Hear from the experts pioneering allogeneic drug development including: Atara BiotherapeuticsAllogeneCelyad and Kuur Therapeutics, who will be addressing:  

  • Translatable analysis to increase depth of response 
  • Process innovation to lower cost-of-goods and meet regulatory standards 
  • Define characteristics for optimal donor selection to achieve high quality starting material  

… and much more! 

Key speakers include: 

Barbra Sasu

CSO

Allogene

Karl-Johan Malmberg

Professor

Karolinska Institute

Lior Raviv

VP, Development & Operations

Pluristem

Olive Sturtevant

Senior Administrative Director of Connell & O’Reilly Families, Cell Manipulation Core Facility

Dana Farber Cancer Institute

9:30 - 5:00 EDT | 6:30 - 2:00 PDT - All times are shown in EDT

9:30 am Virtual Coffee Networking

10:00 am Chair’s Opening Remarks

10:05 am Industry Leader’s Fireside Chat

Synopsis

An executive panel discussion from the C-level leaders of the field to set the scene on allogeneic cell  therapy development. Ask your questions live to understand the expert’s thoughts on key topics including gene engineering, cell persistence, ultimate donor source, optimal cryopreservation, and scalable manufacture.

11:00 am Optimizing Allogeneic Cell Therapy Manufacturing with Next Generation Ancillary Materials and Services

Synopsis

  • Bringing liquid cGMP cytokines and growth factors into functionally-closed, single-use systems for ex vivo applications
  • Improving safety, batch-to-batch consistency and supply through virus inactivated blood products and media supplements at commercial scale
  • Strategic approaches to manufacturing high quality cGMP plasmid DNA: Aligning plasmid development with internal clinical development timelines to reduce costs and optimize material quality

11:30 am Speed Networking

12:00 pm Refreshment Break

Synopsis

Take this time to go for a walk, make a coffee, or reach out to your colleagues on the online chat feature and schedule a video call!

12:30 pm Modification of Gamma Delta T Cell Therapies to Enhance Efficacy

Synopsis

Harnessing the unique properties of gamma delta T cells to revolutionize immunotherapy and improve outcomes for cancer patients

1:00 pm Improve Tolerance and Prevent Host Vs Graft Rejection

  • Mark Johnson Clinical Translational Scientist, Precision Biosciences

Synopsis

• Showcase translatable data to show why a product has been rejected, outlining the mechanism of host Vs graft
• Understand what antigen/protein is causing the host Vs graft rejection, and what modifications are being explored to prevent this
• Analyse translatable data to show what happens to the cells, how they behave and interact, and their phenotype

1:30 pm Standardized Pharmacokinetic Monitoring of Off-the- Shelf Cell Therapies

Synopsis

• Cell therapy product expansion in vivo is correlated with clinical response but requires a sensitive and
reproducible assay to quantify pharmacokinetic profiles
• A highly sensitive and precise NGS-based AlloCell approach measures the amount of cell product irrespective of the engineering construct, making it universally applicable to any allogeneic therapy
• Developed to guide clinical decisions in clinical trials and patient care

12:30 pm Unleashing the Allogeneic Potential: Large Scale Manufacture to Achieve Off-the-Shelf Products

  • Lior Raviv VP, Development & Operations, Pluristem

Synopsis

• The importance of beginning with the end in mind
• Process development considerations for the design of an off the shelf product
• Large scale cold chain during late-stage clinical trials

1:00 pm Scalable Manufacture to Realize the Power of RED™: A New Era In Cellular Medicine

Synopsis

• Describe the RED™ allogeneic cell therapy product and its applications
• Explore the factors that can influence scalable expansion e.g. raw materials, cell scale up, product separation and storage

1:30 pm Improving the Allogeneic Process to Overcome Challenges in Cell Therapy

  • Evan Zynda Scientist, Cell Biology, Thermo Fisher Scientific

Synopsis

• Current challenges in cell therapy
• Advantages of using allogeneic workflows
• Fine-tuning the allogeneic process to improve therapeutic performance

