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7 December, 2021 |
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I'm proud to say our annual Women in Biopharma R&D report is finally out in the world. This was a team effort and something that means a great deal for everyone here. Please note that senior editor Amber Tong and editor Nicole DeFeudis will be hosting our WIB live event starting at 2 p.m. ET. Register here — you won't want to miss it! |
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Kyle Blankenship |
Managing Editor, Endpoints News
@ka_blankenship
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by Endpoints Staff
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Even though many biopharma leaders have come together in recent years to address its gender gap, the consensus is clear: We still have a long way to go. Companies this year were 2.5 times more likely than last year to have a diversity and inclusion program in place, according to a recent BIO survey, but women are still largely absent from executive roles. Getting women to enter the industry isn’t the problem — studies show that they represent just under half of all biotech employees around the world. But climbing through the ranks can be challenging, as women still report facing stereotypes, and, unfortunately, harassment. The second year of the pandemic has coincided with a stark spotlight on some of these issues. In an era where parenting is visible just outside the Zoom frame, organizations are recognizing how the burden of unpaid care often falls disproportionately on women in a household. At the same time, both companies and academic institutions have taken drastic steps to address sexual harassment, ousting prominent employees in the wake of accusations and investigations substantiating those claims. Endpoints News has covered each of those news stories extensively. But beyond the real-time developments, we wanted to dig deeper and tell the stories of those who made it to the top despite the odds — the challenges they faced, the people who helped them overcome those hurdles, the ways they're giving back now, and the direction they think the industry ought to go. |
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Over the past couple of years, the top execs at Roche and Genentech have inked a flurry of deals aligning the global pair with several of the new players that have emerged in the booming AI and machine learning world. That strategy was supercharged in the spring of 2020 by their decision to recruit Aviv Regev out of the computational world she occupied at the Broad. And today they’re taking that computational approach in R&D to a whole new level. |
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by Amber Tong
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AstraZeneca is plucking another antisense drug out of Ionis’ prolific pipeline. Paying $200 million in cash, AstraZeneca has inked a development and commercialization deal around eplontersen — the Phase III TTR amyloidosis drug formerly known as IONIS-TTR-LRX. On top of the upfront and $485 million worth of conditional payments to follow regulatory approvals, the pharma giant is promising $2.9 billion in sales-related milestones should the drug reach megablockbuster status, plus royalties. The deal marks a much-needed boost for Ionis, which has been struggling to realize CEO Brett Monia’s vision of transforming the biotech from one that’s heavily focused on R&D to a commercial company capable of pulling drugs past the finish line. Back in April, Ionis revealed plans to lay off 70% of the staffers at Akcea — the company that it originally spun out to market its existing drugs and develop late-stage candidates for lipid disorders but later reabsorbed — after deciding to enlist Sobi as a commercial partner in Europe. The company also said the restructuring would allow it to focus on high priority programs. A few weeks later, it scrapped an in-house cystic fibrosis program in the wake of a clinical setback. One of those priority programs was eplontersen. A ligand-conjugated antisense, the drug targets transthyretin, the same protein blocked by Ionis’ approved drug Tegsedi. It is currently in Phase III clinical trials for ATTR cardiomyopathy and ATTR polyneuropathy. Under their new alliance, Ionis will be responsible for manufacturing eplontersen throughout the studies and the subsequent process qualification, with AstraZeneca set to take over on commercial supply. |
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Richard Lerner (Scott Audette/AP Images) |
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by Josh Sullivan
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Richard Lerner, the esteemed biochemist who pioneered a new way to develop monoclonal antibodies and led Scripps Research Institute to prominence, has passed away. A spokesperson for Scripps told the San Diego Union-Tribune that Lerner died of cancer in his La Jolla home. He was 83 years old. Among other things, Lerner's lab was known for devising a new technique for creating antibodies — deployed as cancer treatments as well as in immunology and disease research — one that the New York Times called a “major advance in biotechnology." It led to companies making mAbs a thousand times faster, more accurately, at a lower cost. That foundational research cemented the discovery of Humira, which went on to become the world’s best-selling treatment. Lerner was trained at Stanford, and served as the director and president of Scripps from 1987 until 2012. In that time, the institution established a Florida campus, started a bi-coastal graduate school and climbed its way to the top-10 graduate programs of its kind in the US. “We felt we were with him on a non-stop adventure,” Paul Shimmel, a professor of molecular medicine at Scripps, said in an obituary. “Like pioneers of the old west, who would transform medical research and its associated graduate education.” As a manager, Lerner had an eye for star researchers, famously recruiting Barry Sharpless, who went on to win the Nobel Prize. Two other scientists with ties to Scripps — Benjamin List, a former postdoctoral researcher for Lerner — and Ardem Patapoutian, who is currently with Scripps, were awarded Nobel Prizes this fall. |
