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Even as pandemic recedes, short-staffed trial sites leave cancer patients waiting

In the early days of the Covid-19 pandemic, when many trials were grounded, Jason Luke and his fellow clinical researchers at the University of Pittsburgh…

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In the early days of the Covid-19 pandemic, when many trials were grounded, Jason Luke and his fellow clinical researchers at the University of Pittsburgh Medical Center were still testing new cancer drugs in 50 Phase I studies. Now, his colleagues only have the bandwidth to handle one-fifth the amount of early-stage trials as they did in early 2021.

The issue became stark eight months ago. “Wait a minute, everybody stop,” he recalls interjecting his colleagues’ conversation during a weekly team meeting around the beginning of 2022. They were discussing how 36 patients were on the waiting list for clinical studies but UPMC’s cancer trials apparatus could only take in one to two patients per week, about one-fourth the volume as compared to last year.

Jason Luke

The delay befuddled Luke, who directs the Cancer Immunotherapeutics Center at UPMC’s Hillman Cancer Center. He says “on a human level” it tore at him that the number of patients seeking new treatments didn’t let up.

As patients with life-threatening cancers wait for new therapies, trial operators across the US struggle to staff their sites with adequate workforce to meet demand. The intensifying staffing shortages started before the Great Resignation that befell many industries.

Some academic researchers and industry leaders have billed it a crisis, compounded by the influx of therapeutics entering the clinic and as the sheer amount of drug developers has skyrocketed in the past decade. The number of biopharmas with active pipelines is about 4.5 times what it was in 2001, according to an Informa Pharma Intelligence tally.

At one Chicago institution, the shortage has upended studies. In late June, Rush University began temporarily pausing enrollment of new patients in clinical trials in its cancer center, a spokesperson confirmed to Endpoints News via email, saying the halt is “like so many institutions across the country” because of a scarcity of cancer-focused clinical research coordinators. The spokesperson didn’t answer questions about how many studies paused enrollment but said patients who were previously screened and consented can still be enrolled or be sent to another institution conducting the same trial.

Rush University Medical Center on Sept. 26. (Kyle LaHucik/Endpoints News)

Click on the image to see the full-sized version

The problem is particularly acute in oncology because of the complex trial designs and the large variety of tumor and cancer types. The amount of people directly impacted by cancer also factors into the equation: The American Cancer Society estimates 1.9 million new cancer diagnoses this year and more than 600,000 deaths.

Oncology has been one of biopharma’s key R&D areas for years. Researchers began 2,335 new trials last year of oncology therapies, according to IQVIA.

While only about 1 in 20 cancer patients will take part in studies of new therapeutics, clinical trial sites haven’t been able to keep up with the amount of people seeking new treatments that hold the potential for extending and saving their lives.

Tanios Bekaii Saab

Cancer centers have been “bleeding personnel,” partly because of lower pay in academia than industry, says Tanios Bekaii-Saab, leader of Mayo Clinic’s gastrointestinal cancer program, which overburdens existing staffers. The revolving door of new nurses and clinical research coordinators means institutional memory is lost and replacements take as many as six months to get brought up to speed. Meanwhile, work-life balance is hard to achieve.

Within the 300-trial clinical research unit at Abramson Cancer Center at the University of Pennsylvania, the shortage has sometimes impeded the institution’s goal of 90-day trial activation timelines, says medical director Dan Vogl.

Dan Vogl

“We pretty much lost the capacity to conduct research efficiently over the last year, year and a half, and likely for another half to a year, so these are lost opportunities,” says Bekaii-Saab, who is also a chair of medical oncology in Mayo Clinic’s hematology/oncology division.

Not all staff are leaving for industry; some nurses simply want to fulfill their calling. “Nurses love to do what they want to do. They want to be nurses, they don’t want to be research coordinators. So it’s very difficult to essentially convince nurses to remain in research,” he says.

The issues escalated to the point that oncologists, biopharma executives and CROs convened in August to discuss the “Crisis in Clinical Research,” as the virtual summit was titled. The Society for Immunotherapy of Cancer gathered 900 attendees representing biotech, clinical trials, government and regulatory institutions, according to executive director Mary Dean.

