Entrepreneurship – Page 27 – artdiamondblog.com

Tinkerers Build Their Own Pancreases, While Waiting for 100,000 Page Submission to FDA

(p. B1) Third-grader Andrew Calabrese carries his backpack everywhere he goes at his San Diego-area school. His backpack isn’t just filled with books, it is carrying his robotic pancreas.
The device, long considered the Holy Grail of Type 1 diabetes technology, wasn’t constructed by a medical-device company. It hasn’t been approved by regulators.
It was put together by his father.
Jason Calabrese, a software engineer, followed instructions that had been shared online to hack an old insulin pump so it could automatically dose the hormone in response to his son’s blood-sugar levels. Mr. Calabrese got the approval of Andrew’s doctor for his son to take the home-built device to school.
The Calabreses aren’t alone. More than 50 people have soldered, tinkered and written software to make such devices for themselves or their children. The systems–known in the industry as artificial pancreases or closed loop systems–have been studied for decades, but improvements to sensor technology for real-time glucose monitoring have made them possible.
The Food and Drug Administration has made approving such devices a priority and several companies are working on them. But the yearslong process of commercial development and regulatory approval is longer than many patients want, and some are technologically savvy enough to do it on their own.
. . .
(p. B2) “Biology isn’t quite as easy as controlling the temperature in a room,” said Francine Kaufman, chief medical officer for Medtronic’s diabetes division. She sees do-it-yourself efforts as a sign of the interest in the technology, but distinct from the process of getting a commercial device to market. Dr. Kaufman estimates Medtronic’s submission to the FDA will exceed 100,000 pages and hopes that the device will be approved in 2017.
The home-built project that the Calabreses followed, known as OpenAPS, was started by Dana Lewis, a 27-year-old with Type 1 diabetes in Seattle. Ms. Lewis began using the system in December 2014 as a sort of self-experiment. After months of tweeting about it, she attracted others who wanted what she had.
. . .
The FDA declined to comment on the project but said the agency is working with manufacturers to approve a device.
Sarah Howard became interested after she met Ms. Lewis last year. “My first question was: Was it legal?” said the 49-year-old, who has Type 1 diabetes, as does one of her two sons. “I didn’t want to do anything illegal.”
After her husband built the system for her and her son, she said the main benefit is starting each day with her blood sugar in range and not having to wake in the night to check her son’s glucose levels.

For the full story, see:
Kate Linebaugh. “Tech-Savvy Families Build Robotic Pancreas; Companies work on developing diabetes device, but approval process is too long for many patients.” The Wall Street Journal (Mon., May 9, 2016): B1-B2.
(Note: ellipses added.)
(Note: the online version of the story has the Tech-Savvy Families Use Home-Built Diabetes Device; Companies work on artificial pancreas, but approval process is too long for many patients.”)

Starzl Persisted in Trying “Impossible” Liver Transplants

(p. D8) In 1967, Dr. Starzl led a surgical team at the University of Colorado in a procedure that many in the medical community had dismissed as impractical, if not impossible. Although kidneys had been transplanted successfully since the 1950s, all previous attempts to replace a liver had resulted in the death of the patient.
Indeed, Dr. Starzl’s first four attempts at liver transplantation, in 1963, had failed when the patients experienced complications from the use of blood-clotting agents, which in some cases caused lethal clots to form in the lungs.
After a self-imposed moratorium that lasted three years, Dr. Starzl and his colleagues tried again. They first considered inserting a second liver, to function beneath the impaired one, as a possible route to avoiding the heavy bleeding caused by organ removal. But promising results obtained from liver surgeries on dogs could not be replicated in human patients, and that avenue was abandoned.
The team then operated on a 19-month-old girl and replaced her cancerous liver. The transplanted liver functioned without ill effects for more than a year, before the infant died of other causes. In the next year, as surgical techniques were improved, this pathbreaking success was repeated in six children and, ultimately, in adults.
Dr. Starzl later described those early liver transplants as both a “test of endurance” and “a curious exercise in brutality.” It involved, he explained, “brutality as you’re taking the liver out, then sophistication as you put it back in and hook up all of these little bile ducts and other structures.”
“Each one,” he said, “is a thread on which the whole enterprise hangs.”
. . .
With Dr. John Fung, a surgeon and immunologist, and others, Dr. Starzl evaluated FK-506, also known as tacrolimus. They published their findings in the British medical journal The Lancet in 1989.
Their investigation was not without risk; other scientists showed that tacrolimus had proved toxic when tested in dogs, and they doubted that it could be safe for humans. But the unexpected result was a medical breakthrough for patients and lavish headlines for the University of Pittsburgh, which Dr. Starzl helped fashion into an international center for training transplant specialists.
. . .
A former colleague from Pittsburgh, Dr. Byers Shaw Jr., praised Dr. Starzl’s “indomitable spirit” and said that FK-506, eventually approved in 1994 by the F.D.A., was a shining example of tenacity in a career spent “challenging the conventional thinking.”
Dr. Shaw, who is now the chairman of the department of surgery at the University of Nebraska, observed Dr. Starzl in the operating room in the 1980s, when a patient appeared to be dying during surgery. Dr. Starzl, he recalled, showed “persistence when everything else looked hopeless.”
“It affected everybody in the room,” Dr. Shaw said, “as if a fear of failure was driving all of those around him.”

