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10 December, 2021 |
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Hard to believe that we're looking at the last full work week of the year coming up on Monday. What a year. There's a special ASH report and panel review Monday. We'll be wrapping the last daily report of 2021 on December 23 with a special look at top trends for 2022, as picked by the team. And then we'll be working a part-time schedule to stay up with the news, but only online, through the holidays. |
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John Carroll |
Editor & Founder, Endpoints News
@JohnCendpts
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by Nicole DeFeudis
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Roche’s Genentech got a leg up in the packed anti-TIGIT race earlier this year when the FDA granted it the first breakthrough designation in the field based on some upbeat mid-stage data in non-small cell lung cancer. Now, looking to keep its lead, the pharma giant is offering a two-and-a-half-year look at the same patient group — but will two deaths crush its chances? A combination of Genentech’s anti-TIGIT cancer tiragolumab plus PD-L1 inhibitor Tecentriq reduced patients’ risk of disease progression or death by 38% compared to those who received Tecentriq alone at a median follow-up of 2.5 years, the company said on Friday. In a pre-specified exploratory analysis of participants with high levels of PD-L1, the combo reduced the risk of disease worsening or death by 71% compared to the Tecentriq group. The combo also showed a “clinically meaningful” improvement in overall response, with a rate of 69% in the combo group and 24.1% in the Tecentriq group for PD-L1-high patients. On the second endpoint, overall survival, patients in the broader population survived a median of 23.2 months on the combo, compared to 14.5 months on just Tecentriq, according to Genentech. Median OS hasn’t yet been reached in the PD-L1-high subgroup that received the combo. However, the company also reported two treatment-related deaths in the combination group. While no explanation was supplied, Mizuho’s Mara Goldstein thinks tiragolumab still stands a chance. “While Gr.5 events are not to be taken lightly, in the context of the efficacy observed, it may not be a weighty issue,” she wrote in a note to investors on Friday. |
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Stéphane Bancel, Moderna CEO (AP Images, Boston Herald) |
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by Jason Mast
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Moderna says that it's on its way to having an mRNA vaccine against not one, but two different seasonal viruses. The biotech released the first early data from its flu program Friday morning, announcing that all doses of the shot significantly boosted antibodies in younger and older adults without "significant safety findings." A 500-person Phase II will confirm dose levels and compare it to an approved flu vaccine, the company said, and preparations for a large pivotal trial are underway. Moderna said it is also advancing new designs that can have potentially broader coverage of different flu strains than current shots. The results are the opening salvo in a four-headed (so far) race to develop the first mRNA flu vaccine, as Moderna tries to edge out BioNTech, Sanofi subsidiary Translate Bio, and CureVac past the gate. Although all four have programs underway, Moderna is the first to announce data. Those data, though, don't give a clear answer on whether mRNA can improve on previous technologies. Moderna said the 50 microgram dose of the shot, designed like most flu vaccines to inoculate against four different strains of the virus, increased antibodies against the two Influenza A strains by eight-fold and ten-fold, respectively, and against the two influenza strains by three-fold and two-fold. There was little difference in antibodies between dose levels, the company said. Safety data echoed those from the Covid-19 vaccine, with fatigue, myalgia (muscle ache), and headache the most common side effects. |
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Xiayang Qiu, Regor Therapeutics CEO |
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by Josh Sullivan
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Eli Lilly will license in Regor Therapeutics therapies for metabolic disorders, as a part of an agreement announced Friday that will give the Chinese biotech an upfront payment of up to $50 million, part of which is an equity investment. In a vaguely worded release, Lilly said it has a license for certain Regor "intellectual property" and will have an option to extend that license. In exchange, Lilly will oversee global clinical development and commercialization for any therapies, with the exception of China, Macau, Hong Kong and Taiwan. Regor, a Shanghai-based company, will reserve the rights to these regions. The company is eligible for up to $1.5 billion in potential payments based on preclinical, clinical and commercial milestones, as well as tiered royalties from sales. Regor CEO Xiayang