Mary Dean

Investigators and industry leaders point to wage discrepancies between jobs at academic trial sites and within biopharma or clinical research organizations as one reason driving the exodus. Increasing the pay at academic institutions would be an obvious answer, but public universities tend to maintain strict budgets, unlike the more fluid capital flow within Big Pharma and well-funded biotech startups.

“You don’t really have the control to say, ‘I have the money to hire more people,’ because that’s not the way it works in an academic center,” says Mario Sznol, who’s been investigating new immunotherapies at Yale since 2004. “That’s all done through a central office.”

Multiple clinical trial administrative leaders declined interviews.

Luke, at UPMC, says that on a personal level, he believes the research community has been “undervaluing” the contributions of many workers. “We just took it for granted we had coordinators and nurses,” he says. “We probably really need to rethink how we compensate them and how we appreciate them.”

Jeffrey Meyerhardt

The staffing shortage also arises from the mental toll that nursing and clinical research can take on a person, particularly during a pandemic, according to investigators and industry insiders. Some staffers view clinical research roles as stepping stones on the path toward nursing, medical or social work school, says Jeffrey Meyerhardt, chief clinical research officer at Dana-Farber Cancer Institute.

There’s also a paucity of people in the workforce to take up the positions. The ratio of job postings for clinical research coordinator to those looking for a job is 7:1, and climbs to 10:1 for nurses, according to the Society for Clinical Research Sites. And many job postings ask for two years of experience for entry-level positions, which serves as another barrier, per the Association of Clinical Research Professionals.

Susan Landis

The clinical research job gap can in part be attributed to the lack of promotion around the profession, says ACRP executive director Susan Landis, who says it’s a unique community that is “very much a hidden profession” not specifically carved out as a subindustry by the Bureau of Labor Statistics.

Sznol says the shortage has existed for years. He’s long seen staffers move over to industry, but the issue has become a “major problem” in more recent years. He says institutions tend to understaff trials. Phase I, or first-in-human, studies typically require more staffing because of the intricacies involved in figuring out the therapies’ safety, he notes.

“The usual approach is, when you have more accrual, we’ll hire more people, but the problem is that it doesn’t work that way because you have to have the research personnel in order to increase accrual,” Sznol says.

Getting short-term staffing acts as a Band-Aid that can drain finances. Hiring for short-term roles can be “two-to-fourfold over regular expenses,” Suresh Ramalingam, executive director of Winship Cancer Institute at Emory University, said in a spring ASCO report.

One R&D leader at an oncology and infectious diseases biopharma, which markets a cancer drug, says his company has set aside money in their budget to help sites hire more staff. But sometimes throwing money at the problem is not that simple.

David Feltquate

“What the sites tell us is, ‘Thank you, that’s a great idea,’” says the biopharma exec, who spoke on the condition of anonymity, noting sites tell him they’ve received similar offers from additional companies. “But the way the infrastructure is set up at the site, so if we’re doing a melanoma trial, we can’t give money to the melanoma group to hire people. The money goes to a central fund, and they said, ‘If that money goes there, we’ll never see it.’”

While the issues have mounted, people across the clinical trial ecosystem have worked “really, really hard, despite all of this, to get it to work,” says David Feltquate, CMO at Palleon Pharmaceuticals.

Feltquate and Atreca CEO John Orwin say their biotechs have tried alleviating the situation by adding more sites to their Phase I programs, both around a dozen, as compared to a historical approach of eight, according to the Palleon exec. With more sites in tow, the workload spreads out. Atreca also no longer takes doctors’ work of identifying patients for trials for granted, ensuring its trial is front and center for site investigators.

“In the end, if higher costs and more time to actually execute, all that means it’s harder to find the drugs that work and get them to patients. That should be enough motivation for everyone to do better here,” Feltquate says.

(Illustration credit: Assistant editor Kathy Wong)

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No easy solution 

Some institutions have seen their attrition rates start to improve already, like Penn’s Abramson Cancer Center clinical research unit decreasing from 30% last year to 18% so far in 2022, according to Vogl, the medical director.

