May 4–7, 2022 | San Francisco, CA
After two long years, we can finally meet in person again, and we are happy to be a part of the ISCT Annual Meeting.
With more than 30 years of experience, we at Miltenyi Biotec have the expertise and proven solutions and services to support you from bench to bedside.
Discover how together we can level up towards commercial scale, explore our scientific program, and say hello to us at our booth.
No matter what stage of clinical development you are in, our corporate symposium is sure to inspire you. Come along and listen in as our range of early phase to late phase therapy developers discuss how everyone can reap the benefits of automation and move forward toward achieving commercial manufacturing readiness.
Chair: Dirk Windgassen, PhD, Miltenyi Biotec Inc., USA
With 17 years of process and assay development experience in molecular diagnostics and cell therapy, Dirk is the Director or Analytical Development at Miltenyi Biotec. He has previously worked at Exact Sciences and Thermo Fisher Scientific, leading teams in supporting the commercialization of novel molecular diagnostic assays. Prior to that he worked at Dendreon in the process development group, supporting the BLA submission for Provenge, a first-in-class cellular immunotherapy for the treatment of prostate cancer. Dirk completed his PhD thesis work on ex vivo T cell expansion at Northwestern University and graduated from the University of Erlangen-Nuremberg in Bioprocess Engineering.
Speaker: Rizwan Romee, MD, Harvard Medical School/Dana-Farber Cancer Institute, USA
Natural Killer (NK) cells are an attractive immune cell type for cancer immunotherapy. Recent advances in cytokine and gene-based engineering enable the generation of novel NK cell-based approaches to advanced malignancies. Hear about the ongoing endeavors aimed at developing memory-like NK and memory-like NK CAR cell-based immunotherapeutic approaches to patients with advanced Acute myeloid leukemia (AML)/ Myelodysplastic syndromes (MDS) and solid tumors, including advanced head and neck and ovarian cancer.
Dr. Rizwan Romee is an Associate Professor of Medicine at Harvard Medical School and leads the NK Cell Therapeutics Initiative at Dana Farber/Harvard Cancer Center (DF/HCC). A major focus of his lab is the cytokine and genetic manipulation of human NK cells to enhance their anti-tumor function and simultaneously modulate the immune-suppressive tumor microenvironment (TME). His work at Washington University helped describe human memory-like NK cells with enhanced anti-tumor activity, and he led the first-in-human clinical trial of these cells in patients with advanced AML, demonstrating safety and promising activity. Currently, at DF/HCC, he is evaluating memory-like NK cells in combination with immune-modulatory agents IL-15 super-agonist and CTLA4 inhibitor in patients with advanced malignancies.
Speaker: David Langan, PhD, NexImmune Inc., USA
NexImmune is developing highly differentiated immunotherapies to enrich and expand (E+E) tumor antigen-specific T cells using the proprietary Artificial Immune Modulation (AIM™) nanotechnology. A total of 46 HLA-A2 restricted peptides were identified for preclinical screening as potential immunogenic targets for an adoptive cell therapy (ACT) that treats both HPV16- and HPV18-associated malignancies (i.e., cervical, anal, as well as head and neck cancer). Using PBMCs from healthy donor-derived apheresis material, in 6 months a set of 5 peptides were chosen for the NEXI-003 adoptive cell therapy, a pentavalent antigen-specific autologous T cell product. The results reported here are the foundation for future clinical Phase I trials of adoptive T cell transfer in solid tumors.
David Langan is a scientist from the Cell Therapy Group at NexImmune. He works extensively using the CliniMACS Prodigy® system for the pre-clinical development of Artificial Immune Modulation (AIM) adoptive cell therapies (ACT). David Langan received his PhD in 2021 from the School of Medicine, University of Maryland, where he worked on autoimmune-relevant models using mesenchymal and hematopoietic cells.
Speaker: Aileen Kirkpatrick, PhD
GlaxoSmithKline plc., United Kingdom
For ex vivo manufacture, research and early-phase methods using manual, open processing, and complex protocols require development into automated, closed, end-to-end culture systems that reduce operator input. This can reduce contamination risks, improve reproducibility, enable automated batch records, and increase speed of drug product manufacture and release. Standardization simplifies the tech-transfer of robust processes to enable distributed production if required. Importantly, these improvements can drive down cost of goods and ultimately improve patients’ access to medicine. To develop an end-to-end, automated platform for ex vivo T cell production, GSK has worked in collaboration with Miltenyi Biotech to adapt their commercially available T Cell Transduction process on the CliniMACS Prodigy® to increase the capacity and flexibility of the platform for autologous gene therapy in oncology applications.This presentation will discuss elements of the platforms used at GSK, and the development of the large-scale culture chamber for T cell manufacture in preparation for clinical and commercial application.
Aileen graduated from the University of Edinburgh with a PhD in Experimental Medicine before undertaking a postdoctoral position in the Department of Haematology, at the University of Cambridge. Here she continued her research using embryonic stem cells as a model system for investigating the transcriptional control of hematopoietic stem cells. She joined GSK in 2012 as an investigator in the Advanced Therapy Delivery team, where she contributed to the development of GSK’s first Gene Therapy product. In 2015, Aileen moved into a new role and was responsible for building the automated stem and T cell processing platforms required to deliver the next generation of cell and gene therapy products. Aileen now leads the cell process development team within the Cell and Gene Therapy platform, which is focused on supporting early phase assets through to launch, and the development of innovative technologies to enable step-change improvements to CGT manufacture.
Join Kunal Patel, Process Engineering Manager at Miltenyi Biotec, as he and fellow panelists discuss current and future trends surrounding cell manufacturing, automation, process chain optimization, and more.
Join Jessica Oenarto, PhD, Global Product Manager of CliniMACS Prodigy at Miltenyi Biotec , to learn more about the unique features and benefits of CliniMACS Prodigy® Platform.