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FDA Commissioner Dr. Scott Gottlieb’s recently announced appointment of Dr. Amy Abernethy to serve as his first lieutenant perfectly exemplifies the sort of thinking that has enabled Gottlieb to earn nearly universal praise at a time of unprecedented partisanship. He has focused his attention on high-priority, immediate concerns like the targeting of e-cigarettes to children, the opioid epidemic, and the need for a more robust market in affordable generic medications, while also seeking to prepare the agency to engage with emerging technologies, from consumer wearables to applications of artificial intelligence, to expand the breadth of evidence generation and accelerate the speed of analysis.
Abernethy combines the pragmatic humanism of an oncologist (which she is) with the technological sophistication of someone who spent their teenage years attending math camp and programming computers for NASA – after originally learning math by helping her mother edit a nursing textbook, as she recently told Lisa Suennen and me on our Tech Tonics podcast.
The key challenge that Dr. Abernethy has focused on throughout her career – first in academia, at Duke, and more recently in business – is how to close the gap between clinical practice and clinical research. While at Duke, it struck her as odd, if not absurd, that she’d see patients in her oncology practice on a Monday, and then they’d need to come back on Tuesday to participate in a clinical trial she was conducting, because the two activities were considered so distinct. Why shouldn’t the rich, and increasingly digitized information collected during the course of patient care – so called “real world data” – be used to answer important research questions as well?
After working on this problem for a number of years as a physician-scientist at Duke, she ultimately joined a Manhattan-based oncology data company called Flatiron, which was focused on this exact problem. Founded by two sharp young techies who had sold their first company to Google, Flatiron built around the thesis that data from cancer patients must contain important insights; the question was how to extract such insights from reams of clinical data.
Enter Abernethy, who helped transform the company with two key ideas. First, the company would strive to produce data on par with that of clinical trials; this meant that the underlying information had to be meticulously organized and assessed, not simply aggregated and robotically analyzed. Second, she recognized that for all the technological wizardry available to the company, there was simply no substitute for human judgment. Thus, at the core of this tech platform were an army of highly-trained data extractors, mostly nurses and other health care professionals who were expert at piecing together a patient’s story from the shards of information available.
The approach worked; Flatiron was able to generate what they call “regulatory-grade” information used by many pharma companies and regulatory agencies, including the FDA. In March of this year, Flatiron was acquired by Roche for $2.1B – arguably the most significant recent transaction in the health data space. Roche, wisely, has promised to remains hands-off, and Flatiron continues to work with a range of industry partners. (Note: I am not an investor in Flatiron.)
Gottlieb would have been hard-pressed to find a person better suited to many of the key challenges facing the industry. For starters, Abernethy has an appreciation for both the complexity of clinical data and the limitations, as well as the promise, of technology. I expect she will seek to utilize technology in a grounded way, and will neither fear nor fetishize it. She will also keep her focus squarely on the individual patients, whose suffering she has seen up close as they’ve struggled with cancer; she’s seen the impact of emerging therapies, but also appreciates the anguishing difficulty of selecting the right one – as she’s poignantly described.
Like Gottlieb, she has first-hand familiarity with the industry she’ll be entrusted to regulate. While some inevitably will view this as problematic, her extensive working knowledge is likely to prove profoundly enabling, allowing her to provide the most relevant guidance while understanding relevant constraints. Gottlieb’s remarkable success thus far is a testament to the value of sophisticated knowledge of the industry.
We are entering a world where it’s increasingly clear that what matters most is not FDA approval of a medical innovation, but rather, the real world impact the innovation has, its actual performance. How well does it improve the lives of all afflicted patients, not just the select few who qualify for highly structured clinical trials? As our collective focus appropriately expands from approvals to outcomes, fluency with real-world data, and the tools to generate and analyze this information, will be ever-more critical. Abernethy has the right experience, attributes, and instincts to catalyze the FDA’s embrace of this imminent patient-centric future.
December 17, 2018 at 06:30PM
Forbes – Entrepreneurs