Lab Practices Essentials Track

LAB PRACTICE ESSENTIALS TRACK

ABOUT THE PROGRAM

Advancing Excellence in CGT Laboratories: Standards, Innovation, and Collaboration

Presented by the ISCT Lab Practices Committee, this track builds on last year’s foundational program to deliver an advanced, practice-focused experience for seasoned professionals in the Cell and Gene Therapy (CGT) field.

Across four thoughtfully curated concurrent sessions, leading laboratory experts will guide you through critical topics including:

  • Global standardization and harmonization
  • Driving efficiency and automation in cell therapy manufacturing
  • Elevating quality assurance to meet evolving demands

Join us in vibrant Dublin to explore strategies that optimize laboratory practices, align with international standards, and leverage cutting-edge technologies to accelerate the journey from bench to bedside.

Beyond the sessions, this is your opportunity to connect with peers, exchange best practices, tackle shared challenges, and gain fresh insights into the latest developments transforming cell therapy.

Session Details & Learning Objectives

Friday, May 8 • 8:00 AM - 9:00 AM

Standardizing Release Criteria
for Cell Therapy Products

To define essential release criteria for various cell therapy modalities and promote collaborative approaches for assay harmonization across institutions, enabling consistent product quality and streamlined clinical translation.

Learning Objectives
  • Outline essential release criteria for different cell therapy modalities.
  • Outline essential potency/stability for different cell therapy modalities.
  • Propose collaborative frameworks for assay harmonization across institutions.
Session Chair Cheryl Cox, MHA, MT(ASCP), CSSMBB Moffitt Cancer Center, United States
Confirmed Speakers Olive Sturtevant, MHP, MT(ASCP)SBB, SLS, CQA(ASQ) Dana Farber Cancer Institute, United States Lindsay Davies, PhD NextCell Pharma AB, Sweden Wanxing Cui, MD, PhD, CABP(H) MedStar Georgetown University Hospital, United States
Friday, May 8 • 9:15 AM - 10:15 AM

Driving Efficiency, Automation, and Standardization in Manufacturing

Evaluate closed and automated systems, along with standardized modular platforms impact on reducing variability, increasing throughput, and enabling global tech transfer.

Learning Objectives
  • Explore opportunities and barriers for automation implementation.
  • Discuss integration process monitoring, traceability, data integrity, and scalability.
  • Enable Global compliant production.
Session Chair Diane Kadidlo, BSc, MT (ASCP) SBB University of Minnesota, United States
Confirmed Speakers Darin Sumstad, MLS(ASCP) M Health Fairview, United States Kapil Bharti, PhD NEI/NIH, United States Melissa van Pel, PhD NecstGen, Netherlands
Friday, May 8 • 15:45 PM - 16:45 PM

Cell and Gene Therapy (CGT) Standards
and Regulations Across the Globe
– How Different Are We?

As the field of cell and gene therapy (CGT) expands at an unprecedented rate, the demand for standardization "across borders" continues. This session will address changes in the FACT-JACIE international standards, the SOHO regulatory framework in Europe, and the Australian TGA framework to evaluate gaps for the benefit of patients worldwide.

Learning Objectives
  • Describe the changes to the processing and quality management sections in the 9th edition FACT-JACIE international standards.
  • Outline the substance of human origin (SOHO) regulatory framework in Europe and its relevance to CGT.
  • Identify the advantages and disadvantages of the different international accreditations and regulatory frameworks.
Session Chair Joseph (Yossi) Schwartz, MD, MPH FACT, United States
Confirmed Speakers Patrick Hanley, PhD Children’s National Hospital, United States Zlatibor Velickovic, PhD Royal Perth Hospital, Australia Joaquim Vives, PhD Banc de Sang i Teixits, Spain
Friday, May 8 • 17:00 PM - 18:00 PM

How Good is Good Enough: Determining Quality Assurance Needs of a Cell Therapy Laboratory

The session will discuss the determinants of the Quality Assurance program at CGT laboratories, present a data-driven approach to quantifying Quality Assurance needs, and provide guidance on building a business case to justify resources.

Learning Objectives
  • Describe the components of a quality assurance program at CGT laboratories.
  • Define the determinants driving the Quality Assurance requirements at a given laboratory.
  • Present a data-driven approach to qualifying the Quality Assurance needs at a given laboratory.
  • Share the experience of ensuring institutional commitment to Quality Assurance based on a business case approach.
Session Chair Elena Maryamchik, MD, MBA Memorial Sloan Kettering Cancer Center, United States
Confirmed Speakers J. Wade Atkins, MS, MLS(ASCP)SBB, CABP(H), CQA (ASQ) National Institutes of Health, United States Yongping Wang, MD, PhD Children's Hospital of Philadelphia, United States Medhat Askar, MD, PhD, MSHPE, FRCPath Qatar University