Fresh off $100M round, GV-backed real-world data startup woos Duke researcher as CMO
Days ago Verana Health closed $100 million to expand its real-world data system and get ready for “regulatory-grade.” What’s left unsaid was that they’ve also found the guy to help them do it.
The San Francisco startup has recruited Matt Roe from Duke University to be its chief medical officer, overseeing the iterative process of generating clinical data and deriving scientific insight from prospective research. His job is also to work with other stakeholders such as academic centers and the FDA to map out more use cases for real-world data.
By partnering with professional societies to build out their registries, Verana offers a centrally curated data source that can aid physicians in treating patients, whether through showing them insights or connecting them with clinical trial information, Roe said.
“That’s something that I didn’t really have as a clinician when I was in practice for 20 years,” Roe, a cardiologist by training, told Endpoints News.
But for the past six years he’s delved into electronic health records, working with the national initiative known as PCORnet to coordinate a trial testing different doses of aspirin for patients with chronic cardiovascular disease. Dubbed ADAPTABLE, the trial was hailed by former FDA commissioner Robert Califf as “a model of evidence generation to answer critical, pragmatic questions quickly.”
The experience opened Roe’s eyes to the different EHR systems being deployed at clinical sites across the country. It also showed him the the importance of uniting the informatics experts who design the data networks and clinical trial investigators who recruited patients.
That kind of coordination will be critical as he works with the FDA on the kind of data infrastructure that’s “dynamic and evolves over time” but still informs regulator decisions.
“The concerns that most people have about EHR data, which I believe are the foundation for the real world data sources, are related to the data quality and suitability for research purposes. So when we look at that, the three major domains are the completeness of the data, the accuracy and then the traceability of the data,” he said. “And so I think where EHR data are going is having the right or the most modern techniques to curate and trace the EHR data back to the source, and understand the quality and things we could do to improve the quality.”
Moving forward, he also wants to lay the groundwork for linking EHR data with those from other sources such as claims, digital health applications and patient-reported outcomes. And the goal is less to replace randomized, controlled studies but to take advantage of what’s newly possible.
“We should all work to change the tone of the conversation and say we’re not just talking about doing non-randomized studies,” he said. “We’re talking about doing a whole spectrum of research in a new and different way.”