For the full obituary, see:
JEREMY PEARCE. “Thomas E. Starzl, Pioneering Liver Surgeon, Dies at 90.” The New York Times (Mon., MARCH 6, 2017): D8.
(Note: ellipses added.)
(Note: the online version of the obituary has the date MARCH 5, 2017, and has the title “Dr. Thomas E. Starzl, Pioneering Liver Surgeon, Dies at 90.”)

Bud Shaw paints a vivid picture of Starzl in parts of:
Shaw, Bud. Last Night in the OR: A Transplant Surgeon’s Odyssey. New York: Plume, 2015.

Resveratrol Slows Alzheimer’s

(p. D1) A recent human study that suggested resveratrol could slow the progression of Alzheimer’s used a daily dose equivalent to the amount in about 1,000 bottles of red wine, says Scott Turner, director of the Memory Disorders Program at Georgetown University Medical Center, who led the study. Such high doses can lead to side effects such as nausea, vomiting and diarrhea.
Such side effects have caused past efforts to tap the health benefits of resveratrol to founder. GlaxoSmithKline PLC shelved a project to develop a resveratrol-based pill in 2010 after some clinical-trial patients developed kidney problems. The company, which had hoped to develop the drug as a treatment for a type of blood cancer, concluded that while resveratrol didn’t directly cause those problems, its side effects led to dehydration, which could exacerbate underlying kidney issues.
Now, scientists hope to overcome that problem by increasing the potency of resveratrol at more moderate doses. Researchers at the University of New South Wales, near Sydney, suspect the substance is more effective when accompanied by other ingredients found in red wine, which somehow promote its activity. They are developing a pill that combines puri-(p. D4)fied resveratrol with other compounds in wine in an effort to mimic the drink’s naturally-occurring synergies.
. . .
At the University of New South Wales, researchers have combined resveratrol with two other components of red wine: antioxidants and chelating agents, which have separately been shown also to have health benefits.
. . .
The researchers recently tried the combination in a small trial involving 50 people and found it increased the activity of a substance called NAD+ that plays a key role in maintaining healthy cells.

For the full story, see:
DENISE ROLAND. “Scientists Try to Put Red Wine in a Pill.” The Wall Street Journal (Tues., Aug. 2, 2016): D1 & D4.
(Note: ellipses added.)
(Note: the online version of the story has the date Aug. 1, 2016, and has the title “Scientists Get Closer to Harnessing the Health Benefits of Red Wine.”)

A recent article co-authored by Turner, related to the research summarized above, is:
Moussa, Charbel, Michaeline Hebron, Huang Xu, Jaeil Ahn, Robert A. Rissman, Paul S. Aisen, R. Scott Turner, Xu Huang, and R. Scott Turner. “Resveratrol Regulates Neuro-Inflammation and Induces Adaptive Immunity in Alzheimer’s Disease.” Journal of Neuroinflammation 14 (Jan. 3, 2017): 1-10.

Nano-Enhanced Fabrics Can Clean Themselves

(p. D3) Scientists in Australia, one of the sunniest places on the planet, have discovered a way to rid clothes of stubborn stains by exposing them to sunlight, potentially replacing doing the laundry.
Working in a laboratory, the researchers embedded minute flecks of silver and copper–invisible to the naked eye–within cotton fabric. When exposed to light, the tiny metal particles, or nanostructures, released bursts of energy that degraded any organic matter on the fabric in as little as six minutes, said Rajesh Ramanathan, a postdoctoral fellow at RMIT University, in Melbourne.
The development, reported recently in the journal Advanced Materials Interfaces, represents an early stage of research into nano-enhanced fabrics that have the ability to clean themselves, Dr. Ramanathan said. The tiny metal particles don’t change the look or feel of the fabric. They also stay on the surface of the garment even when it is rinsed in water, meaning they can be used over and over on new grime, he said.

For the full story, see:
RACHEL PANNETT. “An End to Laundry? The Promise of Self-Cleaning Fabric.” The Wall Street Journal (Tues., April 26, 2016): D3.
(Note: the online version of the story has the date April 25, 2016.)

