Pre-Conference Workshops

Workshop A Tuesday, May 07

9:00 am - 12:00 am
Effective Scale-Up to Achieve Commercialization of Allogeneic Cell Therapies
Workshop Leader: Evren Alici, CEO , Vycellix Workshop Leader: Robert Igarashi, CSO , CytoSen Therapeutics

Allogeneic cell therapy products are displaying encouraging clinical and pre-clinical results. As therapeutic technologies mature, it is essential for the cell manufacturing industry to correspondingly develop to adequately support commercial scale production. Consequently, there is much that can be learned and adapted from traditional manufacturing fields. Attend this workshop to: • Identify current gaps in cell therapy manufacturing • Discuss strategies for integrating new solutions into allogeneic cell therapy manufacturing • Address the need for a highly controlled, robust and standardized manufacturing engineering strategy

Evren Alici, CEO , Vycellix

Dr. Alici serves as Head, Gene and Cell Therapy Group, Division of Hematology, Department of Medicine, Karolinska Institutet, Karolinska University Hospital, Stockholm, Sweden and as a Visiting Research Professor at the NSU Cell Therapy Institute at Nova Southeastern University, Ft. Lauderdale, Fla.

Dr. Alici received his M.D. degree from Ege University, Faculty of Medicine, Izmir, Turkey, and his Ph.D. in Hematology from the Karolinska Institutet in Stockholm, Sweden. He did postdoctoral research as a molecular biologist at Karolinska University Hospital, Huddinge. He is Vice President of the Swedish Society of Gene and Cell Therapy, and a member of the European Group for Blood and Marrow Transplantation, the Nordic Blood and Marrow Transplantation Society, Nordic Myeloma Study Group, the American Society of Hematology, and the European Society of Gene and Cell Therapy. Dr. Alici’s translational research in cell and gene therapy focuses on human NK-cells. He has published numerous related articles and holds patents in large-scale expansion of primary human NK-cells.

Robert Igarashi, CSO , CytoSen Therapeutics

Robert Igarashi, Ph.D. is the president and co-founder of CytoSen Therapeutics. Dr. Igarashi has a diverse background in life sciences and has played an instrumental role in the development of the particle based natural killer (NK) cell stimulating technology. He has brought his biochemical and physico-chemical expertise to combine with immunology for developing and refining the nanoparticle based method for NK cell stimulation that could be used for ex vivo expansion as well as in vivo stimulation of therapeutic NK cells.He has been crucial in understanding the biochemical aspects of the plasma membrane particles interacting with NK cells and how they can be further innovated to add novel therapeutic dimensions for adoptive NK cell therapy.

Workshop B Tuesday, May 07

1:00 pm - 4:00 pm
Building Your Own GMP Infrastructure for CAR-T – Commercial, Clinical and Regulatory Considerations
Workshop Leader: Michael Leek, CEO , TCBiopharm Workshop Leader: Angela Scott, COO, TCBiopharm

TC BioPharm (TCB) has elected to bring cell and lentiviral vector (LVV) manufacture in-house to guarantee supply of materials for our CAR-T programmes. This decision has been taken primarily to address key concerns facing our future business in the CAR-T space. This is because there continues to be limited availability of GMP-grade LVV from CDMO’s. Subcontractor bottlenecks can lead to significant delay in the manufacturing process and clinical timelines. There also is a high cost with regard LVV manufacturing (this has increased significantly with ongoing interest in CAR-T sector).

Aims of the workshop:
• To address some key considerations facing CAR-T manufacture with regard to γδ T cells
• Gain insight into de-risking strategies for developing allogeneic treatment platforms

GMP manufacture
• In-house vs contracted manufacture
• Regulatory considerations
• Shipment, starting material & end product, validation, shelf-life
LVV manufacture
• Facility design – MHRA review
• QA systems
• Platform considerations
• Release tests
Cell manufacture
• Facility design
• Cell banking – autologous vs allogeneic
• Donor recruitment
• Storage and contingency
• Media optimisation
• Release tests (auto/allogeneic)

Michael Leek, CEO , TCBiopharm

Recently presented the ‘Scottish Life-Sciences Entrepreneurial Business Leadership’ award, Michael is CEO of TC BioPharm, developing clinical-stage allogeneic CAR-T immunotherapies.
Active in the cell therapy sector for 30 years, Michael has developed ten different cell-based products to clinic including the world’s first allogeneic cell therapy to undergo multi-national (EU, US, Canada) phase 3 evaluation when he was previously responsible for moving Intercytex from a pre-clinical startup, to an AIM-listed company.

Angela Scott, COO, TCBiopharm

Angela has 32 years in oncology research and regenerative medicine, was part of the team that cloned ‘Dolly the Sheep’, and has designed, built and commissioned several GMP manufacturing facilities. She manufactured product for the UK’s ‘first-in-man’ stem cell trial (PISCES – ReNeuron), and has held MHRA -MIA and -IMP licenses for several cell therapy products.