Cryogenic Considerations for Cell & Gene Therapy (CGT)
This exclusive event will bring together the top cryo experts from around the world to discuss the nuances of cryogenic solutions, cold chain documentation, and thawing--from collection to manufacturing and distribution. The full conference agenda can be viewed here.
Space is limited - reserve your spot today
Monday, October 17, 2022 - Wednesday, October 19, 2022
The Langham Hotel, 250 Franklin Street, Boston, MA 02110 Event Location
Hotel costs are not covered by Azenta and are the responsibility of the attendee.
Cryo Symposium Agenda and Details
Welcome Reception and Dinner
Monday, October 17, 2022
The reception will kickoff this Cryo symposium event with a keynote speech from Tom Bollenbach at ARMI Biofab, along with dinner at The Langham Hotel.
Symposium Main Program
Tuesday, October 18, 2022
The afternoon will consist of interactive roundtables, discussions, and the opportunity to bring standards into the conversation of cryopreservation. In the evening, attendees are welcome to network and socialize in a casual setting.
Azenta Cryo Facility Tour
Wednesday, October 19, 2022 (Half Day)
In addition to meeting the engineers and touring the cryo facility in the morning, participants will have the opportunity to personally engage with automation, informatics, labware, and devices while on this tour.
GUEST SPEAKERS & TOPICS
Presentations from Top Technical Experts
Topic: The Patient’s Journey from Collection to Administration of a CAR-T Product
Presenter: Albert Ribickas, BMT laboratory and Patient Product Handling Team Manager, Moffitt Cancer Center
Al Ribickas is the Blood and Marrow Transplant Laboratory Manager and the Manager of the Patient Product Handling Team for Clinical Trials and Commercial Cellular Therapies at the Moffitt Cancer in Tampa Florida. Al has provided leadership for cellular therapy facilities for over eighteen years. He attended the University of South Florida receiving a degree in Clinical Laboratory Sciences. He is board certified by the American Society of Clinical Pathology as a Medical Technologist, a Specialist in Blood Banking, and as a Hemapheresis Practioner. He has been at the Moffitt Cancer Center since it’s opening in 1987. He initially worked as a blood bank technologist in the transfusion service until 2001. During his time in the transfusion service, he was trained in extracorporeal photopheresis for the treatment of Sezary syndrome, and for the treatment of graft versus host disease. This inspired him to explore, and move to the apheresis collection and processing laboratories of the blood and marrow transplant program to enhance his skills, and contribute to the emerging area of cell therapies. Al has worked on the production of various cellular therapies clinical trial products, and the implementation of commercial FDA approved products.
Topic: Scalable, Consistent and Cost-Effective: Addressing the Challenges of Manufacturing Human Cells, Tissues and Organs
Presenter: Thomas Bollenbach, PhD, Chief Technology Officer, Advanced Regenerative Manufacturing Institute
Thomas Bollenbach, Ph.D. is Chief Technology Officer at the Advanced Regenerative Manufacturing Institute (ARMI)|BioFabUSA. Tom is responsible for providing leadership to the institute’s technical programs, which include the development of enabling platform technologies for human cell and tissue manufacturing, Quality by Design-based process development methodologies for scalability and GMP-readiness, and development and demonstration of modular, automated and closed manufacturing systems. Prior to joining ARMI, Tom served as Vice President of Research and Development at Harvard Apparatus Regenerative Technology, where he led the development of cell- and biomaterial-based tracheal, bronchial and esophageal implants. Tom joined HART from Organogenesis, where he implemented IND-enabling preclinical programs for bioengineered living skin, and maintained strong cross-functional interactions with Clinical Operations, Manufacturing and Business Units to provide scientific support to corporate strategies.
Topic: Hospital Apheresis Considerations
Presenter: Lizette Caballero, Associate Director, Clinical Cell Therapy Lead, Janssen
For more than 24 years Lizette 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). Most recently she joined Janssen Pharmaceuticals (Johnson & Johnson) as an Associate Director, Clinical Cell Therapy Lead (CTL). Lizette 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. In addition, Lizette is the Global Secretary for the Executive Management Committee of the International Society of Cellular Therapy (ISCT). She also participated on the working group with the Parenteral Drug Association Cell and Gene Therapy Task Force and the Standards Coordinating Body to shape apheresis and cell processing industry standards related to labeling, Chain of Identity (CoI) Identifier and apheresis collection.
Topic: Cryobiology & Formulation Considerations for Best In-Practice Allogenic Cell Therapy Manufacturing
Presenter: Katie Pollock, Associate Director, Head of Formulation and Cryobiology, Bristol Myers Squibb
Katie Pollock, PhD is a cryobiologist specializing in formulation, fill finish, container closure, and cryopreservation of cellular therapies. She currently serves as Associate Director, Head of Formulation and Cryobiology in the Cell Therapy Development Organization at Bristol Myers Squibb. During the last 6 years at Juno/BMS, she has contributed to cryopreservation development and support on 8 cell therapy commercial, clinical, and pre-clinical pipeline products.
