Andrew Fesnak, MD, Director, Cell Manufacturing & Development, Clinical Cell & Vaccine Production Facility, University of Pennsylvania, Philadelphia, PA
Dr. Fesnak is a transfusion medicine physician and cell therapy researcher at the University of Pennsylvania Perelman School of Medicine. He is the director of Cell Manufacturing and Development in the Clinical Cell and Vaccine Production Facility. He shares medical oversight of the Apheresis Clinic and leads a manufacturing group dedicated to developing next generation cell therapies.
Steven Highfill, PhD Research and Product Development Supervisor, Center for Cellular Engineering (CCE) at National Institutes of Health (NIH), Bethesda, MD
Dr. Highfill leads Chemistry, Manufacturing, and Controls (CMC) activities for new cell therapy products ─ building and managing project plans to achieve clinical manufacturing goals that support NIH Clinical Center Investigational New Drugs (INDs). Collaborating with Clinical Center investigators, clinical research managers, and regulatory agencies, Dr. Highfill assures that processes and assays are developed in compliance with FDA regulations to produce consistent biological products. The CCE is located within the Clinical Center of NIH and currently supports >50 active INDs from investigators within, or in affiliation with, the NIH Clinical Center. The clinical trials are predominately Phase I/II, and often first-in-human studies. Products currently in the clinical manufacturing process include T-cells (CART, TCR, virus-specific), mesenchymal stem cells, dendritic cells, natural killer cells, monocytes, and genetically modified hematopoietic stem cells (HSCs).
Emily Hopewell, PhD, MT, Director of Cell & Immunotherapy Manufacturing, Indiana University School of Medicine, Indianapolis, IN
Dr. Hopewell has more than a decade of cellular therapy and laboratory experience. She received a BA in Microbiology and a BS in Clinical Laboratory Science from Miami University in 2002 and 2003, respectively, and obtained her medical technologist certification in 2003. She completed her PhD in cancer biology at the University of South Florida in 2012. Her career in cell therapy began in 2003 at the Moffitt Cancer Center as a technologist processing and analyzing cells for both standard of care and experimental cellular therapies. After completing her PhD, she returned to the Moffitt Cancer Center Cell Therapy team as a development specialist, then as assistant director. She is currently the director of cell and gene therapy manufacturing and an assistant clinical professor at Indiana University and is charged with implementing GMP cell manufacturing at Indiana University. She has extensive experience with flow cytometry for both standard of care hematopoietic stem cell therapy, as well as the next generation of cell and gene therapy.
Jo Lynn Procter, MEd, MT, SBB (ASCP), CQA (ASQ), Center for Cellular Engineering, Department of Transfusion Medicine, NIH Clinical Center, National Institutes of Health, Bethesda, MD
Jo Procter earned her BS in microbiology with a medical technology option from Pennsylvania State University in 1979. She worked as a medical technologist for 40 years. She studied blood bank technology at Michael Reese Research Foundation in Chicago, IL, in 1982 and received a Master of Education degree with a concentration in health services from Augusta College in Augusta, GA, in 1989. She began work in the department of transfusion medicine at NIH in 1991 as technical specialist, Immunohematology Reference Laboratory, transitioned to the Cell Processing Section’s Flow Cytometry Laboratory in 2001, and became supervisor of operations for what is now the Center for Cellular Engineering in 2004. Proctor retired from NIH in May 2019.
Suzanne Thibodeaux, MD, PhD, Assistant Professor, Washington University in St. Louis School of Medicine, Saint Louis, MO
Dr. Thibodeaux earned her MD and PhD degrees at the University of Texas Health San Antonio. As part of her graduate work, which involved investigation of tumor immune therapies, she utilized flow cytometry to evaluate immune cell phenotypes and function. She completed a residency in clinical pathology and a fellowship in blood banking and transfusion medicine at the Hospital of the University of Pennsylvania. Dr. Thibodeaux then joined the Department of Pathology and Immunology at Washington University School of Medicine in St. Louis, MO. She is currently medical director of the Cellular Therapy Laboratory and assistant medical director of transfusion services at Barnes-Jewish Hospital. Her clinical and research interests focus on improving cellular therapies from the clinical laboratory perspective, as well as apheresis and transfusion medicine as it relates to cellular therapy.
Christina M. Celluzzi, PhD, MS
Senior Manager, Cellular Therapies, AABB, Bethesda, MD
Jose Cancelas, MD, PhD
Director, CEO, University of Cincinnati Hoxworth Blood Center, Division Director, Research, Hoxworth Blood Center, Cincinnati, OH
Jennifer L. Chain, PhD
Science Officer for Cellular Therapies, Oklahoma Blood Institute, Oklahoma City, OK
Magali Fontaine, MD, PhD
Associate Professor, Department of Pathology, University of Maryland, School of Medicine, Baltimore, MD
Carolyn Lutzko, PhD
Division Director Regenerative Medicine and Cellular Therapy, University of Cincinnati Hoxworth Blood Center, Cincinnati, OH
Debra L. Smith, MD, PhD
Associate Medical Director, Oklahoma Blood Institute/Texas Blood Institute/Arkansas Blood Institute/Coffee Memorial Blood Center; Medical Director, Cellular Therapy Laboratory; Medical Director, Cord Blood Program, Oklahoma City, OK