Darlene Kitterman

Penn, Dana-Farber, the University of Illinois Cancer Center (UICC) and others have adjusted salaries for existing staff and increased pay for open positions after going through benchmarking analyses to make salaries more level and competitive with the market, leaders say. UICC analyzed information from other institutions, like Oregon Health & Science University, and then reallocated money from its operating budget to the Clinical Trials Office to raise pay, says administrative director Darlene Kitterman.

That’s one piece of the solution, but not one that has been implemented across the board.

Vogl’s unit has teamed up with staffing agencies to recruit people. They’ve also beefed up their training program, which includes an intensive series that begins with a “Clinical Research Education Week” and then a slate of lectures and follow-on meetings, he says, noting 19 of 142 staffers are currently going through the process.

“A lot of the staff that we are recruiting are extraordinarily talented people but who don’t have a lot of experience in either cancer or clinical research or sometimes even both, which means that there are a lot of knowledge and skills gaps that they have to make up, which is why it’s even more important that we have these robust training programs,” he says.

John Orwin

Orwin says the challenges will remain and that industry would benefit from collaborations with sites and nursing societies, potentially around the likes of a certification program. On the clinical research side, two organizations offer accreditation: ACRP and the Society of Clinical Research Associates, according to Landis, the ACRP leader.

“I don’t have the answer, I just know that it’s a challenge that applies to almost every company that’s involved in clinical development and, to the effect that it could potentially delay the time to developing and approving life-saving therapies, it’s really important that this be a high priority,” Orwin says.

Solutions could also entail shifting responsibilities and tasks among trial sites and CROs, researchers and industry leaders say. Or, making more roles permanently remote, like data entry and collection staff.

Deploying staff more efficiently is another tactic. Dana-Farber took a program that its bone marrow transplant group had piloted half a decade ago and asked all departments to implement it this year to be more judicious about staff allocations during the shortage, Meyerhardt says.

Attrition has gone down, he says, as the program allows teams to “appropriately create a portfolio that matches what our staffing is” across 100-plus lead investigators working on more than 600 open studies, he adds.

Institutions must also become better at creating clear job paths that have promotion opportunities and career development baked into the system, leaders say. Career ladders are “what folks want,” says Bekaii-Saab, the Mayo professor, emphasizing research must be valued, but so must every person involved in the studies.

The University of Illinois Cancer Center on Sept. 26. The clinical trials office is a five-minute walk from fellow Chicago institution Rush. (Kyle LaHucik/Endpoints News)

Click on the image to see the full-sized version

Meanwhile, in Chicago, UICC has been in a growth spurt and hiring quickly as it applies for National Cancer Institute designation, Kitterman says. In addition to raising pay, UICC revamped job descriptions to set a blueprint for career development paths.

Kitterman characterizes the center’s current system as “very equitable” with clear job paths in place. Also fueling the staffing increase is the institution’s focus on serving “a very diverse and somewhat underserved population in the Chicago area,” a mission that has attracted staff and been a boon to industry collaboration, she says.

Partnerships among organizations will be key. The American Society of Clinical Oncology and SITC are engaging on potential next steps after last month’s SITC summit on the “crisis,” says ASCO chief medical officer Julie Gralow. Summit organizers and partners will collect data on trial activation timelines to “understand where the bottlenecks are in the system so that when we start to propose solutions,” says Dean, the SITC executive director.

Fixes will require buy-in from industry, institutions, individual investigators and associations, says Luke, the clinical trials leader at UPMC.

“We’re going to have to just really rethink how all of this works because it currently is just treading water, not moving forward,” he says.

Marc Ernstoff

Marc Ernstoff, a five-decade researcher and branch chief of immuno-oncology at the National Cancer Institute, says the improvement process “will probably last for a number of years.”

As the solutions start trickling in, challenges will remain, particularly a conundrum around budding mountains of data and documentation. Staff and investigators already have a hefty workload — recruiting and treating patients, coordinating new studies, and answering cold calls and emails from eager sponsors looking to start trials — but on top of all that is the data collection that limited workforces are required to handle.

Mario Sznol

Study documentation has also ballooned. Synopses today are almost as long as full protocols in the past, says Sznol, the Yale investigator. Vogl, the medical director of the Clinical Research Unit at Abramson Cancer Center, shares an anecdote of his staffers spending hours searching for the date of patients’ onset of hypertension, required by the study sponsor but which has “zero impact on the overall results.”

