2022 Annual Meeting On-Demand: Cellular Therapy/Biotherapies Sessions

Interested in all sessions Cellular Therapy/Biotherapies? Then this is the package for you. We have also thrown in a couple of additional sessions you might also find interesting.

The package includes 10 sessions which provide the opportunity to earn up to 5.75 continuing education credits for physicians or 10 California Nurse contact hours, general credit, California Lab Personnel or Florida Lab Personnel contact hours.

Purchase of this package includes the on-demand recording and a downloadable MP3 audio file for each session. Some handouts may be available, but they are a screenshot of the recording and therefore may contain duplicate slides.

If purchasing these sessions separately it would cost $225/$270 (member/nonmember).

Access is available through December 31, 2024 so purchase this package today.

• Faculty – Disclosures for all faculty are displayed to the learners at the beginning of each presentation.
• Annual Meeting Planners
• Content and Accreditation Reviewers
• All identified conflicts of interest have been mitigated.

Preview Available

AM22-08-O: (On-Demand) Plenary Abstract Session (Enduring)

Expiration Date: Dec 31, 2024

Oral abstract session on Plenary Abstracts.

Moderator(s):

• Melissa M. Cushing, MD, New York-Presbyterian Hospital-Weill Cornell Medicine

Speaker(s):

• John Pitman, Scientific and Medical Affairs, Cerus Corporation
• Rachael Jackman, PhD, Vitalant Research Institute
• Adèle Couvidou, EFS GRAND EST
• Jerry Leung, Biochemistry and Molecular Biology, The University of British Columbia
• Scott Koepsell, MD PhD, University of Nebraska Medical Center
• Ping Chun Wu, MSc, Division of Hematology and Transfusion Medicine, Department of Laboratory Medicine, Lund University

Preview Available

AM22-09-O: (On-Demand) Managing the Apheresis Center: How Do We Produce Enough Products for the Ever-Increasing Demand? (Enduring)

Expiration Date: Dec 31, 2024

Novel biotherapies are often driven by industrial innovations but require clinical and academic medical collaborations. In the evolving fields of biotherapies and transfusion medicine, there is an ever-increasing demand for high quality products as raw materials for further manufacturing. An important challenge for apheresis centers is management of distinct industrial protocol details, including heterogenous operational parameters that may not always conform to routine clinical practices. Factors such adequate staffing, budget, equipment, space and shipping and delivering logistics pose formidable challenges to blood centers and hospitals and threaten the ability of these organizations to meet demand. This session will discuss real experiences from professionals in the field and will propose creative approaches in overcoming those challenges, including the business agreements as well as the regulatory framework involving these type of products. We will engage the audience to map out the goals of their own apheresis production pipelines by applying principles of process improvement that identify and then leverage their operational constraints, with concrete examples. The speakers will also share practical tips regarding the establishment of business agreements that include negotiations between the sponsor(s) and the institution.

All relevant financial relationships have been mitigated.

Speaker(s):

• Patricia A. Brunker, MD DPhil, Massachusetts General Hospital
• Federico Rodriguez Quezada, SBB, MLS(ASCP), UF Health Shands Cancer Hospital

Disclosures

• Nothing to Disclose
• Safi Biosystems: Advisory Board, Consultant

Preview Available

AM22-13-O: (On-Demand) Effects of Transfusion on Bone Marrow Health and Transplant Outcomes in Sickle Cell Disease (Enduring)

Expiration Date: Dec 31, 2024

Bone marrow pathology in SCD, such as decreased mesenchymal stem cell function and disordered vasculature, has recently been described in pre-clinical models and has been shown to be responsive to red cell transfusion. A speaker will review her and others’ research in this area and its implications for peri-transplant transfusion support. Another speaker will discuss the association of HLA and red cell alloantibodies with important allogeneic transplant outcomes in SCD such as graft versus host disease, donor T cell chimerism, and even overall survival. Both speakers will speak to the implication of these findings for best practice transfusion support for SCD patients pre- and peri-transplant.

All relevant financial relationships have been mitigated.

Speaker(s):

• Patricia A. Shi, MD, New York Blood Center
• Robert Nickel, MD, Children's National Hospital

Panelist(s):

• Dr. Avital Mendelson, PhD, Assistant Member, New York Blood Center

Disclosures

• Global Blood Therapeutics: Grant/Research Support (Secondary Investigators need not disclose)
• Nothing to Disclose
• Nothing to disclose

Preview Available

AM22-17-O: (On-Demand) Oral Abstract Session- Genetic Testing and Product Quality (Enduring)

Expiration Date: Dec 31, 2024

This is an oral abstract session about Genetic Testing and Product Quality.