Qiu said that the collaboration is, in part, a recognition of Regor’s core technology, the Computer Accelerated Rational Discovery platform. CARD, another in a long line of fancily named biotech computational platforms, is designed to create a more efficient process for the discovery of new drugs. Through CARD, the team has advanced a number of products in its pipeline in just two years, including RGT-587 for oncology, which is set to enter Phase I trials, and and RGT-075 to target a glucagon-like peptide 1 receptor hormone, which stimulates glucose-induced insulin secretion. That candidate is entering Phase II/III trials. The company was founded in 2018 by a team that includes two Pfizer veterans and three — Qiu and Min Zhong, and CTO Wenge Zhong — who used to work for Amgen’s Chinese R&D operations. Regor’s focus so far has been on oncology, metabolic diseases and autoimmune diseases. |
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by Zachary Brennan
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Bristol Myers Squibb brought in more than $9 billion in sales from its anticoagulant Eliquis in 2020, and it continues to see growth with more than $8 billion in sales in the first nine months of 2021 (and another nearly $4.5 billion for Pfizer in 2021). But in 2022, one of the largest PBMs in the US, CVS Caremark, has recently decided to no longer cover the megablockbuster, and instead will only offer coverage for warfarin and Janssen's Xarelto. That decision will likely put a dent in Eliquis sales next year for both BMS and Pfizer. But BMS said the decision should be limited, telling Endpoints News in an emailed statement that while the Bristol Myers Squibb-Pfizer alliance "is disappointed" by this move to hinder patient access to Eliquis, the drug will continue to have "preferred status for 85% of CVS Health lives in 2022 and only those patients who have commercial health insurance plans with pharmacy benefits managed by Zinc, specifically, are subject to their formularies and this decision, effective January 1, 2022. Importantly, 95% of Eliquis patients nationally will not be effected by this formulary decision by CVS/Zinc." (Bold and italics are theirs.) For some doctors, the decision forces them to scramble and switch patients to a new anticoagulant, and they don't have time to figure out if their patients fall into the gap discussed by BMS and Pfizer. |
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House Speaker Nancy Pelosi (Jacquelyn Martin/AP Images) |
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by Zachary Brennan
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Back in January 2019, the late House Oversight Committee chair Elijah Cummings kicked off a nearly 3-year-long drug pricing investigation that culminated today in a major new report detailing how prices for vital drugs have risen substantially since their launch, while calling on the Senate to pass a bill that will allow Medicare to negotiate some prices. The committee's investigation focused on 12 of the most expensive drugs for Medicare, showing massive price spikes that have accumulated over the years and made some drugs, like insulin, entirely unaffordable for some, to the point where some diabetics have had to ration their life-saving insulin, and some have died. Documents obtained by the committee show that several of the companies targeted Medicare specifically to boost revenues. An internal Novo Nordisk slide deck from October 2013 emphasized, “Part D is the most profitable market for the Novo Nordisk insulin portfolio,” and noted that insulin volume for the Part D market was growing three times faster than the commercial market. A 2016 presentation prepared for Novartis by an outside consultant emphasized, “Medicare is critical to brand success, CMS spent ~$1 billion on Gleevec in 2014.” Building off the work of three hearings with pharmaceutical executives from seven companies, as well as other previous reports, this final report includes new findings from an investigation into Pfizer’s marketing of its blockbuster pain drug Lyrica, and a deeper dive into the insulin products from Eli Lilly, Novo Nordisk, and Sanofi, which collectively control about 90% of the global insulin market. |
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Vlad Coric, Biohaven chariman and CEO |
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by Beth Snyder Bulik
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Days after reporting positive Phase III results for intranasal migraine med zavegepant, Biohaven chairman and CEO Vlad Coric is talking about marketing plans. It’s a month or more before Biohaven will file for FDA approval and likely a year before launch, but Coric is already thinking about messaging and commercialization. His plan? A dual strategy to attract potential patients around speed to relief – zavegepant study results show the spray can provide relief in as fast as 15 minutes and a return to normal in 30 minutes – along with a secondary anti-nausea benefit in using an intranasal versus a pill. “It’s going to be complementary to Nurtec and many people are going to want this around because you don’t control when a migraine hits,” Coric said. “Now you can control which of these tools you can take today to combat your migraine.” He’s already scouting for a new celebrity spokesperson to add another well-known voice to its group of advertising ambassadors for Nurtec ODT that includes reality TV star Khloe Kardashian and actor and talk show host Whoopi Goldberg. That’s all of course conditional on FDA approval. The positive Phase III data Biohaven detailed earlier this week showed zavegepant was superior to placebo on the co-primary endpoints of pain freedom and freedom from most bothersome symptoms at two hours, and superior to placebo in delivering pain relief as early as 15 minutes. |
