COLUMBIA, Md., Jan. 19, 2021 /PRNewswire/ -- Advarra, the market leader in regulatory review solutions and clinical site technologies, announces the Gene Therapy Ready™ site network, a comprehensive collective of clinical research sites ready to conduct clinical trials involving genetically engineered vaccines, gene-modified cellular therapies, and gene therapy research. The powerful aim of gene therapy is personalized medicine at scale with the goal of producing one-time treatments to patients. This initiative will address the challenges and opportunities presented by an accelerating gene therapy market that is expected to grow globally by 16.6 percent in the 2020-2027 period.
The Gene Therapy Ready site network is comprised of more than 350 sites, including health systems, research institutions, National Cancer Institute (NCI) cancer centers, and private research sites that are pre-registered with Advarra's institutional biosafety committee (IBC). Advarra biosafety professionals assess each Gene Therapy Network member to ensure the site and staff are prepared to conduct gene therapy research. The steps include standard operating procedure (SOP) review, site facility inspection, staff training, and registration with the National Institutes of Health (NIH) Office of Science policy, which is a requirement for NIH-funded gene therapy research and an industry best practice. These processes can often take weeks, so pre-registration ensures Gene Therapy Ready sites are ready to start working on a clinical trial as soon as one becomes available.
"The Gene Therapy Ready network demonstrates our commitment to empowering sites and supporting our industry partners as they pursue advanced genetic engineering to find cures for the world's most pressing health conditions," said Scott Uebele, President and Chief Research Services Officer at Advarra. "Our commitment to efficient study activation is unwavering, and this is another example of how Advarra brings life sciences companies, CROs, research sites, investigators, and academia together at the intersection of safety, compliance, technology, and collaboration."
All Gene Therapy Ready sites stand ready to help industry sponsors conduct clinical trials that advance cures, develop vaccines, and find treatments for rare disease. By placing clinical trials with a Gene Therapy Ready site, research sponsors can save significant time during study startup.
"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 startup times by a month or more, potentially placing cures in the hands of patients faster," said James Riddle, Vice President of Research Services and Strategic Consulting at Advarra. "The Gene Therapy Ready site network charts a course to success by providing our sponsor clients with a clear choice for IBC review services."
Advarra advances the way clinical research is conducted: bringing life sciences companies, CROs, research sites, investigators, and academia together at the intersection of safety, technology, and collaboration. With trusted IRB and IBC review solutions, innovative technologies, experienced consultants, and deep-seated connections across the industry, Advarra provides integrated solutions that safeguard trial participants, empower clinical sites, ensure compliance, and optimize research performance. Advarra is advancing clinical trials to make them safer, smarter, and faster. For more information, visit advarra.com.