Health Tech, BioPharma

Why Former FDA & Verily Exec Amy Abernethy Is Launching a New Venture

This week, longtime healthcare veterans Amy Abernethy and Brad Hirsch teamed up to launch Highlander Health — a Dallas-based startup focused on accelerating clinical evidence generation.

Accelerating clinical evidence generation is one of the most important steps the healthcare industry can take to advance personalized treatment, Amy Abernethy declared in an interview this week.

“When I talk about clinical evidence generation, I’m talking about clinical trials — real data, real-world evidence. How do you quickly understand what works for whom and when?” she said.

Abernethy is a veteran healthcare leader, having recently served as principal deputy commissioner and acting chief information officer at the FDA and chief medical officer at Verily, Alphabet’s life sciences spinout. On Tuesday, she teamed up with another longtime health executive to launch a new company focused on supporting clinical evidence generation in the healthcare industry.

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The new Dallas-based company, called Highlander Health, was founded by Abernethy and Brad Hirsch. The pair have known each other for more than a decade, first meeting when they were both oncology researchers at Duke University. After Duke, they worked together as executives at Flatiron Health, a cancer technology company that was acquired by Roche in 2018.

They also worked together as executives at Verily for nearly two years. Hirsch is the founder and former CEO of SignalPath, a clinical trials technology startup that Verily acquired in 2021.

“Brad and I have been working together for 15 years now, and we’ve been talking about setting something up like Highlander Health all along that way. As we look at where things are in 2024, we think there’s been enough maturation across the space in terms of digital and tech capabilities that we can start to see how that vision can be put to work,” Abernethy said.

Highlander is focusing on the clinical evidence generation space because “that’s going to be a key place for unlocking a whole bunch of medical innovation capacity for the future,” she added. The company consists of two branches: Highlander Health Partners and Highlander Health Institute.

Highlander Health Partners is an investment arm that will support middle-market companies in their efforts to advance clinical research, Abernethy explained.

“We’re less focused on venture and startups — and much more focused on established companies. We believe that our investment, our shoulder-to-shoulder coordination and our work with the management team can help those companies continue to be more successful on the pathway towards personalized healthcare and evidence generation,” she remarked.

The institute is a public interest platform that will provide grants to health systems and other organizations conducting clinical research.

Through the institute, Highlander will create “learning labs” in which researchers and tech developers can collaborate with regulators, clinicians, and investors to test new technologies, Hirsch noted. He said many of the projects that the institute will be funding will center on data.

For example, Highlander’s institute is interested in projects exploring how to transform EHR information into a dataset that can be easily used for evidence generation within a clinical trial, Hirsch explained. 

Hirsch and Abernethy’s own capital, as well as money from Dallas-based Lyda Hill Philanthropies, will make these projects possible, he added.

Photo: elenabs, Getty