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by Zachary Brennan
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After trial investigators flagged a drop in immune cell counts that an external committee determined was related to treatment last month, Merck has been pausing HIV-related Phase II and III trials ever since. On Monday, the biopharma company announced it's pausing enrollment in two of its Phase III trials evaluating its leading anti-HIV drug candidate, which is the once-monthly, oral islatravir. "At the recommendation of the ISL PrEP external data monitoring committee (eDMC), Merck is pausing enrollment for the IMPOWER 22 and IMPOWER 24 trials while the company conducts further analyses of these and other ongoing studies," the company said in a statement. "Informed by the recommendations of the PrEP eDMC, Merck is implementing additional monitoring measures for study participants, including increasing the frequency of total lymphocyte and CD4+ T-cell assessments." Mizuho Securities wasn't fazed by the pauses, as it told investors yesterday, "The pause, in our view, is not unexpected as MRK works through the clinical profile of islatravir to determine the true risk profile of the drug. Our forecast remains unchanged at this time based on our modest view on islatravir franchise overall." Earlier last month, Merck paused a Phase II study that first sounded the alarm, dubbed IMAGINE-DR, which was testing the once-weekly combination of MK-8507, a non-nucleoside reverse transcriptase inhibitor, and islatravir, an investigational nucleoside reverse transcriptase translocation inhibitor. The pharma giant and partner Gilead also said they paused enrollment of a separate study using one of the investigational compounds from Merck’s solo trial, out of an abundance of caution. |
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Róbert Wessman, Alvotech chairman and founder |
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by Zachary Brennan
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As Icelandic billionaire Róbert Wessman tries to take down AbbVie's megablockbuster Humira in court, he's also taking his biosimilar upstart to the big time with a $2.25 billion SPAC merger, Nasdaq launch and $450 million raise announced early Tuesday. While Wessman's Alvotech has not won FDA approval for any of its biosimilar candidates yet, the company was the first to file with the FDA for approval of its high-concentration Humira biosimilar and to have successfully conducted a switching study in support of a highly-coveted interchangeability designation. But other companies like Amgen, Boehringer Ingelheim and Pfizer have since caught up ahead of the launches of their own Humira biosimilar competitors in 2023. “So when those biosimilar companies enter in 2023, we expect that only 10% of Humira sales in the US – around 15 to 16 billion, only 10% will be 50 mg. We, on the other hand, were the first to get filing acceptance of the higher concentration, so we can focus on 90% of the market when we come out,” Wessman previously told Endpoints News. But the higher concentration version of a Humira biosimilar may be a moot point, as BI said in a recent citizen petition to FDA that the agency has yet to weigh in on: |
In Boehringer Ingelheim’s view, these biosimilar products, including Cyltezo, should be considered to have the same ‘strength’ as the corresponding OC and HC versions of Humira because they contain the same total drug content per container (e.g., 40 mg), regardless of the volume of excipients. |
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by Paul Schloesser
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AI biotech BenevolentAI is going public in the Netherlands, and it decided to go the SPAC route as part of one of the largest mergers in Europe to date. The AI biotech is joining with a SPAC known as Odyssey, launched by investment banker brothers Michael and Yoel Zaoui. And when it closes early next year and lists on Euronext in Amsterdam, the merger will allow BenevolentAI to raise more than $430 million — and go public with more than $1 billion in value, which should last the biotech for the next few years. Before transaction costs, BenevolentAI will receive the more than $330 million raised by Odyssey when it listed back in July, as well as more than $150 million in the form of a private investment in public equity from existing backers such as Singapore’s Temasek, AstraZeneca, and health investing specialists Ally Bridge, just to name a few. "The combination with Odyssey will allow us to scale our vision and ambition of uniting purposeful technology and cutting-edge science to discover life-changing medicines," said BenevolentAI's CEO Joanna Shields in a statement. Now, the funds will be used to accelerate BenevolentAI's work on drug development and add to its clinical pipeline — which currently has more than a dozen programs and is spearheaded by a candidate for atopic dermatitis. That candidate is currently in Phase I trials. Circling back to AstraZeneca: The British pharma and BenevolentAI have long collaborated before, starting back in 2019. Curtesy of BenevolentAI's platform, Back in January AstraZeneca added its first AI-discovered drug target to its portfolio, going after chronic kidney disease. |
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by Kyle Blankenship
