Category: Entrepreneurship

Citron Research Alleged That DNA Vaccine Firm Inovio Is “the COVID-19 Version of Theranos”

(p. A10) Not long after researchers completed their work with mice, guinea pigs, ferrets and monkeys, Human Subject 8, an art director for a software company in Missouri, received an injection. Four days later, her sister, a schoolteacher, became Subject 14.

Together, the sisters make up about 5 percent of the first ever clinical trial of a DNA vaccine for the novel coronavirus. How they respond to it will help determine the future of the vaccine. If it proves safe in this trial and effective in future trials, it could become not only one of the first coronavirus vaccines, but also the first DNA vaccine ever approved for commercial use against a human disease.

. . .

In many of these studies, the vaccine recipe isn’t the only thing on trial. Gene-based vaccines — and at least 20 coronavirus vaccines in development fall into this category — have yet to make it to market. Should one end up in doctors’ offices amid the rush to shield billions from Covid-19, it would represent a new chapter for vaccine development.

And though vaccine research has never moved this quickly — potentially meaning enhanced risks for volunteers — it has never been easier to recruit subjects, according to Dr. John E. Ervin, who is overseeing the DNA vaccine trial at the Center for Pharmaceutical Research in Kansas City, Mo., in which the sisters are involved. For the Phase 1 trial of the vaccine, which was developed by Inovio Pharmaceuticals, 90 people applied for the 20 slots in Kansas City.

“We probably could charge people to let them in and still fill it up,” he said. (In fact, the participants were paid per visit.)

. . .

Inovio researchers engineered the vaccine in just three hours, according to Kate Broderick, the company’s senior vice president for research and development. Or, rather, their computer algorithm did: On Jan. 10 [2020], when Chinese researchers released the genetic code of the novel coronavirus, the team ran the sequence through its software, which popped out a formula.

This timeline struck some in the financial sector as too good to be true. Citron Research, which advises investors on companies to bet on, called Inovio “the Covid-19 version of Theranos,” referring to the blood-testing device company that imploded as its supposedly revolutionary product was revealed to be a hoax.

“Much like Theranos, Inovio claims to have a ‘secret sauce’ that, miraculously, no pharma giant has been able to figure out,” Citron Research wrote. “This is the same ‘secret sauce’ that supposedly developed a vaccine for Covid-19 in just three hours.”

For the full story, see:

Heather Murphy. “Fight Against Coronavirus Could Produce a First: A DNA Vaccine.” The New York Times (Friday, June 19, 2020): A10.

(Note: ellipses, and bracketed year, added.)

(Note: the online version of the story was updated June 22 [sic], 2020, and has the title “Guaranteed Ingredient in Any Coronavirus Vaccine? Thousands of Volunteers.”)

Covid-19 Caused Mass Transit Use to “Plummet by 80%” or More

(p. D1) Fears of being exposed to germs in cramped underground spaces have reportedly caused mass transit ridership to plummet by 80% in urban centers such as Milan and San Francisco—and by up to 96% in hot spots including New York, Washington, D.C., and Paris. When they head back to their corner offices, car-shunning members of the C-suite set might be more likely to commute in prudent solitude on electric bikes than to trudge up subway steps.

“No one wants to be in a dirty cab. We don’t want to be on a bus or subway. People want their own mode of transportation that they control,” said Michael Burtov, author of “The Evergreen Startup.” Mr. Burtov, who works with entrepreneurs as part of MIT’s Enterprise Forum, also noted a severe dip in usage of shared bikes and scooters; who yearns to spend an afternoon wiping down handlebars or riding in gloves? “For individualized modes of transportation, which are affordable and really efficient, it’s a renaissance.”

To wit, Seattle’s Rad Power Bikes recently announced that sales had leapt nearly 300% this April compared with the same period in 2019. Its Dutch competitor VanMoof claimed a similar growth of 264% for the first half of 2020 compared with the same six months last year.

For the full story, see:

Matthew Kitchen. “Wanted: A Safer Commute.” The Wall Street Journal (Saturday, June 27, 2020): D1.

(Note: the online version of the story has the same date as the print version, and has the title “Wary of Subways? 6 Electric Options for a Solo Work Commute.”)

The book by Burtov, mentioned above, is:

Burtov, Michael. The Evergreen Startup: The Entrepreneur’s Playbook for Everything from Venture Capital to Equity Crowdfunding. Hypercritical Publishing, 2020.

