Inhibrx and Two Top 20 Biopharmas: Building the Right Safety Foundation
Digital transformation was a key theme at recent conferences like World Drug Safety Congress and Veeva R&D Summit. But what does digital transformation in drug safety entail? And, how can organizations take on transformation projects while also managing increasing data volumes with fewer resources?
Although digital transformation may sound complex and daunting, the heart of transformation is simplification. By simplifying and standardizing their systems landscape with unified, connected platforms, Safety teams can lay a strong foundation for advanced automation and innovation while improving productivity and reducing costs.
An associate vice president of pharmacovigilance (PV) operations at a top 20 biopharma is in the process of consolidating the company’s safety system landscape. “We’re building a reliable data foundation to ensure high data quality and reduce handoffs,” she says. “By simplifying our landscape, we will reduce manual effort and optimize our resources to deliver greater value for patients.”
Companies of various sizes are reaping the benefits of digital transformation. Inhibrx Biosciences and two top 20 global biopharmas – companies at different points in their safety journeys – recently shared how they reduce resource effort, save time, and simplify PV by unifying their processes.
Simplifying technology landscape and global case processing
One of the associate vice president of PV operations’ main goals is to simplify her company’s PV landscape of 30 systems by 50% with the help of Veeva Vault Safety. “With over 30 systems, you can imagine the integrations, customizations, and upkeep it takes to keep them running,” she says. Currently, the company also has two separate safety databases – one global and one for Japan. “Once we consolidate the two, we anticipate reduced overhead and costs,” she adds.
Another top 20 biopharma is further along in its transformation journey. Since going live with Vault Safety in 2022, the company has retired 25 systems and consolidated them into a single platform. Simplifying its technology landscape has helped set the foundation for longer-term, strategic initiatives. “We’re focused on low-touch, non-serious case processing,” says the company’s Veeva practice lead. The top 20 biopharma’s PV team just completed its initial low-touch case process program using Vault Safety’s CSV upload capability to process about 800 cases a month. They plan to reach their 100,000 case goal by the end of 2025.
Reducing clinical trial costs and saving time
Inhibrx, a clinical-stage biopharma, has already reduced its study activation timeline by three months since unifying operations into a single platform. By bringing functions in-house using the Veeva platform, including the Safety-EDC Connection, the company anticipates significant savings on clinical trial costs compared to its previous business model using a traditional outsourced CRO model.
“The ultimate goal is to develop more life-saving medications for patients faster. That comes down to saving time and money,” says Bonne Adams, the company’s vice president of operations. “When you get a study up and running quicker, your product gets out into the market sooner.”
Like Inhibrx, the associate vice president of PV operations at a top 20 biopharma is also working to streamline communication between different functional areas. “PV processes touch so many different departments,” she explains. “Vault Connections are going to enable an automated seamless data flow with our manufacturing, medical affairs, regulatory, and clinical colleagues.” The associate vice president of PV operations is especially looking forward to using the Safety-RIM Connection to share registered product data between regulatory and safety, and the Safety-EDC Connection to automate the flow of serious adverse event (SAE) records from clinical to safety.
Building a strong data foundation to mitigate risk
For Adams, the key benefits of a simplified, unified safety platform are risk mitigation and improved data quality. “When data is entered multiple times into different systems, it introduces a high risk of human error. Reconciling that data can come at a very high cost,” she explains. Vault Connections help Inhibrx reach these objectives.
“The Safety-Clinical Operations Connection is helping us ensure we have distributed our cases to the right people and prove that they received them,” says Adams. “And, the Safety-RIM Connection guarantees that the product information is correct because it flows directly from regulatory to safety. Everybody has the same information and it all matches up.”
As Inhibrx continues to build a strong data foundation, Adams hopes to eliminate redundancies across the company’s systems landscape wherever possible. “I wanted to create an environment where the same piece of data is only entered one time at one place, and it flows through all of our systems to break down those redundancies,” she says.
Partnering to streamline operations and improve efficiency
When considering embarking on a digital transformation journey, Adams recommends that companies remain open-minded to new ways of working. “Being willing to adopt tech and taking advantage of new solutions is crucial,” she says. “Our partnership with Veeva allows us to stay at the forefront of technological advancements in the industry. Veeva’s integrated solutions help us streamline our operations and improve efficiency.” With three validated releases per year, Inhibrx can take advantage of new capabilities and stay up to date with the latest regulations.
The Veeva practice lead at another top 20 biopharma echoes Adams’ sentiments. “It’s critical to build a strong, collaborative relationship with a trusted vendor, and we have that with Veeva,” she says. “We’re not just implementing a new solution to fit our current processes, we’re challenging our organization to think differently about how we can leverage our system functionality to work better and more efficiently.”
Learn how Merck is streamlining processes with unified and connected safety.