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The Boston Globe from Boston, Massachusetts • A8

The Boston Globei
Boston, Massachusetts
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SATURDAY SEPTEMBER 17, 2016 BUSINESS New rules tighten drug test reporting Some researchers have been reporting their results long after statutory deadlines or not at all. By Charles Piller STAT WASHINGTON Researchers will have to publicly report the results of many more clinical trials, including some for drugs and devices that never reach the market, under new government rules announced Friday. The federal rules, which also require more complete reporting of deaths, clarify and strengthen a 2007 law that requires researchers to report results of many human studies of experimental treatments for ailments such as diabetes, cancer, and heart disease. A STAT investigation last year found widespread noncompliance with reporting requirements by both drug companies and academic institutions including universities that are among the top recipients of government research funding and by National Institutes of Health staff scientists. In the vast majority of cases, study results were reported long after statutory deadlines or not at all.

Yet not a single researcher or trial sponsor has been fined or penalized, STAT reported though the Food and Drug Administration had the authority to fine violators more than an aggregate $25 billion since the law went into force in 2008. Government officials said the new rules are meant to improve compliance with requirements for public registration of trials and posting of data on the website. But advocates for transparency in clinical research cautioned that the success of the new rules, which take effect Jan. 18, 2017, will depend on the vigor of enforcement. The data help doctors and patients gauge the safety and benefits of treatments and aid researchers in making informed judgments about future research.

Citing the STAT investigation, Vice President Joe Biden called in June for de-funding federal grant recipients who did not comply with the law. On Friday, while announcing parallel improvements to a National Cancer Institute clinical trials website, Biden said the those changes and the new rules for "will improve the safety, accessibility and impact of our clinical re- search system." He added that the changes "will help patients today and help researchers all over the world in their quests to find new cures. And they come at a true inflection point in our fight against cancer." Federal officials said last year that they wouldn't penalize offenders before clarifying the reporting rules. Now that this is happening, "I'm expecting a flood of trials to get registered," FDA Commissioner Robert Califf told reporters during a conference call. "It would be pretty hard to hide that you are doing a clinical trial or hide the result.

I'm very optimistic about this." The new rules leave in place many exemptions to the results-reporting requirement for privately funded studies including small trials examining just the safety of a new drug, small feasibility studies of medical devices, and behavioral intervention studies. NIH-funded projects of those types must report results, based on a separate NIH policy. Most trials entered into before 2008 are also exempt. The exclusions are so broad that only a fraction of all trials have been subject to the full provisions of the law; at the time STAT reviewed the data last year, just about 9,000 trials, among nearly 200,000, were subject to the reporting requirements. Under the final rules, the percentage of trials that must report results gradually should rise.

Researchers will also have to submit the race and ethnic background of trial volunteers if the information is collected, and show more details about adverse events possible side effects of a treatment that occur more than 5 percent of the time. The new rules also require sponsors to update the website annually about the status of ongoing trials. Currently, some entries languish for years without new information, leaving the public and other researchers in the dark about whether a trial is still underway. Charles Piller can be reached at Follow Charles on Twitter cpiller.

Everbridge stock up 27 after debut Burlington-based firm is 2nd Mass. IPO this year PAT GREENHOUSEGLOBE STAFF former gift and gadget chain that went bankrupt in 2008 but was reborn in 2010 under new ownership as an online retailer. On the way out, he high-fives "shark" Day-mond John. In reality, Kaufman claimed in the lawsuit, there was never any agreement. "Sharper Image is the last company in the whole country I would have allowed him to even speak with," Kaufman said.

"We all know their reputation. They went bankrupt." Kaufman sued the show's producers at the time, but said he was desperate for money and accepted a $20,000 settlement from Sony. His new suit focuses on the damages allegedly caused by frequent reruns of the episodes since then. Kaufman is not the first to take issue with "Shark Tank." Former contestant Megan Cummins has said a shark who agreed to invest in her soap company while the cameras were rolling later pulled out of the deal. Another entrepreneur, Scott Jordan, said "Shark Tank" tried to trick him into saying the name of his high-tech clothing company on air in order to grab a slice of its revenues under the contract contestants sign (he was trying to sell the sharks instead on a licensing deal).

The show later removed the clause from its agreement. Kaufman, a former cellphone store executive, has been tinkering with his invention for more than a decade. Kaufman said Nubrella 2.0 especially appeals to people who work outside: photographers, construction workers, and so on. The company's inventory is running low, Kaufman acknowledged, but he's hoping a new sale will let him resume production. A major fast food chain is considering a large order, he said; its workers, who use tablet computers outside to take orders from cars stuck in long drive-through lines, will wear Nubrellas when it's raining, to protect the devices.