Requests like that, he says, “creep into the study database by tradition and inattention.”

Then there’s the strict scrutiny between contracts and consent forms, and when a one-line change about a travel stipend isn’t fixed on both ends, it can throw a wrench in the speediness of treating patients, Sznol says.

“And you think, ‘Gee, is that really the most important thing that we have to worry about for a patient who has advanced metastatic disease?’” says the clinical investigator. “These are the sorts of things that drive me crazy.”

Editor’s note: Endpoints News is looking to hear from you about your experiences with clinical trials. Please fill out this form to contribute your story.

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Team undertakes study of two-dimensional transition metal chalcogenides

Two-dimensional materials, like transition metal dichalcogenide, have applications in public health because of their large surface area and high surface…

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Two-dimensional materials, like transition metal dichalcogenide, have applications in public health because of their large surface area and high surface sensitivities, along with their unique electrical, optical, and electrochemical properties. A research team has undertaken a review study of methods used to modulate the properties of two-dimensional transition metal dichalcogenide (TMD). These methods have important biomedical applications, including biosensing.

Credit: Nano Research Energy, Tsinghua University Press

Two-dimensional materials, like transition metal dichalcogenide, have applications in public health because of their large surface area and high surface sensitivities, along with their unique electrical, optical, and electrochemical properties. A research team has undertaken a review study of methods used to modulate the properties of two-dimensional transition metal dichalcogenide (TMD). These methods have important biomedical applications, including biosensing.

 

The team’s work is published in the journal Nano Research Energy on November 23, 2022.

 

The team’s goal is to present a comprehensive summarization of this promising field and show challenges and opportunities available in this research area. “In this review, we focus on the state-of-the-art methods to modulate properties of two-dimensional TMD and their applications in biosensing. In particular, we thoroughly discuss the structure, intrinsic properties, property modulation methods, and biosensing applications of TMD,” said Yu Lei, an assistant professor at the Institute of Materials Research, Shenzhen International Graduate School, Tsinghua University.

 

Since graphene was discovered in 2004, two-dimensional materials, such as TMD, have attracted significant attention. Because of its unique properties, two-dimensional TMD can serve as the atomically thin platforms for energy storage and conversion, photoelectric conversion, catalysis, and biosensing. TMD also displays a wide band structure and has unusual optical properties. Yet another benefit of two-dimensional TMD is that it can be produced in large quantities at a low cost.

 

In public health, reliable and affordable in vitro and in vivo detection of biomolecules is essential for disease prevention and diagnosis. Especially during the COVID-19 pandemic, people have suffered not only from the physical disease, but also from the psychological problems related to extensive exposure to stress. Extensive stress can result in abnormal levels in biomarkers such as serotonin, dopamine, cortisol, and epinephrine. So, it is essential that scientists find non-invasive ways to monitor these biomarkers in body fluids, such as sweat, tears, and saliva. In order for health care professionals to quickly and accurately assess a person’s stress and diagnose psychological disease, biosensors are of significant importance in the diagnostics, environmental monitoring, and forensic industries.

 

The team reviewed the use of two-dimensional TMD as the functional material for biosensing, the approaches to modulate the properties of TMD, and different types of TMD-based biosensors including electric, optical, and electrochemical sensors. “Public health study is always a major task in preventing, diagnosing, and fighting off the diseases. Developing ultrasensitive and selective biosensors is critical for diseases prevention and diagnosing,” said Bilu Liu, an associate professor and a principal investigator at Shenzhen Geim Graphene Center, Shenzhen International Graduate School, Tsinghua University.

 

Two-dimensional TMD is a very sensitive platform for biosensing. These two-dimensional TMD based electrical/optical/electrochemical sensors have been readily used for biosensors ranging from small ions and molecules, such as Ca2+, H+, H2O2, NO2, NH3, to biomolecules such as dopamine and cortisol, that are related to central nervous disease, and all the way to molecule complexities, such as bacteria, virus, and protein.

