Tuesday, February 21, 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 the biopharma world, subscribe to STAT PlusOn Twitter: @damiangarde@megkesh, and @statnews.

Another big name leaves Moderna

The superlatively well-funded Moderna Therapeutics is losing another top executive, and the latest departure comes right on the eve of a crucial test for the company.

Dr. Stephen Kelsey, hired in 2014 to lead Moderna’s efforts in oncology, is leaving to join a biotech startup, STAT has learned, just as the company prepares to advance its first cancer treatment into clinical trials.

Read more in STAT Plus.

Biotech: the only thing as frightening as nuclear warfare

For all the talk of how CRISPR could help save millions of people, less often discussed its how gosh-wow biological advances could be fashioned into frightening weapons.

“I think if there is going to be something ever that rivals nuclear weapons in terms of the pure fearsomeness of their destructiveness it’s more likely to come from biotechnology than any other technology,” former Secretary of Defense Ash Carter told Wired this week.

Bill Gates made a similar point at a security conference in Germany over the weekend, warning that new technologies could put alarming power in the hands of would-be bioterrorists.

Carter has been beating this drum for some time, and last year he spearheaded a program meant to help the Department of Defense cozy up to biotech startups and make investments in promising companies whose work might translate to stuff the Pentagon can use.

Will the new administration follow a similar path?

“It’s only day 24,” Carter told Wired, “so I don’t know where that will go.”

Where are all the cool new diabetes drugs?

When you gaze across the landscape of late-stage pipelines in biopharma, you see promising advances in oncology, novel approaches to rare diseases, and a bunch of attempts to treat Alzheimer's disease.

But when it comes to diabetes, there's not a lot going on. What gives?

According to doctors, scientists, and drug company execs, the combination of science being hard, trials being expensive, and current drugs being pretty good has made innovation in diabetes particularly challenging. There's a high bar to clear for any new ideas in the field, and that's made for a vexing process.

Read more.

Still waiting on Mr. (or Ms.) Fantastic

Keep holding your horses: We may have to wait until the summer to learn who will deign to serve as FDA commissioner under President Trump. 

Though Trump told pharma CEOs that he’d already chosen a “fantastic person” to lead the agency, Biocentury reports that it could take a month to six weeks for an announcement — and until June to get a Senate confirmation.

Of course, we’ve had similar gaps in FDA leadership before, Biocentury points out. Dr. Margaret Hamburg, the first commissioner under the Obama administration, didn’t take the agency’s helm until May 2009. And when she resigned, it took another 10 months to confirm Dr. Robert Califf.

The Right to Try premise: Peddling false promise? 

The "Right to Try" movement has been misguided, STAT's Ed Silverman opines - and in encouraging several patient families to lobby for this legislation, Vice President Pence is giving them false hope.

The legislation is meant to help patients gain faster access to experimental drugs, even if they don't qualify for clinical trials. A nice thought, in theory, but it's another effort to strip down drug regulation  — and could prove dangerous for patients.

The bill, notably, has a provision that prevents FDA from using data from these patients, who might use the drug outside a monitored trial, in its approval or labeling process.

More reads

  • MD Anderson benches IBM Watson in a setback for artificial intelligence in medicine. (Forbes)
  • The race to map the human body, one cell at a time. (Nature)
  • Critics of experimental cancer therapy just don’t get it, according to the mother of a patient. (STAT)
Correction: Friday's newsletter incorrectly stated that Turing Pharmaceuticals was kicked out of PhRMA. In fact, it was kicked out of BIO. We regret the error.

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Thanks for reading! Until tomorrow,

Damian & Meghana

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