Excellence Achieved by “Deliberate Practice” That Is Critiqued by Tough Expert Teachers

(p. A12) Dr. Ericsson, a professor of psychology at Florida State University, argued that sustained practice was far more important than any innate advantages in determining who reaches the top in athletic, artistic and other fields.

That practice, however, couldn’t be mindless repetition. He called for “deliberate practice,” preferably guided by an expert teacher, focused on identifying and correcting weaknesses and monitoring progress. If you were enjoying the practice, it probably wasn’t working.

Dr. Ericsson’s research gained prominence with the publication of “Outliers,” a 2008 book by Malcolm Gladwell. Drawing loosely on Dr. Ericsson’s findings, Mr. Gladwell proclaimed “the 10,000-Hour Rule,” to denote the typical amount of practice time needed to master certain skills, such as playing the violin at an elite level. Dr. Ericsson later wrote that Mr. Gladwell’s rule oversimplified the relevant research.

. . .

He was comfortable in an office surrounded by mounds of books and papers that appeared to have been arranged by a tornado.

For the full obituary, see:

James R. Hagerty. “Professor Studied Habits Of World-Class Experts.” The Wall Street Journal (Saturday, June 27, 2020): A12.

(Note: ellipsis added.)

(Note: the online version of the obituary has the date June 25, 2020, and the title “Professor Studied How Elite Performers Reach the Top.”)

The Gladwell book that made highlighted Ericcson’s research, is:

Gladwell, Malcolm. Outliers: The Story of Success. New York, NY: Little, Brown, and Co., 2008.

Houghton Shifted Corning from Cookware to Fiber Optics

(p. A13) When Amory Houghton became chief executive of Corning Glass Works in 1964, the company founded by his great-great grandfather was thriving. Known to the general public for Pyrex measuring cups and Corning Ware casseroles, it dominated the U.S. market for the glass used to encase TV tubes.

But the company, now known as Corning Inc., proved too reliant on those tubes, which accounted for as much as 75% of profit. In the mid-1970s, the company faced a recession and the loss of TV-related business as Japanese imports captured the U.S. market. Profits collapsed, and Mr. Houghton had to chop costs, including at the headquarters in Corning, N.Y. The global workforce dropped by more than one-third.

. . .

“It was tough making these cuts,” he said, “particularly when you lived in a small town where you knew a lot of these people.”

Corning bounced back, unlike many other U.S. manufacturing giants. That was partly because Mr. Houghton made a long-term commitment to development of fiber optics. He correctly saw that hair-thin strands of glass would replace copper wire in transmissions of voice and data. “It’s our turf, with our patents,” he said.

By the late 1990s, optical fiber and related telecommunications products accounted for more than half of Corning’s operating profits.

For the full obituary, see:

James R. Hagerty. “Executive Lifted Corning With Bet on Fiber Optics.” The Wall Street Journal (Saturday, March 14, 2020): A13.

(Note: ellipsis added.)

(Note: the online version of the obituary has the date March 13, 2020, and the title “Amory Houghton’s Bet on Fiber Optics Helped Save Corning.”)

Frustration of a Non-Expert Entrepreneur Inspired the Creation of Square

(p. B6) It was 2009, and Mr. McKelvey—a glassblower, computer scientist and serial entrepreneur—had lost a sale of one of his artworks because he couldn’t accept American Express cards. Though neither he nor Mr. Dorsey, now CEO of Square and Twitter Inc., knew much about the world of credit-card transactions, his frustration inspired the creation of Square’s signature white readers, a technology that would revolutionize payments by allowing anyone to accept a card with a smartphone or tablet.

In his new book, “The Innovation Stack,” Mr. McKelvey uses the story of Square’s early days, and its success in fending off a rival product from Amazon.com Inc., to encourage other potential founders with a dearth of credentials to fix unsolved problems and start novel businesses.

“If you’re going to do something that’s never been done, by definition, you cannot be an expert,” he said. “Take it from a glassblower who started a $30 billion payment company: You don’t have to be.”

. . .

“. . . there are no experts anymore. We’re living in a world without expertise, and that’s the world of the entrepreneur, like it or not.”

For the full interview, see:

Peter Rudegeair, interviewer. “Square’s Co-Founder Sees Openings in Recessions.” The Wall Street Journal (Tuesday, May 26, 2020): B6.

(Note: ellipses, and quotation marks around last two sentences, added.)

(Note: the online version of the television review has the date May 24, 2020, and has the same title “BOSS TALK; Square’s Co-Founder: A Recession Is a Great Time to Start a Company.” The first several paragraphs quoted above are from Pter Rudegeair’s introduction to his interview of Jim McKelvey. The last couple of sentences are from McKelvey’s response to the last question in the interview.)

