How an Italian Nonprofit Secured FDA Approval for a Gene Therapy

The discussion focuses on how an Italian nonprofit organization navigated scientific development, manufacturing readiness, and regulatory engagement to achieve U.S. Food and Drug Administration approval for a gene therapy. It reflects broader questions about alternative development models beyond traditional commercial biotech and how regulatory frameworks can accommodate nonprofit-led innovation in rare diseases.

👉 View the full video: EP 29 - How an Italian Non Profit Got an FDA Approved Gene Therapy

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Images are illustrative only. This content does not constitute medical advice. SSCTR is not responsible for clinical or regulatory decisions. The content is provided for informational and educational purposes only.