Technologist Workshop - FUNdamentals of Cell Product Manufacturing


This one-day workshop aims to provide technologists both new and experienced in cell and gene therapy with fundamental training in cell product manufacturing spanning collections, QC/QA, regulatory, distribution logistics, devices, and insight into working with industry.  

FUNdamentals of Cell Product Manufacturing
Separate registration fee required.  See below for rates
Date: Saturday May 7, 2022
Time: 08:30 - 16:15

Two parallel tracks

  • Introduction to Cell Therapy Manufacturing: Vein to Vein for staff new to the CGT field. 
    This track aims to provide attendees with a basic understanding of manufacturing a cell therapy treatment from vein to vein.
  • Cell Therapy Manufacturing: Bench to Bedside for experienced staff and lab managers. 
    This track aims to cover topics in process validation and manufacturing operations.


Target audience

  • Technologists
  • Managers and other leaders
  • Lab assistants
  • Quality and Regulatory personnel
Format
Interactive learning experience featuring: 
  • Open dialogue with expert panelists
  • Exercises to solidify understanding of processes, practice problem-solving issues
  • Engaging discussions on case studies and examples


Continuing Medical Laboratory Education Credits (CMLE)
This workshop provides 6 hours of CMLE credits.  Upon completion of a short questionnaire, attendees will receive a CMLE certificate to claim their credit hours.  

Confirmed Speakers 

  • Wade Atkins, MS, MT(ASCP) SBB, CQA (ASQ)
    QA Specialist, NIH Clinical Center Department of Transfusion Medicine (DTM)
  • Kevin Bosse, PhD, RAC
    Director, Office of Research Regulatory Affairs, Nationwide Children’s Hospital
  • Lizette Caballero, BS, MT(ASCP)
    Associate Director, CAR-T and Apheresis Site Liaison, Janssen Research & Development
  • Emily Hopewell, PhD
    Director, Cell and Gene Therapy Manufacturing, Indiana University
  • Diane Kadidlo, BSc, MT(ASCP), SBB
    Director for Molecular and Cellular Therapeutics, the University of Minnesota
  • Aby J. Mathew, PhD
    Executive Vice President & Chief Scientific Officer, BioLife Solutions Inc.
  • Mary Grable McLeod, MLS(ASCP), SBB
    Cell Therapy Facility Quality Manager, Stanford Health Care
  • Lynn O'Donnell, PhD
    Professor of Clinical Medicine, Director of Cell Therapy Manufacturing & Engineering, OSUCCC-James Cancer Hospital & Solove Research Institute
  • Federico Rodriguez Quezada SBB, MLS(ASCP)
    Collections and Processing Lab Facility Manager, UF Health Shands BMT Program
  • Darin Sumstad, MLS(ASCP)
    Technical Specialist, Health Fairview University of Minnesota Medical Center
  • Ljiljana Vasovic, MD
    Assistant Professor of Clinical Pathology and Laboratory Medicine, Weill Cornell Medicine

Program Organized By :

  • Wade Atkins, MS, MT(ASCP) SBB, CQA (ASQ)
  • Lizette Caballero, BS, MT(ASCP)
  • Diane Kadidlo, BSc, MT(ASCP), SBB
  • Lynn O'Donnell, PhD

Registration Rates

Rates listed are in USD ISCT Members Non-Members
Workshop Only
Lab Technologists/Pharmacist/Nurse Practitioner/Nurse $225 $295
Students/Resident/Fellow/Postdoc $145 $225
Academia $275 $425
Industry $275 $595
Workshop + ISCT 2022 Full Conference
If you are registered for the Full Conference, attend this workshop for only $65! $65 


Program Schedule

Introduction to Cell Therapy Manufacturing: Vein to Vein

Co-Chairs: Wade Atkins & Lizette
Caballero
Room 2A

Cell Therapy Manufacturing: Bench to Bedside

Co-Chairs: Lynn O’Donnell & Diane Kadidlo
Room 2B
08:00 - 08:30 Registration and Coffee
08:30 - 09:00

Introduction and Overview
By Lizette Caballero, BS, MT(ASCP)

• Cell Therapy Terminology
• GTP concepts

Introduction and Overview
By Diane Kadidlo, BSc, MT(ASCP), SBB & Lynn O'Donnell, PhD

• 351 vs 361
09:00 - 09:45

Session 1: Collections
By Federico Rodriguez Quezada, SBB, MLS(ASCP)

• Cell sources and how are they
collected: apheresis, bone
marrow, cord blood
• Comparison of the different cell
sources: apheresis vs bone
marrow vs cord blood
• Types of donors: haploidentical,
matched related, matched
unrelated
• Donor suitability and eligibility