Speaker(s):

• Kaoru Takasaki, MD, Children's Hospital of Philadelphia
• Aline Floch, Univ Paris Est Creteil, INSERM U955 Equipe 2 « Transfusion et maladies du globule rouge », IMRB
• Eldad Hod, MD, Columbia University Irving Medical Center
• Wenjing Cao, M.D., Ph.D, Department of Pathology and Laboratory Medicine, University of Kansas Medical Center

Moderator(s):

• Sunitha Vege, MS, New York Blood Center
• Dr. Elizabeth P. Crowe, MD, PhD, New York-Presbyterian Hospital-Weill Cornell Medicine

Disclosures

Preview Available

AM22-20-O: (On-Demand) Oral Abstract Session- Components (Enduring)

Expiration Date: Dec 31, 2024

This is an oral abstract session about Components.

Moderator(s):

• Robert DeSimone, MD, Weill Cornell Medicine

Speaker(s):

• Ute Gravemann, German Red Cross Blood Service
• Brooke Bartow, MD, University of Alabama at Birmingham Department of Pathology
• Vy Vu, University of Texas Health Science Center San Antonio

Preview Available

AM22-42-O: (On-Demand) Ask the FDA and CMS/CLIA (Enduring)

Expiration Date: Dec 31, 2024

This annual event provides an opportunity for FDA and CMS/CLIA representatives to respond to member questions and present the agency's current thinking on policies, regulations, guidance documents and inspection programs that are relevant to the oversight of blood and HCT/P programs. Questions for the session are submitted in advance to regulatory@aabb.org.

All relevant financial relationships have been mitigated.

Moderator(s):

• Arnold McKinnon, AABB

Moderator & Speaker(s):

• Karen Palmer, MT(ASCP) CQA(ASQ), AABB

Speaker(s):

• Dr. Carlos Villa, MD PhD, Center for Biologics Evaluation and Research (CBER), Food and Drug Administration
• Catherine McGraw, FDA

Disclosures

• Nothing to Disclose
• Nothing to Disclose

Preview Available

AM22-45-O: (On-Demand) Cellular Therapy Service Quality System Considerations from a Standards Development and Application Perspective (Enduring)

Expiration Date: Dec 31, 2024

Quality systems provide a critical framework in which cellular therapy services optimize quality in daily operations. The Association for the Advancement of Blood and Biotherapies (AABB) has established standards for quality systems, adherence to which helps ensure compliance with regulations. AABB Standards for Cellular Therapy Services must consider national and international regulations, variations among institutional practices, and advances in the field when developing new and updating existing standards. Application of standards pertinent to quality systems must be updated with each iteration. Since every quality system’s ongoing application of standards to their program is unique, inspections allow for evaluation of how quality systems are implemented, maintained and updated in cellular therapy services.
This session, supported by the Quality, Regulatory and Management Topics (QRM) subsection of the Cellular Therapies Section Coordinating Committee (CTSCC), will highlight the importance of quality system considerations from the perspective of standards during development and application by inspections.

Moderator(s):

• Dr. Suzanne Thibodeaux, MD, PhD, Hospital of the University of Pennsylvania

Speaker(s):

• Wade Atkins, MS, MT(ASCP)SBB, CQA, ASQ, Dept. of Transfusion Medicine
• Kate Brown, PhD, Generate Life Sciences, a CooperSurgical company

Disclosures

• Nothing to Disclose
• Nothing to Disclose
• CooperSurgical Inc.: Full-time/Part-time Employee

Preview Available

AM22-48-O: (On-Demand) Cryopreservation of Cellular Therapy Products for Allogeneic Stem Cell Transplantation During COVID-19 Pandemic and Beyond (Enduring)

Expiration Date: Dec 31, 2024

The COVID-19 pandemic has affected the practice of allogeneic hematopoietic stem cell transplantation (AHSCT) at multiple levels including stem cell collection and processing. Prior to the COVID-19 crisis, cryopreservation of allogeneic grafts accounted for less than 2% of the total AHSCT. In the past two years, almost all allogeneic grafts were cryopreserved due to COVID-19 risks and restrictions. Although several groups have reported on the cryopreservation of allogeneic products before the pandemic, the number of studies evaluating the impact of cryopreservation on graft quality and transplant outcome is limited.

A systematic review of the data accumulated during the past two years will be presented including the impact of cryopreservation on the viability, safety, and potency of the Cell Therapy products as well as the clinical outcome. In addition, cryopreserving allogeneic grafts beyond the pandemic will be discussed in the context of a typical laboratory setup. That is, strategies for process improvement are warranted to evaluate product quality (i.e., cell enumeration, immunophenotyping) and to maximize efficiency, safety, and resource utilization.

