{"id":78869,"date":"2024-09-04T21:15:51","date_gmt":"2024-09-04T19:15:51","guid":{"rendered":"https:\/\/www.veeva.com\/eu\/?post_type=customer-stories&p=78869"},"modified":"2026-07-10T17:02:00","modified_gmt":"2026-07-10T15:02:00","slug":"sobi-scales-regulatory-operations-for-rapid-global-growth","status":"publish","type":"customer-stories","link":"https:\/\/www.veeva.com\/eu\/customer-stories\/sobi-scales-regulatory-operations-for-rapid-global-growth\/","title":{"rendered":"Sobi"},"content":{"rendered":"

\nWithin 14 years, Swedish Orphan Biovitrum, Sobi<\/a>, 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<\/a> and is growing its immunology and specialty therapy businesses.\n<\/p>\n

\nSobi is taking a multifaceted approach to driving growth. It has increased corporate investment in R&D<\/a> 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<\/a> in 2023, are playing an increasingly important role.\n<\/p>\n

\nIts business strategy<\/a> 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)<\/a> for SEL-212.\n<\/p>\n

\nTo establish a strong foundation for future growth, Sobi\u2019s leaders are integrating processes across regulatory, clinical, and quality functions to enable scalability and improve productivity. They are using a harmonized approach based on ³Ô¹Ï±¬ÁÏ\u2019s Development Cloud and unified applications on the ³Ô¹Ï±¬ÁÏ Vault Platform, including ³Ô¹Ï±¬ÁÏ RIM.\n<\/p>\n

\nEnsuring 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).\n<\/p>\n

Meeting regulatory challenges<\/h2>\n

\nSobi implemented ³Ô¹Ï±¬ÁÏ RIM, including Vaeeva 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.\n<\/p>\n

\nRelying on a paper-based system and manual processes created risks and the potential for error and non-compliance\u2014not only with existing regulations but also with evolving requirements<\/a> such as ISO IDMP<\/a>, changes in EudraVigilance Medicinal Product Directory (X-E-V-M-P-D) product submissions<\/a>, and eCTD 4.0.\n<\/p>\n

\nKaren Timmins, head of regulatory business operations, compliance labeling, and advertising promotions for Sobi, led the company\u2019s regulatory operations transformation with ³Ô¹Ï±¬ÁÏ RIM. Sobi\u2019s regulatory leadership team evaluated seven different RIM solutions before selecting Vaeeva RIM, whose four core products were rolled out in one \u201cBig Bang\u201d implementation. \u201c³Ô¹Ï±¬ÁÏ RIM offered the right level of integration and user-friendliness to enable the scalability and increased productivity we required, especially given Sobi\u2019s business model, rapid growth, and global expansion plans,\u201d explains Timmins. \u201cAnother plus was the fact that, in the future, we could potentially connect ³Ô¹Ï±¬ÁÏ RIM with ³Ô¹Ï±¬ÁÏ Clinical Platform and other Vaults to ensure smooth process integration.\u201d\n<\/p>\n

Ensuring user adoption<\/h2>\n

\nSobi took an agile approach to roll out Vault RIM and ³Ô¹Ï±¬ÁÏ Submissions Publishing, leveraging ³Ô¹Ï±¬ÁÏ\u2019s resources to guarantee successful and sustainable team adoption. \u201cTeam members needed time to learn the system and work through all the sprints to ensure that they were achieving the goals that we\u2019d set within the allotted time. ³Ô¹Ï±¬ÁÏ\u2019s team supported our regulatory team\u2019s efforts and gave team members confidence that they were building a solution that would work with Sobi\u2019s processes and overall model,\u201d says Timmins. \u201cIt was a great collaboration,\u201d she adds.\n<\/p>\n

