Panel Discussion: Building a Robust Raw Material Strategy for Advanced Therapies

• Establishing a phase-appropriate raw material strategy that supports both early development flexibility and late-stage regulatory expectations
• Navigating evolving regulatory expectations for raw materials
• Evaluating supplier strategies, including sole vs dual sourcing, to mitigate supply chain risk while maintaining product comparability and regulatory compliance

Speakers:

Kim Raineri

Chief Technology Officer

Aspen Neuroscience

Basak Clements

Independent Raw Materials Expert & USP CGT Expert Committee Member

Independent Expert

David Sheehan

Founder, President, and CEO

Nucleus Biologics