An Update on Cell Therapy News from AABB
IN THIS ISSUE
Cellular Therapies Certificate Program: CME Opportunity for CT Professionals
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 CME continuing education credits (CMEs).
Look for CT
eCasts coming in 2020!
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.
Christina M. Celluzzi, PhD
Kathy Loper, MHS, MT(ASCP)
AABB Center for Cellular Therapies
4550 Montgomery Avenue, Suite 700, North Tower, Bethesda, MD 20814, +1.301.907.6977
Education and Networking Opportunities Support CT Professionals at 2019 AABB Annual Meeting
A range of programs for cellular therapy (CT) professionals is included on the agenda of the 2019 AABB Annual Meeting to be held Oct. 19-22 in San Antonio. Education sessions will cover popular topics including CAR-T cells, emerging technologies in cell separation, role of blood centers in CT, gene editing, cord blood for spinal cord injury, and many more. New innovative research, “Natural Killer Cell Generation and Novel Applications,” will be presented at the CT Research and Progress (RAP).
Attendees will have ample opportunities to network, specifically at the roundtable session, Solve It! Scenarios in Cellular Therapies, which each year allows colleagues to collaborate to find solutions to challenges presented through “real-world” scenarios created by members of AABB’s CT subsections. Attendees are encouraged to visit the AABB meeting
website and to download the meeting
app for a complete listing of CT activities and not-to-be-missed opportunities.
AABB and Be The Match BioTherapies to Create Synergy in Joint Pre-Meeting Workshop
AABB and Be The Match BioTherapies have teamed together to present “Manufacturing Cellular Therapies: Challenges, Solutions and Creating Synergy for Success,” a workshop to be held on Oct. 18 just prior to the start of the 2019 AABB Annual Meeting in San Antonio. This interactive workshop will incorporate audience response technology and discussion groups to unpack real-world scenarios highlighting the challenges of implementing cellular therapies across various settings and business models. The goal is to explore the differing perspectives of hospitals, blood centers and small startup companies and compare both centralized and decentralized manufacturing models. The
program agenda and
registration information are available online.
Cord Blood Connect — A Hit With Visitors; Extra Surprises Provided at AABB Booth
AABB was proud to be a part of the
Cord Blood Connect Meeting in Miami held Sept. 13-15. The meeting focused on the future of cord blood and birthing tissue therapies and their potential and novel applications for transplantation and regenerative medicine. To help share the value and importance of cord blood, as well as support education in cellular therapies, AABB held a drawing at its booth; the prizes included one of several of its books and registration for AABB’s award-winning online
Cellular Therapies Certificate Program. Pictured left to right are drawing winners: Arun Prasath, Mike Halpenny, MLT(CMLTO), Jonas Wang, PhD (winner of the CT Certificate Program), Shaun Mansfield and Matthew Wilgo. AABB appreciates the support of the meeting hosts and the many visitors to the AABB booth and congratulates the winners.
Preparation for World Cord Blood Day Underway
The third Annual World Cord Blood Day (WCBD) will be celebrated on Nov. 15. AABB, as an inspiring partner, has been participating in activities involving cord blood, including productive discussions about experiences with cord blood on
Twitter and other social media platforms. AABB has long been a supporter of 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 promise. AABB encourages readers to watch in the coming months for a special offer to ring in WCBD. For information on global events, visit the WCBD site
www.worldcordbloodday.org and join the celebration.
AABB and ISCT Release Joint Publication on Human Platelet Lysate
AABB and the International Society for Cell and Gene Therapy (ISCT) formed a
joint working group (WG) in 2014 to collaborate on projects in the cellular therapy arena involving issues important to both organizations. Their first publication, “Gaps in the Knowledge of Human Platelet Lysate (hPL) Production as a Cell Culture Supplement for Cell Therapy,” is now available and, as its title suggests, provides an overview of the important issues in wide-scale use of this potentially important resource. Produced by the AABB-ISCT WG hPL project team, the article has been published jointly in both organizations’ respective journals and is available in
REGULATORY AND GOVERNMENT UPDATE
AABB Releases Proposed 1st Edition of Standards for Point-of-Care, Same-Day Adipose-Based Therapies
AABB is pleased to announce that the proposed 1st edition of Standards for Point-of-Care, Same-Day Adipose-Based Therapies is
available for public comment. The comment period ends on Nov. 19.
