Houston CRO expands oncology network with addition of global clinical trial center

strategic partnership

Houston-based Proxima Clinical Research has expanded its footprint thanks to a recent partnership. Image via proximacro.com

Houston-based Proxima Clinical Research announced this month that it will expand its clinical trial offerings by adding NEXT Oncology to its Early Phase Oncology Network, or EPON.

NEXT Oncology is a Phase I clinical trial treatment center with locations in Austin, Dallas, San Antonio, and Virginia, as well as international locations in Barcelona and Madrid. These centers provide innovative and investigational treatments and therapies to patients with advanced forms of cancers.

The addition of NEXT Oncology's clinics brings Proxima's oncology network up to 14 physical locations and eight clinical practices, Robbin Frnka, executive director of clinical development and strategy at Proxima CRO tells InnovationMap.

“Early phase oncology trials are some of the most delicate and important trials to conduct, both from a science perspective and in offering hope for late-stage patients,” Dr. Anthony Tolcher, CEO and founder of NEXT Oncology, says in a statement. “We proudly designed NEXT Oncology specifically to bring the best new agents to patients through our specially designed centers located around the world. This new relationship with Proxima CRO’s EPON will help us further enhance our mission and contribute to our life’s work of advancing cancer treatments to save more lives from cancer around the world.”

Proxima is a Houston-based contract research organization focused on supporting life science startups as they grow and scale. It was recently named to the the Inc. 5000 regional rankings for the Southwest for its fast-growing revenue.

The company launched its EPON in March to support Phase I and Phase II clinical oncology trials and a group of oncology-specific scientific experts. The Mary Crowley Cancer Research, a specialized clinical research center in Dallas, was one of the first to join the network.

"Finding the right clinical sites and investigators with the right patients is one of the biggest struggles of early phase clinical trials," Frnka says in a March statement. "Our Early Phase Oncology Network, which we're calling EPON, includes some of the most prominent investigators in early phase trials. Receiving expert feedback, insight, and guidance from this skilled scientific panel is critical to the success of these earliest phase trials."

In addition to work in the cancer field, Proxima also launched its M1 MedTech accelerator last year aimed at helping startups quickly grow their health tech businesses. Its inaugural cohort included startups with new tech and treatments for heart arrhythmias, ultrasounds, bioelectric implants in the body and more.

The company also recently expanded its footprint within the Texas Medical Center Innovation Factory.

InnovationMap spoke with Proxima CEO and Co-founder Kevin Coker on the Houston Innovators Podcast.

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A Houston life science expert shares what she thinks Houston needs to work on to continue growing as an health care innovation ecosystem. Photo via Getty Images

Expert: Houston has potential to be a major hub for life sciences — if it addresses these concerns

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Once upon a time in Houston, a promising startup, let’s call it BioMatrix, set out to revolutionize the world of biomaterials. Their groundbreaking product held immense potential, but the company faced the harsh reality of a lack of funding, resources, and talent in their local life sciences sector.

As they watched well-funded competitors in established hubs like Boston and Silicon Valley flourish, the passionate team at BioMatrix persevered, determined to overcome these challenges, and make their mark in the rapidly evolving world of MedTech and life sciences. But would they ultimately move to a richer life science hub?

Over the years, Houston has emerged as a life sciences hub, fueled by the world's largest medical center, Texas Medical Center, and an expanding network of research institutions, startups, and investors. However, despite all its potential, the city still lags other innovation hubs and isn’t included in many of the lists for top life science ecosystems. The challenges are many-fold, but some primary challenges are associated with lack of capital, trouble with talent acquisition, and weak collaboration.

Despite an uptick in venture capital funding, Houston's life sciences sector still trails the likes of Silicon Valley and Boston. Programs like CPRIT help keep companies within Texas, while Houston's unique advantages, such as lower living costs and the TMC's presence, can attract investments, but ultimately, to secure necessary capital, stakeholders must cultivate relationships with investors, government agencies, and other funding sources to infuse more money into the Houston ecosystem. And, when individuals try to do this, the rest of the ecosystem must be supportive.

Talent retention and attraction pose another challenge, as Houston competes with well-funded life science hubs offering abundant research institutions and funding opportunities. While Houston boasts numerous educational institutions producing skilled life sciences graduates, many curricula primarily prepare students for academic rather than industry careers, creating a skills and knowledge gap.

