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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          Houston engineers develop breakthrough device to advance spinal cord treatment

          future of health

          A team of Rice University engineers has developed an implantable probe over a hundred times smaller than the width of a hair that aims to help develop better treatments for spinal cord disease and injury.

          Detailed in a recent study published in Cell Reports, the probe or sensor, known as spinalNET, is used to explore how neurons in the spinal cord process sensation and control movement, according to a statement from Rice. The research was supported by the National Institutes of Health, Rice, the California-based Salk Institute for Biological Studies, and the philanthropic Mary K. Chapman Foundation based in Oklahoma.

          The soft and flexible sensor was used to record neuronal activity in freely moving mice with high resolution for multiple days. Historically, tracking this level of activity has been difficult for researchers because the spinal cord and its neurons move so much during normal activity, according to the team.

          “We developed a tiny sensor, spinalNET, that records the electrical activity of spinal neurons as the subject performs normal activity without any restraint,” Yu Wu, a research scientist at Rice and lead author of the study said in a statement. “Being able to extract such knowledge is a first but important step to develop cures for millions of people suffering from spinal cord diseases.”

          The team says that before now the spinal cord has been considered a "black box." But the device has already helped the team uncover new findings about the body's rhythmic motor patterns, which drive walking, breathing and chewing.

          Lan Luan (from left), Yu Wu, and Chong Xie are working on the breakthrough device. Photo by Jeff Fitlow/Rice University

          "Some (spinal neurons) are strongly correlated with leg movement, but surprisingly, a lot of neurons have no obvious correlation with movement,” Wu said in the statement. “This indicates that the spinal circuit controlling rhythmic movement is more complicated than we thought.”

          The team said they hope to explore these findings further and aim to use the technology for additional medical purposes.

          “In addition to scientific insight, we believe that as the technology evolves, it has great potential as a medical device for people with spinal cord neurological disorders and injury,” Lan Luan, an associate professor of electrical and computer engineering at Rice and a corresponding author on the study, added in the statement.

          Rice researchers have developed several implantable, minimally invasive devices to address health and mental health issues.

          In the spring, the university announced that the United States Department of Defense had awarded a four-year, $7.8 million grant to the Texas Heart Institute and a Rice team led by co-investigator Yaxin Wang to continue to break ground on a novel left ventricular assist device (LVAD) that could be an alternative to current devices that prevent heart transplantation.

          That same month, the university shared news that Professor Jacob Robinson had published findings on minimally invasive bioelectronics for treating psychiatric conditions. The 9-millimeter device can deliver precise and programmable stimulation to the brain to help treat depression, obsessive-compulsive disorder and post-traumatic stress disorder.

          Houston clean hydrogen startup to pilot tech with O&G co.

          stay gold

          Gold H2, a Houston-based producer of clean hydrogen, is teaming up with a major U.S.-based oil and gas company as the first step in launching a 12-month series of pilot projects.

          The tentative agreement with the unnamed oil and gas company kicks off the availability of the startup’s Black 2 Gold microbial technology. The technology underpins the startup’s biotech process for converting crude oil into proprietary Gold Hydrogen.

          The cleantech startup plans to sign up several oil and gas companies for the pilot program. Gold H2 says it’s been in discussions with companies in North America, Latin America, India, Eastern Europe and the Middle East.

          The pilot program is aimed at demonstrating how Gold H2’s technology can transform old oil wells into hydrogen-generating assets. Gold H2, a spinout of Houston-based biotech company Cemvita, says the technology is capable of producing hydrogen that’s cheaper and cleaner than ever before.

          “This business model will reshape the traditional oil and gas industry landscape by further accelerating the clean energy transition and creating new economic opportunities in areas that were previously dismissed as unviable,” Gold H2 says in a news release.

          The start of the Black 2 Gold demonstrations follows the recent hiring of oil and gas industry veteran Prabhdeep Singh Sekhon as CEO.

          “With the proliferation of AI, growth of data centers, and a national boom in industrial manufacturing underway, affordable … carbon-free energy is more paramount than ever,” says Rayyan Islam, co-founder and general partner at venture capital firm 8090 Industries, an investor in Gold H2. “We’re investing in Gold H2, as we know they’ll play a pivotal role in unleashing a new dawn for energy abundance in partnership with the oil industry.”

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          This article originally ran on EnergyCapital.

          3 Houston innovators to know this week

          who's who

          Editor's note: Every week, I introduce you to a handful of Houston innovators to know recently making headlines with news of innovative technology, investment activity, and more. This week's batch includes an e-commerce startup founder, an industrial biologist, and a cellular scientist.

          Omair Tariq, co-founder and CEO of Cart.com

          Omair Tariq of Cart.com joins the Houston Innovators Podcast to share his confidence in Houston as the right place to scale his unicorn. Photo via Cart.com

          Houston-based Cart.com, which operates a multichannel commerce platform, has secured $105 million in debt refinancing from investment manager BlackRock.

          The debt refinancing follows a recent $25 million series C extension round, bringing Cart.com’s series C total to $85 million. The scaleup’s valuation now stands at $1.2 billion, making it one of the few $1 billion-plus “unicorns” in the Houston area.

          Cart.com was co-founded by CEO Omair Tariq in October 2020. Read more.

          Nádia Skorupa Parachin, vice president of industrial biotechnology at Cemvita

          Nádia Skorupa Parachin joined Cemvita as vice president of industrial biotechnology. Photo courtesy of Cemvita

          Houston-based biotech company Cemvita recently tapped two executives to help commercialize its sustainable fuel made from carbon waste.

          Nádia Skorupa Parachin came aboard as vice president of industrial biotechnology, and Phil Garcia was promoted to vice president of commercialization.

          Parachin most recently oversaw several projects at Boston-based biotech company Ginkjo Bioworks. She previously co-founded Brazilian biotech startup Integra Bioprocessos. Read more.

          Han Xiao, associate professor of chemistry at Rice University

          The funds were awarded to Han Xiao, a chemist at Rice University.

          A Rice University chemist has landed a $2 million grant from the National Institute of Health for his work that aims to reprogram the genetic code and explore the role certain cells play in causing diseases like cancer and neurological disorders.

          The funds were awarded to Han Xiao, the Norman Hackerman-Welch Young Investigator, associate professor of chemistry, from the NIH's Maximizing Investigators’ Research Award (MIRA) program, which supports medically focused laboratories. Xiao will use the five-year grant to advance his work on noncanonical amino acids.

          “This innovative approach could revolutionize how we understand and control cellular functions,” Xiao said in the statement. Read more.

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