July 29, 2014

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!

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July 16, 2014

High Quality Data

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.

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