Having a lot of experience in academia doesn’t often translate well into the industry, as is demonstrated by many startup founders who struggle to understand the various stakeholder requirements in bringing a life science product to market.

To bridge this, educational institutions should incorporate more industry-oriented courses and training programs, like Rice University’s GMI Program, that emphasize practical skills and real-world applications. Collaborating with local companies for internships, co-op placements, and hands-on experiences can expose students to industry practices and foster valuable connections.

For any life science company, navigating the intricate regulatory landscape is also a challenge, as missteps can be disastrous. However, it’s even more of a challenge when you lack the fundamentals knowledge of what is required and the skills to effectively engage with industry experts in the space.

To address this, Houston must provide more opportunities for companies to learn about regulatory complexities from experts. Workshops, accelerators, or dedicated graduate and undergraduate courses focusing on regulatory compliance and best practices can facilitate knowledge and experience exchange between regulatory experts and innovators.

The initial inception of M1 MedTech was the result of a personal experience with a company who didn’t understand the fundamentals for regulatory interactions and didn’t know how to appropriately engage with consultants, resulting in time and money wasted.

Enhancing collaboration among Houston's life science stakeholders — including academia, research institutions, healthcare providers, subject matter experts, innovators, and investors — is fundamental for growth. A robust and lively professional network can stimulate innovation and help emerging companies access essential resources.

To this end, Houston should organize more industry-specific events, workshops, and conferences, connecting key life science players and showcasing the city's commitment to innovation. These events can also offer networking opportunities with industry leaders, attracting and retaining top talent. We’ve seen some of this with the Texas Life Science Forum and now with the Ion's events, but we could afford to host a lot more.

Houston's life sciences sector holds immense growth potential, but addressing funding, talent recruitment, regulatory navigation, and collaboration challenges is needed for continued success. By tackling these issues and leveraging its unique strengths, Houston can establish itself as a significant player in the global life sciences arenas. If we wait too long, we won’t be able to truly establish the Third Coast because another player will come into the mix, and we’ll lose companies like BioMatrix to their golden shores.

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Isabella Schmitt is the director of regulatory affairs at Proxima Clinical Research and principal at M1 MedTech.

Five companies have been selected for a brand new accelerator program in Houston. Image via Getty Images

Houston medtech accelerator announces inaugural cohort

future of health care

A Houston medical technology organization has announced the inaugural cohort of a new early-stage accelerator.

M1 MedTech, launched this year by Houston-based Proxima Clinical Research, announced its Fall 2022 cohort.

“This initial cohort launches M1 MedTech with an interactive 14-week agenda covering the basics every emerging MedTech business needs to progress from a startup to an established solution in their market,” says Sean Bittner, director of programs at M1 MedTech, in a news release.

The accelerator will equip early-stage startups with storytelling, business plan support, investor connections, FDA guidance, research, and more through one-on-one consultations, workships, and in-kind services.

The first cohort includes five startups, per the release from the company:

  1. Linovasc. Providing a long overdue major update to balloon angioplasty devices in over 50 years, the Linovasc solution offers a safer branch occlusion and aortic stent dilatation using a toroidal balloon that expands the aorta uniformly without the ischemia caused by current treatments. The company is founded by Bruce Addis.
  2. Grapheton. Founded by Sam Kassegne and Bao Nguyen, Grapheton's patented carbon materials work with electrically active devices to improve the longevity and outcome of bioelectric implants in the body. Terry Lingren serves as the CEO of the startup.
    • Rhythio Medical. Founded by Kunal Shah and Savannah Esteve, Rhythio is the first preventative approach to heart arrhythmias.The chief medical officer is Dr. Mehdi Razavi.
      • PONS Technology. An AI cognitive functioning ultrasound device attempting to change the way ultrasound is done, PONS is founded by CEO: Soner Haci and CTO: Ilker Hacihaliloglu.
        • Vivifi Medical. Founded by CEO Tushar Sharma, Vivifi is the first suture-less laparoscopic technology that connects vessels to improve male infertility and benign prostatic hyperplasia. The company's senior R&D engineer is Frida Montoya.

