Prepare for Industry Changes by Switching to Continuous Publishing

Submissions publishing can be a time-consuming process, often full of delays and rework. This creates unnecessary compliance risk, and takes time away from value-added activities like content messaging and mitigating risk for industry changes like eCTD 4.0 and IDMP. Recognizing this challenge, forward-thinking regulatory teams are using a parallel approach to submission management called continuous publishing.

Continuous publishing allows for the simultaneous and iterative completion of traditional downstream publishing tasks alongside traditional upstream planning and authoring tasks. This speeds and streamlines the entire submission preparation process and encourages more focus on the quality of submissions.

In order to execute continuous publishing successfully, companies must break down information silos, streamline communication, and automate or eliminate redundant steps. Companies should also be prepared to elevate roles that empower team members to bring more value to the process.

Comparing traditional and continuous publishing

In traditional publishing models, publishing teams have to wait for content approval before starting publishing tasks for a given document. Publishers often review and validate submission output only when the entire submission or a given module is completed. The final submission quality check often happens just days before the final submission is due to go out. Once stakeholders see the final published output, they often recognize content revisions that they didn’t catch when they reviewed the individual documents. Correcting last-minute content revisions and validation errors can strain a team’s ability to stay on track for submission timelines.

The traditional publishing approach has many steps that introduce unnecessary complexity and redundancy, such as:

• Planning the outline and tracking progress in a separate tool from where documents are authored and the published output is generated.
• Creating multiple versions of the same file to accommodate different steps in the process or move the files between different tools.
• Manually creating hyperlinks only after the cross-reference is made and the document is approved.

Traditional Publishing

With continuous publishing, teams can publish in parallel with planning and authoring. Users can also conduct content review and approval in the context of the final eCTD output without waiting until the final step. Continuous publishing:

• Allows content approvers to access the HA-centric view earlier, making it easier to follow links and check the consistency of messaging across documents before they are approved. This leads to high-quality content with fewer review cycles.
• Enables regulatory teams to address errors before the document is approved, saving rework and eliminating issue accumulation at the end of the submission process.
• Leverages data and document connectivity within a single platform to automate many “first pass” steps, allowing teams to focus more time and energy on collaboration, unified messaging, and quality control.

Continuous Publishing

Continuous publishing increases productivity

Moving publishing tasks upstream and onto a single, unified cloud platform increases collaboration and agility, leading to faster and cleaner submissions. With traditional publishing approaches, publishers must wait on other teams before hyperlinking and preparing documents for a submission. In continuous publishing, stakeholders can complete publishing tasks in tandem with submission planning and document authoring.

In 2023, Eli Lilly added a continuous publishing solution to their existing regulatory platform. Adding Vault Submissions Publishing to their unified RIM platform eliminated manual data entry of each content plan into an eCTD tool, which reduced publishing timelines and errors from manual data entry. By working more closely with submission teams, publishers could reduce multiple rounds of revisions to publish a submission.

Before implementing continuous publishing, publishers at Eli Lilly could not validate and review submission sections until the authoring of all submission documents within each section was completed. After changing its publishing process, each authored document can be published immediately and iteratively, saving time and resources on each submission. With a more efficient publishing process, Eli Lilly increased submissions output by 50%, from 400 submissions per month to 600 by the end of 2023.

Elevating roles and responsibilities for publishing teams

How well are companies prepared to make the switch to continuous publishing? Some biopharmas are concerned if the effort will be worth it or if their organization could support such a major change with automated publishing steps. Automation can be a scary word that implies a reduction in job opportunities. But continuous publishing is an opportunity to elevate publishers to a higher-impact role and improve productivity and agility for regulatory submissions.

In continuous publishing, publishers can eliminate time spent on manual work creating hyperlinks and bookmarks to become data and process stewards, who oversee the overall health of a submission from start to finish with higher-level publishing planning. Authors can become part of the publishing process with minimal change to their current approach. New training options and best practices can also help ease the transition for publishers with on-demand guidance on new features and use cases. Online training courses provide additional practice and guidance that ease the resistance to change for publishers who switch to continuous publishing.

Atara Bio sought to bring its publishing efforts in-house, believing that continuous publishing would eliminate the time constraints from traditional submission publishing tools and approaches. Expert authors could collaborate, link, and create content independently and in parallel with publishers, accelerating review and validation times and reducing time constraints. Authors and publishers can also work together on an overall content plan that addresses key project management issues like author and reviewer workloads. Atara Bio used this new process to streamline the European MAA submission for its first approved allogeneic T-cell cancer therapy.

Watch this short video to see a summary of the benefits of a continuous publishing solution, and this eLearning video to see how an online course can teach best practices for maximizing your use of continuous publishing.