The book, mentioned above in the introduction to the interview, is:

McKelvey, Jim. The Innovation Stack: Building an Unbeatable Business One Crazy Idea at a Time. New York: Portfolio, 2020.

YouTube, Vimeo, and Twitter Censor Firm Working on Ultraviolet Covid-19 Cure

(p. A15) Early in the Covid-19 pandemic, Aytu BioScience made a commitment to find ways to help. One of those ways came through our newly formed relationship with a prominent Los Angeles hospital.

On April 20 [2020] we put out a press release titled “Aytu BioScience Signs Exclusive Global License with Cedars-Sinai for Potential Coronavirus Treatment.” The treatment is called Healight, and it was developed by research physicians at the hospital’s Medically Associated Science and Technology Program. The technology, which has been in development since 2016, uses ultraviolet light as an antimicrobial and is a promising potential treatment for Covid-19.

Aytu and Cedars-Sinai have engaged with the Food and Drug Administration to pursue a rapid path to human use through an Emergency Use Authorization. But hardly anyone noticed—until Thursday, when President Trump mused, “. . . supposing you brought the light inside the body . . .”

My team and I knew the president’s comments could trigger a backlash against the idea of UV light as a treatment, which might hinder our ability to get the word out. We decided to create a YouTube account, upload a video animation we had created, and tweet it out. It received some 50,000 views in 24 hours.

Then YouTube took it down. So did Vimeo. Twitter suspended our account. The narrative changed from whether UV light can be used to treat Covid-19 to “Aytu is being censored.”

For the full commentary, see:

Josh Disbrow. “Ultraviolet Light Takes Political Heat.” The Wall Street Journal (Tuesday, April 28, 2020): A15.

(Note: bracketed year added, ellipses in original.)

(Note: the online version of the commentary has the date April 27, 2020, and the title “An Experimental Ultraviolet Light Treatment for Covid-19 Takes Political Heat.”)

Seeking Cure for Covid-19, Scientist in Elite Group Identifies the FDA as “the Problem Here”

(p. A1) A dozen of America’s top scientists and a collection of billionaires and industry titans say they have the answer to the coronavirus pandemic, and they found a backdoor to deliver their plan to the White House.

The eclectic group is led by a 33-year-old physician-turned-venture capitalist, Tom Cahill, who lives far from the public eye in a one-bedroom rental near Boston’s Fenway Park. He owns just one suit, but he has enough lofty connections to influence government decisions in the war against Covid-19.

. . .

(p. A6) Brian Sheth, co-founder of private-equity firm Vista Equity Partners, and a Democrat, had been watching the effort gather steam from his home in Austin, Texas. He was an early investor in Dr. Cahill’s fund and had been on the first call. His expertise was technology, though, not immunology.

He had become friendly with Thomas Hicks Jr., the Dallas businessman and co-chairman of the Republican National Committee. Mr. Sheth introduced Mr. Hicks to Dr. Cahill’s group.

The connection cinched ties between a group of mostly liberal scientists from left-leaning institutions with a Republican stalwart who hunts birds with Donald Trump Jr.

In his first chat with the group, Mr. Hicks said, “I’m not a scientist. Make it clear enough for me, and then tell me where the red tape is.”

A major concern of the scientists was the FDA. The scientists had in their research identified monoclonal antibody drugs that latch onto virus cells as the most promising treatment. But to make the medicine in sufficient quantities, one drugmaker, Regeneron Pharmaceuticals Inc., would have to shift some of its existing manufacturing to Ireland. FDA rules required a monthslong wait for approval.

Mr. Scolnick, who had tussled with bureaucracy during the AIDS epidemic, tried reaching the FDA. The call ended poorly after the bureaucrats told the group they already had the pandemic under control. In a group call afterward, one of the scientists said, of the FDA: “They’re the problem here.”

Dr. Cahill got in touch with Mr. Ayers. Once the group briefed the vice president’s aide on the bottleneck, Mr. Ayers said he knew who to call. That evening, March 27, Regeneron received a call from the FDA. They had permission, starting immediately, to shift production to Dublin.

For the full story, see:

Rob Copeland. “Scientists, Billionaires Mount Manhattan Project for Covid-19.” The Wall Street Journal (Tuesday, April 28, 2020): A1 & A6.

(Note: ellipsis added.)

(Note: the online version of the article has the date April 27, 2020, and the title “The Secret Group of Scientists and Billionaires Pushing a Manhattan Project for Covid-19.”)

