How a continuous approach solves the bottleneck of submission publishing
Biopharma organizations often overlook publishing as a final step in the submission process because it doesn’t require the same strategic rigor as other regulatory activities. However, it can become the most stressful and error-prone part of the operation when a problem with publishing halts a submission at the last minute and stops submission development entirely.With a continuous publishing solution in place, companies can proactively mitigate risk and address issues much earlier in the submission cycle, so publishers can review, analyze, and submit a quality application without teams working inefficiently or overtime.
Why publishers struggle with current submissions publishing strategies
Typically, publishers will face several challenges when assembling and submitting a dossier. They must work across separate systems to share, view, and publish files while tracking their progress in inefficient, manual spreadsheets. It also takes time and effort to match and hyperlink keywords and ensure consistent messaging throughout the submission.After they add internal and external navigation, publishers must move files to a submission validation tool for assessment before the submission can be reviewed. If the file does not pass review, they have to go back through the process from the start and resubmit to the validation tool. Tight deadlines compound all of these challenges. If a publisher needs to search for documents, rework content due to errors, or re-submit an application, they must scramble to finish everything in time.
Each piece of the regulatory puzzle is crucial for a successful submission. Teams that work in siloed regulatory systems struggle to keep up with mounting submission volumes and the increasingly fast pace of the industry.
Creating an end-to-end submission publishing strategy
By incorporating publishing activities into a unified RIM solution, biopharma organizations can flip those challenges into collaborative opportunities and mitigate compliance risks.With continuous publishing, teams may use submission content plans to create a table of contents, auto-match relevant documents, and easily repurpose information across regions. They can also real-time using intelligent automation and review key items earlier in the submission process. When the dossier is ready, publishers transmit it directly to health authorities through an integrated gateway. Aggregating these publishing tasks within a single RIM system reduces the risk of last-minute changes or misaligned messaging and speeds overall submission times by moving the publishing work upstream.
This new approach to regulatory publishing was already gaining traction with leading biopharma companies and helped Dermavant Sciences submit an NDA six weeks before their deadline. Rather than take the traditional path, Dermavant utilized a continuous publishing strategy to create, validate, and review eCTD published output within the same system where they created their original submission documentation. This created a faster and more accurate submission process with publishing activities integrated at all life cycle points. As the director of global regulatory systems and information management at Dermavant stated, “We want to make it the center of our regulatory universe, not just the machine that pushes the content through and makes submissions''. Dermavant continues to strive for more efficient publishing with additional training and template reuse across teams.
Brii Biosciences also wanted a way to handle high volumes of submissions with better efficiency and effectiveness than traditional publishing strategies. They committed to building an end-to-end solution that integrated publishing and submission activities, and they invested in training programs to help facilitate the shift to the new platform. As a result, they were able to deliver their first amendment within 30 days of switching. As Brii Biosciences’ regulatory operations consultant shared, “I think that once you start to throw everything you know about publishing, and how it’s traditionally operated, out the door, and you start with a clean slate, you’ll be able to transform your organization.”
To learn more about how continuous publishing can benefit your organization, read this e-book.
Vicki Cookson is Director, Vault RIM Strategy, Veeva Systems
