Has Advarra established the market’s leading network of registered trial sites focusing on gene therapy studies? Put more specifically, has the commercial institutional review board (IRB)-based company now emerged as a leading force in supporting gene-based therapy development because of its position as offering a top institutional biosafety committee (IBC) network? The pharmaceutical clinical development vendor specializing in regulatory review solutions, research quality, compliance consulting, and clinical trial site-centric technology products makes the case that it has via the Advarra Gene Therapy™ Ready site network, with what amounts to over 500 registered trial sites identified by the NIH as associated with gene therapy studies. With the need to ramp up pre-qualified sites with gene therapy-based competency and expertise, adhering to sound and rational quality principles relevant to the gene therapy domain, Advarra suggests they can save CROs and sponsors a month of time, which for some blockbuster prospects, represents about an $80 million time savings.
As commercial IRBs now have big private equity backers, they are on an acquisitive tear, seeking growth and market power in the global clinical trials business. Consequently, there is a whole lot of marketing going on that should be better understood as the boom in clinical study support services continues its torrid pace, despite the pandemic.
TrialSite exists to bring transparency and accessibility to clinical research with an emphasis on trial sites and staff, to the benefit of all stakeholders in research, from patients and volunteers to investigators, coordinators, and sponsors, whether they are industry or academic-based. This particular topic is one of importance to site networks with competency and capability in the field of gene therapy studies.
In “IRB Consolidation Continues with Advarra Gobbling Quorum Review IRB & Kinetiq Research,” TrialSite explained that in the United States there are two consolidating vendors rapidly accumulating and devouring clinical services and technology firms in a bid to dominate the clinical trials services and technology market with an emphasis on quality and compliance. Starting as commercial central institutional review board (IRB) organizations, both Advarra and WCG now battle for market share. Both organizations are backed by deep-pocketed private equity firms as they march forward, in tit-for-tat acquisitions and other deal-making. Yes, there are other choices to select an IRB or find a site compliance consultant or for that matter purchase a site-focused trial management system but more than likely if it is a class of product or service that falls in one of those categories, these players will be in the mix.
TrialSite reviewed the most recent news and offers a basic breakdown of the latest information.
What is Advarra’s claim?
Advarra now claims that their Advarra Gene Therapy Ready network has grown to 500 registered trial site organizations, making them the largest administrator of institutional biosafety committees (IBCs).
What is the Advarra Gene Therapy Ready network?
Launched just at the start of this year, this is a trial site network with what they claim is 500 registered site organizations that are ready to conduct gene-based clinical trials. That is, they are equipped with the expertise and infrastructure to conduct studies involving genetically engineered vaccines, gene-modified cellular therapies, and gene therapy research.
The Gene Therapy Ready network includes sites in myriad forms from health systems and hospitals to research institutions, private research sites to the National Cancer Institute (NCI) cancer centers all pre-registered with Advarra’s institutional biosafety committee or IBC.
What is the basis for membership?
It is marketed as a sort of quality assurance or accreditation that both the site itself and the professionals working therein involved with the Gene Therapy Network are prepared to conduct gene therapy research, meaning, they have all adopted a standard operating procedure (SOP) review, site facility inspection, staff training, and registration with the National Institutes of Health (NIH) Office of Science Policy, which apparently is a requirement for NIH-funded gene therapy research as well as industry “best practice.”
Advarra markets that by combining their standard integrated IRB/IBC service with tens of thousands of protocols, not to mention the organization’s 800+ team members and thousands of experts, the offering provides sites and sponsors with scale and service for gene therapy, gene-modified cellular therapy, and genetically engineered vaccine research.
What are some of the benefits of working with this network?
Well, first, a sponsor developing gene-therapy-based treatments needs a core competency and expertise at the trial site level. Access to that high-level talent is in short supply and continues to represent an industry challenge. Second, assuming that this whole Gene Therapy Network process is working smoothly, this network can afford sponsors benefits in that they can move far more expeditiously to ramp up a study. Third, all things being equal, sites with the proper culture and competency produce higher quality work. As mentioned later on, Advarra executives point out that by using this network gene therapy, drug development sponsors can potentially accelerate study startups by a month.
How fast is this network growing?
They are most certainly signing up trial sites at a healthy clip. In January, they reported 350 sites in the network, and now, six months later, they report over 500 trial sites.
Why is this so important?
Because it is gene therapy, along with cell-based therapy, and the overall precision medicine movement that drives drug development moving forward. Gene therapy can be thought of as “personalized medicine at scale with the goal of producing one-time treatments to patients,” reported Advarra in January 2021. The company reported that the gene therapy market will grow globally by an estimated 16.6 percent between 2020 and 2027.
What is an Advarra POV?
James Riddle is a well-known industry professional who has participated extensively in the Site Accreditation & Standards Initiative (SASI) that was first conceived of by the Alliance of Clinical Research Excellence & Safety but then was separated for operational independence and market execution led by Larry Kennedy, a top-quality expert worldwide. Mr. Kennedy has worked closely with a number of top clinical research experts to introduce SASI, including Advarra’s Vice President of Research Services and Strategic Consulting to develop the world’s first site-centric accreditation standard, a notable accomplishment.
In a press release introducing the network back in January, Mr. Riddle was quoted, “This innovative network is truly the first of its kind. We constantly look for ways to support our sponsors in rapidly starting trials in a safe, compliant, and quality manner. With the Gene Therapy Ready network, we can improve study start up times by a month or more, potentially placing cures in the hands of patients faster.”
More recently, the delivery consultant chimed in, “The growth of this innovative network is truly remarkable and a testament to the superior technology, service, and turnaround times we provide to the research community. By placing your study with the Gene Therapy Ready network, we can improve study startup times by a month or more, placing potential cures in the hands of patients faster,”
Does Advarra offer any evidence in the form of testimonials or case studies?
Yes. In their latest news release, they offer an example via a case study with a large CRO, IQVIA, who significantly improved study startup time by leveraging Advarra’s IRB/IBC service involving the COVID-19 vaccine and Operation Warp Speed, while another case study showcases the site network benefits for a genetically engineered vaccine research endeavor involving Meridian Clinical Research, a leading trial site organization with a sizeable presence in the American Midwest.
What about WCG’s position in the market?
The firm launched a gene therapy advisory committee back in 2016. WCG experts have led various workshops, courses, and events such as conferences. While WCG appears to be contributing valuable insight and services to the gene therapy space, TrialSite wasn’t able to find a gene therapy trial site network centered on a contextualized offering, including standardized IBC services with comparable numbers of sites. That’s doesn’t mean that WCG doesn’t have such a network but it would appear that Advarra may have a jump start in this space
Advarra vs. WCG?
Which company is winning the competitive war to win more business from the global pharmaceutical research complex? It is hard to say, but there are some clues. Both are backed by deep-pocketed private equity groups helping them to continue their growth strategies via both organic and accretive means. TrialSite does not endorse any vendors but is happy to field telephone or Zoom conversations for an objective overview of the two companies’ various offerings—both services and technologies—as well as insight into other factors and elements.
Call to Action: Advarra lists the NIH’s network of Institutional Biosafety Committees here.