How much can change in a year for the private equity-backed, rapidly growing Velocity Clinical Research? A lot! 2020 became a remarkable year to leverage its growing number of trial site locations to help American society combat COVID-19. Actually an amazing story for a startup! Founded just in 2017 as an idea, by early 2019 the firm secured $20 million in funding, using the proceeds to acquire three trial site locations, including Medford Oregon-based Clinical Research Institute of Southern Oregon (CRISO). On a mission to bring innovative medical treatments to patients, by early 2020 Velocity was well positioned to help the major U.S. government research initiative involving National Institute of Allergy and Infectious Diseases (NIAID), NIH’s ACTIV and Operation Warp Speed, as well as the major pharmaceutical companies developing vaccines targeting COVID-19. As TrialSite reported in 2019, the Medford-based trial site was founded by a brilliant NASA scientist turned doctor and principal investigator—Dr. Edward Kerwin—a Board Certified Respiratory, Allergy and Clinical Immunology specialist who built the compelling research organization (and a winery along the way) in this beautiful part of America. Now part of the Velocity Clinical Research family of sites, the Medford, Oregon-based site organization is part of a group that impressively, represents one of just a few elite research organizations participating in all five major vaccine research studies nationwide. Over all, Velocity’s Medford site is actively seeking up to 400 volunteers in three adult and two adolescent studies. Southern Oregon residents, by participating in research, help contribute to the fight against the pandemic. If the newest studies are successful, the outcome will be a competitive portfolio of safe and effective vaccines that will contribute to eventual victory over SARS-CoV-2.
A Diversified Portfolio of Vaccine Products Needed
Although two advanced mRNA-based vaccines have been authorized under emergency use (Pfizer/BioNTech and Moderna), the pandemic continues to rage and it will take some time to vaccinate sufficient numbers of people. The existing vaccines look quite good thus far and frankly represent a near miraculous achievement—they were developed with historical velocity, inclusive of high quality results. There are some challenges with the existing two, notably they are expensive and difficult to distribute and store requiring expensive freezer infrastructure. Hence the importance of competition.
With more vaccination products undergoing testing (AstraZeneca, Novavax, J&J/Janssen), each one potentially offers a different and potentially value added approach. For example, the J&J (Janssen) vaccine requires only one dose while the Novavax investigational product, a protein subunit vaccine, actually uses a lab-made version of COVID-19 spike protein. Of course this spike protein alone doesn’t make anyone sick but rather helps the body recognize the pathogen, potentially strengthening the ability to rapidly product antibodies once exposed. Moreover, Novavax has designed in the product an adjuvant, which helps augment the body’s response. While AstraZeneca’s vaccine demonstrates anywhere from 62% to 90% effectiveness, it could be superior for purposes of storage, affordability, and distribution.
These Products Only Come to Market if Volunteers Participate in Support of Sites
A confluence of factors and forces led to the success of the Moderna and Pfizer/BioNTech accelerated development efforts. In addition to the breakthrough science (e.g. mRNA) and focused government support (e.g. NIAID, ACTIV and Operation Warp Speed, BARDA and DOD), importantly, trial site organizations and participants are essential. That is, trial site organizations and volunteers make or break research. Trial sites such as Velocity represent very serious businesses, incurring great costs and facing tremendous pressures. Their jobs become easier with a dynamic supply of willing participants, hence their models for integrating research and care become paramount. Connecting in meaningful and sustained ways with research participants becomes mission critical. These individuals understand the critical importance of participation in research. This is how the world’s biotech and pharmaceutical companies have come this far with vaccine products to date. Over all, humanity steps up to engage and participate in what has been a historically unprecedented period for research.
People matter and groups such as Velocity understand the importance of highly respected local research centers such as the one developed by Dr. Kerwin. Velocity has made a major commitment to take on all the major studies. They’ll need the help of local participation. NPR’s KLCC recently raised that Medford area residents can contribute up to 400 of the 100,000 participants nationwide needed to ensure sufficient evidence is generated for what will hopefully be at least five high quality, safe vaccine products targeting COVID-19. A dynamic, competitive market for high quality vaccine products will ultimately contribute to overcoming the pandemic in a cost effective manner, along with the development of ongoing treatments and importantly, current measures such as social distancing, good hygiene and masks.
A Notable Venture
Most startups struggle to make it. Not this one. Conceived of in 2017 based on an idea of One Call Medical CEO Bruce Tomason (who serves as executive chair of Velocity), Velocity Clinical Research brought on top research leadership talent, recruiting Paul Evans, PhD. Based on his three decades of experience working in research leadership roles, Dr. Evans was intimately aware of the mounting industry challenges involving patient recruitment models. With too many studies chasing too few subjects in America, Evans understood the urgent necessity for more sophisticated and transformative approaches.
In just a few years, Velocity has expanded to include 14 trial site centers, spanning 10 states across all time zones. Collectively, their trial sites operations have 225 years of experience with over 4,600 successfully completed clinical trials. TrialSite anticipates this “Super Site” will seek additional partnerships or acquisitions in Northern California, the Plains states as well as more locations in the American South. The group could be looking to other nations as well for expansion. For example, its anticipated that China represents the fastest growing research market. In the meantime again they were one of the few trial site organizations to work on all five major vaccine studies. Their investors are undoubtedly watching before their eyes considerable rise in valuation.
Call to Action: Southern Oregonians check out the Velocity registration to consider enrolling. Your contribution is needed. Note Velocity is looking for participation in other locations, including Salt Lake City, UT, Austin, TX, Warwick, RI, Boise, ID, Cincinnati, OH, Banning, CA and Cleveland, OH.