          The program includes support from sponsors and experts from: Proxima Clinical Research, Greenlight Guru, Medrio, Galen Data, Merge Medical Device Studio, Venn Negotiation, Engagement PR & Marketing, Aleberry Creative, and others.

          “This is an amazing opportunity for emerging founders to learn the progression of pipelining their ideas through the FDA and absorb the critical strategies for success early in their business development,” says Isabella Schmitt, principal at M1 MedTech and director of regulatory affairs at Proxima CRO, in the release.

          From research and venture capital funding to startup growth and accelerator applications opened, here's what you need to know in Houston innovation news. Photo via Getty Images

          Houston beauty startup raises $1M, medtech accelerator opens apps, and more local innovation news

          short stories

          The month of May has started strong with Houston innovation news, and there might be some headlines you might have missed.

          In this roundup of short stories within Houston startups and tech, local universities share big moves in cybersecurity and plant research, a Houston entrepreneur raises extra seed funding, and more.

          Houston medical technology accelerator opens applications

          This medtech startup accelerator has applications open. Graphic via proximacro.com

          M1 MedTech, Proxima Clinical Research's medical technology accelerator is accepting applications for its fall cohort. The program is seeking five to seven early-stage medical device companies for the three-month program. The cohort companies will have investment opportunities up to $100,000 as a combination of both cash and in-kind services.

          “Our program is unique in that it combines acceleration capital, company building expertise, and the regulatory and clinical services of a top CRO,” says Larry Lawson, a venture partner and investor with M1, in the news release. “Access to the M1 founders’ network, both within and outside of the Texas Medical Center, sets these companies up for success. There’s no better group to build a MedTech company with, period.”

          M1 MedTech, which was announced last year, was created to support early-stage medical device companies with a unique coaching process that will include a curated educational program, interactive workshops where participants can continually build out specific company deliverables, and tailored one-on-one mentoring.

          “Many MedTech companies are launched by innovative first-time founders with strong scientific and medical expertise, but who have never taken a regulated product to market or built a business. After working with so many companies at various stages of this journey to market, both with Proxima CRO and with accelerators from across the country, we realized there was a gap that needed to be filled for these rising founders. They not only need regulatory and clinical assistance from experts with hundreds of success stories in this field, we found they also need assistance with design, manufacturing, business, IP, and so much more,” says Isabella Schmitt, RAC, Director of Regulatory Affairs for Proxima CRO and Principle at M1. “These rising founders need to know what they don’t know; so, we put a lot of thought into what emerging companies and rising executives really need, and from that, we built the M1 curriculum.”

          Applications will remain open until May 31. To apply for the Fall 2022 cohort or to learn more about M1 MedTech, visit m1medtech.com.

          Houston entrepreneur adds $1M to seed round

          Houston-based Upgrade has raised additional seed funding. Photo via LinkedIn

          Houston-based Upgrade Boutique — which uses technology to connect women with high-quality wigs and hair extensions — extended its seed round by $1 million, Fast Company reported. The round's initial seed leaders included Houston-based venture capital firms Artemis Fund and Mercury Fund, as well as Logitech president and CEO Bracken P. Darrell and ANIM.

          “This [investment] will enable us to scale even faster and continue to invest in tools and resources that will improve the consumer experience, and help stylists operate more efficiently,” Winters tells Fast Company. “Based on feedback from the stylists on our platform, we see this as a natural development in the company’s evolution.”

          University of Houston joins cybersecurity initiative

          UH joins group that's advancing cybersecurity. Image via Getty Images

          The University of Houston has joined a consortium that's funded by the U.S. Department of Defense (DoD) to launch a virtual institute that will recruit and train the next cybersecurity generation that will protect entities from cyber warfare, cyber espionage, and attacks on the electromagnetic spectrum.

          The virtual institute is called VICEROY — Virtual Institutes for Cyber and Electromagnetic Spectrum Research and Employ — DECREE and will be led by Northeastern University and offered across five universities, including UH, Northern Arizona University, the University of Texas at Austin, and the University of South Carolina.

          “The VICEROY DECREE virtual institute consortium model is transformational. It brings together the best offerings from multiple institutions to meet the workforce training needs in these domains," says Hanadi Rifai, Moores Professor of civil and environmental engineering and UH team lead on the project, in the news release.