1:40 pm Track Closed

12:30 pm Cryopreservation Considerations and Consensus; Evaluation of the Effects of Cryopreservation on Mesenchymal Stem Cells

Synopsis

• Mesenchymal stem cells (MSCs) represent an invaluable resource within the field of cellular therapy
• Presently cryopreservation represents the gold standard in cell storage and transportation however, cryopreservation is not a benign process when assessed at the level of cellular function
• The quantitative effects of cryopreservation on cellular function will be presented for therapeutic consideration upon a regulatory backdrop

1:00 pm Standardize Labelling of Allogeneic Cyropreserved HCT/Ps

  • Olive Sturtevant Senior Administrative Director of Connell & O’Reilly Families, Cell Manipulation Core Facility, Dana Farber Cancer Institute

Synopsis

• Review the options as proposed in the ISBT-128 standards by ICCBBA
• Learn why HCT/P products need more than the just the National Drug Code (NDC)
• Understand the consequences of not reaching consensus on standardized labelling

1:30 pm Accelerating Scientific Insights and Time to Market Using Artificial Intelligence and Machine Learning

Synopsis

• Identify how various T-cell factors, solid tumor factors and tumor microenvironment impact the response to CAR-T therapy
• Eliminate the need for extensive laboratory experimentation with in silico systems biology modeling for these factors
• Produce innovative insights, predict resistance mechanisms and accelerate time to market with systems biology modeling techniques

2:00 pm Refreshment Break

3:00 pm Gene Modifications to Achieve Long-term Engraftment

Synopsis

• Discuss the ability of cells to engraft, how does mismatch (major or minor compatibility) limit engraftment?
• Review novel technology to track cells in vivo to reliably measure persistency and trafficking
• Understand the performance of cells in vivo to help inform product modifications with confident endpoints

3:30 pm Driving Persistence with Allogeneic Gamma-Delta T Cell Therapy

Synopsis

• Provide an overview of ACC (Antibody-Cell Conjugation)
• Describe characteristics of Acepodia proprietary gamma delta T cells (NgdT)
• Analyze preclinical studies of ACE-NgdT in both in vitro and in vivo models

3:00 pm Developing a Straightforward Manufacturing Process for Potent and Safe Allogeneic CAR T Cells at Lower Cost

  • Emilie Gauthy R&D Manager, CMC & Process Development, Celyad Oncology

Synopsis

• Review the real bottlenecks of allogeneic CAR-T manufacturing processes
• Simplify the manufacturing process to gain on productivity with an ‘all-in-one’ vector approach
• Discuss how the process can influence and ensure consistent product characteristics

3:30 pm The Evolution of an Allogeneic Process; from Research to Clinical Trials and Commercialization

Synopsis

• Keeping process development aligned with clinical data
• Review regulatory and commercial considerations
• Describe the Target Process Profile; engineering desirable characteristics

4:00 pm Options and Phasing of Viral Manufacturing to Support Cell Therapy Needs

Synopsis

• Explore the different technologies and solutions available for viral vector production
• Phasing of viral manufacturing costs according to product life cycle step needs

3:00 pm Sourcing Superdonors for Allogeneic NK Cell Therapies

Synopsis

• Benchmark the fundamental principles behind the functional diversification of human NK cell repertoires
• Share our approach to source superdonors and cryopreserve starting material for off-the-shelf NK cell therapy
• Assess functional robustness and versatility of the end product

3:30 pm Identifying Optimal Donors for Manufacture of Allogeneic CAR-NKT Cell Therapeutic Products

Synopsis

• Manufacture of CAR-NKT cells from healthy donors for allogeneic use
• Identification of product performance metrics to guide donor selection
• Discovery of biomarkers predictive of the best NKT cell donors

4:10 pm Closing Remarks

4:15 pm Close of Day 1