➤ Aetion is using its real-world evidence platform to explore drug and vaccine development possibilities for COVID-19.

➤ The private New York company has partnered with the U.S. Food and Drug Administration on post-approval monitoring for vaccines and has teamed up with data technology company HealthVerity Inc., as well as Sanofi, Johnson & Johnson and other drugmakers, in the past.

➤ Navigating swaths of data in real-time is a challenge, but scientific rigor and transparency are critical, Aetion's CEO said.

Aetion Inc. CEO Carolyn Magill spoke with S&P Global Market Intelligence about the company's ongoing partnership with the FDA, which has taken a turn to focus on the COVID-19 pandemic; the need for safety and effectiveness monitoring when patients receive a vaccine; and the importance of clear, unbiased data to make healthcare decisions in a crisis.

S&P Global Market Intelligence: How has Aetion worked with the FDA during the COVID-19 pandemic to bring real-world evidence into the drug and vaccine development process?

Carolyn Magill: We're partnering with the FDA on understanding the disease, how it's being treated, the risk factors related to therapies that someone might take and variations among different patient populations. And it's pretty exciting work because not only do we feel like we're having an impact on COVID-19 and our understanding therein, but also because it's helping us to advance the work that we're doing across the industry, to help people understand what real-world data is, and how to transform it into what we consider to be regulatory-grade evidence.

Can you talk about your work with vaccine developers to prepare for worldwide distribution?

Much of what we're doing to support vaccines relates to developing safety and effectiveness monitoring systems. We're partnering with organizations who are developing vaccines so that they can be prepared for when their vaccines come to market — how to structure monitoring and how to assess the real-world data that's coming in real time. Because very quickly, decisions are being made about who has access to which vaccines that have tremendous implications for people's lives. Our clients want to be prepared with a robust safety monitoring system and they want to understand which data to turn to that would be fit for the purpose of assessing how well their vaccines are working.

The pandemic has led to disputes over scientific evidence in the ongoing evaluation of treatments like hydroxychloroquine and convalescent plasma, as well as vaccines. How do you navigate those waters?

The way that we approach some of the challenges that we have seen relates to sticking to our guns in terms of the scientific rigor that underpins the platform and repeatedly emphasizing how important it is to have transparency. And we leave data in its native format most often, which contrasts to using a common data model. And so Aetion is very clear about data provenance, and very committed to making transparent the methodology that we apply. It creates a new level of conversation and supports collaboration between stakeholders in a way that hasn't necessarily existed at this scale before. And that's how we avoid some of the pitfalls of what we've seen in recent weeks and months.

Access to large amounts of data is critical for your platform to work properly and to react to a global crisis. Has your access improved over time?

We as an industry are getting better and better at collecting data in a more systematic way, and ensuring that it can be linked across different data sets to create a longitudinal patient view, which is critical to the work that we do and understanding the broader context of how someone is being treated and has been treated. That data is easier to get access to. What we're seeing in the time of COVID is access to open [health insurance] claims and we get access to that within a few days.

What are some new sources of information that have made real-world data more accessible and three-dimensional?

We are increasingly seeing access to genetic data, as well as data on socio-economic aspects of people's lives which can have an impact on how they access care, how well they do with different treatments. And you have organizations out there that are focused on helping to collect data from wearables, as an example, that are together creating a more robust picture of what's happening in people's lives. So I'd say there continue to be challenges, but there's also great progress in the accessibility of data.