09.18.26 -- When Should R&D Turn Back?

Discover how one family's race against time led to the creation of a groundbreaking gene therapy for their daughter, just 14 months after her ultra-rare disease diagnosis.

Strong local leadership, clear ownership, and governed oversight drove rapid remediation of legacy safety gaps, restoring regulatory confidence and safeguarding market continuity.

Modernizing biomanufacturing requires shifting from rigid, custom setups toward modular automation, data-rich sensors, and plug-and-produce operations. 

This presentation explores organizational culture and the values that are essential to delivering high-quality safety oversight.

U.S. and EU policy shifts are reshaping pricing, access, and launch strategy. Hear expert analysis on IRA, MFN, 340B, EU HTA Regulation, and the Biotech Act to stay ahead of 2025-2026 changes.

Learn how rational plasmid engineering and promoter optimization can significantly improve AAV productivity while reducing plasmid burden, paving the way for more efficient and scalable viral vector manufacturing.