Two Rapidly Growing Pharmas Share Lessons for Speeding Submission Prep and Audit Responses

It has been busy following this year’s R&D Summit, and on behalf of Jim Reilly and myself, we want to thank everyone who joined us in the regulatory track. For those who weren’t able to join, we’d like to share a few highlights starting with the terrific buzz coming into the room. People were clearly excited by Jen Goldsmith and Avril England’s keynote demo and the possibilities that emerge when managing both documents and data in a unified application suite. The energy from the keynote and our new RIM announcement translated into a series of highly interactive sessions.

To start, Hilary Hafeken discussed how United Therapeutics is streamlining document authoring and submission preparations with Vault Submissions. Key for them to address were the difficulties users had finding documents, and the lack of document planning and status reporting in their prior system. Interestingly, when rolling out the system, they didn’t provide live classroom training. Instead, they created four interactive e-learning modules that users can replay as needed, and that required users to pay attention during the training. A second emphasis from Hilary was on the improved performance they’ve seen within the publishing process: Vault renditions generate faster and files transfer quickly when dragged and dropped to their publishing system. Hilary wrapped up with their plans for adopting the full Vault RIM suite and the anticipated benefits from connecting health authority correspondence to related commitments, product registrations, submissions, and source documents.

Frank Bosley from The Medicines Company provided insights into a challenge that is topical of late: mergers and acquisitions. Frank shared the story of The Medicines Company’s rapid growth due to acquisition, and laid out their change management strategy within regulatory. The approach centered on codifying new, standardized processes in system-driven workflows; consolidating resources through a rigorous in-person vetting process; and prioritizing ease-of-use for any new technologies to be used.

One of the most actively discussed topics was the dramatic difference The Medicines Company anticipates in how they respond to regulatory events and requests for information. During the keynote, Frank described responding to an internal audit of label changes and the approximately 45 resource-hours it took to complete. Compare that to the self-serve report that they’ll generate in minutes once they add Vault Registrations and Vault Submissions Archive and have the complete Vault RIM suite. Special thanks to The Medicines Company for agreeing to share their presentation.