          One major focus for the program is the electromagnetic spectrum, which includes radio waves, and is a critical enabler for communications, navigation, radar, training and other military operations. The DoD has been seeking to hire more than 8,000 cyber workers to help defend the virtual space.

          "We recognize the importance and need for workforce training in cybersecurity, electromagnetism, cryptography and data science. These are areas of specific focus and expertise on our campus,” says Paula Myrick Short, UH senior vice president for academic affairs and provost, in the release.

          The two-year program starts in fall 2022 and is funded by a $1.5 million award from the Griffiss Institute, a nonprofit talent and technology accelerator for DoD and its academic, government, and industry partners around the world.

          Local composting company moves into new Houston space and expands to Austin

          Moonshot has expanded locally and statewide. Photo courtesy of Moonshot

          Houston-based Moonshot Composting has announced its relocation to a 8,225-square-foot space in Northside Village at 1410 Bigelow St. The former Yellow Cab outpost is over five times the size of the originally location.

          Additionally, this month Moonshot will open its doors in the greater Austin area with a facility in Creedmoor, just south of Austin. Moonshot's first commercial customer was Austin-headquartered Tacodeli.

          The company has grown its business to nearly 500 subscribers, including 40 commercials accounts, as well as seven full-time and four part-time employees. Moonshot is diverting 30,000 pounds of food waste a week, with a total of nearly 1,000,000 pounds diverted since July 2020, per a news release.

          “We are excited about our growth and all the individuals and companies getting on board to get food waste out of landfills and onto composting sites,” says Chris Wood, Moonshot principal and co-founder, in the release. “Our new space will make for more efficient operations all around.”

          Moonshot Composting's commercial subscribers include Rice University, Houston Baptist University, The Awty International School, ConocoPhillips, Snooze Eatery, Ostia, and Amli Residential.

          Rice University biologist wins NIH award

          This Rice University scientist has received national recognition for her work plant cell analysis. Photo courtesy of Rice

          A Rice University postdoctoral fellow and molecular and cell biologist has received a prestigious National Institutes of Health award.

          Durre Muhammad of Rice Academy won the MOSAIC (Maximizing Opportunities for Scientific and Academic Independent Careers) K99/R00 award, which is intended to help postdoctoral researchers transition into careers while enhancing diversity within the academic biomedical research workforce, according to a news release from Rice. She's only the fourth individual from Rice to receive this recognition.

          The first two years of the award will support the biologist's work in Bonnie Bartel's lab. She is working on defining the mechanisms by which cells in plants identify and eliminate damaged or obsolete organelles known as peroxisomes, which also play important roles in human aging.

          “Our lab in general works on all things peroxisome, and I mainly focus on the latter stage when it’s ready for degradation,” Muhammad says in the release. “We identify the signals and different mechanisms involved in the process of decay.”

          Muhammad joined Rice in 2018. She earned her Ph.D. in plant and microbial biology at North Carolina State University and her bachelor’s degree in biological sciences from the University of Illinois Chicago. She also has her MBA from Benedictine University. She received an NSF Postdoctoral Fellowship in Biology in 2019.

          “Durre is a fantastic scientist who has brought new perspectives and approaches to my lab,” says Bartel, the Ralph and Dorothy Looney Professor of BioSciences. “We are delighted that NIH has recognized her accomplishments and potential with this award.”

          Proxima Clinical Research has its New Year's resolution and is ready to start working hands on with health tech startups. Graphic via proximacro.com

          Houston organization plans to launch health tech accelerator in 2022

          ready to grow

          A contract research organization based in Houston has announced its new accelerator program aimed at helping startups quickly grow their health tech businesses.

          Proxima Clinical Research released details of M1 MedTech, which expects to launch early next year. The CRO has raised funds to launch and invest in members of the inaugural cohort.

          “Our goal is to move these companies substantially forward in a short amount of time,” says Kevin Coker, CEO of Proxima, in a news release. “Proxima is in a unique position to leverage our experienced team of regulatory, quality, and clinical experts. We won’t be working at arm’s length from these companies. We will be a big part of what they do every day.”

          The program will focus on a small group of companies and the Proxima team will provide hands-on support, including instruction, workshops, and one-on-one mentoring.

