Pre-Conference Workshop Day
Monday, May 22
10am – 12pm Innovating the Future of Cell Therapy with Next Generation Gene Editing
- Cedric Cleyrat Scientific Director Cell Therapy Engineering Strategy & Innovation, Bristol Myers Squibb
- Luke Pase Chief Technology Officer, Anocca
The evolution in gene editing tools have been a marvel over the past few years, completely transforming the cell therapy space. Now with the need for more complex gene edited allogeneic products, it is important to stay up to speed with the latest technologies which are spearheading the space. Join this workshop to take a deep dive into base editing, prime editing and more to learn how to incorporate the best-in-class gene editing tool for your therapy
1pm – 3pm Moving to the Future: Translating Product Development for an ‘Off-the-Shelf’ World Beyond Oncology
- Veronica Ricci QA&RA, Oloker Therapeutics
- Elisa Gambini Chief Technology & Operating Officer, Oloker Therapeutics
- Hina Chaudhry Professor of Medicine, Icahn School of Medicine at Mount Sinai
With the clinical landscape for allogeneic cell therapies beginning to evolve and more companies seeking to move into the allogeneic space, it is more important now than ever to place a spotlight on applications of the allogeneic setting to disease indication beyond oncology. Join the workshop to learn how to identify the right patient populations from translational data, determining potency with validated functional assays and maintaining product quality to meet regulatory expectations.
10am – 12pm Unlocking the Power of Cord Blood as a Platform for Scalable Manufacturing of Universal Cell Therapy Products
- William Van Der Touw Senior Vice President - Translational & Discovery Research, Celularity Inc.
- Rui Tostoes Vice President - Chemistry Manufacturing & Control, ImmuneBridge
As differences in CAR-T product potency and persistency have, to date, shown correlation with composition of donor starting material and T cell identity, it is important to understand the phenotypes and functional characteristics that impact in vivo potency. This session will discuss attributes of T cell stemness enriched in the placenta versus adult peripheral blood T cells which translate to in vitro and in vivo functional benefits in a manufactured CAR-T product. Join this session to explore the implications of T cell subsets and further differentiation in CAR-T manufacture, functional characterization of cytotoxicity and cytokine effector responses, immune checkpoints, and considerations for characterizing drug product identity
1pm – 3pm Manufacturing Challenges: Large Scale Complex Editing of Cell Therapy Products
- Joseph Gold Vice President - Technical Operations, Catamaran Bio
- Ruchi Sharma Staff Scientist, National Eye Institute
With the promise of allogeneic therapies to meet the increased patient demand for life changing cell therapies
with ready to use off-the-shelf products, there is a need now more than ever to overcome the scalability challenges associated with advanced gene edited products.
Join this workshop to advance your knowledge on how:
- Complex/multiplexed editing of cell therapy products presents manufacturing and analytical challenges
- How do we balance efficiency and yield?
- Can we test for what really matters?
10am – 12pm Navigating Through a New Complex Regulatory Landscape to Drive Future Product Development
The allogeneic industry is truly setting a trailblazing fire to the cell therapy field – however the price of such an
evolving and innovating space is an unclear regulator landscape. Join this session to take a deep dive into the perspectives of regulatory agencies, and discover acceptance criteria for gene edits, toxicity, potency assay requirements and more.
1pm – 3pm Turning a Universal Dream into a Commercial Reality
The holy grail of cell therapy is to develop a cost-effective universal cell therapy that can be manufactured quickly at a large scale to bring life-saving treatments to thousands of patients in need. With innovations in gene engineering, manufacturing and more steaming ahead, the question of how to successfully bring allogeneic product to commercialisation is coming to the forefront. Join the workshop to delve into the commercial realities of an ‘off-the-shelf’ approach, the current investor landscape and priorities, to help unravel the roadmap to market.