Accelerating Regulatory Outcomes by Optimizing End-to-end Processes
Cross-functional teams and processes have traditionally challenged biopharmas to manage regulatory submissions to health authorities, and to ensure that they are complete and on time. At the 2023 Veeva R&D and Quality Summit in Boston, regulatory leaders shared insights and success stories on how they are leveraging Vault RIM, an end-to-end solution, to streamline collaboration and data-driven processes, including submissions publishing.
Over 400+ attendees in the regulatory zone
Continuous publishing improves the quality and speed of submissions
A number of companies shared how Vault Submissions Publishing, part of the Vault RIM Platform, is improving regulatory submissions publishing. Krystal Bio, for example, is using Vault RIM’s continuous review and submission content plans to improve its biologics license application (BLA) submission process. By providing real-time submissions output, the unified solution has helped the company’s regulatory teams catch validation errors sooner and minimize rework. “We would not have been able to submit our BLA as quickly or with the same level of quality without (Vault RIM),” said Rachel Borromeo, senior director of CMC and operations.
Other companies have realized significant efficiency improvements in their regulatory submissions process by using continuous publishing. Eli Lilly published over 1,200 submissions in Vault RIM within one year of implementation. The company also leveraged the Vault RIM-to-PromoMats connection to streamline its promotional material submission process, reducing data redundancy and compliance errors. Using the Vault connection and Vault Submissions Publishing, Lilly decreased the time spent on manual submissions by 25–40% and plans to increase its use of Vault RIM. By the end of 2023, Lilly’s regulatory leaders plan to use the platform to handle 75% of the company’s eCTD submissions..
The Vault RIM Platform has enabled companies like Atara Biotherapeutics to speed up submissions publishing by reducing reliance on disconnected data sources such as SharePoint and emails. Diverse data sources had slowed the process, impairing the regulatory team’s ability to get things done. “Now, the team is empowered, and can really move fast,”” said Matt Neal, senior director of global regulatory and quality. By making continuous publishing a core part of its submissions publishing process, Atara was able to automate processes, increasing the volume of submissions. Neal described adoption of continuous publishing as a paradigm shift. “But once you’re there, you’ll never ever go back,” he said.
Gilead shares how it is unifying processes for product registrations
Vault RIM empowers new projects and growth
For Gilead Sciences, Vault Registrations enabled regulatory teams to broaden their point of view, from an individual department perspective to a more enterprise-wise mindset, said Fabio Fernandez, Gilead’s senior director of regulatory systems. The company completed its implementation in 18 months, and has migrated one million records successfully.. By consolidating its global data into Vault RIM, Gilead has improved data consistency, simplified workflows, and increased visibility into its global regulatory operations. The company is now evaluating Vault eTMF and Vault PromoMats.
In a joint session with Veeva Business Consulting Services, AstraZeneca regulatory leaders walked through lessons they learned in how to develop a strong business case. “It’s extremely difficult to go with the old ways of mobilizing support, funds, resources, and expertise,” said David Berglund, executive director of global regulatory operations. Instead, he recommends aligning on value drivers, defining measurement approaches and KPIs, and creating reports that track value with data.
However, identifying what to measure in Vault RIM may not always be straightforward. Some things can be harder to track than others, explained Kim Brownrigg, Veeva practice manager for regulatory business consulting. “Having good product knowledge and working with your Veeva team is important,” she said. AstraZeneca collaborated with Veeva Business Consulting to improve its metrics, and now analyzes data from the Vault RIM Platform to determine which KPIs provide the most valuable insights.
As Veeva works to help advance the industry and deliver better results for patients, close partnerships with biopharmas are essential. We thank all the attendees who participated in this year’s Veeva Summit, especially the customer speakers who shared their journeys and the lessons they’ve learned.
To watch key regulatory sessions from this year’s Summit, go to Veeva Connect.