8:30 am Virtual Coffee & Networking

8:50 am Chairman’s Opening Remarks

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

9:00 am Analytical Development Strategies for Polyclonal, Polyfunctional T Cell Therapies

  • Barrett Nehilla Associate Director, Analytical Development/QC, Repertoire Immune Medicines

9:30 am Contextual Reprogramming of Cells to Widen the Therapeutic Index of CAR-T Cells

10:00 am Developing a Potency Assay to Determine Activity of the Cell Therapy Product

10:30 am Allogeneic CAR T- Cells: Analytical Assays for Late Phase Product and Managing Lifecycle of Assays

11:00 am Virtual Speed Networking & Morning Break

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 Virtual Networking & Lunch

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

1:30 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

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