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Business Operations

Vaccine Trials Face Diversity Issues

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As American companies race to create an effective COVID-19 vaccine, they’re facing skepticism from minority communities, according to The Wall Street Journal (subscription).

The problem: This reluctance makes it especially difficult to create diverse clinical trials that gauge whether the vaccines work safely. Public health officials say that vaccines need to be shown to work safely and effectively across all ages, races and backgrounds, and especially among the high-risk. Black and Brown Americans have been impacted disproportionately by the virus—and without their participation, an effective vaccine may face longer odds.

The solution: Companies and researchers are working with churches, minority physicians, radio programs and other media sources for communities—not to mention recruiting in places with high minority populations.

The bigger picture: Clinical trials in general suffer from a shortage of minority participants. Only 9% of participants in clinical trials for new drugs last year were Black, while whites made up around three quarters of participants, according to the FDA.

Business Operations

A Roundup of COVID-19 Vaccine News

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With vaccines being developed as fast as possible, we can barely keep up or keep you up to date. Here are some major stories this week:

  • New experimental vaccine studies from the pharmaceutical company Novavax are promising, reports The New York Times (subscription). One study saw the vaccine produce a high level of antibodies against the virus with no harmful side effects, while the other found that the vaccine strongly protected monkeys from COVID-19 infections.
  • Moderna is setting prices for its vaccine candidate, reports Reuters.
  • Johnson & Johnson announced a deal with the United States to create 100 million doses of its COVID-19 vaccine—with a price tag of $1 billion, reports CNBC. Its late-stage human trials are slated to begin in September.
  • AstraZeneca will make its potential COVID-19 vaccine in mainland China, reports Reuters.

Meanwhile, distribution challenges loom large, according to The Washington Post (subscription). We’re heading toward “what is expected to be the largest single vaccination campaign ever undertaken,” but health experts and state officials have gotten little information from the Trump administration about how that will unfold—and the information they have gotten is often confusing.

As if that weren’t enough: COVID-19 vaccines aren’t the only shots we’re expecting. We’ll also be fighting the seasonal flu—and as CNBC reports, companies are making record numbers of that vaccine, too.

Policy and Legal

Trump Threatens Executive Actions for COVID-19 Relief

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President Trump threatened to use executive actions if Republicans and Democrats can’t reach a deal on the next round of stimulus, reports The Washington Post (subscription). How much he can accomplish unilaterally is unclear, however.

What he said: “We’re negotiating right now as we speak, and we’ll see how that works out,” Trump said. “In the meantime, my administration is exploring executive actions to provide protections against eviction . . . . As well as additional relief to those who are unemployed as a result of the virus. Very importantly, I’m also looking at a term-limited suspension of the payroll tax.”

Meanwhile, on Capitol Hill: Democrats and Republicans intended to come to a deal by the end of this week. The latest word is that it will happen “in the near future,” according to Senate Majority Leader Mitch McConnell.

NAM connection: The NAM has been urging Congress to include liability protections in the next stimulus package. To that end, it organized a “Day of Action” yesterday on social media, calling for “commonsense protection from opportunistic lawsuits in order to fuel our recovery and help creators respond to this crisis.” A range of groups and organizations participated in the Day of Action, including the Minnesota Chamber of Commerce, the Michigan Manufacturers Association and the Illinois Manufacturers’ Association.

Business Operations

Should We Be More Worried about Airborne Transmission of COVID-19?

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Are we paying enough attention to the cleanliness of indoor air? The Atlantic has a deep dive into the importance of ventilation, including what we know—and what we don’t—about how COVID-19 travels.

The rise of super-spreaders: As the article says, “The super-spreader–event triad seems to rely on three V’s: venue, ventilation and vocalization.” That means most events that tend to infect a large number of people occur in an indoor space—and especially one that isn’t well-ventilated—where people might talk or sing. One list of super-spreader events includes only a single event categorized as outdoor transmission—out of more than 1,200 events.

The article raises important questions—such as whether reopening schools safely requires the installation of air filtration systems and whether we should be looking at indoor and outdoor transmission as different problems to solve. Read the whole thing.