          “This will be a unique experience for all parties involved, as Proxima is also a young, yet established, company that is now creating a program to assist companies at an earlier stage,” says Larry Lawson, co-founder of Proxima, in the release. “Our experience in the CRO realm and ability to provide coaching in clinical, regulatory, quality, and go-to-market strategies will only strengthen M1 MedTech’s ability to support the success of emerging companies and provide more life-saving technology to the public.”

          Kevin Coker and Larry Lawson co-founded Proxima in 2017. Photos courtesy

          The accelerator will target Class II and III medical devices for its initial cohort. In the future, Proxima plans to expand to include an even more extensive incubator focused solely on Class III devices, according to the release.

          “M1 will be a place where startups can go to receive concrete resources to further their development. The participant success is our sole focus, and the ultimate goal is to have a substantial impact on the ideation-to-market process for Class II and Class III medical devices,” says Isabella Schmitt, director of regulatory affairs at Proxima and a principal at M1, in the release. “Proxima’s specific expertise alongside our M1 partners will provide resources for all key areas of a medical device entrepreneur’s journey to market and beyond.”

          The M1 MedTech applications will open online in the spring.

          “We don’t view M1 as competitive to other accelerators, rather we believe it will offer a different experience. Our team will strive to create a personalized program where companies have a dedicated touch point throughout the process,” says Sean Bittner, director of programs at M1 MedTech, in the release. “We will also provide specific, tailored connections and resources vetted by our team through professional partnerships, not just a general list of industry contacts.”

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          Pharma giant considers Houston for $1B manufacturing campus

          in the works

          Another pharmaceutical giant is considering Houston’s Generation Park for a manufacturing hub.

          According to a recent filing with the Texas Jobs, Energy, Technology and Innovation (JETI) program, Bristol Myers Squibb Co. is considering the northeast Houston management district for a new $1 billion multi-modal pharmaceutical manufacturing campus.

          If approved, the campus, known as Project Argonaut, could create 489 jobs in Texas by 2031. Jobs would include operations technicians, engineering roles, administrative and management roles, production specialists, maintenance support, and quality control/assurance. The company predicts annual average wages for these positions to be around $96,000, according to the filing.

          The project currently includes the 600,000-square-foot facility, but according to the filing, Bristol Myers Squibb “envisions this site growing in scale and capability well beyond its opening configuration."

          The Texas JETI program offers companies temporary school property tax limitations in exchange for major capital investment and job creation. E.R. Squibb & Sons LLC applied for a 10-year tax abatement agreement in the Sheldon Independent School District.

          The agreement promises a $ 1 billion investment. Construction would begin in 2027 and wrap in 2029.

          “The proposed project reflects [Bristol Myers Squibb Co.’s] enduring commitment to bringing innovative medicines to patients and ensuring the long-term supply reliability they depend on,” the filing says. “The proposed project is purpose-built to support and manufacture medicines spanning multiple therapeutic areas and modalities, positioning the site as a long-term launch and commercial campus for decades to come. These medicines will provide therapies to the [Bristol Myers Squibb Co.’s] patients located in markets both nationally and internationally.”

          The Fortune 100 company is considering 16 other cities for the new manufacturing facility in the Central and Eastern markets in the U.S. According to the Houston Chronicle, Bristol Myers Squibb Co is still in the “evaluation process” for its potential manufacturing site.

          Last fall, Eli Lilly and Co. selected Generation Park for its $6.5 billion manufacturing plant. More than 300 locations in the U.S. competed for the factory. Read more here.

          Houston health tech co. lands NIH grant for AI cancer prediction tool

          fresh funding

          Houston-based CellChorus and Stanford Medicine were recently awarded a Phase I Small Business Innovation Research grant for the company's AI platform to test how certain cancer patients will respond to therapies.

          The funding comes from the National Cancer Institute of the National Institutes of Health. According to a filing, the grant totaled just under $400,000.

          CellChorus, which spun out from the University of Houston’s Technology Bridge, has developed TIMING (Time-lapse Imaging Microscopy In Nanowell Grids), which analyzes the behavior of thousands of individual immune cells over time and can identify early indicators of treatment success or failure.

