Ashley Krull, Ph.D.
Associate Director, Cell Therapy Manufacturing and Engineering
James Cancer Hospital Cellular Therapy Laboratory
Assistant Professor, Hematology
The Ohio State University
Columbus, Ohio, United States
The ISCT Laboratory Practices Committee (LPC) is thrilled to be coordinating eight outstanding concurrent sessions as part of the Laboratory Practice Essentials track at this year’s ISCT Annual Meeting in New Orleans, US. Concurrent sessions allow field experts to present their candid experiences and best practices concerning some of the most pressing issues facing manufacturing labs today. Every session also allows 15-20 minutes for audience Q&A, where participants get the rare chance to hear direct advice from the leaders in CGT manufacturing. Whether your lab is new or well-established, there are always more things to learn to accelerate translation of novel therapies into the clinic. Plan your agenda around these phenomenal sessions that promise to be filled with practical, applicable knowledge and insights.
Thursday, May 8th, 2025
Establishing an In-House CAR-T Manufacturing Platform
Objective: Experts in CAR T cell manufacturing will share their workflows, best practices, and instructions for establishing a new in-house CAR T cell manufacturing platform.
Chair: Tim Wiltshire, PhD, Mayo Clinic, United States
Speakers:
Ashley Krull, PhD, The Ohio State University, United States
Sarah Nikiforow, MD, PhD, Dana-Farber Cancer Institute, United States
Carolyn M. Lutzko, PhD, Dana-Farber Cancer Institute, United States
Change Implementation: New Standards, Deviations, Occurrences and Validations
Objective: Address the upcoming changes in cell and gene therapy standards, demonstrate how to perform a gap analysis of new standards, and use existing quality tools to address issues like deviations, occurrences, and validation.
Chair: Yossi Schwartz, MD, MPH, Moffitt Cancer Center, United States
Speakers:
Phyllis Warkentin, MD, Foundation for The Accreditation of Cellular Therapy (FACT), United States
Phillip Johnson, MMedSc(Path), Mater Health, Australia
Nicole L. Prokopishyn, PhD, Alberta Precision Laboratories, Canada
Building a New Processing Facility: Plans, Challenges, and Solutions
Objective: Review the role and importance of appropriate processing facilities for the ability of clinical centers to offer advanced CGT treatments to patients. This session will provide an overview of the initial considerations that will determine the scope of the project, discuss the business development and budgetary considerations, and address the basic requirements necessary to adhere to the suggested timeline.
Chair: Yossi Schwartz, MD, MPH, Moffitt Cancer Center, United States
Speakers:
Ronit Slotky, PhD, MSc, CABP, Hackensack University Medical Center, United States
Kevin Curran, MD, PhD, BioTech Primer, United States
Jelena Holovati, PhD, University of Alberta, Canada
Long-Term Storage of Cryopreserved Cells
Objective: Address the challenges in managing a growing inventory of cryopreserved products long-term. This session will also discuss relevant standards of accreditation agencies (e.g. FACT) that govern long-term cryopreserved product storage and disposal.
Chair: Ashley Krull, PhD, The Ohio State University, United States
Speakers:
Patrick Hanley, PhD, Children’s National Hospital, United States
Cheryl Cox, MHA, MT(ASCP), CSSMBB, Moffitt Cancer Center, United States
Jelena Holovati, PhD, University of Alberta, Canada
Friday, May 9th, 2025
Validation of Freezing Programs for Cryopreserved Cells
Objective: Focus on the critical considerations necessary for designing an effective freezing program tailored to the development of new cell therapy products.
Chair: Ashley Krull, PhD, The Ohio State University, United States
Speakers:
Kathryn Bushnell, BS, MT(ASCP), Children’s National Hospital, United States
Nicole L. Prokopishyn, PhD, Alberta Precision Laboratories, Canada
Heather Marie Garrity, MHA, Dana-Farber Cancer Institute, USA
Informatics and Data Management Systems for Cell and Gene Therapy Manufacturing
Objective: Discuss the advantages of consistent informatics and data management systems in CGT manufacturing, the available opportunities, and the challenges that the industry is facing. Also, review hospital-based facilities, pharmaceutical manufacturers, and software vendors' challenges and solutions and future improvement opportunities.
Chair: Ronit Slotky, PhD, MSc, CABP, Hackensack University Medical Center, United States
Speakers:
Ronit Slotky, PhD, MSc, CABP, Hackensack University Medical Center, United States
William Shingler, PhD, MBA, Autolus Ltd., United Kingdom
Damian Grantham, MSc, MAK-SYSTEM International Group, United Kingdom
Identifying Core Competencies to Advance Best Practices in CGT Manufacturing
Objective: Examine the range of the training needs of cell and gene therapy professionals, highlight the value of a stepwise hierarchical approach in CGT training, outline the core competencies and advanced areas of expertise in CGT training, and share the insights from the institutions employing various CGT training models.
Chair: Jelena Holovati, PhD, University of Alberta, Canada
Speakers:
Zlatibor Velickovic, PhD, Royal Perth Hospital, Australia
Elena Maryamchik, MD, MBA, Memorial Sloan Kettering Cancer Center, United States
Maggie DiGuardo, MD, Mayo Clinic Center for Regenerative Biotherapeutics, United States
Technical Transfers Production Manufacturing for Clinical Trials
Objective: Review the best practices for a successful technology transfer from a BioTech product development or PI’s lab to the clinical manufacturing lab. It will cover key initial considerations, essential testing requirements, and manufacturing runs needed to ensure a seamless transition following Investigational New Drug (IND) approval.
Chair: Cheryl Cox, MHA, MT(ASCP), CSSMBB, Moffitt Cancer Center, United States
Speakers:
Ashley Krull, PhD, The Ohio State University, United States
Emily Hopewell, PhD, Indiana University School of Medicine, United States
Giselle Perez, Turnstone Biologics, United States
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