CAR-T manufacturing intensification: the next wave of CAR-T commercialization

Tuesday 08:00 PDT / 11:00 EDT / 16:00 BST / 17:00 CEST

Sponsor

CAR-T manufacturing intensification: the next wave of CAR-T commercialization

Since the commercialization of the first CAR-T therapies, these revolutionary treatments have reshaped the landscape of cancer therapy, offering unprecedented hope to patients with hematologic malignancies. OmniaBio, a global cell and gene therapy CDMO, is bringing together a panel of industry and healthcare sector experts to discuss the critical intersection of commercialization strategies and manufacturing technology in advancing the next wave of CAR-T therapies to market.

Join our esteemed panelists as they explore the current industry status and the latest innovations that have the potential to optimize manufacturing processes for scale-up or scale-out, impacting cost of goods and manufacturing success to meet the growing demand and ensure broader patient access. The panel will discuss critical considerations and challenges in handling and processing commercial CAR-T products in all the stages of delivery to patients.

Navigating commercialization challenges for CAR-T therapies through manufacture and final product delivery to patients
Advancements in regulations and market dynamics accelerating CAR-T commercialization
CAR-T manufacturing intensification to meet scale and quality demands
Technology advancements, such as AI, robotics, process analytical technology and rapid release testing to streamline production and improve efficiency

Alexey Bersenev

Assistant Professor of Clinical Laboratory Medicine at Yale University

Dr Bersenev received his medical education and certification as a general surgeon in Russia. He holds a PhD in transplantation/pathology and completed his post-doctoral training in the US at Thomas Jefferson University and at the Children’s Hospital of Philadelphia. He worked as a cell manufacturing specialist at the University of Pennsylvania, trained in clinical cell processing in a GMP cell manufacturing facility, and was involved in the manufacture of CAR-T cell products for clinical trials and technology transfer to industry. He has expertise in the manufacturing of cellular products for clinical trials and regulatory submissions. In addition to his position as Director of the Advanced Cell Therapy Lab at Yale-New Haven Hospital, he is an Assistant Professor of Clinical Laboratory Medicine at the Department of Laboratory Medicine at Yale University.

Emilie Kleiren

Process Engineering & Validation Senior Manager at Legend Biotech

Emilie Kleiren is a Process Engineering and Validation Senior Manager at Legend Biotech Europe, overseeing tech transfer, manufacturing support, and CAR-T process lifecycle management initiatives. She holds a PhD in Bioengineering from the ULB, Brussels, Belgium.
Emilie has been working in the CAR-T field since 2018. Before joining Legend, Emilie held several positions in Quality and Technical Operations in GMP-certified companies at the clinical and commercial level, including in CAR-T GMP manufacturing.

John Knighton

Head, Cell & Gene Therapy API at Johnson & Johnson Innovative Medicine

John Knighton is the Head of Cell & Gene Therapy API at Johnson & Johnson and has been with Janssen for over 18 years. With 30 years of biopharmaceutical development experience, John leads a diverse and dedicated global team of scientists and engineers in biopharmaceutical viral vector & gene therapy drug substance and CAR-T process development as well as global technology transfer.

Paul Bowles

Associate Principal Scientist, Cell and Immunotherapies at OmniaBio

Since obtaining his PhD in immunology, Paul has spent more than a decade in cell and gene therapy process development. Paul started his industrial career working first at GE Healthcare and then part of a collaboration between Cytiva and CCRM, where he worked on process development of various immunotherapy platforms. Paul developed several closed, semi-automated processes, a CAR-T cell, and an antigen-specific T-cells process, that went into Phase I/II clinical trials. He then spent time working at Treadwell Therapeutics, leading the process and analytical team focused on TCR-T therapies. Paul is currently works as an Associate Principal Scientist and is a co-lead of the Immuno Cell Therapy platform, responsible for developing robust platform processes that OmniaBio can offer to benefit therapeutic sponsors.