2019

San Diego, CA

 

Workshop A
Tuesday March 27th, 2018

09.00 - 12.00
Investigating the Regulatory Checkpoints that Need to be met in NK Cell Therapies
Workshop Leader: Jan Spanholtz, Chief Scientific Officer and Research and Development Manager, Glycostem Therapeutics Workshop Leader: Jaikumar Duraiswamy, Biologist, Cell Therapies Branch, Division of Cell and Gene Therapies, Center for Biologics Evaluation and Research, US Food and Drug Administration

As NK cell therapies move into clinical investigation it is important to identify the regulatory framework and procedures that surround this area of research. Attend this workshop to gain an in depth understanding of the regulatory landscape to ensure that safety is of the highest standards.

Attendees will learn:

  • Step by step guidance to ensure regulatory standards are met in preclinical investigations through to clinical development
  • Insights into the regulatory strategy and decision making made throughout development process, aided by indepth case studies
  • A comparison of T cell and NK cell regulatory standards to ensure efficient and comparable studies
  • The necessary time lengths needed for effective results and the reasoning behind this
  • The different regulations regarding sophisticated genetic modification strategies
  • Relevant model systems to ensure safety and efficacy
  • Future perspectives in combination therapies regarding the use of multi-modal therapies
  • Manufacturing and quality of NK cell-based immunotherapy products
  • Regulatory challenges in NK and T-cell -based therapies

Jan Spanholtz, Chief Scientific Officer and Research and Development Manager, Glycostem Therapeutics

Dr. Jan Spanholtz initiated Glycostem’s research in the start-up phase in 2007 and is currently Chief Scientific Officer (CSO) of Glycostem. Dr. Jan Spanholtz has more than 15 years of expertise in research on stem cell biology and immunology at universities and within biotech companies. He is author of various peer-reviewed research articles and inventor of Glycostem’s proprietary technology platform to generate oNKord® from umbilical cord blood stem cells. For Glycostem, he has set-up and managed several national and international collaborations and spearheaded clinical translational of Glycostem’s NK-cell product, oNKord®. He has developed the core IP strategy for Glycostem as inventor of feeder cell free NK-cell culture method from cord blood stem cells, synthetic culture medium for NK-cells and has was also part of several other patent applications in the stem cell field.

Jaikumar Duraiswamy, Biologist, Cell Therapies Branch, Division of Cell and Gene Therapies, Center for Biologics Evaluation and Research, US Food and Drug Administration

Dr. Jaikumar Duraiswamy is a product/CMC reviewer in the Cell Therapies Branch (CTB) at Office of Tissues and Advanced Therapies in CBER/FDA. Jaikumar is responsible for regulatory review of immunotherapy- related products. He participates at several scientific and regulatory meetings, and in working groups focused on the advancement and understanding of basic immunology and immunotherapy. He has many years of academic research experience in immunology and immunotherapy for various cancers and infectious diseases. He has several publications and patents, and received several awards.

 

Workshop B
Tuesday March 27th, 2018

13.00 - 16.00
An Exploration of the Tumor Microenvironment To Prevent Tumor Escape from NK Cell Cytotoxic Activity
Workshop Leader: Robin Parihar, Assistant Professor, Center for Cell and Gene Therapy, Baylor College of Medicine

The “next generation” of cancer hallmarks includes their ability to manage an immune-mediated attack via the generation of the tumor microenvironment. It is important to identify and understand the intricate net of cross-interactions occurring between tumor components and immune cells to challenge the ineffective inflammatory response that supports tumor evasion. Attend this workshop to gain an in-depth understanding of how the cytotoxic activity of the NK cells is escaped by the tumor microenvironment.

Attendees will learn:

  • The biological cross-talk that occurs within the tumor microenvironment between immunosuppressive factors and immune cells
  • How to create an effective design of the NK cell based therapy to overcome the immunosuppressive environment
  • The different challenges faced by liquid tumors and solid tumors

Robin Parihar, Assistant Professor, Center for Cell and Gene Therapy, Baylor College of Medicine

I am a pediatric oncologist with an interest in caring for children with solid tumors. I have an active research lab interested in stimulating the immune system to fight solid tumors. My lab investigates the role of a specific type of immune cell called the natural killer (NK) cell in the control of cancer. My current research projects aim to enhance NK cell function in order to target the tumor microenvironment, essentially getting rid of the accessory cells that help a tumor resist standard therapies. I am currently working on introducing the enhanced NK cells as therapy for children with advanced cancers. In addition, we are using our established lab models to better understand how the tumor microenvironment suppresses the immune system, in order to develop new approaches to overcome this inhibition and improve immune-based therapies for pediatric cancers.