AGTC Goes Mobile to Avoid Clinical Trial Chaos (Bioprocess Online)

AGTC Goes Mobile to Avoid Clinical Trial Chaos

When leaders of UF startup and UF Innovate | Sid Martin Biotech alum Applied Genetic Technologies Corporation (AGTC), a biotechnology company conducting human clinical trials of adeno-associated virus (AAV)-based gene therapies for the treatment of rare diseases, realized how disruptive COVID-19 might become, they developed a plan—several of them, in fact—to minimize clinical chaos.

Sue Washer’s life is dedicated to biopharma. The president & CEO of the early clinical-stage gene therapy company AGTC is working toward 40 years in the space, with deep roots at Abbott and Eli Lilly & Company and more than a dozen years in service to bio associations and organizations. On a soon-to-be-released episode of The Business of Biotech podcast, Washer shares her approach to managing AGTC through what’s been one of the most challenging times to be conducting clinical trials.

“We worked with a third-party provider. We bought the clinical equipment we needed—the same equipment we deployed at our clinical sites for this specific trial—and installed it on their mobile van,” Washer said. “We trained and qualified their technicians on all of the tests we conduct, just as the technicians at our clinical sites would be trained and qualified. We’re adhering to the exact same practices as we would at a clinical trial site, right down to equipment calibration.”

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