8:30 am Online Registration

8:50 am Chair’s Opening Remarks

Standardizing Analytical Tools to Better Understand Product Quality and Attributes

9:00 am Know Your CAR: Toolkit for ACT Product Characterization

• Alessandra Cesano Chief Medical Officer, Director- SITC, Essa Pharmaceuticals

9:30 am Challenges with Creating and Managing Information Systems for Cell and Gene Therapies: The WellSky Solution

• Jonathan Wofford General Manager, WellSky

10:00 am Comprehensive Product Characterization for Prediction of CAR-T Functionality and Durable Response in CAR-T Cell Therapy

• Petrina Georgala Fellow Scientist, Analytical Lead Technical Research and Development, Novartis Pharmaceuticals

10:30 am Get Your Assay in Gear – Removing Analytical Bottlenecks on the Path to Clinical Readiness

• Ian Gaudet Sr. Director, Process Sciences , Miltenyi Biotec, Inc

11:00 am Virtual Speed Networking & Morning Break

Developing Reliable and Sensitive Tools to Optimize Safety and Final Product Quality

12:00 pm Development and Optimization of the Analytical Toolkit for Cell Therapies

• Anthony Leyme Senior Scientist, Analytical Development, Elevate Bio

12:30 pm Utilizing High Parameter Flow Cytometry to Better Understand Your Cell Therapy Products

• Mahwish Natalia Senior Scientist, Advanced analytics Cell therapies Analytical Development, Takeda Pharmaceuticals

1:00 pm Considerations for Platform Methods in Quality Control of Off-the-Shelf, Multiplexed Engineered Natural Killer Cell Cancer Immunotherapy products

• Alice Lin Associate Director, Quality Control , Fate Therapeutics

1:30 pm Virtual Networking & Lunch

Developing Novel and Efficient Analytical Techniques for Development of Next Generation Cell Therapy Products

2:30 pm Paving the Path Toward Well Characterized Allogeneic Cell Therapy Products

• Farah Fawaz VP Quality Control, Allogene Therapeutics

3:00 pm A Risk-Based Approach for Establishing Genomic Integrity and Stability for Genetically-Engineered, iPSC-Derived Cell Therapy Products

• Jennifer Dashnau Head of Analytical Development & Quality Control , Century Therapeutics

3:30 pm Donor Selection for Allogeneic T Cell Therapy

• Mamta Kalra Director, CMC, Immatics US Inc

4:00 pm Afternoon Break & Networking

4:30 pm CD19/22 Bi-Specific CAR T Clinical Trial Perspective: Understanding the Relationship Between the Manufacturing Process and the Final Cell Product

• Shabnum Patel Associate Director, Process Development & Manufacturing , Stanford Cancer Institute

5:00 pm Determining Fluorescent Thresholds and Applying Fluorescent Threshold Gating to Flow Cytometry Methods in Clinical QC

• Rebecca Brunette Senior Manager, Cellular Phenotype, Product & Analytical Development , Bristol-Myers Squibb, Cell Therapy Development Organization

5:30 pm Chairman’s Closing Remarks & Close of Day One