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While the ultimate fate of Novartis’ big generics arm Sandoz may still be up in the air, there’s no doubt it’s in play as a potential buyout target. Overnight, Reuters picked up on a report out of Germany that EQT and the billionaire Strüngmann brothers — enjoying a huge windfall from the overnight success of BioNTech’s mRNA Covid vaccine — are kicking the tires at Sandoz. And Novartis CEO Vas Narasimhan confirmed it. "There have been various requests for more information,” Narasimhan told WirtschaftsWoche. “But no concrete offers.” This is the second report out of Germany on the discussions over Sandoz. Handelsblatt reported more than a week ago that EQT and the Strüngmanns — Thomas and Andreas — were in talks over a $21 billion bid. And it wouldn't be their first generics deal, as the billionaires sold Hexal to Novartis in 2005. Narasimhan's decision to confirm their interest — rather than just remain mum — leaves little doubt in just how much he would like an auction to get going. He just lined up a $21 billion fund for new deals with his sale of the Roche stake. A Sandoz sale would make him a formidable potential buyer in 2022. Narasimhan got everyone’s attention at the end of October when he flagged a plan to undertake a strategic review of Sandoz to see whether the generics group should stay inside Novartis, or be sold or spun off into an independent company. |
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by Max Gelman
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A new healthcare SPAC is expected to price during Friday’s session, and it’s one that wants to take advantage of the industry’s buzziest sector. The blank check company will make a $200 million debut on Nasdaq, coming to the public market on the backs of Stanley Capital fundraising. This SPAC is not only targeting life sciences, but life sciences companies with a specific focus on artificial intelligence. One need not look past the name as evidence — Healthcare AI Acquisition Corp. According to the S-1 filing, the SPAC is aiming to target companies “with high AI readiness and technological transformation potential.” The primary focus will be in the US and Europe in operations “where the additional integration of an AI or automation solution can create incremental transformational value.” Led by Stanley Capital’s founding partners Simon Cottle and Patrick Hargutt, the SPAC team believes such value can be found in any of three sectors in healthcare. The first two deal less with drug R&D but remain tangential: within the S-1, the team lays out how AI will blossom in clinical trial software and healthcare IT. But the company lays out most of its details regarding the third area — outsourced pharmaceutical services, such as CROs and CMOs. The S-1 lays out how such outsourcing has trended up in the last several years, citing a BCC Research estimate saying this services market will grow to $266 billion by 2025. |
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by Paul Schloesser
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Two years ago, life sciences VC Novalis LifeSciences announced that it had raised $85 million for its first fund, looking to invest into anywhere between 8 to 12 companies "in various segments of the life science industry." Novalis now wants to go bigger, announcing earlier this week it raked in $300 million for Novalis LifeSciences Investments II. The New Hampshire-based VC, founded in 2017 by Ginkgo Bioworks board chairman and ex-Bayer CEO Marijn Dekkers, plans to invest into anywhere between 10 and 15 more life science companies. So far, Novalis has not listed from where — or who — it's gotten its funding, but in total, the firm manages approximately $500 million in the two investment funds. Over the past few years, Novalis has invested and backed quite a few companies under the biotech umbrella, from therapeutics to food production. On the therapeutics side, some of those biotechs include: | - Ginkgo, where Dekkers is chairman of the board, and the biotech was the subject of a short sell attack last month — amidst it revealing itself as a target of a DOJ probe;
- Decipher Biosciences, an oncology diagnostics company that emphasizes cancer genomics and was bought out by Veracyte earlier this year;
- Cerevel Therapeutics, a Cambridge, MA biotech focusing on CNS drug candidates that went public via SPAC in October 2020.
