Pediatric COVID-19 Vaccine Study
Help pursue longer lasting protection against COVID-19 While most children do not become seriously ill from COVID-19, some do and require hospitalization. Children can still infect others and may be at risk of developing MIS-C, a rare but life-threatening inflammatory condition related to COVID-19. As new variants and subtypes continue to emerge, approval of a bivalent vaccine for children that effectively targets both current and future variants will be key for protecting them against COVID-19. This study may be an option for infants and children who: A study team member will help determine if this study is right for your child based on all participation criteria. Parents/guardians may be reimbursed for expenses related to participants’ time in the study. Contact a study member to learn more!
Paradigm Clinical Research Featured in NBC 7 San Diego, CA
NBC 7 San Diego recently did a news report on an important issue that has been affecting infants and toddlers. RSV is the leading cuase of serious respiratory tract disease in children worldwide. We are now enrolling infants and toddlers in San Diego, CA for this clinical research trial. Watch the video here to learn more. You can also learn more and sign up on our website.
Paradigm Featured in Clinical Trial Supply and Logistics Magazine
Sites, ‘Smart Money’, and Standard Operating Procedures Kurt Mussina at Paradigm Clinical Research outlines the best practices involved when running multiple research sites, and how to ensure site expansions occur smoothly. ICT: When expanding the number of locations in a clinical research site business, what is needed to ensure efficacy in the supply chains and other logistics? Kurt Mussina: Depending on the types of studies and therapeutic areas in which they are active, sites will require a certain set of common supplies and consumables. These are typically readily available from a variety of sources. For equipment and supplies that are less common or unique to a particular study, it is best practice to have the sponsor acquire and provide these to the sites. Often, sponsors have greater purchasing power and influence than sites. White it is not common to use the term ‘supply chain’ to refer to the availability of volunteers who are eligible to participate in trials, this is a critically important consideration when expanding into new locations and new therapeutic areas. You cannot be successful managing a clinical research site if you can’t effectively access and recruit a sufficient population willing and eligible to join trials. Finally, it is also critical to consider the importance of diversity and inclusion of underrepresented populations in clinical trial participation. This applies not only to volunteers but also to study investigators and site staff. How important is collaboration with other businesses, such as private equity firms, when organizing site expansions? Among many options, private equity is a common source of funding when expanding any business, whether through de novo or acquisition strategies. It is important to discern how familiar the private equity firm, or indeed any funding source, is with the marketplace in which you compete. Some funding sources are considered ‘not smart’ (i.e., unfamiliar with your particular market). Other sources are considered ‘smart money’ or referred to as ‘strategic’. These sources can often be collaborators, customers, or vendors with common interests and motivations. Unless there are good strategic reasons to do otherwise, it is typically best for the business to self-fund an expansion – assuming, of course, it is in good financial condition to do so. Otherwise, strategic money can bring with it good value and certain advantages. What are some common pitfalls of managing a clinical research site business across multiple locations, and how can they be avoided? Sute businesses with multiple locations often manage the business in a way that appears from the outside as multiple businesses. This is especially true of site networks. This lack of integration fails to address many of the fundamental inefficiencies found in clinical research. For example, there are often separate clinical trial agreements and budgets that must be negotiated and executed for each individual site. Indeed, in these cases, separate and distinct standard operating procedures are often in play/ Integrating the site’s operations and centralising common services, such as accounting and business development, is one way to avoid this. Put another way, an operating model that regards the business as one large site with many locations delivers the strongest value to all stakeholders. How might offering trials across multiple therapeutic areas impact the patient experience? Study protocols often, if not always, exclude people already enrolled in another study. However, sites that participate in studies across multiple therapeutic areas can provide more options to people interested in participating. So, if someone turns out to be ineligible for a certain study, they could still meet the criteria for another study – having options can only be a good thing. In addition, deciding which therapeutic area to compete in is strategically important for the site. Disease areas and indications that are adjoining can provide a competitive advantage. A good place to start is by considering the complications that often arise with a particular medical condition. For example, nephrology, endocrinology, and cardiology are specialties that can overlap for certain patients. What are some good practices when coordinating research teams across sites, including internationally? Full operation integration is key. So is strong site leadership and a properly-aligned organizational structure. Site leadership with good people skills is necessary. Combine that with good business acumen, and now you have a great recipe for success at that sire. Site leaders must appreciate that they are managing a business jsut as much as they might be managing studies. That requires an understanding of how the business operates, how value flows and how to measure financial performance. Beyond this, good, clear, and frequent communication is critical. The sharing of best practices and troubleshooting across sites, especially regarding enrolment challenges, can mean the difference between delivering outstanding value and mediocrity. Read the full conversation with Kurt Mussina, CEO of Paradigm Clinical Research and Clinical Trial Supply and Logistics
