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Gene, Cell Therapy Applications Delayed While FDA Tackles Virus

June 8, 2020, 6:58 PM

The Covid-19 pandemic is delaying the FDA’s ability to advance applications for potentially transformative cell and gene therapy treatments, the head of the biologics center’s advanced therapies office said.

The Food and Drug Administration may have to push back meetings for applications that don’t address Covid-19 by a month or two. Agency reviewers also may also have to submit written responses instead of holding teleconferences as they otherwise would have, Wilson Bryan, director of the Office of Tissues and Advanced Therapies in the FDA Center for Biologics Evaluation and Research, said Monday at BIO Digital, the first virtual international convention by the Biotechnology Innovation Organization.

“Pandemic workload does get priority,” Bryan said. “But there are many other serious and life-threatening diseases out there, and we’ve got to pay attention to those as well.”

Ultimately, the meetings will still happen, and the agency will respond to inquiries from companies, Bryan said. “It just not might not be as quick, and we hope that folks will be patient with us because obviously we’re all living in challenging situations.”

The pandemic hit as the FDA’s biologics center already was grappling with an influx of applications for potential therapies that replace defective cells or genes with healthy ones instead of using drugs or surgery. Peter Marks, the director of the biologics center, wanted to double capacity over the next three to five years. The biologics office is the smallest of the three medical product centers.

“Before the pandemic, we’re seeing a huge escalation in the workload that we have to make adjustments for,” Bryan said.

The FDA already has approved products such as Novartis’s Zolgensma to treat a lethal childhood disorder and Spark Therapeutics’ Luxturna to treat inherited blindness. There are more than 900 investigational new drug applications for ongoing clinical studies. The agency anticipates 10 to 20 new products will be coming on the market by 2025.

The pandemic hasn’t brought an increase in gene therapy products, but there has been an interest in cell therapies to address Covid-19. Furthermore, Bryan’s office also oversees immunoglobulin, or antibody, products, and there’s been a lot of interest in the use of antibodies to help Covid-19 patients, he noted.

“The clinical team, particularly, has been stretched trying to deal with the interest for the use of immunoglobulin products and the use of cellular products for the treatment of patients who are seriously ill with Covid-19.”

To contact the reporter on this story: Jeannie Baumann in Washington at jbaumann@bloomberglaw.com

To contact the editors responsible for this story: Fawn Johnson at fjohnson@bloomberglaw.com; Andrew Childers at achilders@bloomberglaw.com

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