Amy Abernethy, M.D., Ph.D., left Verily earlier this year as its chief medical officer and has now teamed up with a long-time colleague to launch an initiative that takes a new approach to modernizing clinical research.
Abernethy and another former Verily executive Brad Hirsch, M.D. have launched Highlander Health to optimize clinical trials, the industry veterans announced today. The aim is to integrate research more seamlessly into day-to-day care to improve treatments and enable individualized patient care.
Highlander Health's work will focus on a combination of supporting learning labs, investing millions into tech startups and philanthropy.
Advancing the use of patient data and real-world evidence to drive medical innovation has long been a focus for Abernethy, whose résumé boasts decades of research-related experience in a variety of regulatory, commercial and clinical roles. Served as principal deputy commissioner and acting chief information officer at the Food and Drug Administration (FDA) before joining Alphabet's healthcare spinout in 2021. She also was an executive at Flatiron Health and an oncology researcher at Duke University.
Abernethy and Hirsch previously worked together at Flatiron Health, where Hirsch was senior medical director, and at Duke Clinical Research Institute. Hirsch also was the founder and CEO of SignalPath, a clinical trials technology solution that Verily acquired in 2021.
"Brad and I have really been talking about the need for an organization like Highlander Health for all the years that we've been working together. This is now our fourth job together, and Highlander Health is really the next step," Abernethy said in an interview with Fierce Healthcare. "As we've been working across the years, we've talked about the importance of really focusing on how to streamline and accelerate clinical evidence generation, so clinical trials, real-world data and remote evidence, in order to make it more efficient and less burdensome to conduct clinical research and be able to know that products are adequately safe and effective. We've also been very focused on how does the healthcare delivery system ensure personalized healthcare for all? And the way that we've organized Highlander Health is really intended to address how those pieces come together."
Hirsch added, "I think that we would all say that the clinical research system as it exists today is both antiquated and not meeting the needs. It's not positioned for the capacity constraints that are coming as more and more cell and gene therapies and other things hit the market. The biggest pain point we're trying to address is, how do we both accelerate the clinical research opportunities that exist to get the answers we need without minimizing the quality or taking any shortcuts for traditional drug development and what the biotech world needs, while also meeting the need of clinicians every day who also don't have enough evidence to say maybe a drug was approved in a controlled phase III population, but they don't really know what does that mean in the patients they're seeing every day?"
The pair's initiative comprises Highlander Health Institute, a public interest platform that will provide grants to health systems while partnering with other ecosystem players to move forward with modern and streamlined evidence generation. The idea is to create clinician-led learning labs to create and test solutions.
Lyda Hill Philanthropies, a charitable group, will provide funding to help develop initial projects with health systems. "We've identified our first couple of projects. The first one's already funded," Hirsch said, noting that the company would provide more details about those projects in October.
"We are looking at how can we partner to develop learning labs with health systems to really prove what's possible? How do you better leverage all available data to answer key questions? How do you help to simplify the operational execution of trials?," Hirsch said.
Highlander Health also will have an investment arm, Highlander Health Partners, which will make investments of $50 million to $100 million in tech companies focused on advancing clinical research. The investment firm will support its businesses with capital, counsel and resources to ensure portfolio company success, the executives said. An evergreen fund that invests internal capital toward long-term value creation, the firm is focused on technology enablement in growth and middle-market companies across healthcare.
"We're really looking for established companies, which we believe we can then help to accelerate, either by bringing together a couple of different companies, or helping to reinforce the vision of an established company," Hirsch said. "The belief there is that we can help to really accelerate things. We can help with a bunch of different siloed companies that can be brought together to make a central solution to areas related to evidence generation, whether that's on the care side or the traditional life sciences side."
Hirsch added that both the investment arm and Highlander Health Institute are "trying solve the same core issue of how do we drive forward evidence generation and how do we optimize both discovery and care." "But, different mechanisms that serve different purposes to a degree," he said.
Abernethy and Hirsch believe they can leverage their combined expertise and five decades in healthcare, across academia, at companies small and large, and at FDA, to help improve clinical research and care delivery, especially where those two intersect.
Many companies have developed isolated point solutions but those approaches have been siloed, Abernethy noted.
"It's hard for those isolated point solutions to come together in aggregate to move the entire space forward," she said. "We saw this at Flatiron where in order for there really to be progress in real-world data and real-world evidence, on one side, there needed to be corporate investment to clean up data in high-quality ways. But, there also has to be multi-stakeholder work across the entire industry to understand what was possible, what was trustworthy, what regulators could use, what academics could use, what health systems needed."
Highlander Health is focused on building connected solutions that work across care settings to "streamline not only a treatment’s evaluation and approval but also its widespread adoption — all with an eye on what patients and providers need to flourish in an age of biological breakthroughs," Abernethy said.
The company is approaching evidence generation from the perspective of "the modern era of clinical research," Abernethy noted.
"That's all of clinical evidence generation, so formalized, traditional clinical trials, but also real-world data and real-world evidence and pragmatic clinical trials, and this landscape that we're finding ourselves in where medical products need to be evaluated over and over again. We've seen that with the shift towards accelerated approvals and needing to shift our evaluation of those drugs to the post-marketing setting. But, now, you also think about AI-based healthcare products that need to be continuously monitored to make sure that they're performing as expected," she said.