8:00 am Check-In & Light Breakfast

8:50 am Chair’s Opening Remarks

• Basak Clements Independent Expert - Raw Materials, Independent

Enabling Alignment & Streamlining Material Control Strategies Through Understanding Regulatory Definitions & Classifications of Raw & Starting Materials for Cell & Gene Therapies

9:00 am FDA Recognized Standards for Raw Materials in Regenerative Medicine Therapies

• Dawn Henke executive director, Standards Coordinating Body

9:30 am Defining Raw & Starting Materials for Cell & Gene Therapies to Ensure Alignment in the Field Between Regulators, Cell & Gene Drug Developers & Material Suppliers

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

10:00 am Worth the Switch? Exploring a Chemically-Defined Raw Material Strategy for Your Cell Therapy Manufacturing

• Phil Morton Chief Technology Officer, Sartorius Albumedix, Sartorius

10:30 am Morning Break & Speed Networking

Achieving Higher Safety & Quality of Raw Materials Through Reliable Manufacturing & Testing Strategies to Ensure Production of High-Quality Cell & Gene Therapies

11:30 am Particle Control with CGT Consumables

• Hannah Schuler Senior Manager - Manufacturing Science & Technology, Cell & Gene Therapy, Vertex Pharmaceuticals

12:00 pm Scalable & Flexible Solutions for Rapid Raw Material Identification

• Soleil Grise Business Development Manager, Agilent Technologies

12:10 pm Raw Materials Considerations for Cell Therapy Product Manufacturing

• Tao Cong Director, BlueRock Therapeutics

12:40 pm Lunch Break & Networking

Unlocking Release & Stability Testing Strategies for Master Cell Banks (MCBs) & Working Cell Banks (WCBs) to Prove Efficiency & Biological Effect of Your Raw Materials

1:30 pm Key Considerations for Establishing a Working Cell Bank (WCB) as a Biological Raw Material for Quality Control Release Testing

• Anthony Garcia Head of Quality Control, Kiromic Biopharma

2:00 pm Roundtable Discussion: An Industry-Wide Opportunity to Benchmark & Knowledge Share on Critical Quality Testing & Regulatory Considerations Associated with Establishing Master Cell Banks (MCBs) & Working Cell Banks (WCBs) to Ultimately Improve Efficiency &

• Anthony Garcia Head of Quality Control, Kiromic Biopharma

3:00 pm Afternoon Networking Break & Scientific Poster Session

Evaluating the Latest Innovations in Manufacturing & Stability Testing of Raw Materials for Cell & Gene Therapies in Line with Regulatory Expectations

4:00 pm Pharma 4.0 Enabling Next-Generation Manufacturing & Distribution of Raw Materials

• Shayoni Dutta Data Science Manager, GlaxoSmithKline

4:30 pm Raw Materials: Their Stability & the Impact to Your Product

• Sarah Powers Senior Stability Manager, Global Quality Control, uniQure

5:00 pm Chair’s Closing Remarks & End of Day One