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Regulatory Focus™ > News Articles > 2019 > 7 > FDA’s No. 2 on RWE, Hype and Speeding Drug Development

FDA’s No. 2 on RWE, Hype and Speeding Drug Development

Posted 26 July 2019 | By Zachary Brennan 

FDA’s No. 2 on RWE, Hype and Speeding Drug Development

Just before PhRMA’s Innovation Day came to a close on Thursday, Novartis CEO Vas Narasimhan sat down with the US Food and Drug Administration’s (FDA) Principal Deputy Commissioner Amy Abernethy to discuss the rise of real-world evidence (RWE), what the technology and biopharma industries are over-hyping and why it’s so difficult to speed up drug development.

Abernethy came to FDA less than a year ago from Roche’s Flatiron Health, which is at the forefront of the real-world data space, and she said she thinks FDA has to reframe how it works with tech companies as its interactions with the biopharma and medical device fields are already mapped out.

“Eye rolls often start when things feel formal and people can’t talk,” she said. “We have to find ways to be at the same table.”

Narasimhan asked her what she thinks is “catching fire” and what falls into the “hype cycle,” to which she responded that momentum is beginning to build in the RWE space.

“I’m cautious, but I think part of the reason is that there are some problems in use cases, and that starts to showcase what can and can’t happen,” Abernethy said. She also explained how in the postmarket space, there’s more opportunity to “fine tune a label, expand a label and for surveillance. But the challenges always go back to the data.”

As far as hype, she pointed to “sophisticated computation.”

“I believe in the power of using computation,” she said, noting that the power of artificial intelligence (AI) “suggests to us that really cool stuff is coming,” but she said FDA and industry are “still trying to figure out how to get the data right. We’re really in just the baby steps in how we use AI in our work.”

Abernethy’s comments coincided with the publishing of a new perspective on Friday in Nature on the use of AI and machine learning in clinical development.

Narasimhan also asked Abernethy about the opportunities to use technology to speed drug development. She said she sees opportunities in this space, but, “We can’t do an end to end solve,” and issues have to be solved “in buckets,” such as how to pull information from alternative data sources.

“Adaptive trials need to get the amendment issue solved,” Abernethy added, noting that she’s asked companies to build a system to allow for 24-hour amendments.

Narasimhan said his company encourages no amendments because it’s the number one reason for cost and time over-runs.

Abernethy also praised CDRH’s work on human factors and usability and called on technology companies to lean into the regulations and government in the same way they lean into their customers.

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