Thursday, November 9, 2017

The Readout by Damian Garde & Meghana Keshavan

Welcome to The Readout, where we keep you on top of the latest in biotech. For more in-depth coverage of biopharma, subscribe to STAT Plus. On Twitter: @damiangarde@megkesh, and @statnews.

What’s going on with Google-backed life science companies?

Calico, the live-forever startup launched by Google's parent company, Alphabet, will be doing business without its top scientist, as Dr. Hal Barron will be leaving to join GlaxoSmithKline. It’s a departure that follows a steady bleeding of talent from Alphabet's Verily, a company at work on all sorts of medicinal tech, and from the Google-backed Grail, which is seeking to revolutionize cancer diagnostics.

So what gives? Calico didn’t explain Barron’s reasoning, and GSK didn’t respond to a request for comment. But here are two potential explanations:

Running research at GSK is a dream job. Yes, things haven’t been great lately, but GSK is a 145-year-old organization with a vaunted place in pharmaceutical history. And if you’re Barron, how could you resist the allure of potentially being the guy who righted such a storied ship? It’s like Mike D’Antoni going to the Knicks or José Mourinho joining Manchester United (though one assumes Barron envisions a different outcome).

Calico is falling apart. Beyond literally laughing in the face of death, Calico never said much about what it was doing — naked mole rats are involved — so it’s impossible to measure its progress, or lack thereof, against any sort of promise. But it’s not impossible that things hit some sort of wall, leading Barron to conclude that his (presumably) finite time on Earth could be better spent.

Desist with the tomfoolery, pharma!

FDA Commissioner Scott Gottlieb didn’t mince his words when addressing pharma companies at a Federal Trade Commission meeting yesterday.

“My message is this: End the shenanigans,” Gottlieb said, his face breaking into a rare smile, of the sort usually reserved for discussions of his chicken flock.

Specifically, Gottlieb is fed up with branded drug companies making it difficult for their generic rivals to acquire the drug samples they need to get their knockoffs tested and approved. What's more, he said other companies in the pharmaceutical supply chain might be in on the game, signing restrictive agreements with manufacturers that prevent generic companies from getting the samples they need. 

“I’m going to contact pharmaceutical supply chain intermediaries to inform them of FDA’s interest in making sure generic firms can gain access to the doses they need to run bio-equivalence studies,” Gottlieb said. He said this would happen “in the coming weeks.”

(And if you can't get enough of pharma shenanigans, here's a flashback to one of our favorite episodes of the Signal podcast.)

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The Real World: Drug development edition

Clinical research is getting a dose of reality, according to a new report from the Tufts Center for the Study of Drug Development. Specifically, trials and post-market studies are relying more and more on real-world evidence (hallelujah?) — thanks largely to last year’s 21st Century Cures Act. 

It’s costly and time-consuming, to be sure, to analyze data that’s been gathered in real time by actual patients, as opposed to drawing information from within the confines of a curated trial. But more drug developers are seeing the value of real-world evidence, and the staff that collect and analyze this data are expected to grow by 25 percent by 2020. 

Social media data are one form of real-world evidence that’s expected to pop up far more moving forward, even in the context of formal reports like new drug applications. Behold: 

Should Regeneron chill out a little?

Did you know Regeneron has had the same top leadership since 1989? That the company invests a lot in R&D? That they’ve never raised the price on a drug?

If the answer is no, then you’ve likely never spent a second listening to Drs. Leonard Schleifer and George Yancopoulos, a Regeneron managerial duo that rarely passes up an opportunity to point out how their company is doing right what the drug industry so often does wrong.

Yancopoulos, speaking at a Bloomberg event yesterday, said the FDA has approved just 22 drugs this year — the agency counts 37 — and only eight were “brand-new, first-in-class” therapies, by his estimation. It just so happens that two of those eight were made by Regeneron, he noted, implying that his company is responsible for 25 percent of biopharma’s 2017 productivity.

It’s statements like this make Regeneron a little grating to some in the industry. Pfizer CEO Ian Read was less than pleased by a similar display from Schleifer last year, and, as EvercoreISI Josh Schimmer recently wrote, “we (and many investors) are growing frustrated with the company’s general tone,” citing management’s “imperious and at times rancorous banter.”

More reads

  • Will tiny OncoSec break out with promising melanoma immunotherapy study results? (STAT Plus)
  • “Surprise” SITC late-breaker breaks Five Prime. (EP Vantage)
  • Gene therapy creates new skin to save a dying child. (New York Times)
  • The FTC takes the long view in effort to foster prescription drug competition. (STAT Plus)

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Thanks for reading! Until tomorrow,

Damian & Meghana

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