| In addition, several other people had recently joined Novalis: trust operations veteran Constantine Pantelis as COO, and ex-Thermo Fisher scientist and former head of DNA synthesis at Ginkgo, Devin Leake, as managing director. Paul Meister, who as then-vice chairman of Fisher Scientific and worked with Dekkers closely on the Thermo Fisher merger back in 2006, has gotten on board and joined the VC firm as partner. |
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by Max Gelman
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Angion’s lead organ damage drug took two strikes earlier this year, flopping as a repurposed effort for Covid-19 and whiffing in high-risk kidney transplant patients. The biotech reported a third on Thursday, raising serious questions about the program’s future. In a Phase II study looking at some cardiac surgery patients at risk of kidney injury, Angion reported its ANG-3777 candidate missed badly on the primary endpoint. The results come about a month and a half after the kidney transplant study and less than five months after the Covid-19 trial, ostensibly leaving the candidate on the chopping block. ANGN shares were down about 18% after the bell Thursday evening and into early Friday morning. During a Thursday afternoon investor call, CEO Jay Venkatesan implied this could be end of the road for ANG-3777, saying Angion’s “primary focus” moving forward will be its Phase II tyrosine kinase receptor inhibitor, ANG-3070. But Angion and its partner Vifor Pharma will need to further review the data, he said, noting a decision will likely be made sometime in early 2022 about next steps. Much of Angion’s focus post-reveal dealt with a secondary endpoint that also missed statistical significance, but one which the company said is more commonly used as a regulatory benchmark. In damage control mode on the investor call, Venkatesan stressed this point and noted Angion still wants to take a closer look at the data. “We have been clear with investors that this trial was not intended to generate statistically significant results, particularly on the MAKE90 endpoint, where we believe we were not sufficiently powered,” Venkatesan said. |
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by Alex Hoffman, Kathy Wong, Paul Schloesser
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Margaret Koziel has bounced back and forth between academia and biotech throughout her career — and after 25 years, she has landed her first position as part of a biotech's top brass. Koziel joined Axcella Therapeutics — founded by Flagship’s Noubar Afeyan, Geoffrey von Maltzahn and David Berry as Axcella Health — in 2019, and as of Monday, she is now in the C-suite as the biotech’s new CMO. As a self-described applied scientist, Koziel’s career has been star-studded: after graduating from Dartmouth and its medical school, she went to Harvard Medical School, where she taught as an associate professor of medicine for 12 years. And after Harvard, Koziel first crossed over into biotech and took a job with Novartis as their head of translational medicine in infectious disease. After jumping from Novartis to Vertex, she returned to academia — but this time at UMass, wearing a variety of hats for the five years she was there: everything from professor of medicine to director of clinical research and up to assistant vice provost in clinical research. And then, she crossed right back into the realm of biotech with a job at Kaleido Biosciences, which then led her to Axcella two and a half years ago, where she climbed the ladder from global program team lead to VP of clinical development and ultimately to CMO. For Koziel, she joined the company because of its model using “endogenous metabolic modulators” — molecules that could potentially restore health across a network of disregulated pathways. |
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by Zachary Brennan
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Viatris (Mylan/Pfizer's Upjohn) and India's Biocon Biologics are reportedly pondering whether to further entwine their biosimilar businesses into a $10 billion standalone company, according to sources from Nisha Poddar at an Indian affiliate of CNBC. Earlier this summer, the two companies won the first highly-coveted interchangeability designation for their biosimilar Semglee, which is an insulin that's interchangeable with Sanofi's Lantus. Although, in a bizarre twist with the way the US insulin market works, the companies had to launch two versions of the interchangeable — one at a 65% discount, and one at a much higher price in order to gain market share. https://twitter.com/CNBCTV18News/status/1468792319625203713 A Viatris spokesperson told Endpoints News via email, "We don’t comment on market rumors and speculation." Such a deal would bring closer together two companies that are already developing, manufacturing and commercializing a portfolio of biosimilars and insulin analogs, including biosimilars to Humira, Herceptin, Neulasta, and Enbrel. Viatris, which saw its complex generics and biosimilars business bring in about $1 billion in net sales in the first nine months of 2021, has exclusive commercialization rights for the biosimilars in the US, Canada, Australia, New Zealand, the EU and European Free Trade Association countries. Biocon Biologics has exclusive commercialization rights for Japan and certain emerging markets. And they have co-exclusive commercialization rights in the rest of the world. |
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by Zachary Brennan
