An Update on Cell Therapy News from AABB | OCTOBER 2020
IN THIS ISSUE
The Cellular Therapies Certificate Program: Providing An Educational Overview
The AABB Cellular Therapies Certificate Program, produced in partnership with the George Washington University, is a self-paced, online program designed for professionals interested in expanding their knowledge of CT. The program features 12 narrated modules covering scientific, operational and regulatory topics. Students who work through the modules, complete each assessment with a score of 80% or higher and complete a program evaluation form will receive a certificate of completion. The program also provides an opportunity to earn up to 37 continuing education credits (CMEs).
Registration for AABB eCasts is available for both individuals and groups, and institutions can host eCasts for employees at one or more sites. Participants in group eCasts are eligible to earn continuing education credit. On-demand recordings of eCast sessions are available for those unable to attend a live eCast.
Upcoming CT eCasts:
Christina M. Celluzzi, PhD, MS
AABB Center for Cellular Therapies
4550 Montgomery Avenue, Suite 700, North Tower, Bethesda, MD 20814, +1.301.907.6977
AABB's Annual Meeting Will Feature More Than 35 Cellular Therapies Sessions
This year, the AABB 2020 Virtual Annual Meeting, to be held Oct. 3-5, will have more cellular therapy content than ever before. Attendees can find a biotherapies-specific virtual networking room and biotherapies-focused industry partners showcasing their latest offerings in the virtual exhibit hall. More information on the content is in the Annual Meeting program. The biotherapies content is presented in collaboration with Be The Match BioTherapies. Hot topic education sessions include “Cellular Therapies for SARS-CoV2” and “The Role of the ‘Super Donor’ in Allogeneic Cell Therapy.” An AABB/TERMIS joint session will cover engineered microphysiological systems, often referred to as “organ on a chip.”
AABB encourages individuals to register for the AABB 2020 Virtual Annual Meeting soon to gain early access to AABB’s state-of-the-art virtual meeting platform. Those who register early will be able to complete their online profile, familiarize themselves with the meeting platform and set up their schedule prior to the meeting’s official start on Oct. 3. While the meeting is virtual, this year’s program will still provide practice-changing information on the field’s hottest topics, the latest scientific research and professional development opportunities that attendees expect from the AABB Annual Meeting. Participants will have the opportunity to earn more than 80 CME/CE credits this year — the most in the history of AABB’s Annual Meeting — and will be able to access the digital platform for a full month after the meeting ends. After that, attendees will be able to access education sessions through the AABB Education Platform.
AABB created a digital swag toolkit — which includes Zoom backgrounds, Facebook frames, Instagram stickers and other social media graphics — to help attendees participate in the meeting in style. AABB encourages attendees to follow along with the meeting and participate online using the hashtag #AABB20. AABB will continue to publish updates until and throughout the meeting on the AABB Blog. More information on the meeting and registration can be found on the AABB meeting website.
Supplement to TRANSFUSION Contains Abstract Presentations from the AABB 2020 Virtual Annual Meeting
The AABB 2020 Annual Meeting abstracts, oral abstracts presentation schedule, abstract selection committee, abstract reviewers and plenary and late-breaking abstract sessions have been compiled in a special supplement to TRANSFUSION.
NBF’s Virtual Walk Offers Fun and Other Benefits
Hundreds of AABB members throughout the world and others in the blood community will be walking together — virtually or separately — on their own time for the National Blood Foundation’s Run For Research. Participants can complete their 5K run or 1-mile walk any time during the AABB Annual Meeting, on the trail, on the treadmill, at the gym or on the track. This virtual event provides the opportunity to exercise safely while also socially interacting with the AABB community (online) and to look fashionable doing so in an event T-shirt, included with each registration. AABB and the NBF encourage you to show your race pride in stride and post your photos and videos. Share your #teamblood stories using the #AABB20 hashtag on Twitter and Instagram for a chance to win and to be featured on AABB’s social media. Follow AABB on Facebook, Twitter, LinkedIn and Instagram for event updates. Registration will be held through Oct. 5. Details on registration and other important information can be found on the NBF Run For Research website.
Applications for NBF Grants Being Accepted Through December 1
ISBT 128 Draft Standard, Labeling Collection Products for Cellular Therapy Manufacturing, Available for Public Comment
The Standards Coordinating Body (SCB) developed an apheresis center survey related to this standard. SCB requests interested individuals to complete the brief survey designed to assess apheresis centers’ capabilities and whether they could be early adopters of this standard.
