OpenCDISC face-to-face, ask questions, collaborate and learn.

In our second Forum, we'll be discussing how to prepare for the new FDA JumpStart and DataFit processes. We'll also give you an in-depth look at OpenCDISC Enterprise and show you how its new advancements can assist the process.

Registration is open for the next meeting, scheduled for September 17, 2014 from 1-5pm. The meeting will be hosted by by Bristol-Myers Squibb at their Hopewell Campus. Web conferencing will also be available. Please register by Friday, September 5. The link to register: https://www.survey-expert.com/surveyIndex.asp?U=6009005008101025352

Meeting agenda:

• Alex Loboda, Eisai:  How to ensure good quality data in your submission
• Vineet Jain, independent consultant:  Robust approach to create Define.xml 2.0
• Marcelina Hungria, DIcore Group:  SDTM / Overview and Status of the new Ophthalmic Examinations (OE) Domain Mode
• Vincent Guo, Novartis:  Model X-Ray Image Data into ADaM BDS Structure – Specialty Data for a Complex and Important Efficacy Endpoint that Assesses Joint/Bone Structural Damage and Progression
• New feature:  Panel discussion

See you there!

You’ve probably heard of JumpStart by now. The FDA is describing it as a “service [that] is modernizing the drug review process.” But how, and why? And how can the pharmaceutical and biotech industries benefit from it?

One of the big drivers of this change was time. Currently, when the FDA receives a submission, reviewers spend up to 45 days just to assess the quality of that submission. They have to first churn through enormous files — some of which are gigabytes in size — to determine if the data quality and content are strong enough to support the review. Between the time spent by the FDA to conduct this “pre-review,” and the time spent by the submitting organization to fix these issues and resubmit, valuable months are often wasted.

Thanks to all who attended the first OpenCDISC Live Forum in Boston, MA!

This inaugural CDISC and FDA educational event was a resounding success. Topics covered included the challenges and opportunities presented by JumpStart, DataFit, and the modern FDA approval process.