The academic article describing the self-cleaning fabric, is:
Anderson, Samuel R., Mahsa Mohammadtaheri, Dipesh Kumar, Anthony P. O’Mullane, Matthew R. Field, Rajesh Ramanathan, and Vipul Bansal. “Robust Nanostructured Silver and Copper Fabrics with Localized Surface Plasmon Resonance Property for Effective Visible Light Induced Reductive Catalysis.” Advanced Materials Interfaces 3, no. 6 (2016): 1-8.

“Slow Is Smooth and Smooth Is Fast”

(p. B2) WASHINGTON — Jeff Bezos, the billionaire chief executive of Amazon, founded a rocket company as a hobby 16 years ago. Now that company, Blue Origin, finally has its first paying customer as it ramps up to become a full-fledged business.
Mr. Bezos announced that customer, the satellite television provider Eutelsat, on Tuesday. In about five years, Eutelsat, which is based in Paris, will strap one of its satellites to a new Blue Origin rocket to be delivered to space, a process it has done dozens of times with other space partners.
. . .
Blue Origin’s deal with Eutelsat is a “definite statement to the industry that Blue Origin will be a viable commercial launch vehicle,” said Carissa Bryce Christensen, the chief executive of Bryce Space and Technology, a consulting firm.
. . .
Mr. Bezos “is investing because he wants to transform people’s lives with space capabilities, but the expectation has always been that this will be a successful business,” Ms. Christensen said.
. . .
Mr. Bezos said he was approaching his space project with an abundance of patience.
“I like to do things incrementally,” he said, noting that Blue Origin’s mascot is a tortoise. With such high costs and risks with each rocket launch, it is important not to skip steps, he said.
“Slow is smooth and smooth is fast,” said Mr. Bezos, who also owns The Washington Post and a clock that will keep time for 10,000 years. “I’ve seen this in every endeavor I’ve been in.”

For the full story, see:
CECILIA KANG. “Blue Origin, Bezos’s Moon Shot, Gets First Paying Customer.” The New York Times (Weds., March 8, 2017): B2.
(Note: ellipses added.)
(Note: the online version of the story has the date March 7, 2017, and has the title “Blue Origin, Jeff Bezos’s Moon Shot, Gets First Paying Customer.”)

For $9,000, No Chicken Need Die, When You Eat a Pound of Chicken

(p. B3) A Bay Area food-technology startup says it has created the world’s first chicken strips grown from self-reproducing cells without so much as ruffling a feather.
And the product pretty much tastes like chicken, according to people who were offered samples Tuesday [March 14, 2017] in San Francisco, before Memphis Meats Inc.’s formal unveiling on Wednesday.
Scientists, startups and animal-welfare activists believe the new product could help to revolutionize the roughly $200 billion U.S. meat industry. Their goal: Replace billions of cattle, hogs and chickens with animal meat they say can be grown more efficiently and humanely in stainless-steel bioreactor tanks.
. . .
On Tuesday [March 14, 2017], Memphis Meats invited a handful of taste-testers to a San Francisco kitchen and cooked and served their chicken strip, along with a piece of duck prepared à l’orange style.
Some who sampled the strip–breaded, deep-fried and spongier than a whole chicken breast–said it nearly nailed the flavor of the traditional variety. Their verdict: They would eat it again.
. . .
The cell-cultured meat startups are a long way from replacing the meat industry’s global network of hatcheries, chicken barns, feed mills and processing plants. But they say they’re making progress. Memphis Meats estimates its current technology can yield one pound of chicken meat for less than $9,000. That is half of what it cost the company to produce its beef meatball about a year ago. The startups, however, aspire to produce meat that can be cost-competitive with the conventionally raised kind.

For the full story, see:
JACOB BUNGE. “Startup Serves Chicken From the Lab.” The Wall Street Journal (Thurs., March 16, 2017): B3.
(Note: ellipses added.)
(Note: the online version of the story has the date March 15, 2017, and has the title “Startup Serves Up Chicken Produced From Cells in Lab.”)

