Independently-owned Columbus Ohio-based Aventiv Research was selected by the Pfizer/BioNTech “Project Lightspeed” program to participate in the Phase 2/3 clincial trial to test the RNA-based COVID-19 vaccine. With involvement of 120 sites around the world, this Columbus based trial site organization has attracted volunteers from the surrounding area such as Steve Tirrell, an owner of a small computer printer and supplies store from North Canton Ohio (2+ hour drive to the northeast). The small business owner, reports Tim Botos of CantonRep, has been tracking the vaccines and believes “The Pfizer one is the best candidate, in my opinion — I signed up online.” Hence, the Ohioan made the 5 hour round trip trek to contribute to the cause of crushing COVID-19.
As Mr. Botos reported, Steve Tirrell is one committed contributor to clinical research. Informed and educated, the small business owner personally thinks that the Pfizer/BioNTech BNT162 is the best candidate among the competitors. Evidencing his dedication, passion and confidence, Mr. Tirrell, based up in North Canton, must make the 5 hour round trip drive six times to the Aventiv trial site. Last Monday, he drove to Columbus for the first of the six times. He’ll be injected with the investigational vaccine twice. As Aventiv Research’s trial site is the only one in the Columbus area, the study will attract dedicated volunteers from this part of Ohio. The COVID-19 vaccine trials are probably the most important studies of this era based on the implications (health, social and economic) of COVID-19. That an independent trial site organization from Columbus was selected by one of the world’s largest multinational pharmaceutical companies (Pfizer) for this endeavor is telling.
On July 30, 2020, Aventiv Research announced to the world its selection by the “Project Lightspeed” team of Pfizer and BioNTech.
The Phase 2/3 randomized, placebo-controlled, observer-blind, dose-finding, vaccine candidate-selection and efficacy study in healthy adults consists of 2 parts, which is now in the latter “expanded cohort and efficacy” stage. Seeking to evaluate the safety, tolerability, and immunogenicity of two different SARS-CoV-2 RNA vaccine candidates targeting COVID-19 and the efficacy of one candidate, the study includes two doses separated by 21 days schedule and three age groups. The candidate that was selected for the Phase 2/3 selection is known as BNT162b2. This vaccine candidate, as described by site spokesperson Danielle Barclay, “doesn’t contain parts of the virus that can make you ill.” Rather, Ms. Barclay, who serves as communications liaison to the public, explained to Mr. Botos with CantonRep that the vaccine was designed with part of the SARS-CoV-2 genetic code that triggers “a patient’s cell protein-making machinery to produce spike protein—ultimately making antibodies to fight against COVID-19.”
Of course, half the patients will receive the actual investigational product and half will receive a placebo, and Tirrell is hoping he of course receives the former. Although most volunteers receive as much as $800, the CantonRep reports Tirrell is a good negotiator (receiving an additional $150 for the two-hour trip).
In a previous local Fox8 report, Dr. Arora forecast the trial site operation would recruit up to 300 volunteers to participate in the BNT162 COVID-19 vaccine trial.
Who is Aventiv Research?
Founded by Dr. Samir Arora in 2007, Aventiv Research is an independent research site operation now with five locations, including three in Ohio (two in Columbus and one in Dublin), one in Pennsylvania (Erie), and one in Arizona (Mesa). The trial site operation represents a multi-therapeutic inpatient and outpatient clinical research center specializing in Phase 1-4 pharmaceutical, device and diagnostic clinical trials in a variety of therapeutic areas. Note that Phase 1 trials involve inpatient safety studies and hence often require greater investment in care infrastructure and resources. Led by Dr. Arora, the trial site operation has conducted 450 clinical trials representing over 55 pharmaceutical sponsors; importantly, Aventiv Research has directly contributed to studies that ultimately supported the approval of the U.S. Food and Drug Administration (FDA) for 15 approved drugs to market.
Independent trial sites can offer advantages to industry sponsors assuming they operate at a certain scale, efficiency and level of quality. In the case of Aventiv Research they have arrived: retaining a staff of over 10 research coordinators with a combined average of over 8 years research experience as well as “many” having achieved their CCRC certification while serving on the local ACRP board. Further evidencing this firm’s value proposition, based on claims on LinkedIn, that they employ 2 full-time recruitment coordinators, 5 research assistance/data specialists and importantly run a quality assurance program. Dr. Arora studied at Hamot Medical (part of UPMC) according to his LinkedIn profile. Clearly one fusing medical care with research and a tinge of entrepreneurialism, Dr. Arora has put together partnerships with local providers, which supports scale and flexibility in the types of trials they can accommodate.
With about 50 employees and contractors, TrialSite estimates Aventiv Research to generate perhaps $5+ million in revenue and with the recognition of this trial—and the growing importance of research—this healthy trial site organization is on the go.
Call to Action: If you reside somewhere near Columbus, Ohio, and are interested in contributing to this effort, at least learn more; see their online enrollment form.