Day Two Agenda

8:00am - 3:50pm | Boston, MA

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8:00 am Registration Open & Coffee Networking

8:50 am Chair’s Opening Remarks

  • Joseph Lee Senior Director, Product Sciences, Affini-T Therapeutics

Maximizing Method Development to Achieve Commercial Success

9:00 am Lessons Learnt in Potency Assay Development on the Route to Commercial Validation

Synopsis

• Potency assay developments to support BLA application
• Commercial thoughts surrounding assay selection
• Discussing translational strategies from R&D through to commercial and production

9:30 am Roundtable Discussion: Cytotoxicity Method Development to Maximize Robustness and Minimize Variability

  • Yan Gu Associate Director, CMC, Analytical Development, Cell Therapy, Takeda

Synopsis

• Comparing the benefits of chromium release, MTT and LDH, luciferase and flow cytometry in choosing assay type
• Considering assay conditions to provide automation friendly assays
• Planning studies early to account for complex potency methods
• Discuss assay specificity against innate killing

10:30 am Morning Break & Poster Session

Synopsis

Poster Abstract Submission here

Considering Variability and Consistency to Gain Effective QC

11:30 am A DOE Approach to Potency Method Optimization

Synopsis

• Assess how allogeneic cell therapies have high lot to lot variability
• Discussing the impact of donor and assay variability on method optimization

12:00 pm In vitro Potency Assay Optimization for Robust and Sensitive Characterization of CART Drugs

  • Sunil Tomar Scientist II, Analytical Development, Poseida Therapeutics

Synopsis

• Establishing regulatory compliant assays to satisfy quality and validation requirements
• Developing robust assays to overcome variability when encountering complex MoA

12:30 pm Lunch Break & Networking

Commercial Applications of Potency Assays

1:30 pm Panel Discussion: Addressing the Key Challenges for Potency Assay Strategies for TIL Candidates

Synopsis

• Discussing tumor specific vs. tumor-antigen specific assays and ideal tumor target material
• Addressing the need for robust, reliable and reproducible assays for TIL therapies
• TIL is a complex, patient-specific therapy, including product variability against unknown antigen specificity

2:30 pm In Vitro Potency Assays for Commercialization of Cell Therapy Products

  • Damien Fink Director, Analytical Development, Century Therapeutics

Synopsis

• Considerations for in vitro potency assay development for cell therapy products with complex MoAs
• Case studies demonstrating functional activity
• Long term considerations for potency assay approaches from R&D through to commercialization

3:00 pm Chair’s Closing Remarks

  • Yan Gu Associate Director, CMC, Analytical Development, Cell Therapy, Takeda

3:10 pm Close of Conference