Think ahead: preparing for challenges to accelerate your cell therapy commercialization

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

Sponsor

Think ahead: preparing for challenges to accelerate your cell therapy commercialization

For successful commercialization of CAR-T cell therapies, it is critical to not only have a safe and effective product, but to establish a cost-effective and reliable manufacturing process. During this webinar, we will discuss how decisions made during the early stages of process development can have long-lasting effects.

Too often, advanced therapy companies ignore the important consequences of decisions made during early development. Let’s discuss how to avoid potential future pain by thinking about critical factors necessary for the successful commercialization of an advanced therapy such as:

Contamination risk
Inconsistent process prone to human errors
Non-scalable process
High COGs due to labor-intensive process in a high classification cleanroom

Understand all the benefits of implementing the appropriate closed and automated process during early clinical trials such as:

Scalability
COGs optimization
Process integrity

Saba Ghassemi

Assistant Professor, Center for Cellular Immunotherapies at University of Pennsylvania

Dr Saba Ghassemi is an Assistant Professor in the Department of Pathology and Laboratory Medicine and serves as a Principal Investigator at the Center for Cellular Immunotherapies at the University of Pennsylvania. Her research focuses on developing novel CAR-T cells with enhanced potency through a multidisciplinary approach that integrates engineering with CAR-T cell immunology.

Dr Ghassemi pioneered the development of an abbreviated culture paradigm, resulting in less differentiated progeny with improved potency. This breakthrough led to a successful clinical trial at UPenn, utilizing a 3-day manufacturing process. Additionally, she has devised a novel method for delivering CAR transgenes into quiescent T cells, enabling the generation of highly potent CAR-T cells within 24 hours. Dr Ghassemi is currently spearheading efforts to transition this innovative platform into an upcoming clinical trial at Penn.

Her groundbreaking work has garnered recognition through several research grants and patent applications aimed at enhancing CAR-T cells' efficacy, expansion, and fitness for adoptive immunotherapy. Dr Ghassemi's ongoing research endeavors focus on optimizing, streamlining, and automating the manufacturing process of CAR-T cells, with the overarching goal of enhancing the translational applicability and accessibility of these novel therapies to a broader range of geographical locations and patient populations.

Sabrina Carmichael

Fast Trak Global Technical Leader at Cytiva

Sabrina Carmichael is the Fast Trak Global Technical Leader at Cytiva. Fast Trak™ services from Cytiva focus on process development, training, and applications content development. In her role, Sabrina creates content for training courses and delivers those courses to customers interested in cell therapy manufacturing. She also engages with customers for process development, working with them to optimize and automate their cell therapy manufacturing processes. Prior to her work at Cytiva, Sabrina was a Lab Manager and Lead Research Technologist at the Center for Platelet Research Studies at Boston Children's Hospital. At Boston Children's she worked on clinical trials related to pediatric and adult patients with various platelet disorders, focusing on flow cytometric analysis. Sabrina has also worked for The State of Massachusetts Department of Public Health as a Bacteriologist in an HIV and Hepatitis Diagnostics lab, as well as a Molecular Technologist for Genzyme Genetics focusing on prenatal diagnostics. Sabrina has a background in Biology and Biotechnology with a Master of Science degree in Biotechnology from Johns Hopkins University.

Kathryn Henckels

Associate Director, Cell & Gene Therapy API at Johnson and Johnson

Kathryn Henckels is an Associate Director at Johnson & Johnson in the API Cell & Gene Therapy organization, where she leads a team focused on autologous and allogeneic process development for both early and late stage CAR-T cell therapy assets. She holds a PhD in Biological Sciences from Columbia University.

With 14 years of biopharmaceutical development experience, Kathryn has been working in the CAR-T field since 2018. Before joining Johnson & Johnson, she held positions in Inflammation Discovery Research, Cell Line Development, and Cell Therapy Process Development focusing on early stage autologous CAR-T and TCR-T programs.

Hannah Song

Biologist, Product Development at National Institutes of Health

Dr Hannah Song develops manufacturing processes for engineered T cell therapies for phase I/II clinical trials at the NIH Clinical Center in Bethesda, MD. She performs IND-enabling studies, drafts batch records, authors CMC sections for IND submissions, and routinely evaluates cutting-edge technologies for potential use in clinical manufacturing. She has a special research interest in understanding how to utilize advanced manufacturing techniques to optimally control T cell therapeutic profiles.

Prior to joining the NIH, Hannah earned her PhD in Chemical Engineering from the University of Wisconsin-Madison and trained as a post-doc at the Georgia Institute of Technology.

SPEAKERS