World Cord Blood Day 2020: November Virtual Conference Designed For Celebration
World Cord Blood Day (WCBD) will be celebrated on Nov. 17. AABB, as an inspiring partner, participates in activities involving cord blood, including discussions on Twitter and other social media platforms. AABB has long supported the promise of cord blood, as demonstrated in its cord blood subsection — which was established in 2009 and continues to facilitate discussions on challenges, protocols and research findings that help to promote the value of cord blood and highlight its immunotherapeutic potential. AABB encourages readers to watch for a special offer to ring in WCBD. WCBD 2020 will feature a complimentary two-part online virtual conference: 1) LIVE STREAM: A 1-hour live streaming event on Facebook (10 a.m. ET on Nov. 17) and 2) ON-DEMAND Presentations: A spotlight on cord blood experts, transplant doctors and cord blood recipients with in-depth presentations and discussions including a Q&A session with WCBD inspiring partners on the impact of COVID-19 on cord blood. More information on the virtual conference as well as global events can be found on the WCBD site www.worldcordbloodday.org.
AABB Promotes Careers in CT to College Students From Historically Black Colleges and Universities
AABB recently participated in The National Institute of Innovation in Manufacturing Biopharmaceutical’s (NIIMBL) Virtual eXperience to promote careers in cellular therapies (CT) to students from historically Black colleges and universities (HBCUs), as well as at NIIMBL member institutions that have been traditionally underrepresented in the biopharmaceutical industry. The program, which took place July 21-Aug. 13, linked students at HBCUs who are interested in pursuing a career in biopharma with professionals working in the field from 12 organizations, including AABB. AABB members Suzanne Dworsky, MBA, MT(ASCP), and Celina Montemayor-Garcia, MD, PhD, along with AABB staff Susan Leppke, MPH, public policy advisor, and Christina M. Celluzzi, PhD, MS, senior manager of CT, discussed how their career paths led them to professions in CT. The students, who were rising sophomores and juniors, questioned the presenters about careers in CT and shared their own educational interests. AABB is grateful to have had this opportunity to encourage diversity and inclusion, values the Association strongly supports, and to welcome potential members of the next generation to the CT workforce.
REGULATORY AND GOVERNMENT UPDATE
FDA Accepting Comments on Adverse Event Reporting System
The Food and Drug Administration announced an opportunity for public comment on the proposed extension of the collection of information requirements related to FDA’s Adverse Event Reporting System (FAERS) for licensed biological products and general records associated with the manufacture and distribution of biological products. The primary purpose of FAERS is to identify potentially serious safety problems with biological products. Comments close Nov. 2. Submission information is available in the Federal Register notice.
FDA Issues Temporary Guidance on Resuming Drug, Biologics Manufacturing
FDA issued a new temporary guidance to help drug and biological product manufacturers during the COVID-19 public health emergency plan and prioritize current good manufacturing practice (CGMP) activities as they transition to normal manufacturing operations. The guidance explains how to evaluate and prioritize the remediation of CGMP activities that were necessarily delayed, reduced or modified during the public health emergency. The guidance will remain in effect only for the duration of the COVID-19 pandemic.
Studies Suggest Human MSCs May Have Application For COVID-19 Treatment
Mesenchymal Stromal Cells (MSCs) are potent immune regulators that secrete immunomodulatory factors and interact with a variety of immune cell types. Previous studies have reported safety and applicability of MSCs to ameliorate pulmonary inflammation in acute respiratory distress syndrome (ARDS). For this reason, their potential for treating COVID-19 is being studied in multiple clinical trials. Though SARS-inducing corona viruses have been reported to infect stem/progenitor cells, it is unclear whether MSCs can be infected by SARS-CoV-2 upon transplantation to COVID-19 patients. Schäfer et al, in a journal pre-proof appearing in Stem Cell Reports, found that MSCs from bone marrow, amniotic fluid and adipose tissue carry angiotensin-converting enzyme 2 (ACE2) and transmembrane protease serine subtype 2 at low levels on the cell surface under steady state and inflammatory conditions. The research team did not observe SARS-CoV-2 infection or replication in MSC at steady state, under inflammatory conditions or in direct contact with SARS-CoV-2 infected Caco-2 cells (epithelial cell used for functional assessment of cell entry and receptor usage for SARS-CoV-2). Resistance of MSCs to SARS-CoV-2 infection and retention of their immunomodulatory activity lends support to the potential use of MSCs for COVID-19 treatment.