The manufacturing angle: NAM.org recently profiled Carrier Global Corporation, a Florida manufacturer of heating, ventilation and air conditioning systems, which created a portable air-cleaning device that can convert normal hospital rooms into air isolation rooms. The company also hopes its OptiClean devices will be used in homes, businesses and other facilities in need of safer air.

Others in the market: In addition to Carrier Global Corporation, Trane Technologies plc and Honeywell International Inc. are, according to a recent report in Bloomberg, “offering everything from air-monitoring sensors to portable filter machines to help make up for deficiencies in ventilation.”

Business Operations

Two Manufacturers Make Personal Boxes of PPE

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On a long flight home from a women’s business conference, Arbill CEO Julie Copeland and IPAK CEO Karen Primak fell into conversation about being mothers, CEOs, entrepreneurs and getting it all done. So when the COVID-19 crisis began, the two leaders—now good friends—knew they were the perfect collaborators to make an innovative safety product: a personal kit full of protective gear.

The idea: Though Arbill has a 75-year history of making and distributing safety products for industrial workers, when the pandemic hit, the company started thinking about protecting people in their everyday lives. It decided to produce an easy-to-ship kit of essential products, which employers could brand and purchase for their workers and customers—for use at home as well as at work.

The kit: Arbill’s team thought that shipping out bulk product was too impersonal. So IPAK, as a specialty packaging company collaborated with Arbill to package the protective products in a retail-like box. According to customers, employees appreciate the tailored presentation of the kit, which includes:

  • Cloth masks: Arbill’s antimicrobial fabric masks, which protect users from particles as small as three microns, and can be washed over 50 times without losing their effectiveness. The masks also have high testing scores for breathability and are extremely comfortable.
  • Cloth gloves: Instead of disposable gloves, Arbill developed a washable and reusable option for everyday use.
  • Sanitizer: Arbill produced sanitizer that can be used on hands and surfaces, based on CDC recommendations.

Special delivery: Hundreds of thousands of these safety kits have already shipped to customers across the country. With millions of masks already made, and new orders in production, it’s clear these products have hit the mark. 

The last words: “IPAK’s ability to create custom packaging helped us take the industrial product category of safety and make it personal,” says Copeland. “The Truline Safety Kit now provides companies a wonderful way to connect with their employees. It’s compassionate, sensible and safe.”

“IPAK was open during the heat of the pandemic in NJ,” explains Primak. “7 percent of our workforce was infected before our governor declared a state of emergency in March. As an essential business, we were permitted to stay open…but the only way I would stay open was with the right protective products. Partnering with Julie and Arbill allowed me to protect IPAK personnel as well as help other companies protect their own employees. Since we have been using the fabric face coverings, we have not had another case of COVID.”

Business Operations

Can Antibody Find Me…A Treatment for COVID-19

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Manufactured antibody treatments could be the next big thing in the fight against COVID-19, Reuters reports. The therapy is often used against illnesses like cancer, and a range of biotech companies are working together to test this approach.

Who’s involved: Several companies have been allowed by the U.S. government to combine resources to manufacture supplies, should any of the companies’ drugs succeed. Those companies include Eli Lilly and Company, AstraZeneca, Amgen and GlaxoSmithKline.

Meanwhile, The Wall Street Journal (subscription) reports on a Lilly study involving antibody drugs in nursing homes.

  • The study, which aims to enroll up to 2,400 subjects in nursing homes and other long-term care facilities, is intended to test whether the company’s antibody drug can reduce rates of infection.
  • If the study is successful, Lilly hopes its drug could receive government approval by the year’s end.

Go deeper: Revisit our recent writeup of an important new study on America’s effective policies for pharma development—and how these should be preserved.

Business Operations

Wearables Could Predict COVID-19

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Smart watches and smart rings are the newest COVID-19 detectors, according to The Wall Street Journal (subscription). Devices like Oura rings, Fitbits, Garmin fitness bands and Apple Watches pull in vital information that may predict an infection.

How it works: Tech companies are taking in wearable sensor data from smart sensors on both healthy people and those afflicted by COVID-19, comparing results and looking for patterns. They’re hopeful that they can use this information to create artificial intelligence that could alert people with early signs of the virus.

