How Continuous Publishing Speeds Regulatory Submissions
John Lawrie
Vice President, Vault RIM
Veeva Systems
A

cross the life sciences industry, companies are increasingly focused on how they can improve the speed and efficiency of their operations. This is especially true now with greater attention being paid to drug prices. From the clinical through the commercial phases, companies are seeking unique ways to reduce costs to maintain their margins; regulatory operations is no exception.

One new approach being explored is “continuous publishing,” which reduces steps in a traditionally lengthy process. Continuous publishing replaces serial publishing with a parallel process where regulatory teams identify issues in real time rather than waiting until the end. This allows regulatory teams to resolve validation errors faster and eliminate cumbersome manual hand-offs to significantly reduce time from planning to submission.

Continuous publishing is similar to continuous manufacturing, another promising model that’s widespread in other industries and is starting to replace traditional batch manufacturing in the life sciences. Vertex, Johnson & Johnson, and Eli Lilly are a few of the earliest adopters of continuous manufacturing, which is essentially an end-to-end assembly line where raw ingredients are seamlessly processed in a single production line that ends with the finished product. As is the case with continuous publishing, the aim is to improve efficiency, quality, and speed.

The Move from Serial to Seamless

Currently, submitting information to regulators is a disjointed process that can involve multiple systems, contributors, and tracking spreadsheets. It’s a step-by-step approach similar to batch manufacturing instead of being, more desirably, one seamless process.

When an event such as a manufacturing change triggers a new submission, companies must go through as many as four steps to publish that submission. The first step is to create a submission plan. Next, the regulatory team authors and reviews individual documents in the submission. The approved documents are either transferred or linked to a publishing tool, where publishers add PDF navigation. Finally, publishers compile and validate the submission so it is ready for subsequent staging and delivery. If the agency has an electronic submissions gateway, the submission is then transferred to the gateway via another tool.

At least five systems or tools are involved in this process, including a document management system, a publishing tool, a file share system, a viewing tool, and one or more spreadsheets for planning and tracking. Each gap between systems introduces inefficiencies, delays, and potential for errors as documents move in and out of these systems.

A biopharmaceutical firm focused on the design and development of novel broad-spectrum antibiotics for the treatment of antibiotic-resistant infection, managed the submission process using various tools, spreadsheets, and Gantt charts across a dozen different users. Each person or team contributed their part to the submission, such as a New Drug Application (NDA), one at a time and spent additional time emailing documents back and forth to get answers to questions or find missing information. The process was long and required careful coordination across teams.

When it came time to publish, the firm needed to take the extra step of transferring all of the necessary documents from their systems into a publishing tool to process the submission. The process grew even longer because, as with many traditional publishing models, this firm could only see issues after running the published output through a separate submission validation tool. Then, after correcting errors, this lengthy validation process needed to be repeated until all issues were resolved. For a large filing like an NDA, this could require several rounds.

“One of the biggest challenges with this approach is that you don’t know if there are issues with your submission until after you publish. Then, you get a validation report, make all the corrections, and re-submit to the publishing tool. It’s a tedious process and wastes valuable time,” explained the firm’s director of regulatory operations.

“This is a very common issue across the industry. Publishing documents must always go through this QC (quality control) process, which may happen multiple times and always at the end of the line,” she continued. “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.”

Continuous publishing is now possible at the firm because most of the submission-readying processes are carried out in a single, unified system. Every submission is tracked and tagged with planning information that specifies which country it’s connected to, the submission type, the expected submission dates, and more. Within the same system, the firm can also develop a submission content plan that outlines required content and includes links to existing documents and those that still need to be created.

Traditional publishing activities such as adding bookmarks and navigation are moved upstream with content creation, while other activities such as hyperlink testing, XML compilation, and validation are automated and running behind the scenes as documents become ready for publishing. This workflow-driven process moves documents and the plan itself through various lifecycle stages and allows the submission plan to become an automatically publishable structure. With every step connected, there is real-time tracking for clear visibility across the entire process, up to and beyond submission.

Benefits of Continuous Publishing

Continuous publishing makes the submission process significantly faster, easier, and more efficient. It can turn a week of effort into just hours while dramatically reducing time spent on tracking or searching. In addition, continuous publishing automatically matches documents to the submission structure, eliminating redundant effort otherwise required in a traditional publishing model.

“Continuous publishing allows us to cut out hours of tedious rework by not having to recreate the submission in an external publishing tool. Using this system, we have cut submission time by at least half,” said the director of regulatory operations.

Continuous publishing also improves the quality of submissions because validations are performed behind the scenes and from the start, so any issues are identified earlier in the process when they are easier to fix. “In the traditional serial publishing process, you review documents in the system, arrange them into a submission structure, and rebuild that in the publishing tool,” she explained.

“You must take documents out of a secure system to move them into a publishing tool and then they often go out to an unsecure file share. However, with a continuous publishing approach in one unified system, there’s less compliance risk because there’s total visibility from beginning to end. The result is a higher quality submission created faster.”

Unify Regulatory to Enable New Model

Traditional publishing has been evolving – in fact, companies have been using electronic formats for decades, even considering that eCTD submissions were not required by the FDA until just last year. However, progress has been slow, and the process remains inefficient, causing delays during crunch time when timelines are tightest. These delays are as impactful on clinical-stage pharmaceutical companies–such as with investigational product reporting and compliance, managing protocol amendments, and safety reporting–as they are on commercial organizations, managing global complexities like labelling and manufacturing changes that impact multiple markets.

The number of disparate systems commonly used by regulatory teams has created the current disjointed nature of submission publishing and contributed to a slower, serial process. Even with all these systems in place, current processes and systems require publishers to spend a lot of time keeping everything in sync instead of focusing on publishing.

The answer is not more technology, but less. One unified system in the cloud brings together the end-to-end regulatory process, providing transparency and consolidating steps to make continuous publishing possible. This also enables new, more collaborative ways of working by bringing authors, reviewers and publishers closer together and enabling them to work on the same documents in the same submission at the same time. It eliminates versioning issues and improves quality while ultimately reducing overall time spent preparing submissions.

With continuous publishing, life sciences companies can explore a new model. As in manufacturing, switching to a continuous model in regulatory operations provides the industry with a new opportunity to deliver high-quality submissions to health authorities faster than ever before.

Back to Issue