Navigating current translational challenges in establishing clinical CAR T cell therapy manufacture

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

Sponsor

Navigating current translational challenges in establishing clinical CAR T cell therapy manufacture

CAR T-cell therapy is a highly complex and specialized treatment. To date, CAR T cells have been used in several different cancer categories, with hematologic malignancies the focus for more than half of all clinical trials (57%). CD19 is the most targeted antigen in lymphoid malignancies.

In this webinar, we are going to take a look at the manufacturing process of CAR-T cells from pre-clinical models through to clinical-grade manufacture. We will explore the key challenges of establishing this revolutionary therapy in the clinical setting and share our experiences on how to navigate them. Topics will include:

What are the expectations and requirements from regulatory bodies as you transition your product from the pre-clinical setting through to the clinic?
What process analytics can be incorporated into your manufacturing process and how can this impact release testing of your product?
What is the state-of-the-art in terms of monitoring cell therapies in patients, post treatment?

Estefanía García Guerreiro

Lead Researcher, Institute of Biomedicine of Seville (IBIS)

Sadik Kassim

CTO, Vor BioPharma

Dr. Sadik Kassim is Executive Director at Kite Pharma, where he oversees the CMC activities for all next generation immune cell therapies for cancer. Previously, Sadik was Chief Scientific Officer of Mustang Bio. Prior to Mustang, Sadik was Head of Analytical Development for Novartis’ Cell and Gene Therapies Unit in Cambridge, MA where he contributed the BLA and MAA filings for Kymriah™. Earlier in his career, Dr. Kassim was a research biologist in the Surgery Branch at the National Cancer Institute, where he was involved in early research and CMC work that led to the development of Kite’s Yescarta™ (CD19 CAR T) for lymphoma. Sadik was a research fellow in the University of Pennsylvania’s (Penn) Gene Therapy Program where he led the initial discovery efforts and pre-clinical studies for an AAV8 gene therapy for familial hypercholesteromia. This program is now in the clinic as part of RegenexBio’s RGX-501 program.

Mark Dudley

Senior Vice President Early Development, Adaptimmune

Dr. Mark Dudley is a Senior Vice President at Adaptimmune Therapeutics, a leader in genetically modified T cell therapies for solid cancers, where he is responsible for manufacturing and development. Dr. Dudley has been a pioneer in the field of immunotherapy manufacturing, and has developed and implemented innovative early process design with accompanying analytics for multiple therapies. Previously, as Director of New Cell Products in the Cell and Gene Therapies division of Novartis Pharmaceutical Corp, Dr Dudley was responsible for establishing scalable, GMP-compliant production strategies and facilitating globalization of CAR-T products and platforms.

As Director of the Cell Manufacturing Facility at the Surgery Branch of the National Cancer Institute, NIH, in Bethesda, MD, Dr Dudley investigated tumor rejection antigens, T cell specificity and function, and methods for the generation and administration to patients of T cell therapies. His work has resulted in more than 100 peer-reviewed publications, and he is co-author on numerous seminal papers including early tumor-infiltrating lymphocytes studies demonstrating that adoptive T-cell transfer has tumor eradicating potential. Dr. Dudley earned a PhD in Biological Sciences at Stanford University, and had post-doctoral fellowships at The University of Pennsylvania in Philadelphia, PA and at the Jackson Laboratory in Bar Harbor, ME.