Day Two Agenda

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8:00 am Chair’s Opening Remarks

  • Mamta Kalra Senior Director - Process, Analytical Development Chemistry Manufacturing & Controls q, Immatics

8:15 am Working Smarter Not Harder a Platform Approach to Streamline Development of UCART Cell-Based Gene Therapy

  • Guillaume Cornelis Associate Director & Principal Scientist - Analytical development, Cellectis

Synopsis

  • A platform approach increases flexibility of the analytical toolbox in a fast-paced environment.
  • Designing phase appropriate platform assays supports product characterization and development across programs.
  • Caveats and pitfalls of the platform approach.

8:45 am Using Advanced Analytics for Cell & Gene Therapy Process Development and Manufacturing

  • Yama Abassi Associate Vice President, Agilent Technologies

Synopsis

  • The value of real-time non-invasive and non-perturbing approaches for assessment of cellular therapies
  • Key measurements beyond cell viability and cell count informing cell therapy design, development and manufacturing
  • Incorporation of key analytics for in-process measurement of cells throughout the value chain of cell therapy development

9:15 am Interactive Roundtable: Strategies for Analytical Measurement of Potency Assays: Building ATMP Productivity

  • Jorge Burns Assistant Professor, University of Ferrara

Synopsis

  • Determining critical quality attributes (CQA)
  • Measurement procedures and quality control (QC)
  • Defining best practice guidelines specific for ATMP characterization and analysis

10:15 am Morning Break

10:58 am
Track A: Immunophenotype Assays

  • Ajit Kamath Senior Scientist I, Analytical Research & Development, Beam Therapeutics

10:59 am Managing Multi-Color Immunoassays to Refine Your Product Development

11:00 am Using Immunoassays to Characterize CAR-T Quality and Donor Cell Variability

  • Huan Yang Associate Principal Scientist, Merck & Co

Synopsis

  • Harnessing immunophenotyping to develop CAR-T products
  • Using flow assays to assess quality of CAR-T products
  • Leveraging MSD to fully characterize CAR-T products

11:30 am Flow Cytometry-Based Analysis of Genomic Copy Numbers Cells and Nanometer-Sized Particles

  • Sumeet Poudel Biologist, National Institute of Standards & Technology - NIST

Synopsis

  • Genomic vector copy number (VCN) reporter cell lines
  • Analysis of Exosomes and Lentiviral particles using flow cytometry
  • NIST Flow Cytometry Standards Consortium

12:00 pm A Statistical Approach to Robust Design of Cell-Based Assays

  • Sayani Majumdar Senior Scientist - Analytical Development, Atara Biotherapeutics Inc.

Synopsis

  • Demonstrate utility of resampling methods in estimating assay variability for laborious cell-based assays
  • Assess impact of biological variability on assay outcome
  • Balancing clinical and quality considerations to finalize design of potency assay

10:58 am
Track B: Molecular Assays

  • Taisen Hao Senior Scientist, Cell Therapy Analytical Development, Bristol Myers Squibb

10:59 am Exploring Vector Characterization to Advance Safety in Analytical Development for Cell Therapies

11:00 am Providing a Holistic View of Vector Testing and Characterization for Manufacturing of Genetically Modified T-Cells

  • Mamta Kalra Senior Director - Process, Analytical Development Chemistry Manufacturing & Controls q, Immatics

Synopsis

  • Leveraging molecular tools for vector characterization
  • Determining optimal vector dose with the goal to balance potential safety risks and anti-tumor activity
  • Planning batch comparability and scale-up for late-stage development

11:30 am Early-Stage Molecular Assay Development for Characterization of Gene-Edited iPSC Banks

  • Lifu Sheng Analytical Development Scientist, Notch Therapeutics

Synopsis

  • Exploring the strategies to develop and optimise reliable ddPCR assay(s) for characterizing gene-edited iPSC
  • Sharing the experience for selecting molecular assays at early stage of iPSC banks development
  • Addressing method optimization to minimize introduction of artifacts during iPSC sample testing

12:00 pm Tools to Assess Purity of Viral Vectors Used for Cell & Gene Therapy Applications

  • Ravi Dyavar Senior Scientist Cell Therapy Analytical Assay Development Lead, Adicet Bio Inc.