All relevant financial relationships have been mitigated.

Moderator(s):

• Joseph Schwartz, MD, MPH, Mount Sinai Health System

Speaker(s):

• Dr. Camelia Iancu-Rubin, PhD, Icahn School of Medicine at Mount Sinai
• Dr. Ronit Slotky, PhD, Hackensack University Medical Center

Disclosures

• Nothing to Disclose
• Nothing to Disclose
• Nothing to Disclose

Preview Available

AM22-51-O: (On-Demand) Global Regulatory Pathways for Biotherapies – Spotlight on New Regulations in Gulf Cooperation Council and Latin American Countries and the European Union (Enduring)

Expiration Date: Dec 31, 2024

Biotherapies and regenerative medicine trials are being explored for diseases in which there are no, or limited alternative treatment options. The Asia Pacific, Gulf Cooperation Council (GCC), and Latin American Countries (LATAM) are hubs for new emerging technologies and are growing at a compound annual growth rate above 65 % despite the pandemic. The biotherapy sector consisting of cell and gene therapies, and regenerative medicine markets in these regions are now outpacing the rest of the world.

In 2020, the largest proportion of trials in the region (58.1%) took place in China. The Middle East saw a 94% increase in the number of oncology trials and Israel saw the largest overall number of trials, at 62.5%. South and Central America saw a 58% increase in the number of trials, followed by Brazil, Argentina and Chile, at 41.1%, 23.3% and 12.3%, respectively. Critical factors for the shift are the ease of subject enrollment, diversity of subjects, and lower cost of conducing clinical trials.

The biggest challenges for this process are; what are the applicable regulations , how should the regulatory framework be incorporated, and on how can they be applied for clinical trials? There is clearly a need for creating awareness of these challenges and for training the multilingual, multinational teams to manage the Quality Management Systems in real time to optimize clinical outcomes.
This session will provide updates to regulations and guidance for biotherapies such as HCT/P (Human Cell therapy/Products), cord blood, adipose cell therapies and other products in Asia Pacific, GCC and LATAM countries.

The session will provide examples and case studies in order to implement these new regulations and guidelines and will provide knowledge to understand the similarities and differences about the regulatory framework. Tools (e.g. websites) to manage and operate the on-site and off-site Quality Management systems for clinical trials will be presented.

All relevant financial relationships have been mitigated.

Moderator(s):

• Thomas Spitzer, MD, Massachusetts General Hospital

Speaker(s):

• Asawari Bapat, DPB, PGDHHM, CABP, Infohealth FZE and Questar Enterprises
• Federico Rodriguez Quezada, SBB, MLS(ASCP), UF Health Shands Cancer Hospital

Disclosures

• Infohealth, FZE/ Questar Enterprises/MEMP, London, UK/Regenerative Outcomes, LLC.: Consultant Infohealth, FZE/ Questar Enterprises/MEMP, London, UK/Regenerative Outcomes, LLC.: Full-time/Part-time Employee
• Nothing to Disclose
• Ossium Health: Consultant Bluebird Bio: DSMB Qihan Biotech: Scientific Advisory Board Syneos Health: DSMB, Adjudication Committees

Preview Available

AM22-61-O: (On-Demand) New Frontiers for Unmanipulated Cord Blood as Well as Its Derivatives (Enduring)

Expiration Date: Dec 31, 2024

The advent of haploidentical transplants has led to a decline in cord blood (CB) transplants, especially considering the cost of double-cord transplants. Cord blood expansion techniques, while promising, are likely to be expensive. In this session, a speaker will describe the advantages of combined haplo-unmanipulated CB transplants, including the recent cure of both HIV and myeloid malignancy with this method, and adoptive immunotherapy with unmanipulated CB following chemotherapy for refractory myeloid malignancy. Another speaker will describe the utility of pluripotent stem cells derived from CB in comparison to other starting material sources. They will also review the clinical success with CB-derived immune effector cells such as NK cells and T-regulatory cells.

All relevant financial relationships have been mitigated.

Speaker(s):

• Larry Luchsinger, PhD, New York Blood Center
• Koen van Besien, MD, PhD, Weill Cornell

Moderator(s):

• Patricia A. Shi, MD, New York Blood Center

Disclosures

• Nothing to Disclose
• Hemogenyx, Intellia, Glycostem, Gamida Biosciences, CTI: Consultant Pfizer: Speaker's Bureau ADC Therapeutics, Autolus, Intellia: member DSMB Miltenyi Biotec, Precision Biosciencs, Orca Biotherapeutics, BMS, Caibr: Grant/Research Support
• Global Blood Therapeutics: Grant/Research Support