In July, a panel of expert speakers—Christine Lebec (Sensorion), Leigh Shaw (SpliceBio), Nathalie Clement (Siren Biotechnology), and María Orío (Viralgen)—came together to explore the evolving regulatory landscape in the cell and gene therapy (CGT) space, with a particular focus on patient safety considerations.
Key topics include:
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Are U.S. regulatory concerns overstated?
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How are AI and emerging technologies shaping regulatory frameworks?
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How can developers strike a balance between innovation and proven approaches while aiming for regulatory approval?
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What risk-reduction strategies can streamline development?
Watch now to gain insights into:
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Regulatory pathways for AAV-based therapeutics—from IND through to BLA
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The current state of gene therapy regulation, with a focus on U.S. shifts
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Practical advice for navigating regulatory complexity in gene therapy development