 

The research team determined that despite the remarkable potentials, many challenges related to TMD-based biosensors still need to be solved before they can make a real impact. They suggest several possible research directions. The team recommends that the feedback loop assisted by machine learning be used to reduce the testing time needed to build the database needed for finding the proper biomolecules and TMD pairs. Their second recommendation is the use of a feedback loop assisted by machine learning to achieve the on-demand property modulation and biomolecules/TMD database. Knowing that TMD-based composites exhibit excellent performance when constructed into devices, their third recommendation is that surface modifications, such as defects and vacancies, be adopted to improve the activity of the TMD-based composites. Their last recommendation is that low-cost manufacturing methods at low temperature be developed to prepare TMD. The current chemical vapor deposition method used to prepare TMD can lead to cracks and wrinkles. A low-cost, low-temperature method would improve the quality of the films. “As the key technical issues are solved, the devices based on two-dimensional TMD will be the overarching candidates for the new healthcare technologies,” said Lei.

 

The Tsinghua University team includes Yichao Bai and Linxuan Sun, and Yu Lei from the Institute of Materials Research, Tsinghua Shenzhen International Graduate School and the Guangdong Provincial Key Laboratory of Thermal Management Engineering and Materials, Tsinghua Shenzhen International Graduate School; along with Qiangmin Yu and Bilu Liu from the Institute of Materials Research, Tsinghua Shenzhen International Graduate School, and the Shenzhen Geim Graphene Center, Tsinghua-Berkeley Shenzhen Institute & Institute of Materials Research, Tsinghua Shenzhen International Graduate School.

 

This research is funded by the National Natural Science Foundation of China, the National Science Fund for Distinguished Young Scholars, Guangdong Innovative and Entrepreneurial Research Team Program, the Shenzhen Basic Research Project, the Scientific Research Start-up Funds at Tsinghua Shenzhen International Graduate School, and Shenzhen Basic Research Project.

 

##

 

About Nano Research Energy 

 

Nano Research Energy is launched by Tsinghua University Press, aiming at being an international, open-access and interdisciplinary journal. We will publish research on cutting-edge advanced nanomaterials and nanotechnology for energy. It is dedicated to exploring various aspects of energy-related research that utilizes nanomaterials and nanotechnology, including but not limited to energy generation, conversion, storage, conservation, clean energy, etc. Nano Research Energy will publish four types of manuscripts, that is, Communications, Research Articles, Reviews, and Perspectives in an open-access form.

 

About SciOpen 

 

SciOpen is a professional open access resource for discovery of scientific and technical content published by the Tsinghua University Press and its publishing partners, providing the scholarly publishing community with innovative technology and market-leading capabilities. SciOpen provides end-to-end services across manuscript submission, peer review, content hosting, analytics, and identity management and expert advice to ensure each journal’s development by offering a range of options across all functions as Journal Layout, Production Services, Editorial Services, Marketing and Promotions, Online Functionality, etc. By digitalizing the publishing process, SciOpen widens the reach, deepens the impact, and accelerates the exchange of ideas.

 


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Climate-Change Lockdowns? Yup, They Are Actually Going There…

Climate-Change Lockdowns? Yup, They Are Actually Going There…

Authored by Michael Snyder via The End of The American Dream blog,

I suppose…

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Climate-Change Lockdowns? Yup, They Are Actually Going There...

Authored by Michael Snyder via The End of The American Dream blog,

I suppose that we should have known that this was inevitable.  After establishing a precedent during the pandemic, now the elite apparently intend to impose lockdowns for other reasons as well.  What I have detailed in this article is extremely alarming, and I hope that you will share it with everyone that you can.  Climate change lockdowns are here, and if people don’t respond very strongly to this it is likely that we will soon see similar measures implemented all over the western world.  The elite have always promised to do “whatever it takes” to fight climate change, and now we are finding out that they weren’t kidding.

Over in the UK, residents of Oxfordshire will now need a special permit to go from one “zone” of the city to another.  But even if you have the permit, you will still only be allowed to go from one zone to another “a maximum of 100 days per year”

Oxfordshire County Council yesterday approved plans to lock residents into one of six zones to ‘save the planet’ from global warming. The latest stage in the ’15 minute city’ agenda is to place electronic gates on key roads in and out of the city, confining residents to their own neighbourhoods.

