Pre-Conference Workshop Day

Monday May 9, 2022 | 9am-4pm EST

Pre-Clinical/Translation Workshops

9am-12pm Characterizing Allogeneic Cells and Understanding How They Behave In Vivo to Clarify Mechanisms of Clinical Outcomes

Synopsis

Cell based therapy is at the forefront of clinical investigation in the field of regenerative medicine, backed by over a decade of pre-clinical study of cell biology and immunology. However, characterizing allogeneic cells and understanding how they behave in the body remains of utmost importance. Attend this workshop to streamline your pipeline from an early stage.

In this session we will be:

  • Exploring the key drivers of the cell cycle of allogeneic therapies in the body
  • Understanding the modalities available to assess the immune response to allogeneic cell therapies
  • Outlining biomarkers contributing to the assessment of safety and efficacy of allogeneic cell therapies

 

 

 

 

Manufacturing Workshops

9am-12pm How to Best Achieve Effective Potency Testing

  • Donald Healy CTO, Adicet Bio
  • Wendy Larson Associate Director, Regulatory CMC Strategy, BlueRock Therapeutics
  • Carl Simon Biologist, National Institute of Standards & Technology

Synopsis

Achieving regulatory approval on potency assays is as huge issue for the off-the-shelf therapies with many submissions being rejected due to not hitting the standards for the complex product needs. Gain unparalleled insights to equip your team with lessons learned to achieve success in
analytical submission.

In this session we will be:

  • Outlining mechanisms of action vs potency vs clinical efficacy
  • Addressing potency assays within an allogeneic setting
  • Addressing key aspects for early assay development emphasizing the importance of functional/potency to support accelerated development timelines

 

 

 

 

Supply/Storage Workshops

9am-12pm Exploring Cryopreservation of Allogeneic Cells to Ensure Efficient Storage

  • Jason Acker Professor, Department of Laboratory Medicine & Pathology, University of Alberta
  • Allison Hubel Professor, Department of Mechanical Engineering & Director, Technological Leadership Institute, University of Minnesota

Synopsis

One major challenge of developing allogeneic cell therapies is to preserve post thawing cell viability, purity and antitumor killing functionality. Attend this workshop to equip your team with the latest cryopreservation knowledge, with two presentations and a discussion session.

In this session we will be:

  • Understanding scientific principles governing the response of cells to freezing and thawing and summarizing key elements practitioners should focus on during the cryopreservation process to enable functional recovery
  • Reviewing new methods of preservation that can be integrated into robotic cell culture
  • Understanding how the freezing behavior of cells change as they become more highly differentiated and addressing how the development of protocols must reflect those differences

Refreshment Break & Networking

1pm-4pm Next-Generation Genetic Engineering of iPSCs to Expand the Accessibility of Off-the-Shelf Therapies

Synopsis

The iPSC field is exploding with excitement and investment, as the potential for these cells is being realized. Thus, they are becoming an increasingly important tool for the development of novel allogeneic cell therapies. Attend this workshop to take advantage of their unlimited supply and
explore recent developments of gene editing strategies.

In this session we will be:

  • Discussing knock-in and knock-out strategies in iPSCs and the clonal derivation of targeted integration of CARs, enhancers of function, and blocking inhibition of immune cells
  • Exploring the killing capacity of iPSC derived T cells and NK cells
  • Outlining how challenges were overcome throughout development

 

1pm-4pm The “Build vs Buy” Decision in Manufacturing

Synopsis

Off-the-shelf products are generating encouraging pre-clinical and clinical results. However, as therapeutics technologies mature, it is essential for manufacturing to correspondingly develop and adequately support their production. Join the debate and discuss whether inhouse manufacturing or outsourced solutions are better when producing an allogeneic cell therapies. Examine the practical challenges in manufacturing allogeneic cell
therapies at scale with this dedicated workshop.

In this session we will be:

  • Reviewing Cellectis’ and Rubius’ GMP plant design and operations for allogeneic therapies
  • Exploring the pros and cons of building your own facility, while considering the cost-benefit analysis
  • Incorporating isolation technology into the Drug Substance/Drug Process operation: assuring maximum product quality for the patient

1pm-4pm Supply Chain Management for Multicentered Clinical Trial Set up

Synopsis

Take advantage of this dedicated workshop to ensure that your operations organization emerges after a time of unprecedented disruption with strategies to establish deliberate, robust and repeatable supply for multicentered clinical trial set up and commercial readiness of your
allogeneic cell therapy.

In this session we will be:

  • Discussing the scaling of supply chain management: moving from a single to multicentered clinical trial in cell therapy
  • Addressing resource planning: managing technology transfer and planning in complex cell manufacturing and COVID impact on supply chain
  • Managing donors as part of the supply chain – the challenges of allogeneic cell therapy in solid tumors