Building a Human Being, Cell By Cell
Homer called it “a thing of immortal make.” The Chimera (have your pick of spellings) was a hideous hybrid: “lion-fronted and snake behind, a goat in the middle, and snorting out the breath of the terrible flame of bright fire.”
So, natch, the biomed fandom has been all goat-in-the-middle over a report in the current issue of Cell that conjures up this monstrous mash-up once more. Scientists at the Salk Institute for Biological Studies, led by Juan Carlos Izpisua Belmonte, revealed that they’d created their own viable chimeras—or, in polite company, “interspecies blastocyst complementations.” Using the gene-editing tool CRISPR-Cas9 to turn off certain genes in a mouse zygote as well as other new techniques to enrich the pluripotent stem cells of a rat, the group managed to grow various rat organs (a pancreas, heart, and eyes) in a mouse embryo.
“Once implanted in surrogate mouse mothers, the embryos developed normally—except for the fact that each mouse was growing a rat pancreas” [or heart, or eyes], said the Salk Institute’s own news analysis—which, incidentally, called the Salk team’s paper a “tour de force.”
The group also reported—and I guess I’m burying the sci-fi lede here—growing human cells and tissues in pig and cattle embryos. Oh yeah…that.
Now, why is this important, beyond making Hollywood screenwriters salivate? Because, as Belmonte rightly explains, the new “precisely targeted” tools can help us “study species evolution, biology and disease, and may lead ultimately to the ability to grow human organs for transplant.”
As cool as the Salk experiments are, though, they overshadowed several other important reports on the stem cell front over the past few weeks. A research group at Cincinnati Children’s Hospital Medical Center used human pluripotent stem cells (hPSCs) to grow human stomach tissue (paywall)—and, notably, the part of the organ that produces digestive enzymes.
And, perhaps most strikingly, a team at a gaggle of New York research institutions published a paper showing how they’d used hPSCs to cook up—in just days, rather than several months—cortical neurons (critical central nervous system cells) that had normal electrophysiological signaling properties. That noteworthy advance could have huge implications for those with brain and other CNS disorders one day.
In sum, it’s been a great few weeks for blind Greek poets and science.
Some more news below.
MD Anderson teams up with liquid biopsy upstart Guardant. Guardant Health, a "liquid biopsy" startup that's trying to displace the traditional tissue biopsy with what's essentially a blood test, has struck a partnership with the University of Texas' MD Anderson Cancer Center to help make the tech standard of care for cancer patients. There's a long way to go before that becomes a reality. But the two organizations see the promise of replacing pricey and complicated biopsies with Guardant Health's technique, which can suss out genetic mutations in the little shreds of tumor DNA that are left in the blood stream. "Liquid biopsies are far less invasive than traditional biopsies, a development that not only benefits our patients through a simplified diagnostic procedure but also by significantly enhanced analysis of samples taken," said Dr. Stanley Hamilton, professor of Pathology and division head of Pathology and Laboratory Medicine at MD Anderson, in a statement. "This unique partnership will greatly contribute to bringing liquid biopsies to the forefront of cancer care. We have already seen in the medical literature the impact this technology can have on patients, and we anticipate this agreement will drive broader access for our patients in the future."
