When Maria Ferrara joined HUTCHMED in 2020 as the senior director, head of regulatory operations and submissions for the U.S. and EU, she had a clear and pressing mandate: bring submissions publishing in-house for greater scalability and control over the submission process. HUTCHMED, an innovative, commercial-stage biopharma developing targeted therapies and immunotherapies for cancer and immunological diseases, was managing about six applications at the time. But the number was growing steadily.
“It was very important for us to bring submissions publishing in-house,” says Ferrara. “We wanted to be able to own submissions from beginning to end to improve efficiency, reduce costs, and give us the responsiveness and flexibility we needed both in the U.S. and beyond as we continued to grow.”
But, a few challenges stood in her way: a fragmented, linear, outsourced publishing ecosystem; finite resources; and a small but mighty team to implement the new solution – without jeopardizing the submissions process.
Navigating a fragmented and costly submissions process
When Ferrara started at HUTCHMED, the submissions process was spread across three different CROs. “That meant three different systems, three different processes, and three different contacts,” recalls Ferrara.
“Sometimes, the regulatory function is just seen as paper pushing. People might perceive it as standing in between the submissions and the health authority. But Veeva has really helped us shine a spotlight on the function.” – Maria Ferrara, Senior Director, Head of Regulatory Operations & Submissions – U.S. and EU, HUTCHMED
The lack of a centralized system meant the team was primarily using SharePoint and Outlook to communicate and share information with outside vendors. The siloed systems lacked the unified and collaborative capabilities the team needed to be agile. Because of the sensitive nature of the information exchange, they also required a high level of diligence and quality control. The biggest problem, however, was a lack of ownership over the end-to-end process.
HUTCHMED wanted a system that was easier to use and gave them more control over the submissions process, including timelines, financial predictability, and quality standards. “These were our applications. These were our assets. We wanted to be able to own them in totality,” says Ferrara.
HUTCHMED also had an eye toward the future, not only adding capabilities in the U.S. but expanding business interests in the EU and Asia. “We really needed one unified platform that we could build on as we continue to grow,” says Ferrara.
Taking ownership of regulatory submissions
While HUTCHMED considered several publishing solutions, the IT leader’s prior positive experience with Veeva Vault Submissions Publishing led them to consider it during evaluation. Once they started comparing solutions, two things stood out: continuous publishing capabilities and the level of service and support.
Unlocking new ways of working with continuous publishing
Ferrara was most excited about Veeva’s continuous publishing, which allows parallel submission publishing and authoring. This reduced redundancy and improved efficiency also enabled earlier identification of validation errors in the submissions process.
With this capability, Ferrara says she is able to easily manage multiple submissions at once, seamlessly switching back and forth between them. She can also identify issues with the submission earlier in the process rather than learning later that something is wrong. This reduces bottlenecks and validates the quality ahead of time without the usual frenetic pace that regulatory operations teams are accustomed to with submissions.
“The continuous publishing capability was one of the things that really sold us. I have 30 years of experience and I’ve never seen the continuous publishing capability in any other publishing system I’ve worked with.” – Maria Ferrara, Senior Director, Head of Regulatory Operations & Submissions – U.S. and EU, HUTCHMED
Hands-on training and implementation support
When HUTCHMED decided to implement Vault Submissions Publishing, a new chapter began: moving from three outsourced CROs to one in-house submissions system. This was a significant undertaking for the lean, four-person team. They needed to establish the new system, migrate vital information from the CROs, execute a huge volume of administrative work, and work internally with the IT team to map out and execute the process.
“One of the things that just made us choose Veeva was the level of support we were given – not only after we went live, but prior to that,” says Ferrara. “We’re a small group, and quite honestly, no one in my group had any experience implementing a new in-house system from the ground up.”
With Veeva’s support, the team mapped out a phased rollout plan to minimize disruption. Veeva got HUTCHMED live with Vault Submissions Publishing in about four months. From there, they were able to execute their first in-house IND and gradually bring everything in-house over the next year. “It was seamless, and a really great learning experience,” says Ferrara.
Highlighting the value of the regulatory function
“I’m happy to say, as of today, and for about the last two and a half years, our submissions publishing is totally in-house,” says Ferrara.
Perhaps most rewarding of all, unifying the end-to-end submission process drove progress much further upstream, rather than being the big hurdle at the end. “Sometimes, the regulatory function is just seen as paper pushing, standing in between the submissions and health authority. However, Veeva has really helped us shine a spotlight on the value of the function,” says Ferrara. “And personally, it has also renewed my interest in things we can achieve.”
Looking toward the future, Ferrara says HUTCHMED is exploring Veeva Vault eTMF to drive further operational efficiency and collaboration across the business. The company’s EU and Asia regulatory needs are also on the radar. For other small regulatory teams who are considering bringing submissions publishing in-house, Ferrara describes it as “one of the best decisions I’ve ever made.”
“I have two words,” says Ferrara. “No regrets.”
Learn how you can elevate your submissions process and transform your regulatory function with Veeva Vault RIM.
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