In this session, 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. 

SESSIONS:

1. Provide CAR-T Workflow Examples
2. Understand CAR-T Manufacturing Process Validation
3. Provide guidance on deciding on manufacturing platforms

CHAIR: Tim Wiltshire, MD, 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, Cincinnati Children’s Hospital, United States  
  
  
  
  

The session will address the upcoming changes in cell and gene therapy standards, demonstrate how to perform a gap analysis of new standards, and lastly use existing quality tools to address issues like deviations, occurrences, and validation. 

SESSIONS:

1. Discuss the upcoming major changes in the FACT-JACIE standards
2. Highlight change implementation using deviations and occurrences as examples
3. Demonstrate using quality tools to perform validations.

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

This session will review the role and importance of appropriate processing facilities for the ability of clinical centers to offer advanced CGT treatments to patients. It will provide an overview of the initial considerations that will determine the scope of the project. It will discuss the business development and budgetary considerations, address the basic requirements necessary, and the suggested timeline. 

SESSIONS:

1. Understand the key elements that will determine the scope of the new processing facility project.
2. Discuss how to develop a proper business plan and budget.
3. Review the minimal facility, equipment and personnel, and regulatory requirements.

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
  

This session will 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.

SESSIONS:

1. Learn how to design an inventory system and workflow for long-term storage of cryopreserved products.
2. Learn when and how to dispose of cryopreserved products.
3. Learn how to plan for inventory expansion and freezer maintenance over time.

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
  
  
  
  

This session will focus on the critical considerations necessary for designing an effective freezing program tailored to the development of new cell therapy products. 

SESSIONS:

1. Learn what options are available for controlled cryopreservation of cell and gene therapy products.
2. Learn how to design a freezing protocol.
3. Learn how to validate a product-specific freezing protocol to support IND submissions.
4. Gain Cryopreservation Strategies for CAR-T 

CHAIR: Ashley Krull, PhD, The Ohio State University, United States

SPEAKER:

• 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 
  
  
  
  
  
  

This session will discuss the advantages of consistent informatics and data management systems in CGT manufacturing, the available opportunities, and the challenges that the industry is facing. It will also review hospital-based facilities, pharmaceutical manufacturers, and software vendors' challenges and solutions and future improvement opportunities.  

SESSIONS:

1. Discuss the advantages of using a comprehensive informatics system in CGT manufacturing.
2. Review the challenges and limitations of implementing informatics and data systems for CGT manufacturing in both hospital-based and pharmaceutical manufacturing.
3. Describe practical approaches for the successful implementation of informatics and data systems. 

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

The session will 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.

SESSIONS:

1. To discuss the range of the training requirements of cell and gene therapy professionals practicing in a different type of settings.
2. To highlight the value of a hierarchical approach to cell and gene therapy training.  
3. To delineate the stepwise curriculum and the resources available for CGT training.  
4. To share the insights gleaned from countries/institutions (ISCT ANZ; ISCT NA) that successfully either worked or implemented various 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 

This session will 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. 

SESSIONS:

1. Considerations and planning steps for the Tech Transfer
2. Documentation, testing sequence, and analytical testing recommendations to establish for IND-enabling data.
3. Expectations and requirements from both parties. 

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