The Largest Cell and Gene Therapy Site Network Now Includes 1,500 Members

Advarra’s Gene Therapy Ready global site network expands to better support and accelerate the rapidly growing number of investigational new drugs through approval

COLUMBIA, MD – Advarra, the market leader in regulatory review solutions and clinical research technology for sites, sponsors, and clinical research organizations (CROs), today announced the milestone of vetting more than 1,500 sites for its Gene Therapy Ready (GTR) site network. Through a robust evaluation process to confirm their specialized expertise and infrastructure capabilities, Advarra has registered more Cell and Gene Therapy (CGT) ready sites than all other institutional biosafety committee (IBC) review providers combined to create the largest CGT site network in clinical research.

Institutions that receive funding or support from the National Institutes of Health (NIH) and are conducting research involving recombinant or synthetic nucleic acid molecules must establish IBCs to ensure the safety of trial participants, institution staff who handle such molecules, as well as the public. With its broad geographic span, Advarra can deliver NIH-compliant IBC oversight for CGT trials globally.

CGT innovation is moving at lightning speed, with the number of CGT investigational new drug (IND) applications more than doubling since 2017. Now there are more than 1,000 CGTs in clinical development in the U.S., and more than 3,000 in pre-clinical development across CAR T-cell, mRNA, immunotherapies, genetically engineered vaccines, and more. The U.S. Food and Drug Administration (FDA) has prepared for the boom by creating a specialized “super office” called Office of Therapeutic Products, officially established in March 2023 as the first super office at the FDA’s Center for Biologics Evaluation and Research (CBER).

“The potential for cell and gene therapies in treating rare diseases and cancers is incredible. To fully seize the momentum, the industry needs to clear some complex research hurdles,” said Lauri Carlile, Advarra Chief Research Services Officer. “Gene therapies have unique challenges, including ethical and safety considerations, regulatory barriers, precarious logistics, and potentially staggering costs. Advarra’s expansive GTR network help sponsors efficiently address CGT research and safety challenges while also supporting diversity goals, recruitment targets, and geography-specific study requirements.”

Advantages to Sponsors and CROs

In addition to providing critical safety oversight of CGT trials, Advarra’s GTR site network enables sponsors and CROs to start trials faster. CROs and sponsors that select Advarra’s GTR sites reduce startup delays – in fact, GTR sites activate two times faster than traditional sites using a local IBC and six times faster than sites not part of Advarra’s GTR network.

“Studies involving genetically engineered materials have the potential to bring incredible options to patients but involve greater complexity to operationalize,” said Teri Karcher, Parexel International’s EVP, Head of Launch Excellence and Chief Drug Development Officer. “We worked diligently to de-risk startup of a CGT trial by pre-planning the site activation strategy, selecting sites from Advarra’s GTR network, and pre-reviewing IRB/IBC site applications for potential issues. When it was time to review and activate sites, Advarra held 68 IBC meetings in one week to approve our first batch of sites. IRB review followed right behind, with nearly all 145+ sites reviewed and approved within two weeks. We achieved startup targets for sites utilizing Advarra and got them up and running in an impressive timeframe.”

Advantages to Sites and Institutions

Advarra GTR network sites, including academic medical centers, cancer centers, and other institutions, are fully prepared to meet biosafety requirements and benefit from hands-on, customized support to ensure they are properly trained and prepared to safely conduct all types of complex CGT trials. GTR sites also benefit from extra efficiencies, including complementary registration with the NIH.

“As members of Advarra’s GTR site network, all Velocity Clinical Research sites are prepared to conduct clinical studies involving novel genetic engineering and other GMOs,” said Nick Spittal, Chief Operations Officer from Velocity Clinical Research, the largest global organization of fully owned clinical research sites. “Membership allows Velocity to start studies over a month faster and provides a meaningful credential and important validation that increases sponsors’ confidence in our specialized capabilities to conduct complex clinical research safely.”

Advantages to Patients

While exciting in their possibilities, CGT clinical trials are not widely accessible to patients, especially those living in rural areas who do not receive care at an academic medical center. “We are working to reverse this trend with our 1500+ site network across many regions, which gives Advarra a uniquely broad and diverse perspective on the CGT research landscape. We are better equipped to support these important trials to help safely bring patients innovative treatment options where there are few or none at all,” concluded Carlile.

Advarra leads the market in comprehensive research review services and clinical research technology for sites, sponsors and CROs. Advarra is trusted by the top 50 global biopharma sponsors, top 20 CROs, and over 50,000 site investigators worldwide, and oversees 12,000+ studies annually. The company’s integrated solutions, including IRB services, site and sponsor technology, and consulting services, provide critical support and enable regulatory compliance.

Additional Information

• Learn more at the Cell & Gene Meeting on the Mesa (Oct 7-9) in Phoenix, AZ, and the upcoming ABSA conference (Nov. 3-6) in Phoenix, AZ, Advarra Booth #408P.
• Apply to become part of Advarra’s GTR Site Network: https://www.advarra.com/review-services/institutional-biosafety-committee/gene-therapy-ready-site-network/

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