Addressing Barriers in Gene Therapy
Navigating Regulatory Challenges with Viralgen's Head of Regulatory Affairs
GEN Podcasts · Genetic Engineering & Biotechnology News (GEN)
December 14, 202313m 8s
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Show Notes
In this podcast episode, join us as we delve into addressing regulatory challenges in gene therapy with María Orío, the Head of Regulatory Affairs at Viralgen. Learn about the mission of Viralgen as a Contract Development and Manufacturing Organization specializing in Adeno-Associated Virus (AAV) gene therapy products. Uncover the unique challenges faced by the gene therapy industry, from the evolving regulatory landscape to the setting of acceptance criteria with limited available data. Learn how Viralgen addresses these challenges, leveraging historical data and innovative approaches. Gain valuable insights from the Chemistry, Manufacturing, and Controls (CMC) perspective, while learning how regulatory agencies are actively supporting sponsors in their quest for life-changing treatments.
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