8:00 am Check-In & Light Breakfast

8:50 am Chair’s Opening Remarks

• Lili Belcastro Associate Director, Bristol Myers Squibb

Improving Final Drug Product Quality Through Sourcing & Characterizing Safe & Premium Raw Materials Used in Cell & Gene Therapy Development Process

9:00 am Deep-Dive Workshop: Shining a Spotlight on Key Considerations & Strategic Plans for the Sourcing of Safe & Reliable Raw Materials to Accelerate Production of Cell & Gene Therapies

• Lili Belcastro Associate Director, Bristol Myers Squibb
• Vandana Sharma Head of Direct Procurement, Astellas Gene Therapies

12:00 pm Lunch Break & Networking

De-Risking Raw Materials Safety & Reliability Through Understanding Key Considerations for High-Risk Human Derived Materials & Single-Use Systems

1:00 pm Human-Derived Raw Materials & Their Associated Risks & Mitigation Strategies

• Houman Dehghani Vice President - Technical Development, Cabaletta Bio

1:30 pm Implementation of Raw Materials & Single-Use Systems in Commercial Manufacturing

• Asif Mahmood Director, Bristol Myers Squibb

2:00 pm Roundtable Discussion: Achieving Alignment in Single-Use Systems to Improve Sustainability, Manufacturing Controls & Release Testing Approaches

• Aida Rouzmehr Associate Director - Material Science & Strategy, Genentech

2:45 pm Afternoon Networking Break

Establishing Regulatory Compliance by Streamlining Supply Chain & GMP Manufacturing of Your Raw Materials to Develop Scalable Cell & Gene Therapies

3:15 pm Panel Discussion: Delving into the Regulatory Frameworks Governing the Use of Raw & Starting Materials, Including GMPs & Exploring Strategies to Achieve Compliance

• Dawn Henke executive director, Standards Coordinating Body
• Basak Clements Independent Expert - Raw Materials, Independent
• Ashley Fernandez QC Associate Director Raw Materials, Neurotech Pharmaceuticals
• Asif Mahmood Director, Bristol Myers Squibb

4:00 pm Maintaining the CDMO Supply Chain, Ensuring Your Cell & Gene Therapy are Manufactured on Time

• Scott Jeffers Chief Technology Officer, GenSight Biologics

4:30 pm Chair’s Closing Remarks & End of Raw Materials for Cell & Gene Therapy Summit 2024