Cellular Therapies Section Subsections – AABB

Posted: February 8, 2019 at 4:45 pm

Groups called subsections allow members of the CT Section to focus on specific topic areas. Subsections work to identify challenges and develop materials to meet the needs of the field. Section participation is open to all AABB individual members who may enroll in any subsection(s) they choose.

CT Spanish LanguageCord BloodCT Asia Pacific GroupCT ManagementCT Product Collection and Clinical PracticesCT Product Manufacturing and TestingCT Quality OperationsCT Regulatory AffairsNovel Therapies and CT Product Development

This group is for Spanish-speaking members or those members located in Spanish-speaking regions. Members will be able to join live discussions and participate with fellow SLS members in regular subsection meetings held at 'convenient' times for the zones encompassed in the Latin America region. The SLS will address CT issues related to cord blood; donor qualification; manufacturing; storage and transport challenges; quality operations; regulatory issues; and development. The group will also address specific regional issues for developing programs. All interested individual AABB members who speak Spanish and would like to share their CT interests, insights and expertise in may join. (Meets 3rd Wednesdays at 10:00am ETmonthly)

La Subseccin en Espaol (SLS) ofrece a todos sus miembros la oportunidad de conocer e interconectarse con otros profesionales hispanohablantes. Los miembros pueden formar parte de discusiones estimulantes con otros colegas de la subseccin durante las reuniones regulares. Los convenientes horarios de estas reuniones han sido establecidos para acomodar a miembros localizados en Latinoamrica. El SLS abarcar temas de Terapia Celular (CT) relacionados con cordn umbilical; requisitos para donacin de productos celulares; retos en la manufactura, almacenamiento y transporte de productos de terapia celular; operaciones de calidad y temas especficos para el desarrollo de otros programas regionales. Todos los miembros hispanohablantes de AABB que deseen compartir sus intereses, visiones y experiencias pueden ser parte de esta subseccin. (Se rene el tercer mircoles de cada mes a las 10:00 am ET)

This group works on topics such as donor issues for public banking (recruitment, consent, screening/testing), manufacturing, storage and transport challenges, licensure, international issues, and private and family banking issues. (Meets 1st Thursdays at 1:00pm ET monthly)

For members located in the Asia-Pacific region, a designated group called the Asia Pacific Group or APG is available. Members will be able to join live discussions and directly participate with fellow APG members in regular subsection meetings held at 'convenient' times for the zones encompassed in this region. Countries in the region include Australia, China, Guam, Hong Kong, India, Indonesia, Japan, Malaysia, New Zealand, Philippines, Qatar, Singapore, South Korea, Sri Lanka, Taiwan, Thailand and Vietnam.

CT issues related to cord blood, donor qualification, manufacturing, storage and transport challenges, as well as quality operations, regulatory, development and specific regional issues will be addressed. The APG meeting time is tailored to those in the Asia-Pacific; however, all interested individual AABB members who would like to share their CT interests, insights and expertise may join. (Meets 2nd Wednesdays, monthly at 0400 UTC coordinated universal time)

This group works on topics such as reimbursement issues (Centers for Medicare/Medicaid (CMS), Food and Drug Administration (FDA)), funding sources for cell therapy development and clinical trials - federal and other public sources, venture capital, charitable donations (disease advocacy groups), as well as the administrative business (e.g. budgets, human resources , workload recording, cost accounting, job descriptions, staffing models, personnel management/project management, strategic planning, Lean/process engineering tools, expense reduction initiatives and cost containment) of cell therapy production. (Meets 2nd Tuesdays at 12:00pm ET bimonthly)

This group focuses primarily on clinical topics associated with the collection, transport, utilization and outcomes of cellular therapy products obtained from peripheral blood by apheresis, bone marrow, cord blood and other sources by the use of new technologies. Clinical topics include donor and recipient screening, eligibility, mobilization and collection, informed consent, product administration and infusion-related adverse events. (Meets 2nd Mondays at 1:00pm ET monthly)

This group works on technical topics and operational aspects related to the manufacturing and testing of CT products such as cryopreservation, cell separation and selection, automation, product characterization, assay development, validation and implementation. (Meets 3rd Thursdays at 11:00am ET monthly)

This group works on topics such as Quality Program design, risk assessment and risk management, vendor and supply qualification, facility, environmental and operational controls. (Meets 3rd Thursdays at 2:00pm ET monthly)

This group works on US and international topics involving regulations, guidance and policies from a variety of sources. Examples include FDA, Health Canada, European Medicine Evaluation Agency (EMEA), Office for Human Research Protections (OHRP), NIH, Regulatory Affairs Certification (RAC), and Health Resources and Services Agency (HRSA). (Meets3rd Tuesdays at 11:00am ET monthly)

This group works on topics such as 'new' research and preclinical studies, new devices for manipulating cells as well as later-stage cellular product development, validation, and technology transfer for clinical production. Examples include developments in the areas of induced pluripotent cells (iPS cells), tissue-derived cells, genetic engineering, structural materials, and biomaterials to name a few. (Meets 2nd Thursdays at 12:00pm ET monthly)

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Cellular Therapies Section Subsections - AABB

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