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With reports of Omicron cases in over 50 countries, and at least 19 US states, some regions like the UK are now expecting a rapid rise of Omicron as community spread takes off. While the UK has only seen about 800 Omicron cases so far, the government’s Health Security Agency warned that if the recent growth rate continues, “we expect to see at least 50 percent of Covid-19 cases to be caused by the Omicron variant in the next two to four weeks,” according to the New York Times. John Edmunds, an epidemiologist at the London School of Hygiene & Tropical Medicine, said that plan B measures announced by PM Boris Johnson were “absolutely not an overreaction” even if Omicron turned out to be milder than the current dominant variant, according to The Guardian. Edmunds told a Royal Society of Medicine webinar Thursday that it was “extremely likely” there's more Omicron in communities, adding, "With the speed of spread of this virus, we may well have really significant numbers of cases by Christmas." Meanwhile, CDC director Rochelle Walensky said Wednesday that her staff is "available 24/7, as they have been throughout this entire pandemic, to provide in-person and remote technical support for the public health response to the Omicron variant, including investigations of the epidemiologic and clinical characteristics of Omicron or other SARS-CoV-2 infections." |
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by Beth Snyder Bulik
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People with certain chronic conditions are faring worse than others during the pandemic. A new survey from The Harris Poll commissioned by GlaxoSmithKline finds that people with asthma, specifically severe eosinophilic asthma, are among them. More than two-thirds (68%) of patients diagnosed with severe eosinophilic asthma surveyed describe their health as fair or poor – and that may be downplaying the reality. Ninety percent of physicians who see severe asthma patients surveyed rate their patients’ overall quality of life using the same fair or poor descriptors. "We know that patients will often accept where they are and just feel this is how it is with severe asthma," Tom Corbridge, senior medical lead at GSK in the US, said. "When they come into the office and are asked how they're doing, they may say 'OK.' But that type of underreporting may set the doctor up for potentially under-recognizing where they truly are." Meanwhile, the ongoing Covid-19 pandemic has been both blessing and curse for asthmatics. Fewer patients are having flare-ups thanks to less exposure to triggers like respiratory infections and poor air quality aided by masking and staying home more often. However, it’s also likely that fewer patients have been diagnosed because of skipped or delayed doctors' visits and less testing, Corbridge said. The Harris Poll results show that while GSK has made some progress in severe asthma, it needs to double down on education and awareness efforts with both patient advocacy groups and physicians, he said. |
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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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Kathy Wong
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Assistant Editor
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Melissa Nazzaro
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Sales Director
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Cassidy Murphy
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Sales Associate
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Jaime Bruder
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Sr. Operations Manager
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Kara Thibault
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Operations Manager
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Jordan Collins
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Operations
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Lirra Selibio
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Subscriptions
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Dawn Cleveland
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Controller
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Amanda Florez
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Executive Assistant
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Alex Lefterov |
Graphic Designer |
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DeAna Catoni
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Operations Coordinator
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Kari Abitbol
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Director, Studio
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Julie Notario
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Sales Director
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Rachel Wilson
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Operations Coordinator
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Derek Graf
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Copy/Visuals Editor
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Paul Schloesser
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Associate Editor
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Andriy Tomchyshyn
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Lead Developer
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Worldwide made. Thanks for reading.
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