Paradigm Clinical Research Featured in Fox 5 News La Mesa, CA
La Mesa clinic conducting vaccine trials against RSV LA MESA, Calif. — A local La Mesa clinic is looking for patients to test vaccine trials for RSV. Researchers are hoping these vaccine trials can help combat the so-called “tripledemic” that many health officials are warning about. Researchers are looking for more patients to take part in this study. Jamie Williams of Paradigm Clinical Research showed FOX 5 kits they use to track antibodies in patients against respiratory syncytial virus or RSV. “The idea is that the subjects get one vaccine and they’re protected against RSV, so we follow them both for safety and to see if they develop RSV throughout the season,” said Williams. She is helping conduct clinic trials of an mRNA vaccine to protect against RSV in the elderly population. “What that means is there’s no live virus in the vaccine,” said Jamie. “We give that vaccine like a message and that tells your body to develop antibodies, which our immune systems build to fight infection.” The study comes at a time when respiratory virus cases are rising across the county. Health officials are warning of a “tripledemic” surge of cases of flu, COVID-19 and RSV. “The numbers are really high right now and there is research saying that our bodies are actually capable of carrying more than one virus at a time,” says Williams. County health officials say they don’t have a role in clinical trials, but released its latest respiratory virus report. It reported nearly 90,000 COVID-19 cases and more than 3700 flu cases in the county. “Having those cases helps bring awareness of how serious RSV can be. We’re trying to get subjects vaccinated before those cases really get out of control,” says Williams. Paradigm Clinical Research says it is still looking for hundreds of patients in the San Diego and La mesa area to participate. They say each patient will receive compensation per visit. Read the full article by Fox 5
Paradigm Clinical Research Featured in KRCR News Redding, CA
Redding-based clinical research center helps combat flu, RSV and COVID-19 by Mike Mangas, Adam Robinson – Monday, October 31st 2022 REDDING, Calif. — A Redding-based clinical research center is helping combat communicable diseases like COVID-19, RSV, and the flu to name just a few. Paradigm Clinical Research was started in Redding in 2009 and now has sites in the San Diego and Denver, Colo. areas, with plans to expand to three more locations in the next year. They enroll volunteers to research the effectiveness of vaccines. “They either receive an RSV vaccine or a placebo. They don’t know; we don’t know. It’s bonded data. Essentially, we draw their blood, we send it to a central lab, and they’re checking antibodies to check to see if the vaccine is efficacious. And we don’t get data of that until after the study ends,” said Sarah Sandberg, the center’s site manager. Volunteers do it for different reasons; there’s a small stipend. But, for someone like registered nurse Dawn Smith, it’s because she’s seen patients die unnecessarily. “I am an RN, and I have observed, participated [in], and witnessed patients who have not been able to, or not educated to, have immunizations. And that gap has caused dire consequences in our community,” Dawn told Mike during an interview on Monday. “I get [that] it’s for the research purposes. Not only does it further the research [on] the last vaccine, which was for COVID-19—that was Moderna. It’s helped out a lot; got the vaccine out to people a lot quicker. And, also, there’s the money factor. It helps out having a little extra money in your pocket,” said Mike Woodward, another research volunteer. Although they have a healthy database, Paradigm is always looking for more volunteers on any number of research projects. “We’re currently doing a flu vaccine study. It’s an mRNA-based flu vaccine for Pfizer. The placebo is the marketed flu vaccine. And that’s 18 and older. We just started enrolling for the full age group today,” Clinical Research Coordinator Emily Crews. Read the full article by KRCR
As Paradigm Clinical Research Expands, So Does the Executive Team
