Sobi Scales Regulatory Operations
for Rapid Global Growth

Within 14 years, Swedish Orphan Biovitrum, Sobi, has gone from a regional leader in rare disease and specialty therapies to a global presence supplying treatments for unmet medical needs. Spurred by ambitious goals set by its business leaders, the company is now poised to meet or exceed its target revenues of $US 2.32 billion (SK 25 billion) by 2025. It has also expanded its global hematology pipeline and is growing its immunology and specialty therapy businesses.

Sobi is taking a multifaceted approach to driving growth. It has increased corporate investment in R&D from 10% of revenues in 2021 to 13-15% in 2022 and 2023. Innovative partnerships and strategic acquisitions, such as its purchase of hematology specialist CTI Pharma in 2023, are playing an increasingly important role.

Its business strategy focuses on the global in-licensing of late-stage therapies, and developing them in-house. One recent success story is SEL-212, the chronic gout therapy candidate that Sobi licensed from Selecta Biosciences (now Cartesian Therapeutics) in 2000. With a fast-track designation, the FDA is currently reviewing the rolling biologics license application (BLA) for SEL-212.

To establish a strong foundation for future growth, Sobi’s leaders are integrating processes across regulatory, clinical, and quality functions to enable scalability and improve productivity. They are using a harmonized approach based on Veeva’s Development Cloud and unified applications on the Veeva Vault Platform, including Veeva Vault RIM.

Ensuring that all functions have access to the same unified and harmonized data will be especially important as Sobi continues to expand its operations outside of the US, Europe, China, and Japan, for example in Latin America and East Asia. By 2025, leaders expect its revenue from international expansion to exceed $371 million (SK4 billion).

Meeting regulatory challenges

Sobi implemented Vault RIM, including Vault Submissions Publishing, in 2023. Given the importance of efficient regulatory operations for any biopharma company, this was crucial for scalable growth. Sobi sought a unified platform that would give teams access to centralized regulatory data, increasing reporting accuracy, cross-team collaboration, and speed and efficiency in the publishing process globally.

Relying on a paper-based system and manual processes created risks and the potential for error and non-compliance—not only with existing regulations but also with evolving requirements such as ISO IDMP, changes in EudraVigilance Medicinal Product Directory (X-E-V-M-P-D) product submissions, and eCTD 4.0.

Karen Timmins, head of regulatory business operations, compliance labeling, and advertising promotions for Sobi, led the company’s regulatory operations transformation with Vault RIM. Sobi’s regulatory leadership team evaluated seven different RIM solutions before selecting Vault RIM, whose four core products were rolled out in one “Big Bang” implementation. “Veeva Vault RIM offered the right level of integration and user-friendliness to enable the scalability and increased productivity we required, especially given Sobi’s business model, rapid growth, and global expansion plans,” explains Timmins. “Another plus was the fact that, in the future, we could potentially connect Vault RIM with Vault Clinical and other Vaults to ensure smooth process integration.”

Ensuring user adoption

Sobi took an agile approach to roll out Vault RIM and Vault Submissions Publishing, leveraging Veeva’s resources to guarantee successful and sustainable team adoption. “Team members needed time to learn the system and work through all the sprints to ensure that they were achieving the goals that we’d set within the allotted time. Veeva’s team supported our regulatory team’s efforts and gave team members confidence that they were building a solution that would work with Sobi’s processes and overall model,” says Timmins. “It was a great collaboration,” she adds.

“Veeva’s team supported our regulatory team’s efforts, and gave team members confidence that they were building a solution that would work well with Sobi’s processes and overall model. It was a great collaboration.” – Karen Timmins, Head of Regulatory Business Operations, Compliance, Labeling and AdPromo, Sobi

Initially, some team members were concerned about data-entry requirements and approaches and their impact on downstream data and processes. There were also concerns around the time needed to become proficient with the new platform. “Regulatory team members were learning while we were launching, but they did a great job adjusting to Vault RIM applications including Vault Submissions Publishing, and I’m proud of them. They’re more comfortable with the new approach and are freely asking questions when they need to,” says Timmins.

However, Timmins is working on ongoing efforts to measure engagement and offer the right level of user support. Currently, Sobi is collaborating with Veeva’s Business Consulting team to optimize communication, outreach, and training and to monitor results to ensure user adoption.

Creating value with continuous publishing

Timmins is especially pleased that the company implemented Vault Submissions Publishing. Discussions between Sobi and Veeva initially focused on Vault Registrations, Vault Submissions, and Vault Submissions Archive. However, it quickly became clear that Vault Submissions Publishing would be critical to Sobi’s success and strategic vision. Vault Submissions Publishing supports scalability for global growth, allowing teams to readily adapt to new regulatory requirements — for example, rolling BLAs and NDAs — and increasing speed to market by moving many of the publishing processes upstream.

“The publishing piece has gone incredibly well, and the team is very pleased with the progress they have seen so far. It has been a great addition.” – Karen Timmins, Head of Regulatory Business Operations, Compliance, Labeling and AdPromo, Sobi

With rolling submissions, for instance, regulators review core parts of the submission first, and sponsors send additional sections based on a set schedule. As Sobi’s Vault RIM implementation progressed, the team focused on ensuring that Vault Submissions Publishing was rolled out in a way that would maximize efficiency and drive overall business improvements. “The publishing piece has gone incredibly well, and the team is very pleased with the progress they have seen so far. It has been a great addition,” she says.

To learn more, visit Vault RIM, Submissions Publishing, or watch the full interview with Karen Timmins from Sobi.