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Rare neurological disorders have long proved difficult for drug developers, with huge R&D budgets and commercial plans often going bust at the very last minute. Now, Acadia Pharma is touting a win for its late-stage candidate in Rett syndrome, which could help juice its competitors' efforts as well. Acadia's trofinetide hit its co-primary endpoints in Phase III study in 187 girls and young women with the rare neurological disease Rett syndrome, which impacts between 6,000 and 9,000 US patients and is often misdiagnosed as autism, cerebral palsy or non-specific developmental delay, the company said Tuesday. The drug bested placebo on two metrics judged by a patient's caregiver and physician, respectively, called the Rett Syndrome Behaviour Questionnaire and the Clinical Global Impression–Improvement (CGI-I) assessment. Both assessments determined improvements in patients' symptoms over the 12-week duration of the study. On the RSBQ assessment, patients' scores dropped an average of 5.1 points versus a 1.7-point decrease in the control (p=0.0175). Meanwhile, the CGI-I test showed a 3.5-point change for patients in the trofinetide arm versus 3.8 for placebo (p=0.003). Taking home a late-stage win in Rett syndrome is a good look for Acadia, and investors cheered the news with the company's stock ACAD trading at just above $20 early Tuesday, up roughly 5% from Monday's closing price. Acadia now plans to take its data in front of the FDA by the middle of next year, with a pre-NDA meeting scheduled for the first quarter, it said. Trofinetide has received fast track designation from the agency and would be eligible for priority review. |
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by Zachary Brennan
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Quebec-based Medicago and its adjuvant partner GlaxoSmithKline said Tuesday that their plant-based Covid-19 vaccine candidate proved to be 71% efficacious against all variants of SARS-CoV-2 in a Phase III trial of more than 24,000 adults in Canada, the US, UK, Mexico, Argentina and Brazil. In addition to showing 75% efficacy against the Delta variant specifically, the companies also said the vaccine proved to be generally safe, with no serious adverse events reported and reactogenicity generally being mild to moderate. The results mean that a regulatory submission will be filed with Health Canada imminently, they said. Like its mRNA counterparts, the Medicago/GSK vaccine is two doses, with each dose provided 21 days apart. "These are encouraging results given data were obtained in an environment with no ancestral virus circulating. The global COVID-19 pandemic is continuing to show new facets with the current dominance of the Delta variant, upcoming Omicron, and other variants likely to follow," Thomas Breuer, GSK's global Covid-19 adjuvanted vaccines lead, said in a statement. "The combination of GSK's established pandemic adjuvant with Medicago's plant-based vaccine technology has significant potential to be an effective, refrigerator-stable option to help protect people against SARS-CoV-2." GSK is also still working with Sanofi and SK bioscience to develop adjuvanted, protein-based vaccines, which are now in Phase III trials, as well as with CureVac, to jointly develop a next-gen mRNA vaccine, with the potential to address emerging variants in one vaccine. |
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by Max Gelman
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A new European biotech has put together a nearly $100 million Series A, and its lead program is going after a target recently validated by the FDA. Emergence Therapeutics raised €87 million in its first big raise Tuesday, good for roughly $97.8 million, coming out of stealth with a plan to tackle antibody-drug conjugates. The first program up is setting its sights on nectin-4, the target for Astellas and Seagen’s Padcev drug, which gained full FDA approval for urothelial cancers this past summer. CEO Jack Elands said the company got its start after working with researchers at the University of Marseille Cancer Research Center to develop the lead candidate. “We started thinking about what we actually need to do in order to outperform Padcev, because we didn't want to just blindly develop , we really wanted to develop something that was markedly better,” Elands told Endpoints News. He added: “We're now in a phase where we just have to execute rapidly and with high quality, and the ability to raise this Series A is going to enable us to do that.” The program in question is known as ETx-22, and Emergence is pinning its high hopes here. By sharpening the message that researchers want to tackle nectin-4, Elands is all but declaring his company can develop a Padcev successor. There are scant hard data to go on so far, as Emergence has only conducted preclinical work for the candidate to this point. The biotech is predicting, however, ETx-22 will prove less toxic than other nectin-4 ADCs, allowing for higher dosing and greater efficacy. |
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by Max Gelman
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Gary Glick is back at it again, founding yet another biotech company. And by the sheer size of its first raise, this may be the biggest one yet. Glick has assembled what he calls an all-star roster and recruited one of the biggest healthcare investors in OrbiMed to put together a massive $218 million Series A for his newest venture, Odyssey Therapeutics. The launch, announced Tuesday morning and co-led by SR One Capital Management, comes not three months after Glick sold First Wave Bio to AzurRx for $229 million. But Glick has had Odyssey on his mind since at least early this year, first crafting the vision back in March with co-founder David Pompliano, with whom Glick did his postdoc at Jeremy Knowles’ Harvard lab. Likening Odyssey to one of his earlier companies, IFM Therapeutics, Glick said the new biotech is placing a similar bet on ensuring the best people are involved. “What's occurring at Odyssey is just something on a much larger scale, with a considerable amount more depth in many of those sort of drug discovery disciplines,” Glick tells Endpoints News. “The financing allows us to support not only a larger number of programs, but quite a bit of technology development and integration to create the platform. “It’s a recipe for success that's worked across all my companies,” he added. |