Redding, California – Oct. 6, 2022 — Paradigm Clinical Research, with three dedicated research sites in California and Colorado, announced it has grown its executive leadership team, bringing on board Travis Milnes as chief financial officer (CFO) and Amy Henderson as head of clinical operations. These industry veterans provide additional leadership to Paradigm Clinical Research as the company executes on its plans to expand as a dedicated clinical research business covering a range of therapeutic areas for the biopharmaceutical industry. Travis Milnes, CPA, CFO, is focused on corporate strategy, finance, tax, treasury, information technology, human resources and contracts for Paradigm Clinical Research. He has extensive experience building teams and companies. Previously, at Advarra, Inc., he led the finance department through 11 acquisitions and integrations and four change-of-control transactions and was instrumental in the integration and implementation of standardized processes and procedures for an internationally dispersed team. He began his career as an audit manager with SB & Company, LLC. Amy Henderson, CCRC, head of clinical operations, brings deep experience leading international clinical research teams in highly complex interventional trials. She joined Paradigm Clinical Research from Frenova, the contract clinical research services business of Fresenius Medical Care, where her leadership was instrumental in achieving record-setting productivity, revenue and profitability performance for both Frenova and its partner investigators. At Paradigm Clinical Research, she has an integral role ensuring patient enrollment goals and financial performance objectives are met, as well as growing and managing high-performing sites. Kurt Mussina, who was recently announced as Paradigm Clinical Research’s new CEO, said, “Amy and Travis bring impressive records of success to Paradigm Clinical Research’s executive leadership team. Their experience and subject matter expertise are instrumental to drive our expansion plans not only in terms of additional site locations, but also therapeutic areas and our relationships with principal investigators and the clinical research community in general. I look forward to work with Amy and Travis as we build upon Paradigm Clinical Research’s history of achievement to become a dominant player in the clinical research site market.” About Paradigm Clinical Research Paradigm Clinical Research operates dedicated clinical research facilities with principal investigators actively involved in medical practice and clinical research. Founded in 2009, the company offers clinical trial opportunities to patients and healthy volunteers and provides high-quality study data to the biopharmaceutical industry.
Kurt Mussina Joins Paradigm Clinical as CEO to Lead Strategic Growth
REDDING, Calif.; Sept. 27, 2022 — Paradigm Clinical Research (Paradigm) announced the appointment of Kurt Mussina as CEO. He will bring more than 30 years of international business success to the clinical research site company, including a record of leadership and achievement structuring and orchestrating global teams in the CRO, CDMO and clinical research site industries. Founded in 2009, Paradigm currently operates three dedicated research sites with two in California and one in Colorado. Paradigm partners with principal investigators who are practicing physicians in a wide variety of medical specialties to execute both healthy volunteer and patient studies. Paradigm has deep expertise that is continuing to grow and a track record of success in neurology, ENT, internal medicine, pulmonology, infectious disease and dermatology, as well as deep experience in vaccine studies. “As the clinical research site landscape evolves, Paradigm is uniquely positioned for growth to become a dominant player in the space,” said Mussina. “Our approach is strategically tailored to addressing the day-to-day demands on our partner investigators, allowing them to participate in clinical trials while also managing successful medical practices. We are intensely fixated on creating and delivering value for all our stakeholders, including partner investigators, study volunteers, sponsors, CROs and our employees. We pride ourselves on delivering as promised, and I look forward to building on Paradigm’s history of achievement.” Before Paradigm, Mussina was president of Frenova, the contract clinical research services company of Fresenius Medical Care (FMC), while also serving as senior vice president in the Global Medical Office of FMC. The business expanded significantly under his leadership to become a network of managed and associated sites, including more than 550 principal investigators across 350 research sites in the U.S. He also led Frenova’s global expansion, leveraging an international network that included over 1,300 clinicians in 45 countries. Paradigm is backed by the private equity firm Crane Street Capital. Managing partner at Crane Street Capital Aleem Choudhry said, “Mussina has decades of experience and leadership with a passion for moving drug development, thus patient care, forward. This will not only help Paradigm to continue growing as a dedicated research business for a wide range of trials for the pharmaceutical industry, but his expertise will also continue to advance clinical research.” About Paradigm Clinical Research Paradigm Clinical Research operates dedicated clinical research facilities with principal investigators actively involved in medical practice and clinical research. Founded in 2009, the company offers clinical trial opportunities to patients and healthy volunteers and provides high-quality study data to the biopharmaceutical industry. About Crane Street Capital Group Crane Street Capital Group specializes in micro growth buyouts in a few selected fragmented industries with untapped white space potential for growth. Its investments target companies that not only have outsized growth potential within their industries but also have the ability to make tremendously positive impacts within the communities in which they operate. Crane Street maintains a concentrated portfolio, deploys capital on an independent basis when outstanding opportunities are available and implements a patient approach in value creation over typically 5+-year holding periods. Currently, there are six companies in the portfolio, three of which are in education services and three of which are in healthcare services.