Cellular Therapy Manufacturing: From Starting Material Collection to Drug Product ReleasePresented by the ISCT Lab Practices Committee
Yvette Tanhehco, PhD, MD, MSDirector of Cellular Therapy LaboratoryNewYork-Presbyterian Hospital/Columbia University Irving Medical CenterUnited States
Dr. Yvette C. Tanhehco is an Associate Professor of Pathology and Cell Biology at Columbia University Irving Medical Center (CUIMC) and the Director of the Cellular Therapy Laboratory and Assistant Director of Transfusion Medicine at NewYork-Presbyterian Hospital/CUIMC. Dr. Tanhehco received her Bachelor of Arts degree in Microbiology and Molecular and Cell Biology from Cornell University in Ithaca, NY. She then received her Doctor of Philosophy degree in Viral Oncology from Johns Hopkins University prior to obtaining a medical degree from the University of Pittsburgh. She completed her residency training in Clinical Pathology followed by fellowship training in Blood Banking/Transfusion Medicine at the Hospital of the University of Pennsylvania. In addition, she obtained a Master of Science degree in Translational Research from the University of Pennsylvania. Dr. Tanhehco’s clinical and research interests focus on cellular and gene therapies for sickle cell disease and hematologic malignancies. She is particularly interested in strategies to optimize patients and procedures for apheresis collections of hematopoietic progenitor cells and mononuclear cells to minimize patient adverse events and improve cell yields for drug product manufacturing.
Sarah Nikiforow, MD, PhDAssistant Professor, Stem Cell TransplantationMedical Director, Cell Manipulation Core FacilityTechnical Director, Immune Effector Cell ProgramDana-Farber Cancer Institute United States
Dr. Nikiforow is currently an Assistant Professor at Harvard Medical School with the Stem Cell Transplant Program at Dana-Farber Cancer Institute, Medical Director of the Cell Manipulation Core Facility (CMCF), and Technical Director of DFCI’s Immune Effector Cell Program. Dr. Nikiforow earned her MD and a PhD in Immunobiology at Yale University working on the differential roles of CD4 and CD8 T cells in immune control over Epstein-Barr virus-induced B-cell transformation.Dr. Nikiforow has pursued a translational research career focusing on immune reconstitution after stem cell transplant and therapeutic use of adoptive cellular products. Through the CMCF and as Principal Investigator of Phase I and II clinical trials, she is working to bring cellular therapies such as chimeric antigen-receptor T cells, genetically-modified stem cells, and regulatory T-cell infusions into the clinic at Dana-Farber. Her work with the International Society of Cellular Therapy, the Foundation for the Accreditation of Cellular Therapy and the Center for International Blood & Marrow Transplant Research have promoted education and set standards for safe implementation of new approaches within the broader and ever-growing cellular therapy field.
David Stroncek, MDChief, Cell Processing SectionNational Institutes of HealthUnited States
David Stroncek the Director of the Center for Cellular Engineering (CCE) at the NIH Clinical Center. The CCE is a comprehensive facility that develops and manufactures a wide range of cell and gene therapies for phase 1 and 2 clinical trials. The CCE is currently manufacturing CAR T-cells, TCR-engineered T-cells, cancer vaccines, induced pluripotent stem cells (iPSC), retinal pigmented epithelial cells derived from autologous iPSC and genetically modified hematopoietic stems cells. In the past, the CCE has manufactured dendritic cells, NK cells, virus specific T-cells and bone marrow stromal cells. The CCE also processes hematopoietic stem cells for transplantation.He received a Bachelor of Science degree in Chemical Engineering and a Medical Degree from the University of Minnesota. He completed residency training in Internal Medicine and fellowship training in Hematology and Oncology at the University of Minnesota.
Jay Tanna, MS, RACQuality Assurance ManagerCellular Therapy LaboratoryChildren's National HospitalUnited States
Short Bio forthcoming.
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