The Cellular Therapies Section has established subsections to allow members of the section to focus on particular areas of interest. All subsections will work on meeting the section charges, which involve developing educational programs, responding to questions posted on the Community CT Group, and developing products and services to meet the needs of the field. The work will be accomplished primarily through conference calls and e-mail communication, managed by a subsection leader and assistant leader. Section participation is open to all AABB individual members, who may enroll in multiple subsections. Click on a link below to read more about each Cellular Therapies Section Subsection.
Cord Blood
CT Management
CT Product Collection and Clinical Practices
CT Product Manufacturing and Testing
CT Quality Operations
CT Regulatory Affairs
Novel Therapies and CT Product Development
Cord Blood
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, Leader: Salem Akel/Associate Leader: Gwen Epstein)
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CT Management
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, Leader: Kevin Bundy/Associate Leader: Suzanne W. Dworsky)
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CT Product Collection and Clinical Practices
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, Leaders: Michele Sugrue and Michael Linenberger
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CT Product Manufacturing and Testing
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 2nd Mondays at 2:00pm ET monthly, Leader: M. Victor Lemas/Associate Leader: Mary McLeod)
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CT Quality Operations
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, Leader: Diane Kadidlo/Associate Leader: Kathy Fortune)
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CT Regulatory Affairs
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). (Meets 3rd Tuesdays at 11:00am ET monthly, Leader: Fran Rabe/Associate Leader: Joseph (Yossi) Schwartz)
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Novel Therapies and CT Product Development
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, Leader: Pampee Young/Associate Leader: Magali Fontaine)
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