 Session 1: Process Development & Validation
By Lynn O'Donnell, PhD

• Does terminology matter?
• How much is really needed?
• Test method qualification requirements
• Has the goalpost been moved?
09:45 - 10:00 Break
10:00 - 10:45 Session 2: Processing and Quality Control
By Diane Kadidlo, BSc, MT(ASCP), SBB

• Basic processing techniques
• Manual vs automated systems
• Fundamentals & advances in
processing and manufacturing

Session 2: Role of Manufacturing in Regulatory Submissions
By Kevin Bosse, PhD, RAC

• CMC preparation and expectations
• Impact of product changes
• FDA interactions
10:45 - 11:30 Session 3: Quality Assurance/Regulatory
by Wade Atkins, MS, MT(ASCP) SBB, CQA (ASQ)

• Operational GTPs
• Nonconformities & deviations: Communication & roles
• Product release

Session 3: Manufacturing Devices
by Darin Sumstad, MLS (ASCP)


• Current role of cell processing devices in
process development and clinical manufacturing
• Lessons learned: benefits and challenges of
manufacturing device integration
11:30 - 12:30

Biopreservation & Bioproduction Challenges and Best Practices for Cell/Gene Therapy Manufacturing

by Aby J. Mathew, PhD

Sponsored by

 
12:30 - 13:15 Session 4: Product Storage, Distribution & Logistics
by Ljiljana Vasovic, MD

• Scheduling, orders & communication
• Shipping vs transportation
• Equipment associated with storage
and distribution
• Thawing, tracking

Session 4: Manufacturing Operations
by Emily Hopewell, PhD

• EM & Cleaning: can you have too much of a “good” thing?
• Aseptic technique and process-specific
competency assessments

    13:15 - 14:00 Session 5: Immunotherapy: Working with Industry
    by Mary Grable McLeod, MLS(ASCP), SBB

    • Role of pharmacy
    • Quality and service agreements
    • Commercial vs in-house vs investigational products
    14:00 - 14:45 Break and Networking
    14:45 - 15:45 Learning Activities
    15:45 - 16:15 Closing Remarks

    Speakers and Planning Faculty Bios

    Wade Atkins, MS, MT(ASCP) SBB, CQA (ASQ)
    QA Specialist
    NIH Clinical Center Department of Transfusion Medicine (DTM)
    United States
    J. Wade. Atkins earned a Bachelor’s of Science in Biology from Pfeiffer College in 1987 and was awarded a second degree in Medical Technology in 1988 after completing the rigorous program at Charlotte Memorial Hospital in North Carolina.

    He successfully challenged the American Society of Clinical Pathologist Specialist in Blood Banking exam in 1995. He earned a Master of Science degree from the University of Maryland University College in 1998.

    For the last nineteen years he has worked as a quality assurance and regulatory specialist for the Department of Transfusion Medicine (DTM) for the National Institutes of Health in Bethesda Maryland. He is the current supervisor of a team of five quality specialists. The DTM is a full service blood bank with a licensed collection facility and a full transfusion service.

    He often speaks at local, national and international meetings on quality and regulatory related topics for biological products. 

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    Kevin Bosse, PhD, RAC
    Director of Research Regulatory Affairs
    Nationwide Children's Hospital
    United States

    Kevin Bosse, PhD, RAC is Director of Research Regulatory Affairs at Nationwide Children’s Hospital and the ISCT Early Stage Professional Committee Co-Chair. As a RAC-certified regulatory professional, he advises the development and regulatory strategy of novel drugs, biologics and devices, with primary focus on gene and cellular therapies. Kevin leads a team who provides regulatory affairs support and consulting for numerous academic, private, and publicly traded programs working towards clinical development of AAV-based gene and cell-based therapies. Since 2012, Nationwide Children’s has launched over twenty investigator-initiated first-in-human clinical biologic programs and has obtained fast-track, breakthrough, orphan and rare pediatric disease designations for many submissions. With this experience, the Research Regulatory Affairs team under Kevin assists through the full spectrum of regulatory submissions from preliminary FDA meeting requests (INTERACT, PreIND, RFD, etc.) to IND/IDE filings and CMS coverage.

    Prior to joining DDDS, Kevin was assistant director of communications for Nationwide Children’s Hospital Foundation, helping to raise critical funds for the advancement of research and clinical programs at Nationwide Children’s. He holds a bachelor’s of science degree in biology from Xavier University and a doctoral degree in molecular, cellular and developmental biology from The Ohio State University. Kevin completed a postdoctoral research fellowship at Nationwide Children’s Center for Cardiovascular Research.
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    Lizette Caballero, BS, MT(ASCP)
    Associate Director, CAR-T and Apheresis Site Liaison
    Janssen Research & Development
    United States

    For the last 24 years I have worked in the cellular therapy field, first managing the cellular therapy laboratory at Florida Hospital, Orlando, FL (1996-2011), and the Blood and Marrow Transplant (BMT) Laboratory at UCSF, San Francisco, CA (1996-2020). I was responsible for compiling quality control data, assisting in the research and developmental of new instruments and techniques, training employees, and development and revision of laboratory procedures, among other things. I also ensure that our responsibilities include assurance that the Cellular Therapy Laboratory adheres to the rules and regulations of all applicable local, state and federal agencies.

