Apr
7
2021
On demand

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?

Dr. Estefanía García Guerreiro

Lead Researcher, Institute of Biomedicine of Seville (IBIS)

Dr Guerreiro currently leads the emerging line of research “Generation of CAR T cells for the treatment of hematological diseases” at the Institute of Biomedicine of Seville. In addition, Dr Guerreiro has specific training in clean rooms and Correct Manufacturing Standards. Dr Guerreiro serves as Production Manager in Immunotherapy and Biosafety in the GMP room of the Virgen del Rocío University Hospital Campus since 2018, where she have implemented CAR technology with the objective of generating CAR T cells for clinical use.

Dr. Sadik Kassim

CTO, Vor BioPharma

Dr. Sadik Kassim is CTO at Vor Biopharma. His previous role was Executive Director at Kite Pharma, where he overaw 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.

Dr. Mark Dudley

SVP, Product Development, Adaptimmune Therapeutics

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 Product Development. Dr. Dudley is a pioneer in the field of cell and gene therapies, and has implemented innovative process design, product analysis, and lifecycle management for cellular therapies from exploratory clinical trials to commercial products. His work has resulted in more than 100 peer-reviewed publications including seminal studies demonstrating that patient’s own T-cells can mediate complete responses in refractory solid cancers. Dr. Dudley earned a Ph.D. in Biological Sciences at Stanford University, and a B.S. at MIT. He previously held leadership positions at the Surgery Branch, NCI, and in Novartis’s Cell and Gene Division.

Dr. Anthony Welch

Program Officer/Program Director Biological Resources Branch, National Cancer Institute

Dr. Anthony Welch is a Project Officer in the Biological Resources Branch and Developmental Therapeutics Program in the Division of Cancer Treatment and Diagnosis at NCI. Dr. Welch is currently responsible for oversight of translational research projects involving cell and gene therapy and for the cGMP manufacturing activities that support those projects. This includes current support of multi-center autologous CAR T-cell trials in pediatric AML and pediatric sarcoma and neuroblastoma. Dr. Welch obtained his PhD from The Johns Hopkins University School of Medicine followed by post-doctoral research studying structure-based drug design and enzyme engineering at Roche Bioscience. Previous to joining NCI, Dr. Welch was responsible for discovery research programs at biotech companies Bioqual Inc and Wellstat Biologics. Dr. Welch is co-inventor on multiple US patents and co-author of numerous scientific papers.

SPEAKERS

Dr, Estefanía García Guerreiro
Lead Researcher, Institute of Biomedicine of Seville (IBIS)
Dr, Estefanía García Guerreiro
Lead Researcher, Institute of Biomedicine of Seville (IBIS)
Dr. Sadik Kassim
CTO, Vor BioPharma
Dr. 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.
Dr. Mark Dudley
Senior Vice President Early Development, Adaptimmune
Dr. 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.

Dr. Anthony Welch
Program Officer/Program Director Biological Resources Branch, National Cancer Institute
Dr. Anthony Welch
Program Officer/Program Director Biological Resources Branch, National Cancer Institute