\n\u201c³Ô¹Ï±¬ÁÏ\u2019s team supported our regulatory team\u2019s efforts, and gave team members confidence that they were building a solution that would work well with Sobi\u2019s processes and overall model. It was a great collaboration.\u201d
\n \u2013 Karen Timmins, Head of Regulatory Business Operations, Compliance, Labeling and AdPromo, Sobi<\/span>\n<\/p><\/blockquote>\n

\nInitially, 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. \u201cRegulatory team members were learning while we were launching, but they did a great job adjusting to Vault RIM applications including ³Ô¹Ï±¬ÁÏ Submissions Publishing, and I\u2019m proud of them. They\u2019re more comfortable with the new approach and are freely asking questions when they need to,\u201d says Timmins.\n<\/p>\n

\nHowever, Timmins is working on ongoing efforts to measure engagement and offer the right level of user support. Currently, Sobi is collaborating with ³Ô¹Ï±¬ÁÏ\u2019s Business Consulting team to optimize communication, outreach, and training and to monitor results to ensure user adoption.\n<\/p>\n

Creating value with continuous publishing<\/h2>\n

\nTimmins is especially pleased that the company implemented ³Ô¹Ï±¬ÁÏ Submissions Publishing. Discussions between Sobi and ³Ô¹Ï±¬ÁÏ initially focused on ³Ô¹Ï±¬ÁÏ Registrations, ³Ô¹Ï±¬ÁÏ Submissions, and ³Ô¹Ï±¬ÁÏ Submissions Archive. However, it quickly became clear that ³Ô¹Ï±¬ÁÏ Submissions Publishing would be critical to Sobi\u2019s success and strategic vision. ³Ô¹Ï±¬ÁÏ Submissions Publishing supports scalability for global growth, allowing teams to readily adapt to new regulatory requirements \u2014 for example, rolling BLAs and NDAs \u2014 and increasing speed to market by moving many of the publishing processes upstream.\n<\/p>\n

\n\u201cThe 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.\u201d
\n \u2013 Karen Timmins, Head of Regulatory Business Operations, Compliance, Labeling and AdPromo, Sobi<\/span>\n<\/p><\/blockquote>\n

\nWith rolling submissions, for instance, regulators review core parts of the submission first, and sponsors send additional sections based on a set schedule. As Sobi\u2019s ³Ô¹Ï±¬ÁÏ RIM implementation progressed, the team focused on ensuring that ³Ô¹Ï±¬ÁÏ Submissions Publishing was rolled out in a way that would maximize efficiency and drive overall business improvements. \u201cThe 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,\u201d she says.\n<\/p>\n

\nTo learn more, visit ³Ô¹Ï±¬ÁÏ RIM<\/a>, Submissions Publishing<\/a>, or watch the full interview<\/a> with Karen Timmins from Sobi.<\/p>\n","protected":false},"excerpt":{"rendered":"

As the Swedish company establishes a global presence in rare diseases, it is strengthening its regulatory infrastructure with Vault Submissions Publishing and end-to-end RIM. <\/p>\n","protected":false},"featured_media":62744,"parent":0,"template":"","product-link-list":[1395,1418,1424,1432,1439],"class_list":["post-78869","customer-stories","type-customer-stories","status-publish","has-post-thumbnail","hentry","product-link-list-veeva-commercial-cloud","product-link-list-veeva-etmf","product-link-list-link-key-people","product-link-list-veeva-opendata-clinical","product-link-list-veeva-quality-cloud"],"aioseo_notices":[],"_links":{"self":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/78869"}],"collection":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories"}],"about":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/types\/customer-stories"}],"version-history":[{"count":2,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/78869\/revisions"}],"predecessor-version":[{"id":99475,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/customer-stories\/78869\/revisions\/99475"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media\/62744"}],"wp:attachment":[{"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/media?parent=78869"}],"wp:term":[{"taxonomy":"product-link-list","embeddable":true,"href":"https:\/\/www.veeva.com\/eu\/wp-json\/wp\/v2\/product-link-list?post=78869"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}