Under the new scheme if residents want to leave their zone they will need permission from the Council who gets to decide who is worthy of freedom and who isn’t. Under the new scheme residents will be allowed to leave their zone a maximum of 100 days per year, but in order to even gain this every resident will have to register their car details with the council who will then track their movements via smart cameras round the city.

Are residents of Oxfordshire actually going to put up with this?

[ZH: Paul Joseph Watson notes that the local authorities in Oxford tried to ‘fact check’ the article claiming they’re imposing de facto ‘climate lockdowns’, but ended basically admitting that’s exactly what they’re doing...]

I never thought that we would actually see this sort of a thing get implemented in the western world, but here we are.

Of course there are a few people that are loudly objecting to this new plan, but one Oxfordshire official is pledging that “the controversial plan would go ahead whether people liked it or not”.

Ouch.

Meanwhile, France has decided to completely ban certain short-haul flights in an attempt to reduce carbon emissions…

France can now make you train rather than plane.

The European Commission (EC) has given French officials the green light to ban select domestic flights if the route in question can be completed via train in under two and a half hours.

The plan was first proposed in 2021 as a means to reduce carbon emissions. It originally called for a ban on eight short-haul flights, but the EC has only agreed to nix three that have quick, easy rail alternatives with several direct connections each way every day.

This is nuts.

But if the French public accepts these new restrictions, similar bans will inevitably be coming to other EU nations.

In the Netherlands, the government is actually going to be buying and shutting down approximately 3,000 farms in order to “reduce its nitrogen pollution”

The Dutch government is planning to purchase and then close down up to 3,000 farms in an effort to comply with a European Union environmental mandate to slash emissions, according to reports.

Farmers in the Netherlands will be offered “well over” the worth of their farm in an effort to take up the offer voluntarily, The Telegraph reported. The country is attempting to reduce its nitrogen pollution and will make the purchases if not enough farmers accept buyouts.

“There is no better offer coming,” Christianne van der Wal, nitrogen minister, told the Dutch parliament on Friday.

This is literally suicidal.

We are in the beginning stages of an unprecedented global food crisis, and the Dutch government has decided that now is the time to shut down thousands of farms?

I don’t even have the words to describe how foolish this is.

Speaking of suicide, Canada has found a way to get people to stop emitting any carbon at all once their usefulness is over.  Assisted suicide has become quite popular among the Canadians, and the number of people choosing that option keeps setting new records year after year

Last year, more than 10,000 people in Canada – astonishingly that’s over three percent of all deaths there – ended their lives via euthanasia, an increase of a third on the previous year. And it’s likely to keep rising: next year, Canada is set to allow people to die exclusively for mental health reasons.

If you are feeling depressed, Canada has a solution for that.

And if you are physically disabled, Canada has a solution for that too

Only last week, a jaw-dropping story emerged of how, five years into an infuriating battle to obtain a stairlift for her home, Canadian army veteran and Paralympian Christine Gauthier was offered an extraordinary alternative.

A Canadian official told her in 2019 that if her life was so difficult and she so ‘desperate’, the government would help her to kill herself. ‘I have a letter saying that if you’re so desperate, madam, we can offer you MAiD, medical assistance in dying,’ the paraplegic ex-army corporal testified to Canadian MPs.

“Medical assistance in dying” sounds so clinical.

But ultimately it is the greatest lockdown of all.

Because once you stop breathing, you won’t be able to commit any more “climate sins”.

All over the western world, authoritarianism is growing at a pace that is absolutely breathtaking.

If they can severely restrict travel and shut down farms today, what sort of tyranny will we see in the future?

Sadly, most people in the general population still do not understand what is happening.

Hopefully they will wake up before it is too late.

*  *  *

It is finally here! Michael’s new book entitled “End Times” is now available in paperback and for the Kindle on Amazon.

Tyler Durden Fri, 12/09/2022 - 06:30

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How Noggin Boss Became the Next Big Thing in Sports Apparel

The Brian Robinson photo was just the latest moment in company history.
The post How Noggin Boss Became the Next Big Thing in Sports Apparel appeared first…

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The story of Noggin Boss really begins three times.

