Pharmacovigilance and Regulatory Trends: An Interview with IQVIA’s Joe Rymsza

Pharmacovigilance (PV) is basically drug safety. It is, at its core, the collection, detection, evaluation, monitoring and prevention of adverse effects of pharmaceutical products. And it’s an increasingly important—and increasingly complex and expensive—component of biopharmaceutical drug discovery, development, manufacturing and commercialization.

Joe Rymsza, vice president of Pharmacovigilance and Regulatory Technology Solutions for IQVIA, took time out to discuss trends in PV and regulation in the biopharma industry in the coming year as well as to talk about the company’s software-as-a-service (SaaS)-based safety platform.

Rymsza notes that volumes of adverse events have been increasing by more than 20% year-over-year across the biopharmaceutical industry. “It’s the number one challenge the industry is facing and there’s no end in sight. It’s being driven by obvious and non-obvious things, like the introduction of new productions, expansion and marketing of products into new geographies, and requirements to start to mine third-party social media sources for adverse events.”

In fact, biopharma companies spend around 70% to 80% of their operational budget on meeting regulatory requirements, what Rymsza called an “inverted pyramid.”

“They probably spend about 80% of their financial resources on getting data into the system and doing rote reporting to the health authorities and various agencies,” Rymsza said, “and various obligations in countries in which they market, and less than 20% on things that give discernible value to patient safety or that feeds insight back into the drug discovery processes.”

And this is something that most biopharma executives would like to flip.

Although PV is separate from regulation, it is both overlapping and synergistic. Rymsza says that on the regulatory side, “you see the parallel regulatory burden in the companies, particularly companies that market products at scale in 150-plus geographies. They’re dealing with a massive number of country regulations. Once a product is approved, which is in and of itself an amazing and time-consuming process, you have to maintain the labels and do goofy things like paying an application fee in all the countries it’s marketed. If there’s a change, like a change in the supply chain in the ingredients, that also creates a cascading regulatory modification.”

In terms of trends for PV and to a similar extent, regulation, Rymsza believes that automation, with a fair amount of nuance, will be the biggest umbrella trend. He stratifies the market into three layers, essentially large, middle and small/emerging biotechs. Although the trends will undoubtedly affect all three types, in this context Rymsza is primarily focusing on the large biopharma companies with international markets.

 “You’re going to see 90% of the top 100 to 200 pharma companies engage in automation-driven projects and pilots and proof-of-concept programs,” he said. “There is absolutely no question it’s started to occur. It began with a trickle in 2017 and now you see it across the board. The industry is just recognizing that their current aged and inflexible technology isn’t able to meet the growing needs of the business.”

This is automation in terms of PV, in particular. Companies, Rymsza said, “are looking to reimagine the end-to-end solutions that need to be on a SaaS platform that’s being built from the ground up with the tenets of automation in mind.”

Part of this need for automation comes from the growing number of resources companies need to keep up with PV activities. “Ultimately,” Rymsza said, “there are not enough people around the world to hire to process this information with the increased number of adverse events and increasing burden of regulations. It’s becoming a really important inflection point from the standpoint of how the industry has to look at their end-to-end processes and systems through the lens of automation.”

Rymsza also cautions about focusing just on the clichés of machine learning and artificial intelligence (AI). “The technology itself is less important than the basic question of how do we make the most value-added processes for the organization without compromising quality and compliance.”

In a related theme, companies are implementing a regulatory information management system to have a single source of information about their product portfolio. Rymsza says, “If you go into a top 40 company and ask for a list of products marketed in which country and which doses, it’s a mess. And it’s an unsustainable way to operate.”

To assist in dealing with this trend, IQVIA has developed Vigilance, a SaaS-based PV system that the company and Rymsza hope will help biopharma companies “flip the pyramid.”

“It’s essentially the cornerstone of our strategy to reimagine PV. We built it from the ground up on Salesforce.com. If you look at the trend, our industry is so far behind the rest of the industry in terms of running their businesses on classic SaaS structure, shackled with expensive upgrade projects, unlike the SaaS arena.”

Vigilance is about looking at the full end-to-end process from the viewpoint of adverse event identification through assessment, signal management and reporting, and, Rymsza said, “how we can intelligently use automation, natural language processing and bits of pieces of machine language and AI where appropriate, to automate every aspect of that process. And to do things with real-world data beneath it so when you get adverse events, you can conduct inline comparison automatically against massive multi-million-dollar assets to determine the probability that an adverse event may be important.”

The company also provides E2B(R3) operational PV services, biostatistics, management on top of the Vigilance, if companies want to purchase them. “We think there’s a lot of advantages to combining the technology and services, but we are also offering the technology as a standalone technology SaaS platform,” Rymsza said.

E2B(R3) doesn’t have a direct translation, but it relates to the efficient transfer of PV safety data electronically. The U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Japan’s Ministry of Health, Labour and Welfare (MHLW) have all adopted E2B(Re) as their standard submission formation. All companies that report safety data to these agencies using E2B will be required to adopt E2B(R3) format.

Digital transformation, Rymsza noted, is a buzzword across life science companies, but usually, that has revolved around commercial and clinical activities. “But now they are turning their attention to safety and regulations, and asking, Why aren’t we using commonly accepted processes like natural language processes and automatic ingestion of documents from regulatory affairs, move them in, prep them to learn basic ingestion into the system and begin to automate some of the analysis?”

Only three years ago there wasn’t much interest, but now everyone in the life sciences is interested and wants to find algorithms that can actually perform causality analysis on significant parts of their product portfolios.

“There isn’t an organization in the top 50 that isn’t interested, and in certain cases, have already started running pilot projects with the intention of going live in the latter part of 2020 or in 2021,” Rymsza said.