Merck's path toward pharmacovigilance transformation

By Isabel Cameron

- Last updated on GMT

© Getty Images
© Getty Images

Related tags Merck Pharmacovigilance Technology

At Veeva R&D and Quality Summit 2023, Bio Pharma Reporter caught up with Courtney Gilbert, senior director, business system management and innovation, PV operations and global process enablement, at Merck.

BPR: Could you please tell us a little about where Merck's journey toward digital transformation started and the drivers for change?

The mission of our business system management and innovation team is to optimize the experience for our pharmacovigilance colleagues. We had technologies that were sufficient to maintain compliance but did not provide opportunities to innovate the way we work. There is a lot of effort and resources to maintain and keep systems connected.

A big driver for transformation was the opportunity to partner with Veeva to build safety solutions that align with how we work while ensuring flexibility to adapt to regulatory change. When a change takes effect, we can work together to support that efficiently. This is huge since the offerings in the pharmacovigilance space are not plentiful because it's such a niche area.

Merck has engaged in a strategic partnership​ with Veeva at an enterprise level. This helped advance our work to modernize pharmacovigilance, but the partnership presents a significant opportunity to advance product development. So, from clinical to medical to quality management, we're taking a holistic approach.

BPR: How does taking a holistic approach impact pharmacovigilance?

What's exciting for us in pharmacovigilance is that we work across stakeholders to advance our systems while ensuring connectivity across functions. The opportunity to have a unified platform is a key enabler to working end to end, not just in safety but across our business. Bringing together a platform that can do those things is just enormously exciting.

BPR: What is the long-term vision for safety?

We're on track to be one of the first large biopharmas to launch Veeva's safety database. We will also be among the first, if not the first, to implement a safety case intake solution. This will help us capture adverse experiences or reported product quality concerns (PQC) at the country level and provide modern case processing capabilities.

If those things progress positively, our long-term vision is to really have an end-to-end platform supporting our product development. This would save valuable time so our safety teams can drive innovation.

Cortney-Gilbert-1
Merck's Cortney Gilbert. © Merck

BPR: How has using a cloud-based pharmacovigilance application improve safety operations?

Using a cloud safety system provides us with three software releases a year that bring with them new capabilities that can improve how we work. The releases are also seamless. With our legacy systems, releases aren't always the most pleasant thing, and they're infrequent, costly, and burdensome.

A cloud safety app provides a chance to have a better release experience more frequently. As a strategic partner, we have the opportunity to say, 'Here's a functionality that brings value to pharmacovigilance, let's think purposefully and develop it together.'

BPR: What makes a good technology partner in the PV space?

Some technology providers emphasize technology​ and less on pharmacovigilance processes, and that can be challenging. I advise other PV leaders to find a technically adept partner with pharmacovigilance experts on their team. They're not unicorns. They exist, but they're rare.

Partnering with someone who's got experience in the domain is more efficient and can drive better outcomes. Because of the complexity of pharmacovigilance, the technology provider must have an experienced team with background and understanding of the safety space. I think that's been super important.

BPR: You've mentioned an end-to-end approach to development several times. How is this initiative bringing together pharmacovigilance with other areas like clinical and commercial?

Clinical is an excellent and easy example since it's not uncommon for data to go from the clinical team to safety. When this happens, the safety teams usually query back to the research sites to confirm data. Often, it's for something avoidable, like a missed data field. That query in and of itself is not a complicated task.

But at a larger scale, when we're talking about hundreds of adverse event cases a year, querying back to sites can cause delays. This makes you realize the safety team is devoting many resources to doing something that should be avoidable. With the opportunity, for instance, for a clinical system and a safety system to be connected on the same platform, we can prompt the research site with activities they need to complete or requests for additional information.

This would reduce the manual back and forth that usually happens via email, saving significant time that can now be applied in areas that add value. The most important thing is ensuring that the safety team executing processes is rapidly connecting with clinical and can quickly get the information they need. And we now have an opportunity to build out an optimized process for how we want to manage safety from a strategic perspective.

BPR: What's next for Merck's safety operations, and how do you see things evolving in the coming year?

We will continue to evolve our work as our safety tools and systems advance, not just within safety but across the other development functions at Merck. We are taking a collaborative and holistic approach.

We're shifting the thinking from 'Let's talk about what a pharmacovigilance tool can help us improve' to 'How can clinical and pharmacovigilance work better together.' The more we explore that, the more we think about it, and the more we plan around what this should look like. The opportunities to drive more collaboration and connectivity across teams are exciting.

Returning to where we started, optimizing the experience for pharmacovigilance with the tools they use is a priority. Taking the opportunity to shift from doing things that are very tactical, like data entry, to more strategic activities. This helps the people doing the work to be more deliberate with their time, put their skills to great use, and focus on the things that drive them, that excite them. And for pharmacovigilance, that is driving better patient safety.

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