Day One Agenda

7:30am - 5:10pm | Boston, MA

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7:30 am Registration Open & Coffee Networking

8:20 am Chair’s Opening Remarks

  • Tam Soden Executive Director, Global Head of Quality Control, Kite: A Gilead Company

8:30 am Industry Leader’s Fireside Chat: Key Analytical Challenges & Considerations for the Next Five Years

  • Mandy Xie Executive Director, Cell Therapy Product & Analytical Development, Bristol Myers Squibb
  • Chelsea Xue Senior Director, Head of Analytical Development, Cell Therapies , Takeda
  • Lantz Mackey Associate Director, Cell Therapy Development, Novartis

Synopsis

  • Discussing lessons learned and challenges to come in the cell therapy field, regarding analytics and QC
  • Leading to tomorrow’s advances: What are the main takeaways from updates to regulatory guidelines earlier this year? How will these effect future plans?
  • Ask your questions to key experts in the cell therapy field

9:30 am Cell Therapy End-to-End Control Strategy

Synopsis

  • Reviewing the complicated cell therapy landscape
  • End-to-end control strategy for cell therapy: why and how?
  • Exploring the main challenges and considerations

10:00 am Lead Partner Presentation by Miltenyi Biotec

10:30 am Morning Break & Speed Networking

Synopsis

As the cell therapy community is reunited, this valuable session will ensure you can connect with your peers in the room to make new and lasting connections.

Updating the Industry on Current Expectations for Reference Standards & Controls

11:30 am Standards & Control Materials for Cell Counting & Viability Measurements for Cell Therapies: Novel Techniques & Tips for Making Your Measurement the Best It Can Be

  • Laura Pierce Biomedical Engineer, National Institut of Standards & Technology

Synopsis

  • Outlining published and in-progress documentary standards for cell counting and viability methods
  • Utilizing the graphical user interface COMET to validate and compare counting methods
  • Developing and implementing reference and control materials for cell counting and viability with an emphasis on image-based control materials and quality assurance for imaging

12:00 pm Real-Time Measurement of Immune Cell Cytotoxicity & Metabolic Fitness and Persistence: Robust Potency and Characterization Assays Meeting the Demands of Cell Therapy Discovery, Process Development and QC/Release Criteria

  • Yama Abassi PhD Head of Strategic Marketing and Business Development, Agilent Technologies, PLXA Cell Analysis Division

Synopsis

  • Overview of the general challenges around designing robust potency assays satisfying the needs of analytical development in cell therapy manufacturing setting
  • Evaluation of cell fate, function and fitness using real-time cytotoxicity assays as well as metabolic assays
  • Identification and optimization of critical process parameters (CPPs) using real-time metabolic and cytotoxicity readouts

12:30 pm Selection of Reference Standard for Release Assays for Cell & Gene Therapeutics

Synopsis

  • Reviewing USP reference standards. What does the US pharmacopeia recommends in the Pharmaceutical industry?
  • Exploring product-specific standards selection and considerations for each assay.
    • When to start the production of your own reference material?
    • How stringent do you want to be?
    • How to accommodate the RS to the possible changes from initial product development to commercial product?
  • From fit for purpose to qualification. When to qualify your standard materials?

1:00 pm Lunch Break & Networking

Pre-IND & Early Clinical Development
Chair:
John Yu, Associate Director, Cell Product Characterization, Sana Biotechnology

Exploring Assay Development for Best-in-Class Early Stage Characterization

2:00 pm Using IP-MS for Characterizing CARs from the Cell Surface

Synopsis

  • Exploring the type of data obtained in a single MS experiment
  • Using MS as a tool for exploring PTM differences in CARs to explain differences in efficacy between candidates
  • Addressing method optimizations to minimize introduction of artifacts during sample preparation

2:30 pm Panel Discussion: Early Stage Characterization & Analysis of Cellular Therapeutics

  • Bo Yan Associate Director, Analytical Sciences, Beam Therapeutics
  • Jim Shaw Director, Analytical Development, Chimeric Therapeutics
  • Isabelle Riviere Director, Cell Therapy & Cell Engineering Facility, Memorial Slon Kettering Cancer Center
  • Jenifer Kaplan Principal Scientist I , Novartis

Synopsis

  • What is the best strategy to characterize cell therapies when their dynamism makes it impossible to fully characterize all properties and functions?
  • Given each assay only reveals a limited number of attributes, how many assays do we need to fully characterize our cell products?
  • How do we select the most appropriate cellular attribute?

Clinical Development & Commercialization
Chair:
Tam Soden, Executive Director, Global Head of Quality Control, Kite: A Gilead Company

Improving Method Validation to Prepare for Successful Clinical Production

2:00 pm Bioanalytical Method Validation for a Cell-Based Assay

  • Jenny Kim Director, Quality Control, Cell & Molecular Biology, Allogene Therapeutics

Synopsis

  • Outlining the process taken to validate a flow cytometry and cell-based potency assay including robustness studies
  • Discussing challenges that arose during the process and how we overcame them
  • Providing bridging strategies when deficiencies are discovered in the development lifecycle

2:30 pm Panel Discussion: The Strategic Path from Assay Development to Validation to Fast Track Regulatory Approval

Synopsis

  • How do we establish regulatory compliant assays that satisfy quality and validation requirements?
  • What is the best time to begin the process of method validation?
  • At what point is full validation required?
  • How to strategize the different quality standards depending on the assay phase?

3:00 pm Tech Slam with Innovation Partners

3:30 pm Afternoon Break

Establishing the Safety of Cell Therapy Products with Comprehensive Analytics

4:00 pm Understanding the Key Considerations & Analytical Methods to Ensure Product Safety in Cell & Gene Therapy

  • Kruti Shah Director, Analytical R&D, Mnemo Therapeutics

Synopsis

  • Describing potential strategy using the fit-for-purpose approach for selecting analytical methods at early stage of product development
  • Discussing selection of model systems for safety and efficacy testing for effective preclinical development
  • Reviewing tactics on engaging manufacturing partners to develop the phase I product

4:30 pm Testing the Genomic Instability in Gene-Edited iPSC Banks to Ensure Safe Use in Clinical Manufacture of Immune Cell Therapies

Synopsis

  • Developing an analytical strategy to characterize and release gene-edited iPSC banks
  • Beyond the g-band- investigating orthogonal methods to analyse genomic instability and on/off targeted editing

Approaching Later-Stage Analytical & Process Technology Transfers

4:00 pm Technology Transfers to Vendors for Early & Pivotal Phases of Development

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

Synopsis

  • Exploring the requirements for a successful tech transfer to CMOs and other service providers
  • Addressing how best to demonstrate analytical robustness and tech transfer success
  • Reviewing the challenges and risk mitigations of tech transfer to CROs

4:30 pm Exploring Technology Transfer to Quality Control Teams

Synopsis

  • Working collaboratively between analytical development and quality control teams
  • Outlining the needs of quality control teams so delays can be avoided during transfer
  • Reviewing common challenges and lessons learned

5:00 pm Chair’s Closing Remarks

  • Tam Soden Executive Director, Global Head of Quality Control, Kite: A Gilead Company

5:10 pm End of Conference Day 1