          The company will work with Stanford's Dr. David Miklos and Dr. Saurabh Dahiya, who have built the Bone Marrow Transplantation and Cell Therapy Biobank. The biobank manages and stores biological samples from patients treated at their clinic and in clinical trials.

          "Predicting which patients will achieve durable responses after CAR-T therapy remains one of the most important challenges in the field,” Miklos said in a news release. “We aim to uncover functional cellular signatures that can guide treatment decisions and improve patient outcomes.”

          The project will specifically profile cells from patients with relapsed/refractory large B-cell lymphoma (r/rLBCL). According to CellChorus, only about half of r/rLBCL patients who receive CAR-T therapy "achieve a durable, long-term remission." Others do not respond to therapy or experience relapse.

          “The sooner we know whether a cancer therapy is working, the better. To maximize patient benefit, we need technology that can provide a robust and early prediction of response to therapy. The technology needs to be scalable, cost-efficient, and capable of rapid turnaround times,” Rebecca Berdeaux, chief scientific officer of CellChorus, added in the release. “We are excited to work with Drs. David Miklos and Saurabh Dahiya and their colleagues on this very important project.”

          CellChorus has previously received SBIR grants from federal agencies, including a $2.5 million award in 2024 from its National Center for Advancing Translational Sciences (NCATS) and a $2.3 million SBIR Fast-Track award from the National Institute of General Medical Sciences in 2023.

          Houston museum showcases America's founding documents in rare exhibit

          Experience History

          As the United States prepares to celebrate its 250th birthday, Houstonians have a chance to see rare documents from the founding of the nation. Freedom Plane National Tour: Documents That Forged a Nation, presented by the National Archives Foundation, will be on display at the Houston Museum of Natural Science through Monday, May 25.

          The collection includes a rare engraving of the original Declaration of Independence; official Oaths of Allegiance signed by George Washington, Aaron Burr, and Alexander Hamilton; a draft of the Bill of Rights; the Treaty of Paris, the documented that recognized America's independence from Great Britain; and the tally of votes approving the Constitution.

          The National Archives specifically chose Houston as one of only eight cities in the country to host the exhibit as a means to help the documents reach a wider audience outside of the main hub of semiquincentennial events in New England and the Washington, D.C. area.

          "One of the things we decided when we put the tour together because we wanted to be off the East Coast," said Patrick Madden, CEO of the National Archives Foundation, who was onsite for the exhibit's opening in Houston. "There's a lot of 250th celebration stuff happening in the original 13 colonies. How do we get it to major markets where larger numbers of people can see it? So in the case of Houston, obviously, [is a] major market in this part of the country, but also we've partnered with the museum twice before with National Archives exhibits, so we knew that they would be up to the task of handling the exhibit and the crowds."

          The star of the collection is a rare engraving of the original Declaration of Independence. Secretary of State and future president John Quincy Adams commissioned 200 exact replicas of the document from engraver William J. Stone in 1823. Less than 50 now remain. Madden joyfully pointed out that there are errors in this document, a potent reminder that the men who forged a nation made mistakes.

          "There's a couple of typos in it where they had to make corrections," said Madden. "So even the founders, you know, they're all human. That resonates because here these people are making this move against the most powerful nation in the world and putting their lives on the line for a country based on ideas."

          Other impressive parts of the collection include official Oaths of Allegiance signed by George Washington, Aaron Burr, and Alexander Hamilton, as well as one of the drafts of the Bill of Rights. Many states would not ratify the Constitution until certain rights were included in the document, leading to Washington going on a national tour assuring state leaders enshrining protections was first on the list. The draft copy on display specifically shows the First Amendment in progress.

          Houston is the fourth stop on the exhibition's tour, which will take the documents to Denver, Miami, Dearborn, and Seattle through the summer. Freedom Plane is just one part of a larger patriotic celebration at the HMNS, which includes a film series celebrating American science and culture and general Americana decoration throughout the main hall.

          Admission to Freedom Plane is free to the public, but separate from general admission to the museum. Space is limited, and passes are available on a first-come, first-serve basis. Non-members should expect long waits or the possibility that the day's passes are sold out. Only museum members can reserve passes for specific times. Flash photography is prohibited due to the fragile nature of the documents.

          ---

          This article originally appeared on CultureMap.com.

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