• Analyze the regulatory and safety assessment challenges that limit the use of novel excipients, focusing on implications for early-phase drug development
• Explore USP’s initiatives to advance novel excipient development, including the creation of Novel Excipients Expert Panel and revisions to General Chapter <1074> Excipient Biological Safety Evaluation Guidelines
• Gain insights into USP’s iterative approaches and emerging standards for novel excipient standard development and stakeholder engagement, highlighting their role in addressing evolving quality needs in pharmaceutical development

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