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by Zachary Brennan
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The World Health Organization said late today that it's not recommending the use of convalescent plasma as a treatment for Covid-19 for mild or severe cases, but some U.S. experts disagree with the recommendations and say there are patients who can benefit from the plasma of those who've recovered from Covid-19. The recommendation is informed by a review of 16 RCTs and a "meta-analysis on antibodies and cellular therapies for covid-19," the WHO said, adding in a statement: |
Despite its initial promise, current evidence shows that it does not improve survival nor reduce the need for mechanical ventilation, and it is costly and time-consuming to administer. As such, the WHO makes a strong recommendation against the use of convalescent plasma in patients with non-severe illness, and a recommendation against its use in patients with severe and critical illness, except in the context of a randomised controlled trial (RCT). |
| The WHO wrote in the BMJ that, "Most importantly, given there was no benefit demonstrated in any of the critical or important outcomes for non-severe covid-19, the GDG did not see any justification for the resources (including time and cost) that would be associated with administration of convalescent plasma." The announcement builds on recently published data showing that while convalescent plasma has proven to be generally safe, it also failed to show signs of efficacy in some large RCTs of outpatients, including on mortality in a UK trial of those hospitalized with Covid, published in The Lancet in May, and another for outpatients in August in the New England Journal of Medicine. |
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by Beth Snyder Bulik
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What would you do with $100 and the simple instruction to “spread joy?" That’s what pharma and healthcare agency Klick Health asked its employees as part of its annual holiday greeting for clients, friends and future recruits. More than 600 Klicksters, as the agency folks call themselves, took up the challenge. For each person who signed up, Klick sent a box with a royal blue agency branded scarf, cards and a $100 bill. Each person filmed themselves opening the box, starting out on their “joy” missions and their recipients’ reactions. The smartphone videos were then compiled into a three-minute “#SpreadJoy” holiday video, a process that chief creative officer Rich Levy said took about three weeks. While the annual greeting is a popular tradition inside the company, it also serves as a default recruiting tool with millions of views and almost every interviewee mentioning they’d seen one of the videos. The 2020 animated video clocked 4.8 million views while 5.9 million watched the last previous live-shot video in 2019. “When you start getting that number of views, everyone sees it and everyone remembers it. I think people like them because they show what the company stands for, and people want to work for companies that match their personal values,” Levy said. In the video, some Klick employees hand big tips to waiters or baristas, while others gift the money to bus drivers, crossing guards and kind neighbors. |
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by Kyle Blankenship
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Once largely a mystery to researchers, the far-flung realm of cells in the immune system has emerged as a fruitful sandbox for drug developers. A new UK biotech is leaning on research into the growing role of dendritic cells in spurring immune responses, and US venture firm Apple Tree Partners is bankrolling its early efforts. London-based Adendra Therapeutics launched Tuesday with $53 million from founding investor ATP and research out of the Francis Crick Institute looking to leverage new insights into how dendritic cells sic predatory T cells onto tumors — and their role in driving autoimmune disease. Leveraging research out of the lab of Caetano Reis e Sousa, Adendra starts life with cutting-edge research into dendritic cells under its belt and a hefty paycheck to boot. Reis e Sousa, who helped kickstart the company as scientific co-founder, pointed to dendritic cells' dual role in both taking pieces of foreign bodies and presenting them to T cells for identification but also acting as T cells' "on-off" switch. Newer research has also pointed to those cells' role in "goading" prolonged T cell activation, which means dendritic cells not only turn T cells on or off but also tell them how long to engage their target. "It's not just about triggering it but also about continuing to push the response forward," he told Endpoints News. "That is important particularly in the context of autoimmunity when you actually want to interrupt that cycle. You can think of it as a therapeutic target where you can effectively try and block these positive signals coming from the dendritic cells, thereby breaking the cycle that is leading to continual activation of those T cells." |
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by Beth Snyder Bulik
