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Member Exclusive 2024 Webinar: Advances in Point-of-Care Manufacturing: Promise vs. Reality

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Presented by the ISCT North America Regional Executive Committee and Lab Practices Committee

March 12, 2024

Webinar Description:

This webinar will feature updated definitions of point of care (POC) manufacturing and feature two leading innovators in POC manufacturing to offer real-world examples of – and insights from – successful POC programs. 

Real-life experts will speak about their experience of building a point-of-care manufacturing program at a clinical laboratory. They will discuss the challenges, the potential solutions, and the regulatory aspects of in-house manufacturing, and provide perspective from the different vantage points of their respective roles.

Key Learning Objectives:

  • To discuss the regulatory landscape surrounding point-of-care manufacturing of cell and gene therapy products from the FDA perspective.

  • To delineate the process of establishing a point-of-care manufacturing program in an academic institution.

  • To highlight potential challenges and possible solutions from the experts who have built successful programs.

Ashley Krull, PhD (Moderator)

Associate Director, W.W. Williams Cellular Therapy Laboratory

The Ohio State University

Ashley Krull received her undergraduate degree in Biochemistry from the University of Iowa and her Ph.D. in Neuroscience from the University of Washington. After graduate school, Dr. Krull completed a postdoctoral fellowship in regenerative neurobiology within the Department of Neurology at Mayo Clinic in Rochester, Minnesota. In 2019, Dr. Krull became Mayo Clinic’s second-ever Cellular Therapy Fellow and was granted an extended two-year fellowship, which she completed in 2021. This fellowship program included didactic, experiential, and project-driven training with an emphasis on directorship of a clinical cell therapy laboratory. Subsequently, Dr. Krull held an appointment as Instructor within the Department of Laboratory Medicine and Pathology and served as a senior program coordinator within the Mayo Clinic cellular therapy lab and as a consultant for a joint venture biotechnology company spun out of the lab’s work at Mayo Clinic. In 2022, Dr. Krull moved to The Ohio State University where she currently serves as the Associate Director of Cell Therapy Manufacturing and Engineering. She also holds an appointment of Assistant Professor within the Department of Hematology. Her work focuses on the optimization of manufacturing processes for immune effector cells and the translation of novel cellular therapies into the clinic.

Elena Maryamchik, MD, MBA (Moderator)

Director of Cell Therapy Laboratory

Memorial Sloan Kettering Cancer Center

After receiving a dual MD/MBA degree from the University of Miami in 2016, Elena completed her residency in Clinical Pathology at the Massachusetts General Hospital, Cell and Gene Therapy Fellowship at the University of Pennsylvania/Children’s Hospital of Philadelphia, and Transfusion Medicine Fellowship at Harvard. She is a Director of Cell Therapy Laboratory at Memorial Sloan Kettering Cancer Center, and an Assistant Attending in Transfusion Medicine. Her interests include Point-of-Care manufacturing of cell therapy products, exploring the role of stem cell graft characterization and post-thaw viability monitoring in guiding clinical decisions and improving patient outcomes, developing training programs to facilitate the entry of qualified technicians into the field of cell therapy, teaching the next generation of cell therapy leaders, and optimizing operations of a clinical laboratory to meet the rising demand. As an early-stage professional, she is a member of ISCT Lab Practices Committee, ISCT Expanded Access Working Group, ASTCT representative to the AABB COI for Cellular Therapies Task Force, and a member of the FACT-JACIE Standards HCT Processing Subcommittee.

Kimberly Schultz, PhD

Director of Division 2, Office of Gene Therapy

US Food and Drug Administration (FDA)

Kimberly Schultz is Director of Division 2 in the Office of Gene Therapy at FDA’s Office of Therapeutic Products in the Center for Biologics Evaluation.  Kim joined the FDA in 2015 as a Commissioner’s Fellow to conduct a cross-study analysis of CAR T cell CMC data and contributes to FDA review, guidance, and policy.  Prior to joining the FDA, she received her PhD from the University of Wisconsin and conducted postdoctoral studies at Johns Hopkins Bloomberg School of Public Health specializing in virology and immunology.

Yongping Wang, MD, PhD

Director, Cell and Gene Therapy Laboratory

Children’s Hospital of Philadelphia

Dr. Yongping Wang is a pathologist in Philadelphia, PA and currently working as the Director of Cell and Gene Therapy Laboratory at Children's Hospital of Philadelphia. He received his medical degree from Geisel School of Medicine at Dartmouth and has been in practice for more than 15 years. He is one of 39 doctors at Children's Hospital of Philadelphia who specialize in Pathology. He has more than 20 publications and over 500 citings.

Patrick Hanley, PhD

ISCT NA Regional VP 2022-2024

Chief & Director, Cellular Therapy Program, Associate Professor, Children’s National Hospital

Dr. Hanley 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 cell and gene therapies. Over the past 16 years he has helped to translate more than 550 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.

Dr. Hanley was elected VP-North America of the International Society for Cell and Gene Therapy (ISCT) where he also serves on the board of directors, co-founded and served as the inaugural co-chair of the Early Stage Professionals committee which focuses on workforce development, and is the commissioning editor of the society’s journal, Cytotherapy. Representing ISCT, he serves on the Regenerative Medicine Forum of the National Academies where he co-leads the workforce working group. He also serves on the board of directors of the Foundation for the Accreditation of Cellular Therapy (FACT) and is a FACT representative at the Cell Therapy Liaison Meeting, serving as a thought leader in a forum with the FDA. Dr Hanley also serves as an advisor for a number of cell and gene therapy biotech companies. In his free time he enjoys tweeting with fellow scientists and Bills fans, playing soccer, cycling, cooking, and traveling.

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