Panel Discussion: Drug Product Final Dosage Form/SKU Considerations vs. Clinical Dose Strategies From The Drug Product Development Perspective

• How to configure drug product final dosage form for a wide range dose in clinical trials in phase 1?
• What triggers dosage form changes or addition in later phase development/commercialization? What are the typical challenges?
• How to set drug product specifications when the projected clinical dose range is wide?

Speakers:

Sunny Zhang

Senior Director, Pharmaceutical Development

ADC Therapeutics

Weijun Li

Senior Director & Team Lead - Biologics Analytical Development Chemistry, Manufacturing, & Controls

Exelixis