Autologous versus allogeneic: the future of manufacturing and standardization in cell therapies

Abstract

Rupa Pike, PhD is the Senior Director of Technical Affairs for Advanced Therapies, Pharma Services Group at Thermo Fisher Scientific. The Office of Technical Affairs comprises scientific experts that serve as a strategic, innovational and educational leaders in the area of cell-based therapies, plasmids and mRNA therapeutics. In her prior role as the Director of Enterprise Science and Innovation Partnerships, she developed and managed strategic partnerships with global BioPharma, Biotech and Healthcare customers in the area of Cell and Gene Therapy. Prior to this, she was the Head of Technical Operations (Patheon/Thermo Fisher Scientific) where she worked closely with customers to conduct technology transfer and process optimization activities related to GMP manufacturing of cell-based therapies. She has over 15 years of expertise in GMP manufacturing and has successfully led GMP operations, Process Development and MSAT activities, infrastructure buildout, customer relations and business development.Delara Motlagh, PhD the General Manager of Cell Therapy Technologies at Terumo Blood and Cell Technologies, headquartered in Lakewood, Colorado. She is passionate about the cell & gene therapy market and the potential these innovative therapies hold to improve the lives of patients.She brings more than 18 years of experience in biotechnology and healthcare in various therapeutic areas including oncology, cardiology, orthopedics, hematology, and nephrology. Prior to joining Terumo Blood and Cell Therapies in 2017, Delara served in diverse leadership roles at Baxter Healthcare in marketing, research & development, and operations. Her cross-functional background provides a unique perspective and deep understanding of development, cell manufacturing, and commercialization elements in the industry. Delara received a PhD in Physiology and Biophysics from the University of Illinois, fellowship in Vascular Tissue Engineering at Northwestern University, and Executive MBA from Kellogg School of Management.Patrick Hanley, PhD is the Chief and Director of the Cellular Therapy Program and an associate professor of pediatrics at Children’s National Hospital and the George Washington University, respectively. He oversees processing for standard of care stem cell transplantation as well as the development, manufacture, quality, and testing of novel cellular therapies and is responsible for seeking partnerships and commercialization of promising cell and gene therapies. Trained as an Immunologist, Dr Hanley has an extensive background and interest in cellular therapy and is passionate about improving regulations for cellular therapy, training the next generation of cell therapists, and facilitating the translation of new therapeutics. Over the past 15 years he has helped to translate more than 300 products on over 25 cell therapy protocols – ranging from mesenchymal stromal cells to cord blood virus-specific T cells and tumor-associated antigen specific T cells – into the clinic.