Fitbit sales slump and firm plans big job cuts. The fitness tracker industry has been facing some market headwinds lately, and the trend is hitting wearables king Fitbit where it hurts. The firm is lopping off about 6% of its workforce amid a massive sales slump. The company reported Monday that sales had plunged 20% during the holiday quarter last year, which is a do-or-die period for wearables makers. As a result, Fitbit announced the layoffs, which are part of a drive to cut $200 million in annual spending. But while Fitbit believes it can course correct with the spending cuts and an entry into higher-end smartwatch markets, my colleague Aaron Pressman notes the firm still has its work cut out. "The weak ending to 2016 and poor outlook for early 2017 are the result of market saturation for fitness bands, unappealing features, a lack of new products, greater competition from Apple, Garmin (GRMN, +0.55%) and a host of cheap Asian manufacturers, and growing economic weakness in China, depending on which analyst or market research firm is talking," he writes. (Fortune)
Genentech oncology head moves over to a CAR-T biotech. Yet another biopharma bigwig is taking his talents over to a smaller, aspirational biotech. This time, it's Roche/Genentech oncology chief Rick Fair, who's moving on to become CEO and president of Texas-based Bellicum. Bellicum is among the flurry of biotechs investing heavily into cell therapies such as experimental chimeric antigen receptor T-cell (CAR-T) treatments for cancer (this is the next-gen treatment that involves reprogramming immune cells to become cancer killers and has shown promise in blood cancers, which Bellicum specializes in). Fair is a particularly good fit given his history helping launch Roche/Genentech's first major "checkpoint inhibitor" cancer immunotherapy, Tecentriq. (FiercePharma)
Trump meets with big pharma CEOs and issues a list of demands. President Donald Trump on Tuesday morning met with a host of pharma bigwigs, including the CEOs of: Novartis, Merck, Eli Lilly, Johnson & Johnson, Celgene, Amgen, and industry lobbying powerhouse Pharmaceutical Research and Manufacturers of America (PhRMA). Trump reportedly pressed the biopharma chiefs on drug price hikes, which he's heavily criticized as the sector "getting away with murder," and pushed for more U.S.-based production and manufacturing of drugs. In exchange, Trump promised a new era at the Food and Drug Administration (FDA) that will include more rapid drug approvals (a major component of the 21st Century Cures Act, which President Obama signed into law just before leaving office). But how much will such a meeting actually change pharma's behavior, or the regulatory landscape overall? I'll have more on this today. (Fortune)
Mylan facing antitrust investigation into EpiPen practices. EpiPen maker Mylan is facing a Federal Trade Commission (FTC) probe into whether or not it improperly acted to prevent competition from generic alternatives to its flagship product, Bloomberg reports. There are two main parts to the investigation: 1) whether or not Mylan engaged in "product hopping," or making small tweaks to the EpiPen in order to preserve IP protection; and 2) whether or not the pharma giant entered into certain agreements that stalled the entry of cheaper generics into the market. Mylan is already facing competition from a number of companies ever since the backlash to its massive price hike on the EpiPen. Rival Kaleo's Auvi-Q is set to make a comeback in the coming months and will reportedly be offered for $0 out of pocket to most consumers, while CVS is offering a generic competitor for $110 before rebates. (Bloomberg)
THE BIG PICTURE
Premium spikes lead to 5% profit growth at Aetna. Insurance giant Aetna managed to pull off an impressive 5% spike in profits despite hemorrhaging 377,000 members in 2016. So how did Aetna pull it off? Via premium hikes in its Medicare and Medicaid businesses, as well as membership growth in its private Medicare Advantage plans for seniors. Much of the overall membership drop has to do with Aetna's individual insurance sector, which has been struggling to maintain profits in the Obamacare insurance marketplaces (which Aetna largely pulled out of for 2017.) But the insurer's rationale for abandoning the health law has also come under question, with a judge asserting that it was actually retaliation for the Obama administration's push to block a proposed merger with rival Humana. (Modern Healthcare)
Today is the last day to sign up for Obamacare. While Obamacare's fate still remains very much up in the air, today is the last day to sign up for individual health insurance plans through HealthCare.gov and other statewide marketplaces. (The question is if this will be the last day ever to sign up under the health law.) As of January 14, 8.8 million Americans had signed up, an uptick from last year.
What CEOs Fear Most Right Now, by Alan Murray
Democrats Just Walked Out of Mnuchin and Price Confirmation Votes, by Reuters and Fortune Editors
Biopharma Leaders Are Slamming Trump's Immigration Ban, by Sy Mukherjee
Eric Schmidt Says Trump Administration Will Do "Evil Things," by Don Reisinger
|Produced by Sy Mukherjee|
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