    Most recently I join Janssen Pharmaceuticals (Johnson & Johnson) as an Associate Director, CAR T Apheresis Site Liaison (CASL).  My position serves as a cross-functional, point of contact within Janssen for operational and technical aspects of collections and cryopreservation of apheresis cells used to manufacture chimeric antigen receptor T cells (CAR-T). The CASL also provides technical and operational support to clinical sites participating in Janssen global CAR-T clinical trials.

    I am an active member of the International Society of Cellular Therapy (ISCT) where I’m holding the position of Secretary for the Executive Management Committee for 6 years.  I have experience as a FACT inspector for cellular therapy processing facilities, having completed more than 20 inspections during the last 15 years.

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    Mary Grable McLeod, MLS(ASCP), SBB
    Cell Therapy Facility Quality Manager
    Stanford Health Care
    United States

    Mary has over 25 years of experience in cellular therapy and transfusion service medicine. She earned her Bachelor of Science in Medical Technology from Rush University and Bachelor of Arts in Liberal Arts Monmouth College. Mary later completed the Specialist in Blood Banking program at Barnes Washington University. Mary started at Stanford Health Care in 1994 and she has had a variety of roles, starting as a Cell Therapy Technologist, then Processing Facility Supervisor in 2000, now Quality Manager since 2017. Mary’s experience includes cellular therapy product collection, processing, cryopreservation, regulatory compliance, labeling, process improvement, audits, and quality management oversight. Mary is active with AABB, FACT, and ISCT organizations as a standards board committee member and as an AABB accreditation committee chair. Mary serves as an AABB assessor and as a FACT inspector for cellular therapy facilities and she has conducted over 50 assessments or inspections with these organizations over the past 20 years.



    Emily Hopewell, PhD
    Director, Cell and Gene Therapy Manufacturing
    Indiana University
    United States

    Emily Hopewell began her career at the Moffitt Cancer Center as a technologist in the Cell Therapy Facility in 2003. She received her PhD in Cancer Biology from the University of South Florida in 2012. She joined Indiana University in 2018 and is the Director of Cell and Gene Therapy Manufacturing (CGTM) and an Assistant Professor in Clinical Medical and Molecular Genetics. The CGTM group comprises the Vector Production Facility, Cell Immunotherapy and Transduction Facility, and the Bioprocess Development Laboratory. Dr. Hopewell oversees all aspects of manufacturing, from development efforts to clinical production of cell and gene therapies for use in clinical trials. She provides leadership, strategic direction and input on education, research and clinical missions within the Cell and Gene Therapy GMP Facilities, the Department of Medical and Molecular Genetics, and the Brown Center for Immunotherapy.  


    Diane Kadidlo, BSc, MT(ASCP), SBB
    Director for Molecular and Cellular Therapeutics
    University of Minnesota
    United States

    Diane Kadidlo is the Director for Molecular and Cellular Therapeutics (MCT) at the University of Minnesota. She is responsible for the clinical manufacturing and product development of biotherapeutic agents produced at MCT. She oversees environmental monitoring, critical systems and all equipment for the MCT facility. She directs the development of research protocols to clinical status with oversight of scale up studies, budget development, project timelines, master batch production records, validation studies and clinical production.

    Ms. Kadidlo also serves as the Technical Supervisor of the University of Minnesota Medical Center Cell Therapy Laboratory. The Cell therapy Clinical Laboratory performs somatic cell and tissue graft engineering for hematopoietic transplantation and immune adoptive therapies in support of the University of Minnesota Blood and Marrow Transplant program. She has over 20 years experience in cell and tissue manufacturing, regulation and quality assurance.

     


    Aby J. Mathew, PhD
    Executive Vice President & Chief Scientific Officer
    BioLife Solutions Inc.
    United States

    Dr. Mathew was part of the founding team of BioLife Solutions, Inc., and is a co-developer of BioLife’s biopreservation media solutions. Dr. Mathew has been researching low temperature biopreservation and stability since 1994, and his studies contributed to the development of BioLife’s commercial HypoThermosol® and CryoStor® product platforms. Dr. Mathew was BioLife’s first Director of Manufacturing, established BioLife’s initial Quality system, and is currently BioLife’s Executive Vice President & Chief Scientific Officer.


