Panel Discussion: Establishing Risk-Based Process Development Decision Frameworks to Accelerate Clinical Progression

• Defining fit-for-purpose process performance criteria to accelerate clinical progression while maintaining robust, reliable and reproducible viral vector manufacturing
• Assessing technology adoption and supplier diversification strategies to reduce operational risk while maximizing value from established manufacturing platforms
• Balancing process optimization efforts against program timelines, manufacturing costs and patient demand to enable data-driven development decisions

Speakers:

Julia Rohlhill

Associate Director - Viral Vector Sciences

Legend Biotech

Jessie Sun

Senior Director - Drug Substance, Manufacturing Science & Technology

Ultragenyx Pharmaceutical Inc.

Jing Li

Associate Director, Viral Vector Analytical Tech Transfer

Exelixis, Inc.

Seth levy

Vice President, Manufacturing

Modalis Therapeutics