Progress and Challenges of Mesenchymal Stromal Cells and Exosomes
MSCs have been used as a cellular therapy for a number of human diseases. Part of MSCs’ mechanism of action is the production of extracellular vesicles (EVs) containing proteins, nucleic acids and lipids that transmit signals to recipient cells that change their biologic behavior. In a review article, Forsberg et al briefly summarize the development of MSCs to treat human diseases, as well as the current understanding of exosomes, how they exert their effects on target cells and how they are differentiated from other EVs. Treatments — including for acute radiation syndrome (ARS), radiation exposure, graft versus-host disease and cardiovascular disease/stroke — are discussed.
Researchers Assess Discarded Plasma From Cord Blood Volume Reduction as Alternative to Fetal Calf Serum In Mesenchymal Stromal Cell Cultures
Utilization of fetal calf serum (FCS) carries potential health risk and raises economic and ethical issues. Researchers are exploring other potential sources that provide benefit for various types of cell culture, including MSCs. Umbilical cord blood volume reduction, required for banking, provides clinical-grade umbilical cord blood plasma (UCBP), which is usually discarded as a waste. Vlaski-Lafarge et al tested whether serum derived from UCBP could replace FCS for the amplification of MSCs. Utilizing cytometric bead array and enzyme-linked immunosorbent assay techniques, the researchers compared cytokine content of MSCs and mesenchymal progenitors grown in the presence of serum derived from UCBP to a variety of other sources of clinical-grade human serum in parallel cultures. Findings show that cultures supplemented with UCBP were comparable to those cultured with FCS, suggesting that discarded human cord blood plasma from volume reduction may be an easily obtainable and greatly available, xeno-free source of serum that could be a highly efficient replacement for FCS in sustaining MSC growth.
EVENTS, OPPORTUNITIES, RESOURCES
NEW AABB Introduces ‘Bringing Flow Cytometry to Life: Applications in Cellular Therapies’
AABB’s newest online course, “Bringing Flow Cytometry to Life: Applications in Cellular Therapies,” introduces students to flow cytometry and how it is applied to characterize many of the cells used in cellular therapies today. The course provides interactive examples to simulate real-word experience — bringing flow cytometry to life. The course is divided into three sections, each of which highlights important aspects of flow cytometry practice. The first section covers foundational concepts in flow cytometry, the second addresses cellular therapy applications using flow cytometry in the laboratory and the third section reviews these concepts. A continuing education credit certificate will be provided upon review of all sections of the course and completion of the course evaluation. Visit the course website for more details.
AABB Releases 2020 Billing Guide as Complimentary Benefit
AABB is pleased to release the AABB Billing Guide for Blood Products and Related Services as a complimentary benefit in the AABB Marketplace. The billing guide is an indispensable tool that provides up-to-date information on coding, Medicare billing and reimbursement relating to blood products. The guide’s seven major sections contain critical details on the rules and exceptions that apply in both inpatient and outpatient settings. Nine appendices address specific situations, such as nonhospital settings, molecular testing, physician services, and handling rejected or denied claims. This revision is made possible through the efforts of the AABB Coding and Reimbursement Committee and the support of the Commonwealth Transfusion Foundation.
Members of the AABB Center for Cellular Therapies' subsections meet regularly via teleconference to participate in interactive activities, including developing tools and reference materials, as well as discuss CT topics. For more information visit www.aabbcct.org.
The Latest on CT Subsection Activities
The AABB Center for Cellular Therapies encourages members to enroll in subsections to enrich their professional experience and stay in the loop of CT happenings. Selected materials presented on monthly calls can be found on the CCT projects’ website. Some of the recent highlights include:
Asia Pacific Group: APG welcomed Colleen W. Gilstad, MD, who presented “Rapid Implementation of a COVID Convalescent Plasma Program in a Hospital Without a Blood Donor Center.”
CT-CET: This group discussed topics including a clinical scenario on second day HPC-A collections for NMDP donors and held a journal club meeting on storage, utilization and disposal of hematopoietic stem cell products in patients with multiple myeloma.
SLS: This group welcomed Indira Guleria, PhD, who spoke on stem cell tourism.
The subsections will take a break in October to enjoy and soak in all that is the AABB 2020 Virtual Annual Meeting. Regular subsection calls will resume in November.
Copyright 2020 AABB. All rights reserved.
4550 Montgomery Avenue, Suite 700, North Tower, Bethesda, MD 20814 | +1.301.907.6977 | aabb.org