Synopsis

  • Discussing residual impurities present in Viral vector materials.
  • Exploring analytical assays to Quantitate Residual BSA and HCP in viral vector materials.
  • Benchmarking quantitation of Residual BSA and HCP in Viral vector materials

10:58 am
Track C: Cell-Based Assays

10:59 am Overcoming Heterogeneity for Robust Cell Based Assays to Improve Confidence in Behavioral Assessments of Your Product

11:00 am Focusing on Controllable Aspects of the Process to Minimize Effects of Biological Variability

  • Anu Vasudevan Principal Scientist - Analytical Development, Cargo Therapeutics

Synopsis

  • Understanding biological variability and patient history to overcome bottlenecks
  • Benchmarking the most important attributes to quantify in cell based assays
  • Minimizing environmental variability to increase confidence in your functional assessments of your product

11:30 am Developing Documentary Standards for Cell Based Assays to Provide Clear Guidelines and Harmonize Analytical Development

  • Laura Pierce Biomedical Engineer, National Institute of Standards & Technology - NIST

Synopsis

  • Discussing measurement methods to accurately capture cell populations
  • Understanding statistical methods to establish level of acceptable deviation
  • Developing fixed cell materials for cell counting to reduce variability

12:00 pm Panel: How Do Characterization Approaches Differ Between Cell Types to Manage Complexity in Cell Differences

  • Jennifer Dashnau Vice President - Analytical Development & Quality Control, Century Therapeutics
  • Mariska ter Haak Senior Director - Analytical Development, IN8Bio

Synopsis

  • Taking learnings from CAR-T to inform product characterization
  • Optimizing analytical development for Gamma Delta, NK and iPSC derived products
  • Determining the technologies required for automation and high-throughput characterization of different cell types

12:30 pm Lunch & Networking Break

1:29 pm
Improving Vein-to-Vein Time to Expedite Product Release & Align Analytical Development

  • Hadar Adams Director, Analytical Development, Atara Biotherapeutics Inc.

1:30 pm Developing Rapid Analytics to Speed Up Turnaround Time for Sterility Testing

  • Anna Lau Chief, Sterility Testing Service, National Institute of Health Science

Synopsis

  • Exploring how to move towards a more unified approach to sterility assessment
  • Focusing on best practices for approaching meaningful sterility testing
  • Looking at validating novel technologies, beyond cell growth for rapid detection and quick product release

2:00 pm Reviewing the Hurdles of Shortening Sterility Tests

Synopsis

  • Exploring different rapid methods to understand their strengths and weaknesses
  • Working with international regulatory bodies to align sterility tests with expectations
  • Developing a novel, improved method for sterility testing according to pharmacopeia recommendations

2:30 pm Afternoon Networking Break

3:00 pm Roundtable: Discussing Analytical Life Cycle Management: Refining Your Process to Improve Efficiency

Synopsis

  • Reviewing process development to identify necessary assays for more efficient processing
  • Translating research protocols to industrial processes for smoother tech transfer
  • Discussing key differences to developing analytical suites with autologous and allogeneic products

3:30 pm Collecting Functional Data for Meaningful Product & Process Characterization to Better Understand Cell Behavior

  • Lena Yang Cell Therapy Analytical Development Scientist, Takeda Pharmaceutical Co. Ltd.

Synopsis

  • Leveraging technical understanding of underlying mechanism of action to guide functional assay development
  • Discussing the pros & cons of cell counting assays as measurements of functionality
  • Exploring the potential of dilution dyes to give a more holistic view of functionality

4:00 pm Chair’s Closing Remarks

  • Hadar Adams Director, Analytical Development, Atara Biotherapeutics Inc.