Despite his contentious relationship with Shark Tank, Kaufman is hoping to appear on the show one more time and set the record straight. "Just be fair. Tell the truth," Kaufman pleaded. "Put me on the air and let's tell the audience, 'this is the new design, and I never did a deal with Sharper Dan Adams can be reached at daniel. adorns

Still feeling the 'Shark Tank' hite Nubrella creator sues shows producers over reruns, says they misrepresent product By Curt Woodward GLOBE STAFF Stock-market investors welcomed Friday's debut of Everbridge boosting shares of the Burlington-based emergency communications software company 27 percent in its first day of trading. Everbridge raised $75 million Thursday by selling its shares at $12 apiece, while some previous investors sold another $15 million worth of shares. The stock opened at $12.30 Friday morning on the Nasdaq and closed at $15.25. It was the second initial public offering of a Massachusetts-based technology company this year, following May's $103.5 million IPO of Maynard telecom equipment maker Acacia Communications Inc. Only one Massachusetts tech company, security software maker Rapid7 went public last year.

Everbridge's software controls emergency-alert systems for government and corporate clients. Those systems can be used to broadcast evacuation orders or locate far-flung employees, routing the information over land-line phone or wireless Internet networks if cellular towers are jammed with traffic. Chief executive Jaime Ellertson said the company's management team has years of experience at multiple public companies, which could give Everbridge an edge as it seeks to grow under new scrutiny. "Having the experience of doing it not once or twice, but multiple times across our entire management team will help," Ellertson said. "We believe we've got the scale and the growth to prove ourselves as a public company." Ellertson also said he was "delighted" to plump up the region's roster of publicly traded companies.

But beyond cash and hometown pride, he said the IPO should lend a stamp of legitimacy that will help Everbridge win sales pitches and hire more people. The company has about 430 employees worldwide, with more than 200 at its Burlington headquarters, and is advertising about 50 job openings, Ellertson said. Everbridge has more than 3,000 customers around the world, including eight of the 10 largest US investment banks and 24 of North America's busiest airports. Everbridge's system has been used in several high-profile emergency situations. Boston officials employed the software to marshal police and firefighters during the Marathon bombings, while Sony Pictures relied on Everbridge to communicate with thousands of employees after the studio's regular systems were crippled in a 2014 hacking attack.

The company has grown its sales rapidly in recent years, but has not yet turned a profit. Everbridge got close to break-even in 2013 and 2014, but expenses jumped last year, when Everbridge lost $10.8 million on sales of $58.7 million. Ellertson said the increased spending helped Everbridge add several new products and expand its sales and marketing campaigns, which he said would help the company quickly return to a more sustainable financial path. Ellertson said Everbridge is different from some other high-growth subscription-software companies "that seem to spend $2 for every $1 they make," a model that has drawn skepticism on Wall Street. "I think what you're seeing in our business is a slightly more mature and seasoned team that is able to deliver high growth and recurring revenue," he said.

Curt Woodward can be reached at sion of his product have brought him to the brink of ruin. So last week, he filed a pro-se lawsuit in Suffolk Superior Court against the media and production companies behind "Shark Tank," seeking compensation for lost investment opportunities, a cut of the revenue earned each time an episode featuring Nubrella airs, and a clear label indicating when the episodes originally ran. "For the first six months it was great exposure," Kaufman said. "But I never knew they'd be running reruns for six years, after Nubrella has gone through a massive transformation." Nubrella is currently out of cash, Kaufman said, and potential new investors won't bite.

Would-be customers, meanwhile, don't realize the Nubrella episodes were taped years ago, and accuse Kaufman of pulling a bait-and-switch when they learn his improved wearable umbrella costs By Dan Adams GLOBE STAFF By now, most of us know better than to take "reality" TV at face value. But Alan Kaufman, a Newton entrepreneur who pitched his hands-free "Nubrella" on ABC's "Shark Tank" back in 2010, claims in a lawsuit that the show's producers didn't just fudge a few inconsequential details for the sake of drama they lied about nearly everything. A verbal agreement made on air that would have seen two of the "sharks," or judges, invest $200,000 in Nubrella? Kaufman said he never got a penny. And a follow-up episode in which Nubrella appears to sign a distribution deal with The Sharper Image? Completely fabricated, he claimed. Kaufman claims these distortions along with reruns of the show that depict an outdated ver $59.99, not $29.99.

Sony Pictures Television which produces the show, declined to comment. After his initial appearance on TV, Kaufman said, he and the two judges who expressed interest were supposed to consummate their deal in a formal contract. Instead, he alleged in his lawsuit, both simply walked away. "They didn't even bother doing diligence," Kaufman said. "They just blew the whole thing off." Before long, though, Kaufman heard from the show's producers again.

According to his lawsuit, they wanted to film a follow-up segment showing how the sharks' (allegedly nonexistent) investment in Nubrella was helping the company thrive. Kaufman scoffed at the idea, but said he was heavily pressured to play along. In the resulting episode, Kaufman is seen striking a deal to sell Nubrellas to Sharper Image, the lHL flk vfllk VfitrBE. TiMMflBH.k CALL WAITING Kevin Sullivan (center) of Brighton set up his chair at 1 a.m. Friday morning to be one of the first in line to buy the new iPhone 7 at the Apple Store on Boylston Street in the Back Bay.

More than 100 people lined up to buy the latest smartphone. The iPhone 7 is water resistant and uses a wireless ear bud set. JOHN TLUMACKIGLOBE STAFF.

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