Developing Clinically Relevant Potency Assays for Control of Product Quality and Consistency

9:30 am Virtual Coffee & Networking

9:50 am Chairman’s Opening Remarks

10:00 am Allogeneic CAR T- Cells: Analytical Assays for Late Phase Product and Managing Lifecycle of Assays

10:30 am Developing Unique Analytical Assays for Potency and Characterization of Next Generation CAR-T Cells

11:00 am Group Networking & Audience Discussion

Optimizing Release Testing to Accerlerate Administration of Cell Therapy Products

11:30 am Developing Release Testing Specifications in the Phase I Environment

12:00 pm Accelerated μbio Testing in Cell and Gene Therapies

12:30 pm Maximizing Patient Access to Safe & Effective Autologous Cell Therapy Products through Patient-centric Specifications

  • Neil Haig Associate Director , Bristol Myers Squibb

1:00 pm Lunch & Virtual Exhibition Booth

Optimizing Cell Counting Techniques to Allow for Accurate Identification of Product Attributes

2:00 pm Panel Discussion – Understanding the Need for Phase Appropriate Analytics to Supercharge Commercialization of Cell Therapy Products

  • Sumona Sarkar Biomedical Engineer, National Institute of Standards and Technology
  • Alessandra Cesano Chief Medical Officer, Director- SITC, Essa Pharmaceuticals
  • Barrett Nehilla Associate Director, Analytical Development/QC, Repertoire Immune Medicines
  • Rona Harari Steinfeld Senior scientist, Analytical development lead , Refuge biotechnologies

2:30 pm Integration of Quality and Harmonization in Assay Development: Cell Counting Case Study

  • Michael Marit Senior Scientist, Process and Analytical Development, Triumvira Immunologics, Inc.

3:00 pm Standards Development and Collaborative Efforts in Analytical Methods for Cell and Gene Therapy

  • Sumona Sarkar Biomedical Engineer, National Institute of Standards and Technology

3:30 pm Chairman’s Closing Remarks

3:45 pm Close of 2nd Cell Therapy Analytical Development Summit