California Places the Regulatory “Final Straw” on Elon Musk’s Tesla

(p. A15) Informed by Democratic Gov. Gavin Newsom’s authorities that his factory in Fremont had to remain in lockdown, Mr. Musk tweeted: “Frankly, this is the final straw. Tesla will now move its HQ and future programs to Texas/Nevada immediately.”

The keyword here is “final straw,” suggesting that Mr. Musk’s cost-of-doing-business problems with California predate this virus. Hundreds of businesses already have relocated out of California, fleeing the uncountable regulatory straws the state has laid across the backs of anyone doing business there.

For the full commentary, see:

Daniel Henninger. “WONDER LAND; Elon Musk’s ‘Final Straw’.” The Wall Street Journal (Thursday, May 21, 2020): A15.

(Note: the online version of the commentary has the date May 20, 2020 and has the same title as the print version.)

Methotrexate Hoped to Moderate Covid-19 Cytokine Storm

(p. A15) Today Dr. Frohman and his team of researchers believe one treatment for MS could do the same for seriously ill Covid-19 patients.

The drug is called methotrexate, and it’s already proven to calm the chaotic responses of panicked immune systems. “A blast of this drug, over a matter of hours . . . pulls the cord on the panic button and resets the immune system,” Dr. Frohman tells me.

The new research is set to be published as early as this week in the Journal of the Neurological Sciences. Methotrexate already has been approved by the Food and Drug Administration, meaning doctors treating Covid-19 patients could begin using it immediately. National Institutes of Health immunologist Avindra Nath said this week that combining methotrexate with remdesivir, an antiviral drug, may set a new standard for fighting the most serious Covid cases.

For the full commentary, see:

Peggy Wehmeyer. “A Covid Drug to Help Fight the Storm.” The Wall Street Journal (Thursday, May 14, 2020): A15.

(Note: ellipsis in original.)

(Note: the online version of the commentary has the date May 13, 2020 and has the same title as the print version.)

The Frohman research, mentioned above, is reported in:

Frohman, Elliot M., Esther Melamed, Roberto Alejandro Cruz, Reid Longmuir, Lawrence Steinman, Scott S. Zamvil, Nicole R. Villemarette-Pittman, Teresa C. Frohman, and Matthew S. Parsons. “Part I. Sars-Cov-2 Triggered ‘Panic’ Attack in Severe Covid-19.” Journal of the Neurological Sciences (in-press 2020).

Frohman, Elliot M., Roberto Alejandro Cruz, Reid Longmuir, Lawrence Steinman, Scott S. Zamvil, Nicole R. Villemarette-Pittman, Teresa C. Frohman, and Matthew S. Parsons. “Part II. High-Dose Methotrexate with Leucovorin Rescue for Severe Covid-19: An Immune Stabilization Strategy for Sars-Cov-2 Induced ‘Panic’ Attack.” Journal of the Neurological Sciences (in-press 2020).

Trump Walks the Walk on Hydroxychloroquine

(p. A6) WASHINGTON—President Trump said he is taking hydroxychloroquine, an antimalarial drug that he has cited as a possible defense against the novel coronavirus but that some scientists have cautioned needs further study and could be dangerous.

“I happen to be taking it, hydroxychloroquine,” he told reporters at the White House on Monday. He said he had consulted with the White House doctor and suggested he is taking the drug as a preventive measure. Mr. Trump said he has been checked regularly for Covid-19, has tested negative and has no symptoms. He said he has been taking hydroxychloroquine for about a week and a half.

. . .

On Monday [May 18, 2020], Mr. Trump continued to stress anecdotal evidence in favor of the drug and told reporters, “I was just waiting to see your eyes light up when I said this.” He also expressed confidence in the drug’s safety. “I’m not going to get hurt by it. It’s been around for 40 years for malaria, for lupus, for other things.”

For the full story, see:

Catherine Lucey, Jared S. Hopkins. “President Trump Says He Is Taking Hydroxychloroquine as Preventive.” The Wall Street Journal (Tuesday, May 19, 2020): A6.

(Note: ellipses, and bracketed year, added.)

(Note: the online version of the story has the date May 18, 2020, and has the title “Trump Says He Takes Contested Drug for Prevention.”)

The key reference on advocates of a drug who take it first themselves, without confirmation from randomized double-blind clinical trials, is:

Altman, Lawrence K. Who Goes First?: The Story of Self-Experimentation in Medicine. Berkeley, CA: University of California Press, 1998.