The metrics: There are a range of measurements that might help to detect COVID-19 early on, including:

  • Temperature tracking, which can help give early warnings about possible fevers;
  • Heart-rate tracking, which can reveal an infection early; and
  • Blood oxygen and cough tracking, which keeps an eye on specific COVID-19 symptoms.

Go deeper: Independent testing laboratory UL is at the forefront of these developments, and we recently talked to one of its leaders about how it’s helping to get such devices to market. Read the whole thing.

Business Operations

Manufacturing Activity Rebounds, Reaching its Highest Level in a Year

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In some good news, an Institute for Supply Management survey released on Monday showed U.S. manufacturing activity reaching its highest level in more than a year, according to Reuters.

  • The index of national factory activity reached 54.2 in July—up from 52.6 in June. A reading above 50 indicates growth.
  • New orders increased to 61.5 from 56.4 in June—the highest since September 2018.

But don’t break out the party hats yet. The resurgence in COVID-19 across the United States could halt manufacturers in their tracks, which is why face coverings and other precautions remain critical.

Meanwhile, we’re seeing a reduction in construction spending, which dropped 0.7% in June after decreasing 1.7% in May. More discouraging numbers included the following:

  • 0.7% drop in spending on private construction
  • 1.5% loss in spending on residential projects
  • 0.7% drop in spending on public construction projects

NAM Chief Economist Chad Moutray has the numbers for manufacturers: “After declining for six straight months, private manufacturing construction spending rose 1.7% from $70.86 billion in May to $72.07 billion in June.”

Related: In another milestone, New York City retail rent fell below $700 for the first time since 2011, according to CNBC. With fewer people shopping in retail environments, rents are dropping, and retail stores are reevaluating the way they serve the public.

Business Operations

The Way We Live Now

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In honor of Friday, here are some interesting and amusing stories about life under COVID-19 and in this generally surreal year of 2020.

Pixelated pilgrimage: The annual Muslim pilgrimage to Mecca has been restricted due to COVID-19, so many people will be unable to go. But it wouldn’t be 2020 if enterprising developers weren’t trying to create a virtual hajj.

Fashion masks: You know you need to wear a face covering (if you’ve been within a lightyear of the NAM’s Creators Respond communications campaign, that is), but who says it has to be a boring, scratchy surgical mask? What about a mask cover made of pearls? Or a mask that “serves as a combination walkie-talkie, personal secretary and translator”? If you’re curious about your options, The New York Times (subscription) has you covered.

Bioprinting: If you can believe it, researchers are 3D-printing “tiny replicas of human organs—some as small as a pinhead—to test drugs to fight Covid-19,” according to The New York Times (subscription).

And last, if you’re looking to distract yourself from earthly woes:

  • NASA’s latest mission to Mars is on its way. The rover Perseverance and helicopter Ingenuity were launched yesterday morning.
  • The Pentagon’s U.F.O. Unit will start telling the public some of what it’s found.
Policy and Legal

FDA Issues Guidance for Rapid At-Home Tests

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The FDA announced new standards for companies seeking regulatory approval of rapid at-home COVID-19 tests, reports Bloomberg Law.

Why it’s good: Creating a fast, cheap test that can be used regularly at home would allow people to test themselves once or twice a week, or before coming into contact with others—giving them the ability to quarantine when necessary and reduce the likelihood of spreading the illness.

But not so fast: The FDA’S rules for rapid at-home COVID-19 tests are pretty strict, which could discourage some companies from giving it a try, according to USA Today.

Xtra help: On Tuesday, The XPRIZE—a nonprofit organization that hosts public competitions— announced a $5 million prize for “five winners who can produce a test that delivers results in as little as 15 minutes and costs less than $15” (also from USA Today). An additional $50 million will be available to help scale up manufacturing for any contestant.

The NAM’s view: “Long wait times for tests can present a personnel challenge for manufacturers that have workers who might have been exposed outside the workplace,” said NAM Vice President of Infrastructure, Innovation and Human Resources Policy Robyn Boerstling. “The NAM recently joined a letter to ensure more federal resources are committed to testing. We are focusing our advocacy efforts on solutions that will provide more robust and reliable testing solutions in every community.”

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