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Yossi Schwartz, MD, MPH
Senior Member
Department of Pathology/Hematopathology and Laboratory Medicine
Moffitt Cancer Center
Tampa, Florida, USA

Wanxing Cui, PhD
Director, Cell Therapy Manufacturing Facility
MedStar Georgetown University Hospital
Washington, DC, USA

Members of the ISCT Laboratory Practices Committee and many other ISCT members share close ties with the Association for the Advancement of Blood & Biotherapies (AABB). The AABB Annual Meeting took place in Nashville, Tennesee, shortly following the North America Regional Meeting in Houston, Texas (where AABB will be in 2024). Dr. Yossi Schwartz and Dr. Wanxing Cui summarized the main takeaways from the sessions they organized and attended. Overall, the AABB 2023 Annual Meeting presented a comprehensive array of topics, underscoring the dynamic shifts in transfusion medicine and cellular therapies.

• Cellular and Gene Therapies: Many sessions explored the complexities of hematopoietic stem cell gene therapies, focusing on the optimization of apheresis collections and post-thaw viability testing. The discussions also touched upon U.S. coverage and reimbursement policies, emphasizing the pivotal role of clinical centers in pioneering cell and gene therapy manufacturing. The introduction of innovative biotherapies, such as exosomes and cytokines, signified a promising direction in the domain.
• Diversity, Equity, and Inclusion (DEI): The conference highlighted the criticality of DEI in healthcare. Sessions were tailored to elucidate leadership's responsibility in nurturing a DEI-centric environment, confronting implicit biases in the workforce, and offering tools to counteract unconscious biases.
• Regulatory and Standards: Regulatory-focused sessions shed light on the FDA licensure process, inspection outcomes, and the application of real-world data and evidence. Moreover, attendees engaged in direct dialogues with representatives from the FDA and CMS/CLIA during interactive segments.
• Quality and Process Improvement: The conference accentuated the significance of quality, introducing a toolkit aligned with AABB Standard 5.0 and emphasizing the role of audits in enhancing processes.
• Biotherapies and Blood Products: This section spotlighted recent breakthroughs in biotherapies, with a special emphasis on abstracts and dialogues concerning apheresis techniques for managing solid organ transplant rejections.
• Workforce and Leadership Development: The event highlighted the essence of nurturing talent in cell processing laboratories and provided valuable insights into cultivating leadership acumen among lab professionals.
• Miscellaneous: Other sessions of note encompassed data science methodologies in transfusion medicine, cellular therapy scenarios, and evidence-based rationales for refusing therapeutic apheresis requests.

Key Sessions:

• FDA & CMS Discussion: This sought-after session featured FDA representatives elucidating regulatory guidelines and sharing pivotal insights.
• Solve It! Scenarios in Cellular Therapy (Live): This collaborative session revolved around cell therapy. Discussions spanned various scenarios, queries, and considerations related to deviation management, accurate reporting, and product release protocols.
• Leadership in Labs: This in-depth session aimed to foster leadership capabilities among laboratory professionals and garnered significant interest.
• Starting Material Symposium: This session facilitated a robust conversation with pharmaceutical industry stakeholders about the management of starting materials. It also included insights from FDA officials. A primary concern voiced was the rigorous auditing of evidence collection sites by pharmaceutical entities, juxtaposed with a lack of equivalent transparency.
• Post-thaw Viability Analysis: A session led by an attendee focused on the "Standardization of the Post-thaw Viability Testing Technique for Cryopreserved Humanoid Progenitor Cells."
• Enhancing Workforce Capabilities: This session curated discussions around skill augmentation and retention within cell processing laboratory settings.
• CABP Credentialing Initiative: To date, over 120 individuals have secured the CABP certification, with 94 currently holding the credential and 29 receiving the honorary CABP(H) distinction. Illustrating its international influence, certified professionals hail from over 10 countries. A concerted effort is in progress to promote the global acceptance of this credential, underscoring its pertinence in the sector.