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How Lilly is Streamlining Regulatory Operations

Using agile methods, and starting with CMC post-approval submissions, an innovative team has brought the benefits of cloud-based RIM to users throughout the world.

In 2016, a cross-functional team at Lilly began to re-evaluate its approaches to global submissions and determine if newer technologies or processes could help improve efficiency. Reliance on traditional RIM software and manual processes hindered the regulatory team’s ability to keep up with submission volumes. This was especially true in the CMC space, explains Paula Hudson, senior director of global regulatory affairs, who led the team with Amber Karns, senior director of information and digital solutions.

The CMC portion of any submission is crucial to show regulators that the process for making a new therapy will consistently deliver safe and effective products. Getting it right is essential. Errors or data omissions, whether in pre-approval applications, post-approval supplementary applications, or annual reports, will delay patient access to therapies and compromise confidence in drug supply chains. However, collecting the data required can be time-consuming and costly, prompting the industry to study new ways to streamline the process by shifting from narrative to data-based applications.1

Starting with Post-approval CMC Submissions

Hudson and Karns started the project by evaluating the way postapproval CMC submissions were handled. The department that focused on these was relatively small but had struggled to keep up with increasing workloads. “We needed better tools for audit readiness and strategic forecasting,” Hudson recalls. In addition, the team had never used collaborative authoring tools before, and leaders wanted them to be trained.

Close analysis of processes and performance gaps revealed the need to standardise processes and data, integrate systems, and automate. The company also needed to consolidate fragmented data and documents, which were dispersed across two different authoring systems – one for commercial products and another for products that were still in development.

Bringing the two systems together, connecting them with the publishing system, and retrieving correspondence from the submissions archive required manual processes. “Anyone trying to trace the history of activities related to a product submission had to go to multiple places to find information, which made it difficult to respond to questions, manage institutional knowledge, and handle other daily work responsibilities efficiently,” Hudson recalls.

Lilly’s team decided to focus efforts on integrating processes and data and standardising across its different submission groups. It implemented a suite of advanced regulatory applications on a single cloud platform for post-approval CMC so that submissions could be written, reviewed, validated, and archived within one central location. Viewed as setting the foundation for their transformation, this stage of the project had a large scope and took more than nine months to complete but yielded positive results.

Speeding Up and Extending Implementation

Hudson and Karns then moved to speed up the new RIM system’s implementation throughout Lilly’s commercial and development portfolio. They moved on from post-approval into pre-approval CMC and safety periodic report submissions, which required working with different groups of people. At the same time, they extended the work into new functionalities such as publishing.