Pre Conference Workshop Day
Tuesday, June 3
8:30AM Registration & Coffee
9:00AM – 12:00 PM | Workshop A
Navigating Regulatory Submissions & Ensuring Safety in Early-Phase Trials
Synopsis
This workshop will equip you with the knowledge and strategies needed to navigate complex regulatory expectations, proactively address safety concerns, and streamline the submission process for IND and CTA applications.
In this workshop, you will:
• Review the essential components of an IND or CTA submission, including the nonclinical safety data required to meet regulatory expectations
• Identify potential safety red flags and discuss how to address them proactively to ensure patient safety in first-in-human studies
• Simplify regulatory guidance and practical tips for small companies to navigate the submission process effectively and avoid common pitfalls
12:00PM Lunch
1:00PM – 4:00 PM | Workshop B
Workshop: Optimizing Vector Design & Manufacturing to Minimize Immunogenicity – A CMC Perspective
Synopsis
This interactive workshop will explore how improvements in vector engineering, production methods, and analytical characterization can reduce immune responses, enhance therapeutic efficacy, and streamline regulatory approval.
In this workshop, you will:
• Understand how vector design influences immune responses and identify engineering strategies to reduce immunogenicity
• Evaluate manufacturing and purification approaches to minimize contaminants and immunostimulatory byproducts
• Explore how capsid modifications, codon optimization, and payload engineering can enhance vector stealth and immune evasion
• Discuss analytical techniques to characterize vector-associated immunogenicity and ensure CMC strategies align with regulatory expectations
• Hear case studies on how leading companies are refining vector production to improve safety and efficacy while maintaining scalability