As Consumers Accept Surge Pricing, More Will Accept Congestion Pricing Too

(p. B2) With remarkable consistency, the research finds the same thing: Whenever a road is built or an older road is widened, more people decide to drive more. Build more or widen further, and even more people decide to drive. Repeat to infinity.
Economists call this latent demand, which is a fancy way of saying there are always more people who want to drive somewhere than there is space for them to do it. So far anyway, nothing cities have done to increase capacity has ever sped things up.
The extent of this failure was chronicled in a 2011 paper called “The Fundamental Law of Road Congestion,” by the economists Gilles Duranton, from the Wharton School of the University of Pennsylvania, and Matthew Turner, from Brown University.
The two went beyond road building to show that increases in public transit and changes in land use — basically, building apartments next to office buildings so that more people can walk or bike to work — also fail to cut traffic (or do so only a little).
This doesn’t mean public transit and land planning are bad ideas, or that widening freeways is a bad idea. When roads are bigger, more people can get around. More people see family; more packages are delivered; more babies are lulled to sleep. It just means that none of those measures have done much to reduce commute times, and self-driving cars seem unlikely to either.
That’s where charging people during busy times comes in. “Maybe autonomous cars will be different from other capacity expansions,” Mr. Turner said. “But of the things we have observed so far, the only thing that really drives down travel times is pricing.”
This is because the average person prefers the privacy and convenience of riding in a car.
. . .
“This idea of congestion pricing is not completely dismissed the way it once was,” said Clifford Winston, an economist at the Brookings Institution.
Mr. Winston said the eventual introduction of self-driving cars would probably lessen consumer opposition to paying more to use roads during peak periods. Ride-hailing apps have taught consumers to accept surge pricing, and people are generally less resistant to paying for something new. The result would be something like variably priced lanes dedicated to fleets of robot vehicles.
If that happens, one of the hidden benefits of this revolutionary new technology will be that it got people to accept an idea that economists started talking about at least a century ago. And you get home a half-hour earlier.

For the full story, see:
Conor Dougherty. “A Cure for Traffic Jams.” The New York Times (Weds., March 8, 2017): B1-B2.
(Note: ellipsis added.)
(Note: the online version of the story has the title “Self-Driving Cars Can’t Cure Traffic, but Economics Can.”)

Restaurants Add Labor Surcharges to Help Pay Minimum Wage Costs

(p. B1) In lieu of steep menu price increases, many independent and regional chain restaurants in states including Arizona, California, Colorado and New York are adding surcharges of 3% to 4% to help offset rising labor costs. Industry analysts expect the practice to become widespread as more cities and states increase minimum wages.
“It’s the emerging new norm,” said Sharokina Shams, spokeswoman for the California Restaurant Association. She said California restaurants are adding surcharges as the state lifts the minimum wage every year until it reaches $15 an hour by 2023. It is currently at $10.50 an hour for employers with 26 or more workers.
. . .
While adding a surcharge risks turning diners away, some restaurateurs say they want customers to understand the consequences of higher wages on a business with profit margins of generally between 2% and 6%.
. . .
(p. B2) Sami Ladeki added surcharges to the menu at six Sammy’s Woodfired Pizza & Grill restaurants in San Diego and eight more across California. He said it was a mistake to call the charge a state mandate, and has changed the wording. But he remains critical of rising minimum wages.
“This is not sustainable,” said Mr. Ladeki, who says he makes a profit of around 1% charging $12 to $14 a pizza. “People are not going to pay $15 or $20 for a pizza.”
. . .
David Cohn, who owns 15 restaurants in San Diego, including BO-beau, said his 3% surcharge wasn’t a stunt.
“We want people to understand there is a cost,” Mr. Cohn said. “How do we stay in business with margins shrinking and competition increasing?”

For the full story, see:
JULIE JARGON. “New on Your Dinner Tab: A Labor Surcharge.” The Wall Street Journal (Fri., March 10, 2017): B1-B2.
(Note: ellipses added.)
(Note: the online version of the story has the date March 9, 2017.)

Entrepreneur Rothblatt Was Highest-Paid Female CEO in 2013

(p. 3) Martine Rothblatt, a serial entrepreneur, has a unique perspective on female 1 percenters. She not only founded Sirius Satellite Radio, but also founded and serves as chief executive of United Therapeutics, a pharmaceuticals company. Ms. Rothblatt was the highest-paid female chief executive in the country in 2013, with compensation of $38 million, yet she does not see her success as a victory for women. She was born as Martin and underwent gender reassignment surgery in 1994.
“I’ve only been a woman for half of my life, and there’s no doubt that I’ve benefited hugely from being a guy,” she told Fortune magazine.
In an interview, Ms. Rothblatt had some surprising suggestions for helping women reach the top. She supports eliminating “say on pay” rules that allow shareholders to vote on executive compensation, and eliminating shareholder advisory groups. “If shareholders do not like the pay a woman is receiving as C.E.O., they should simply sell the stock, and vice versa,” she said.

For the full commentary, see:
ROBERT FRANK. “INSIDE WEALTH; Plenty of Billionaires, but Few Are Women.” The New York Times, Sunday Business Section (Sun., Jan. 1, 2017): 3.
(Note: the online version of the commentary has the date DEC. 30, 2016, and has the title “INSIDE WEALTH; Why Aren’t There More Female Billionaires?”)

Category: Entrepreneurship