Veeva Systems Europe’s Paul Attridge highlights how a switch to a continuous model for regulatory operations could allow biopharmaceutical companies to submit high-quality regulatory submissions for their products faster than ever before.
Like continuous manufacturing, which is widely employed in other industries and is starting to show signs of adoption in life sciences, continuous publishing aims to improve efficiency, quality, and speed
Life sciences companies are increasingly focused on improving operational speed and efficiency. Across the industry, companies are looking for new ways to reduce costs to protect margins. This includes regulatory operations.
“Continuous publishing” is one such approach. Like continuous manufacturing, which is widely employed in other industries and is starting to show signs of adoption in life sciences, continuous publishing aims to improve efficiency, quality, and speed. It replaces serial publishing with a parallel process that enables regulatory teams to identify issues in real-time. This means validation errors can be resolved faster and manual hand-offs can be eliminated, significantly reducing the processing time from planning to submission.
Transitioning to Seamless Regulatory Submissions
The process of submitting information to regulators is disjointed and cumbersome, involving multiple systems, contributors, and tracking spreadsheets.
If manufacturing changes occur, new submissions are needed, which can take up to four steps to publish. Firstly, a submission plan must be created. This is followed by authoring and reviewing of documents in the submission by the regulatory team. Documents that are approved are then either linked or transferred to a publishing tool, where PDF navigation is added by publishers, who, lastly, compile and validate the submission to make it ready for subsequent staging and delivery. For an agency with an electronic submissions gateway, the sponsor will then transfer the submission to the gateway through another tool.
In addition to the document management system, publishing tool, file-sharing system, and viewing tool used in the process described above, spreadsheets are likely used for planning and tracking. The gaps that exist between all these systems create inefficiencies, contribute to delays, and increase the potential for errors as documents are handled and passed through the process.
Take for instance a biopharmaceutical firm looking to complete a submission such as a Marketing Authorization Application (MAA) for novel broad-spectrum antibiotics which will treat an antibiotic-resistant infection. One at a time, each individual or group contributed their part to the submission using their tool of choice. Documents were sent back and forth to plug in missing information in an attempt to answer questions. Come time to publish, all the necessary documents then had to be transferred from the companies’ systems to a publishing tool so the submission could be processed. The long, drawn-out process was made more arduous by the fact the firm could only see issues once the published output was run through a separate submission validation tool. Any corrections then had to be made and the process repeated until all issues were resolved. For a sizeable filing like an MAA, this could take several runs.
The firm’s director of regulatory operations explained that one of the major problems with this traditional approach was that issues only became apparent after the submission was published, and quality control was only introduced at the end of the line. In contrast, “With a continuous model, regulatory teams can identify any errors and address broken links to source data as the submission is being built so teams don’t have to go through the lengthy re-publishing process over and over. By the time you are ready to publish, the submission is already quality checked and correct.”
The firm now engages in continuous publishing, with most of the submission-readying processes carried out in a single, unified system. In addition to tracking and tagging each submission, planning information pertaining to the submission, such as content requirements and links to existing documents, can be included in the same system.
This workflow-driven process moves documents and the plan itself through different lifecycle stages. It allows the submission plan to become an automatically-publishable structure that provides clear visibility across the entire process. Publishing activities, including adding bookmarks and navigation, move upstream with content creation, while activities such as hyperlink testing, XML compilation, and validation are automated, running in the background.
Time Saving Benefits of Continuous Publishing
Continuous publishing reduces a week-long exercise to one that takes just hours. It can also automatically match documents to the submission structure, eliminating the effort needed to achieve this in a traditional publishing model. We have seen customers cut submission times by half by using this system.
The quality of submissions is also improved because validations are carried out behind the scenes from the outset, so issues are identified earlier when they are easier to fix.
There is also less compliance risk because the continuous publishing approach eliminates the need for non-secure file-sharing; documents remain in one unified system that offers total visibility from beginning to end.
Taking Publishing to the Next Level by Unifying Regulatory
While traditional publishing has been evolving for decades, progress has been slow and the process remains inefficient, putting pressure on already-tight timelines. From clinical-stage pharmaceutical companies to commercial organizations, these delays can have a significant impact.
Regulatory teams using a wide range of disparate systems has resulted in the disjointed nature of submission publishing and contributed to a slower, serial process. Despite the number of systems in place, publishers are currently forced to spend vast amounts of time ensuring everything is in sync rather than focusing on publishing.
Less, not more, technology is the solution to this problem. One unified cloud-based system delivers an end-to-end regulatory process, offering transparency and consolidating steps to make continuous publishing possible. It also enables more collaborative working practices, as authors, reviewers and publishers can work on documents in the submission concurrently, eliminating versioning issues and cutting the time spent preparing submissions.
As in manufacturing, switching to a continuous model in regulatory operations gives life sciences companies the opportunity to publish high-quality submissions ready to deliver to health authorities faster than ever before.