    Federico R. Quezada, SBB, MLS(ASCP)
    Collections and Processing Lab Facility Manager
    UF Health Shands BMT Program
    United States

    Federico Rodriguez Quezada has over 30 years of experience in cellular therapy and immunohematology fields; earned his Bachelor of Science in Medical Technology from the Autonomous University of Nuevo Leon in Monterrey, MX; he attended Specialist in Blood Banking School at the University of Texas Medical Branch in Galveston, TX. He later on became accredited as an SBB by the American Society for Clinical Pathology (ASCP). He has held different positions during his professional career: Medical Technologist, Sales Specialist, Laboratory Supervisor, Education Coordinator, Laboratory Manager, Technical Director, Adjunct Faculty, Coordinator and recently as a Consultant. His experience includes all aspects of manufacturing, regulatory requirements and compliance, process design, process improvement and quality management systems in the Cellular Therapy field, including bone marrow, cord blood and peripheral blood as well as other novel therapies. He has provided guidance to laboratories and institutions worldwide, including the United States, Europe, Latin America and the Middle East. He is an active member of the AABB, ASTCT, ISCT and SCABB; has participated as a member in several Committees within these organizations: Former Chair for the ISCT Laboratory Practices Committee, FACT-Netcord Processing, Selection and Release Standards Subcommittee; FACT Web Oversight Committee, FACT-NetCord Accreditation Committee, FACT International Affiliations Committee; he was also FACT-Netcord assessor for both Processing Laboratories and Collection as well as AABB inspector for Cellular Therapies.


    Lynn O'Donnell, PhD
    Professor of Clinical Medicine, Director of Cell Therapy Manufacturing & Engineering
    OSUCCC-James Cancer Hospital & Solove Research Institute
    United States

    Dr. Lynn O'Donnell is a Professor of Internal Medicine and the Director of Cell Therapy Manufacturing and Engineering at the OSUCCC-James Cancer Hospital & Solove Research Institute. Her research interests include novel cellular therapies for malignancies and regenerative medicine, translational development, GMP manufacturing, IND and IDE submissions for FDA.

    The OSUCCC-James Cell Therapy Laboratory (CTL) services include processing, testing, storage, distribution and advanced manufacturing of cellular products such as hematopoietic progenitor cells (HPCs), mesenchymal stem cells (MSCs), Natural Killer (NK) cells and T cells. Lynn has been responsible for CTL operations for the past twenty years when she moved from a James-funded research scientist position to full time CTL Director. CTL supports two BMT/CT programs, currently participates in 2-3 dozen cell therapy clinical trials at any given time, and has manufactured investigational cell therapies for over 20 INDs/IDEs.

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    Darin Sumstad, MLS(ASCP)
    Technical Specialist
    Health Fairview University of Minnesota Medical Center
    United States

    Darin Sumstad currently serves as a Technical Specialist in the MHealth, Fairview, University of Minnesota Medical Center, Cell Therapy Laboratory. The Cell Therapy Clinical Laboratory performs somatic cell and tissue graft engineering for hematopoietic transplantation and immune adoptive therapies in support of the Blood and Marrow Transplant program.

    Graduating in 1999 with a Bachelors of Science degree in Medical Laboratory Science from the University of Minnesota, he has over 20 years of experience in cell and tissue manufacturing.  As a Technical Specialist, he is responsible for product development and technology transfer from the research environment to GMP production and during this time has been involved with the successful scale-up and manufacturing of over 50 INDs/IDEs. Mr. Sumstad’s expertise in process optimization expands across a wide array of technologies and cell types ranging from cell expansion and cell and tissue culturing techniques, equipment selection, to cell selection, cryopreservation, QC assay development, and tumor lysate techniques.  Past development projects he has worked on include iPSC reprograming and differentiation, natural killer cells, regulatory T cells, mesenchymal stem cells, cardiac derived stem cells, vascular tissue scaffolds, creation of master cell banks and dendritic cell production.  His interests include translational development, data management, and cell processing automation.

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    Ljiljana Vasovic, MD
    Assistant Professor of Clinical Pathology and Laboratory Medicine
    Weill Cornell Medicine
    United States

    Dr. Vasovic is Medical Director of the Clinical Cellular Therapy Laboratory at New York-Presbyterian Hospital and Assistant Professor of Pathology and Laboratory Medicine, Weill Cornell Medicine. Dr. Vasovic received her Medical Degree from the School of Medicine University of Belgrade. In addition, she completed an immunology research fellowship at Memorial Sloan Kettering Cancer Center, a Pathology residency at Lenox Hill Hospital, New York University, a Hematopathology fellowship at Albert Einstein College of Medicine and a Transfusion Medicine Fellowship at Harvard Medical School, Joint Program in Transfusion Medicine. His primary research interests include optimizing stem cell products manufacturing for transplant and enhancing quality assurance programs for cellular therapy laboratories.