Most recently, it began in late November, when a photo of Washington Commanders RB Brian Robinson wearing a giant hat lit the internet ablaze.

After that, Noggins started popping up everywhere.

Buffalo Bills QB Josh Allen was awarded one from Amazon Prime’s Thursday Night Football crew as the player of the game after Buffalo’s win over New England. Players from the Orlando Magic did a photo shoot wearing the hats. Players from the University of Georgia wore them after winning the SEC Championship.

ESPN’s Scott Van Pelt also notably sported one on SportsCenter, having gotten in on the action long ago when Noggin Boss co-founders Gabe Cooper and Sean Starner were just trying to spread the good word about their product.

“We have planted seeds for years, and we will do whatever it takes to try to find people that we feel would be good promoters of the brand,” Cooper told Front Office Sports. “We literally shipped those years ago to Scott Van Pelt and never heard anything back, but all of a sudden, it resurfaced.”

Those promoters all notably wore Noggins with logos that Noggin Boss is unlicensed to sell — but Cooper says that’s a fortunate piece of serendipity for the company.

Noggin Boss has never sold a hat with an unlicensed logo on it, doing everything “100% above board.”

“Fans will take liberties on their own,” Cooper says. “We are very interested in going down the paths of obtaining the proper [league] licensing ourselves, so we wouldn’t do anything to jeopardize that.”

A Hot Item

Of course, the sudden popularity of the brand means that everyone wants one.

After the Robinson photo, several outlets reported that Noggin Boss saw a 2,000% spike in sales. Cooper says that number was misrepresented — but the company has certainly seen a wild spike in orders, especially at this time of year.

“We’re just thankful for the grace that our fans are extending to us during the holiday season, which is crazy enough,” Cooper says.

Brian Robinson Photo Leads to 2,000% Spike for Big Hat Company

Monday was one of the biggest sales days in Noggin Boss history.
November 30, 2022

Noggin Boss was ready for this moment. That’s because its second pivotal moment happened in the studios of the extremely popular television series “Shark Tank.”

Cooper and Starner appeared on the show earlier this year, very quickly striking a deal with apparel magnate Daymond John.

But that wasn’t all: Dallas Mavericks owner Mark Cuban verbally agreed to sell Mavs Noggin Bosses in the team’s store. Cuban held up his end of the deal — and even delayed the Dallas Stars from selling Noggins because he wanted an exclusive selling period for his Mavericks.

The Noggin Boss founders purposely came into the Tank with a very low company valuation — realizing that what John and Cuban could offer them was much more valuable than money.

“These professionals have more connections than we could possibly ask for,” says Cooper, “so why would we disrespect them with an offer that we wouldn’t even give to a friend if we were trying to invite them into the business?”

Those connections are already paying dividends: Besides the Dallas teams, Noggin Boss has sold hats — through approved buyers — to the Arizona Cardinals, New Jersey Devils, New York Islanders, and San Jose Sharks.

Cooper also says that the company will have a strong presence during college football bowl season — and that it is finalizing licensing for a much more expansive offering.

How It All Started

But for all of its high-profile moments in the last few months, Noggin Boss’ story really began in early 2020 at the notorious Waste Management Phoenix Open. The raucous atmosphere of the golf tournament provided the perfect proving ground for the product.

“[It] was just such a huge hit, and that was the validation of like, ‘Okay, this is the good kickoff that we needed,’” Cooper says.

That success began to roll over into MLB Spring Training in Arizona — but then, of course, the world shut down because of COVID-19.

But that didn’t dampen Cooper or Starner’s spirit in the slightest. The pair knew they had something here — and they believe it could last in the long term.

Outside of the sports world, Noggin Boss has had a strong presence at bachelor and bachelorette parties, college campuses, and charity events — where Cooper says the hats get auctioned off for over $1,000.

He says the product’s universal appeal will keep it relevant for years to come.

“It just brings so much joy to people,” says Cooper. “We call it the Noggin Boss effect: When they wear it, they have so many smiles and so many conversations with complete strangers. It’s better than any medicine out there.”

The post How Noggin Boss Became the Next Big Thing in Sports Apparel appeared first on Front Office Sports.

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