8:00 am Coffee & Registration

8:55 am Chair’s Opening Remarks

  • Eric Alonzo Senior Scientist, Cell Analytics, Bluebird Bio

Exploring Analytical Developments in Allogeneic Cell Therapies

9:00 am Development of Allogeneic Stem Cell Memory CAR-T Cells Using Poseida Nonviral Technology

Synopsis

  • Development of a robust allogeneic production process
  • Understanding the role of starting material in allogeneic CAR-T production
  • Discussing analytical methods and techniques in allogeneic production processes

9:30 am Exploring Century Therapeutics’ Approach to Analytical Development

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

Synopsis

  • Developing a comprehensive quality control and characterization strategy for allogeneic, engineered iPSC-based products
  • Discussing considerations associated with cell banking

10:00 am CAR T Cell Characterization During Manufacturing Using the CliniMACS® Prodigy

  • Tatjana Holzer Team Coordinator, Concomitant Research of Cellular Immunotherapies , Miltenyi Biotec

Synopsis

  • Automated CAR T cell manufacturing using the CliniMACS® Prodigy
  • Characterization of CAR T cells during manufacturing
  • Automated flow cytometric IPC/QC measurement and analysis
  • Monitoring cell expansion and CAR transduction
  • Phenotypic characterization of CAR T cells
  • Next generation characterization of the CAR T cell phenotype

10:30 am Speed Networking

Synopsis

This session is the ideal opportunity to get face-to-face time with many of the brightest minds working to advance cell therapies. Benchmark against the industry leaders and establish meaningful business relationships to pursue for the rest of the conference and beyond.

11:00 am Morning Refreshments

11:30 am Functional Bio-Assays Development for Allogeneic CAR T-Cell Therapies

Synopsis

  • New generation of cancer therapies based on gene-edited CAR T-cells (UCART)
    brings new challenges for functional assay development
  • In addition to assess UCART batch functionality, the goal is to evaluate batch-tobatch
    variability. To this end, the assay itself must be as less variable as possible
  • Here we will discuss our approaches in which sources of variability (materials and
    techniques) are limited

Examining Cell Therapy Product Release Testing

12:00 pm Addressing Sample-Introduced Variability in Cell Product Release Testing

Synopsis

• Sampling method suitability – ensuring the sample is representative of the product
• The effect of final formulation constituents on analytical testing
• Sample handling practice – to ensure stability and reproducible results

12:30 pm Rapid Microbial Methods for Final Release of Cell & Gene Therapy Products

Synopsis

• Classical versus fast track μbial alternatives
• Mycoplasma & endotoxin testing
• Method validation
• Regulatory guidance

1:00 pm Lunch & Networking

Exploring Methods to Define Mechanism of Action of Cell Therapies

2:00 pm Product Potency in the Era of “Synthetic Biology”

Synopsis

• Conditional cell behavior is a dynamic entity – how to pin down its motion?
• How to define mechanism of action (MOA) and mechanism of efficacy (MOE)?
• What are off-target effects?
• How specific needs specificity to be?
• From MOA/MOE to proof of concept: the big divide

2:30 pm Leveraging High-Dimensional ‘-omics’ Technologies for Comprehensive Profiling of CAR-T Cells to Resolve Drug Product Complexity

  • Eric Alonzo Senior Scientist, Cell Analytics, Bluebird Bio

Synopsis

• Challenges faced in identifying the active ingredient/characterizing the cell therapy drug product
• Move from more traditional assays to single-cell omics to uncover cellular drug product structure
• Challenges/learnings from single-cell approaches

3:00 pm An Integrated Microfluidic Platform for Multi-dimensional Analysis and Multi-omic Classifications of Effector Immune Cell Functions

Synopsis

  • The outcome of many pathological diseases such as infection and cancer is determined
    by the interaction of diseased cells with various immune cell subsets, both of which are
    phenotypically and functionally diverse. Induced resistance to chemo- and immunotherapeutic
    drugs remain one of the main challenges in modern medicine
  • There exists significant inter-patient and even intra-patient variability in response to
    well-established drug regimens, making it difficult to predict a patient’s response to
    applied treatments. Single-cell analysis techniques have great potential in revealing,
    and ultimately utilizing, patient-specific cellular information to devise a more
    personalized approach to therapeutic regimens
  • Towards this goal we have developed a platform technology for characterizing single
    cell response, cell-cell communication and novel drug/immunotherapy targets in
    various diseases and overall could be beneficial in improving the efficacy of antibody
    drug therapy and develop effective drug combinations

3:30 pm Afternoon Refreshments & Scientific Poster Session

Synopsis

The learning and networking continues at the Poster Session, an informal part of the conference agenda, allowing you to connect with your peers in a relaxed atmosphere and continue to forge new, beneficial relationships. You will have the opportunity to present and review presentations displaying new data from analytical techniques for cell therapies.

4:30 pm Interactive Roundtable Discussions: Deep Dives into Key Existing & Emerging Technologies

Synopsis

Participate in a focused roundtable discussion to discuss key analytical technologies in an intimate environment. Each table will be led by an industry leader with experience in using the relevant methodology, so this is your opportunity to have your burning questions answered and benchmark your approach with your colleagues in the field. Roundtables will discuss the use of the following approaches

1. Novel Assay Development

2. Discussing New & Novel Analytical Techniques

3. Next Generation Sequencing

Moderator:

Ajit Kamath
Analytical Development Scientist
Mustang Bio

Moderator:

Barrett Nehilla
Analytical Development
Torque Therapeutics

Moderator:

Dipen Sangurdekar
Director, Data Science
Bluebird Bio

5:15 pm Chair’s Closing Remarks

  • Eric Alonzo Senior Scientist, Cell Analytics, Bluebird Bio