Workshop A

Exploring Solid Tumor Assay Development

9:00 am to 12:00 pm

Many of the assays developed for use with cell therapies work well in liquid tumors. However, they do not address the inherent challenges associated with solid tumors. The need for more relevant technologies and methods in solid tumors is paramount. Flow cytometry is an essential tool for analysis of cell therapies, and mass cytometry is garnering significant interest as it promises to vastly expand the power of cytometry.

Challenges with both of these technologies arise when complex experiments require extensive analysis of multiple cell types and various functions within each of these groups in order to uncover relevant biology. The analysis panels become significantly large, leading to difficulties with spectral compensation (in flow cytometry), and multidimensional data interpretation (in CyTOF). Moreover, sample size is often a limiting factor, thus requiring appropriate preparation for each specific application. This workshop will address the challenges associated with the mentioned technologies and highlight approaches for mitigating these challenges.

Attendees will:

• Learn the requirements for design and development of cytometry-based assays
• Discuss how to improve flow cytometry validation methods
• Discuss important considerations when designing cytometry-based assays for solid tumors

Portraits of post-doctoral candidates at social media networking event by the University of Texas MD Anderson Cancer Center ,Faculty & Academic Development, September 22, 2015. Photo - F. Carter Smith

Tamara Laskowski
Senior Research Scientist, Immunotherapy
MD Anderson Center

Dr. Tamara J. Laskowski received her doctorate degree in Human Molecular Genetics and Immunology from University of Texas Health Science Center where her work focused on genome editing of patient-derived stem cells to correct genetic mutations causative of Wiskott-Aldrich Syndrome, an immunodeficiency disorder that results in severe impairments to the immune system.

Workshop B

CAR-T Cell Manufacturing – Current Methods & Trends

1:00 pm to 4:00 pm

This workshop will provide an overview of current methods, used in manufacturing of CAR-T cells. As response to market demand, the number of competing technologies and platforms for manufacturing therapeutic T-cells continues to grow.
What is changing in manufacturing since the first generation of CAR-T products were approved and what is coming? How do manufacturing processes dictate analytical testing of CAR-T cell products? Limitations and bottlenecks of the current manufacturing platforms will be discussed. Limitations and bottlenecks of the current manufacturing platforms will be discussed. The overview of CAR-T manufacturing methods is based on analysis of clinical trials databases and results of CAR-T cell
therapy trials, published in peer-reviewed medical literature.

Attendees will:
• Discover current manufacturing limitations and potential solutions
• Hear analytical techniques used during manufacturing whilst discussing their respective limitations and advantages

Alexey Bersenev

Alexey Bersenev
Director, Advanced Cell Therapy Lab
Yale University

Dr. Bersenev received his medical education and certification as a general surgeon in Russia. He holds a PhD in transplantation/ pathology. He gained expertise in immunology, hematology, stem cell biology and published scientific papers during post-doctoral training in the US in Philadelphia at the Thomas Jefferson University and the Children’s Hospital of Philadelphia. He worked as a cell manufacturing specialist at the University of Pennsylvania and 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 clinical manufacturing of cellular products for clinical trials, including product and process development, cell processing and culture, operations of academic GMP facility and compliance with regulations. 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 the Yale University.