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Pharma companies have more digital doors to doctors than ever because of the Covid-19 pandemic, but healthcare providers think many can do better. While 86% of HCPs recognize that pharma companies are more considerate of their needs now, almost two-thirds (65%) also say at least one pharma has “spammed” them with digital content in the past year. And 64% agree that the volume of digital content from pharma companies is too much, according to the Accenture study set for release Monday. “There’s great opportunity here, but also great caution to be had,” Suzy Jackson, managing director in Accenture’s life science practice, said. “The answer is not quantity, but quality, and making sure you’re cutting through the noise. And if you do so, we’re showing that you get rewarded for that.” That reward? More time and attention from doctors. Time, in fact, is something most HCPs have more of today. About three-fourths reported drops in patient numbers over the past year, consistent across specialties, including oncology (76%), immunology (78%), cardiology (72%) and general practice (73%). The good news for pharma is that more free time – and better communications – translates to more access with 88% twice as likely to meet with a pharma rep if it were similar to their best interactions. When questioned further, they agreed they would be more open to meeting others in the company, open emails and listen to messages from that company versus others. |
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by Paul Schloesser
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With the rush of AI permeating the biotech industry, another AI player is coming out well-organized and flush with cash. METiS Therapeutics announced this morning that it successfully put $86 million in the bank, thanks to a Series A. Two investment firms connected to the Chinese government (People's Insurance Company of China and China Life Insurance Company) led the financing round — and were joined by Sequoia Capital China, 5Y Capital and several other investors. "Today’s news represents the first of many significant milestones that we will be accomplishing throughout the next year," METiS CEO Chris Lai said in a statement. The biotech, founded back in 2017 and with 70 employees in both China and in Cambridge, MA, plans to triple its US-based employees within the next 12 months. After its founding, METiS partnered with XtalPi, a Cambridge AI-focused R&D company — where the biotech got seed funding and incubated for a time before spinning out in early 2020. So where is this Series A money going? The $86 million will be used to advance the company’s pipeline, METiS said, along with continued development of its AI drug discovery and delivery platform, along the lines of RNA therapeutics, gene therapies and small molecules. Concerning how far it'll last the company? The company remained mum on the topic, only saying "$86 million will take them through multiple milestones and value inflection points." And while it is still early in the company's history, the company told Endpoints in an email that they do have something in mind for initial targets: "orphan diseases, CNS, autoimmune systems and nephrology," they said. |
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by Paul Schloesser |
vTv Therapeutics has decided to chop down its workforce by almost two-thirds. The High Point, NC biotech announced Monday that it would pivot and now prioritize its lead program, the oral glucokinase activator TTP399, as it gears up for Phase III pivotal trials. The drug was granted breakthrough therapy designation after showing a 40% reduction in hypoglycemic episodes compared to placebo, and back in October vTv announced positive results in a study showing no increased risk for ketoacidosis, a severe complication of diabetes. And because of that shift, vTv is undergoing the massive restructuring, including cutting the workforce, adding "several consultants" and pausing development on another drug — a PDE4 inhibitor for psoriasis. "It is always difficult to restructure but this allows us to focus on TTP399 and our future growth," said vTv CEO and president Deepa Prasad. "We continue to engage with the FDA to map out a clear and positive path forward on our Phase 3 pivotal studies with the goal of improving quality of life for patients managing this chronic, burdensome disease." | Oncology-focused Freenome raises $300M in Series D round | South San Francisco's Freenome today announced a massive Series D haul this morning, bringing in $300 million and pushing Freenome's total funding to over $800 million since 2014. This round of financing was led by Perceptive Advisors and Peter Kolchinsky's RA Capital Management, joined by existing investors Artis Ventures, Kaiser Permanente, Novartis and Ridgeback Capital Management. And with this kind of funding, there were several new investors that tagged along: Logos Capital and Pure Vida Investments, to name two. |
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John Carroll
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Editor & Founder
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Arsalan Arif
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Publisher & Founder
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Shehla Shakoor
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Managing Director
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Igor Yavych
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Chief Technical Officer
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Mike Peck
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Chief Revenue Officer
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Valentin Manov
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Creative Director
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Kyle Blankenship
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Managing Editor
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Beth Snyder Bulik
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Senior Editor
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Zachary Brennan
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Senior Editor
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Josh Sullivan
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Associate Editor
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Assistant Editor
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Operations Manager
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Worldwide made. Thanks for reading.
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