When Biological Sample Issues Become Regulatory Review Problems

Across Dr. Richard Graham’s work on five approved therapeutics, a pattern started to emerge: biological sample issues kept surfacing during regulatory review.

In this short webinar excerpt, Dr. Graham explains what led him to look more closely at clinical trial execution and what he uncovered when he mapped the path from sample collection to regulatory submission. His takeaway was not that one breakdown was to blame. It was the process itself.