Spotlight session: Navigating early clinical milestones in cell & gene therapy

Successfully navigating early clinical milestones is critical for translating cell and gene therapies into clinical benefit. This session provides practical guidance on overcoming operational and regulatory challenges, engaging investigators, and ensuring site readiness while preparing for future regulatory submissions. 

Key Takeaways:  

• Advance from IND approval to first-in-human trials with practical strategies 

• Overcome challenges in site selection, investigator engagement, and patient recruitment 

• Ensure clinical site readiness and operational efficiency for early trials 

• Demystify BLA preparation for cell and gene therapy products 

• Develop frameworks to streamline early clinical development and regulatory compliance