Topic: Labeling & Tracking Advanced Materials
Presenter: Karen Moniz, Technical Director, ICCBBA
Karen is a broad-spectrum blood bank specialist with decades of management experience in a variety of settings including donor centers, academic medical centers, community hospitals, reference laboratories, military settings, and information technology. She was an early advocate for the use of ISBT 128 labeling to support the globally unique identification of medical products of human origin (MPHO).
Topic: Cryopreservation Process Parameters and the Importance of Post-Thaw Analysis
Presenter: Alireza Abazari, PhD, Associate Director of Process Development, Pluristyx, Inc.
Dr. Alireza Abazari is Associate Director of Process Development at Pluristyx, Inc., an advanced therapy tools company providing seamless client support to cell therapy groups through CMC consulting, contract development services, and research- and clinical-grade Ready-To-Differentiate® (RTD®) Pluripotent Stem Cells and their differentiated Progeny. Dr. Abazari previously served as Scientific Applications Director at BioLife Solutions, where he aided numerous commercial groups in the optimization of cryopreservation protocols for their cell therapy products. Prior to joining Pluristyx in 2021, Alireza was a Senior Scientist at Lyell Immunopharma in the Process Development Department, where he was responsible for setting up the process development lab with a particular focus on drug product formulation and cryopreservation. Dr. Abazari is an active member of numerous professional organizations, and was a taskforce member for the recent Cryopreservation Standards document published by the American National Standards Institute (ANSI) and the Parenteral Drug Association (PDA).
Topic: Cryogenic Packaging (R)Evolution 2022-2032
Presenter: Riu Li, Sr. Scientist, Cryobiology, West Pharmaceutical Services
Dr. Rui Li is a senior scientist at West Pharmaceutical Services. As their cryobiologist, Rui is driving innovation in cryogenic packaging solutions and leveraging containment and delivery technologies to improve the safety and quality of advanced therapies. Before joining West in 2021, Rui was advised by Professor Allison Hubel at the University of Minnesota, where she led the invention of a DMSO-free cryopreservation formulation for cell therapy and regenerative medicine applications and helped to found a cryogenic formulation product-service hybrid startup that later became Evia Bio.
Topic: Building a Scalable On-Demand HLA Cell Bank
Presenter: Erik Woods, Co-Founder, EVP & Chief Science Officer Ossium Health
Dr. Woods has devoted his career to advancing cell isolation, culture and cryopreservation to facilitate mainstream clinical use of cellular therapies. He is Chief Science Officer, EVP and Co-Founder of Ossium Health, a clinical-stage company developing the first cryopreserved bone marrow bank from deceased organ and tissue donors, and he holds Adjunct positions at the Indiana University School of Medicine and the Marian College of Osteopathic Medicine. Dr. Woods is a Fellow and Past President of the Society for Cryobiology and has published peer reviewed manuscripts and book chapters and holds multiple patents in the field.
Topic: Impact of Transient Warming
Presenter: Dr. Jason Acker, Professor, Laboratory Medicine and Pathology, University of Alberta
Dr. Jason Acker is the Senior Research Scientist with Canadian Blood Services and a Professor in the Department of Laboratory Medicine and Pathology at the University of Alberta, Edmonton, Canada. His cryobiology research program focuses on understanding the response of cells and tissues to ex vivo storage and the development of methods for their preservation and use as therapeutic products. His blood services laboratory has responsibility for developing scientific and technical evidence to support innovative changes in blood product manufacturing, storage and utilization. Dr. Acker is a Fellow and Past-President of the international Society for Cryobiology.
Topic: Cryo Standards Discussion
Presenter: Lexi Garcia, Director of Strategic Projects, Advanced Regenerative Manufacturing Institute (ARMI) | BioFabUSA
Lexi Garcia is the Director of Strategic Projects at the Advanced Regenerative Manufacturing Institute (ARMI) | BioFabUSA. As such she is responsible for coordinating and leading cross-functional teams to drive key project activities to help shape the long-term vision of the company. She leads ARMI | BioFabUSA’s strategic standards initiatives, which includes guiding both ARMI members and other tissue engineered medical product (TEMP) subject matter experts through the standards development process, particularly those related to bioprinting. Lexi has a wide TEMP network and works to facilitate connections between key stakeholders throughout the tissue engineering community to enable partnerships that will propel the field forward. With degrees in Neuroscience from Middlebury College, and Conservation Biology and Sustainable Development from the University of Maryland, College Park (UMD) she has a unique systems perspective and approach to nurturing the tissue engineering ecosystem to garner consensus and improve collaborative efforts.
Topic: Cryo Standards Discussion
Presenter: Dawn Henke, Ph.D. Senior Scientific Program Manager, Standards Coordinating Body
Dawn holds a PhD in Genetics and Genomic Sciences from University of Alabama at Birmingham. Currently Dawn is the senior scientific program manager at The Standards Coordinating Body. She is responsible for overseeing all standard development and technical efforts. Prior to joining SCB, she worked as a post-doctoral fellow at the National Institutes of Health in the National Eye Institute performing stem cell research developing retinal organoids for testing and therapeutic purposes from stem cells.
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