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Bloomberg – Roche Subsidiary Official to Take No. 2 Role at FDA

Bloomberg – Roche Subsidiary Official to Take No. 2 Role at FDA

One of the leading voices in using health data to advance targeted treatments known as precision medicine has been tapped for the second-highest post at the FDA.


Amy Abernethy, chief medical officer for Flatiron Health, will join the Food and Drug Administration as its principal deputy commissioner early next year, FDA Commissioner Scott Gottlieb announced Dec. 17. She will replace Rachel Sherman, a longtime FDA staffer who is retiring in January.


The announcement comes as an increasing number of new treatments cleared by the FDA are personalized therapies—such as Gilead’s Yescarta—which use diagnostic tests and patients’ genetic makeup to guide individualized medical decisions. Her appointment indicates the agency will continue its push toward precision medicine, accelerate the use of real-world evidence in its regulation of drugs and devices, and advance drug development that incorporates the patient experience.


“I’m so fortunate that the things I’ve worried about and the things that I’ve worked on for a long time are also being prioritized by the FDA,” Abernethy told Bloomberg Law in a Dec. 17 interview. “I’m really honored to do this.”


In announcing the appointment, Gottlieb said Abernethy “has pioneered the development of technology platforms to accelerate clinical evidence development, including the development of systems by which aggregated clinical data can support personalized medicine, outcomes research, cancer care quality monitoring, and scientific discovery.”

Two Major Focus Areas

Abernethy said there are two major areas she’s looking forward to undertaking as she transitions from Flatiron, a New York City-based oncology data company that pharmaceutical giant Roche spent nearly $2 billion to acquire in February, to agency life.


The first is working with Gottlieb to define fully what the scope of her new job will be. Second, she listed some personal priority areas on which she’d like to focus, including:

  • precision medicine;
  • accelerating the generation of the clinical evidence used to make approval decisions about medical products; and
  • making sure “we keep the patient at the center of everything we do.”

New Framework

The FDA recently unveiled how it plans to incorporate real-world evidence—data pulled from electronic health records, health-care claims, and even from mobile apps like Apple Watches and Fitbits—into its regulation of drug effectiveness. Abernethy said her focus on real-world evidence over the past 15 years was “very much a part of the reason” why both the FDA asked her and why she wanted to take on the agency’s No. 2 job.


“One of the main areas that we have to think through is what do the regulations look like and how do we make sure that what’s happening on the medical product development side lines up with what the FDA wants and needs?” Abernethy said. “My going to the FDA is part of my long-standing commitment to that whole question.”


“This bodes well for continued progress with real world evidence,” tweeted Kathy Hudson, who is the executive director of the People-Centered Research Foundation. She also led the early stages of the National Institutes of Health’s precision medicine initiative.


On patient centeredness, Abernethy said incorporating the user experience has become an increasing part of the conversation at the FDA, adding that Congress made this a priority in 2016’s 21st Century Cures law to speed development of drugs and devices.


“My hope is that these are topics that as a society we continue to take forward.” At the FDA, she hopes to advance patient-centered drug development “in a thoughtful and credible way.”

‘Most Influential Leaders’

Public interest group Friends of Cancer Research described Abernethy as “one of the most influential leaders in the oncology and data science spaces.


“Amy’s most recent endeavor as a pioneer in electronic data science is a true contribution that stands to transform the ability to better understand the safety and effectiveness of new medicines,” Jeff Allen, president and chief executive officer of Friends, said.


When former President Barack Obama announced his precision medicine initiative three years ago, Abernethy participated in many of the key events and panels as the government was shoring up the initiative.


“It felt like something that was so important,” she said about her participation at that time. Now she believes there’s a chance to support those efforts going forward from the FDA side.


Stephen L. Eck, chairman of the Personalized Medicine Coalition board, said Abernethy “brings a wealth of experience in integrating patient care, advanced data analytics, and health care policy in a health care environment that demands greater personalization to improve outcomes and reduce costs.” Eck is also the chief medical officer for the Houston-based biotechnology company Immatics. Abernethy is a member of the coalition’s board.…