This first edition focuses solely on same-day services for the procurement of autologous non-cultured, non-cryopreserved cells — specifically stromal vascular fraction cells derived from adipose tissues. The facilities performing this procedure are primarily orthopedics clinics, plastic surgery centers and academic institutions. Although the standards are not based word-for-word on FDA policies and guidance, the Adipose-Based Therapies Working Group created them with these policies and guidance in mind, with the aim of steering practitioners toward methods and processes that dovetail with FDA expectations.
AABB encourages members of the public to review and submit comments on the proposed standards to the Adipose-Based Therapies Working Group. Individuals may submit comments using an
online form or
The Working Group requests that commenters first identify the standard on which they are submitting feedback by providing the standard number at the beginning of the comments. This identification is especially helpful when submitting comments on more than one standard. Additionally, the Working Group encourages commenters to provide alternative wording if they think it would improve the clarity of a standard, and if they agree or disagree strongly with a proposed standard, to share their reasoning.
US Senate Appropriations Committee Releases FY2020 Labor-HHS Funding Bill
The Senate Committee on Appropriations released the Fiscal Year 2020 Labor, Health and Human Services, Education and Related Agencies (Labor-HHS) Appropriations bill, which includes a 1% increase in funding for the Department of Health and Human Services over the 2019-enacted level. The
bill and its accompanying
report include several areas of interest to the cellular therapies communities.
The bill includes funding increases for the National Institutes of Health ($3 billion above FY 2019) and the Centers for Disease Control and Prevention ($180.5 million above FY 2019). Notably, the Committee recommended more than $3.69 billion in funding for the National, Heart, Lung, and Blood Institute (NHLBI) and specifically addressed the agency's efforts to treat or cure sickle cell disease (SCD). The Committee encouraged NHLBI to continue to prioritize the study of SCD and to implement robust investment to drastically spur, strengthen, accelerate and coordinate SCD research. The Committee also urged NHLBI to increase its focus on disease-modifying therapies that could improve day-to-day care for patients, to address issues such as organ damage and pain management, and to support translational research and implementation science to improve medical care from childhood through adulthood.
Under the Senate bill, the Biomedical Advanced Research Development Authority (BARDA) would receive $561 million in funding. The bill would increase funding of the C.W. Bill Young Cell Transplant Program and for the National Cord Blood Inventory (NCBI). Both programs are part of the Health Resources and Services Administration (HRSA), which the Committee applauded for its efforts to diversify the adult volunteer donor registry and for increasing the number of units collected and maintained under NCBI. The Committee also encouraged HRSA to continue to improve the availability, efficiency and safety of transplants and improve outcomes for all blood stem cell transplant recipients.
Special Issue: Supplement to
Transfusion Contains Abstract Presentations from the 2019 AABB Annual Meeting
The 2019 AABB Annual Meeting abstracts, oral abstracts presentation schedule, abstract selection committee and acknowledgement of abstract reviewers have been compiled in a
special supplement to
Structuring Logistic Processes in Preparation for Outsourcing Cellular Therapy Manufacturing
There is heightened interest in the standardization and automation of manufacturing processes in preparation for commercialization of cell and gene therapies (CGT). Based on their institutional experience,
Chen et al. summarize logistical challenges encountered in the handling and distribution of CGT products in early phase studies, specifically those involving contract manufacturing organizations (outsourced) manufacturing. The authors also make recommendations to standardize processes unique to the CGT supply chain, emphasizing the need to maintain needle-to-needle traceability from product collection to infusion. These guidelines are meant to inform the development of more complex supply-chain models for larger-scale cell and gene therapeutics.
Forks in Road Led to Great Discovery
Carl June, as an immunotherapy pioneer, created the first "living drug" that treats cancer. With an understanding of the immune system’s processes, June and his team used genetic engineering to build a synthetic immune system that could detect and kill cancer cells. The CAR T cells he invented divide and multiply in the body to destroy cancer cells. As a “living drug,” a CAR T infusion has the ability to stay “on patrol” in the body for decades. Watch
June's TEDMED 2018 Talk to uncover the research behind this discovery — as well as the “forks in the road” that led to the momentous medical progress in widespread trials today.
EVENTS, OPPORTUNITIES, RESOURCES
Applications for NBF Grants Being Accepted
NBF encourages innovation through early-career scientific research grants and strategic research and education grants. Both grant programs supplement AABB’s mission to further develop transfusion medicine, cellular therapies and regenerative medicine science.
Applications for 2020 grants will be accepted until
Is There Standard Consent?
The International Society for Stem Cell Research (ISSCR) recently released a professional
standard of informed consent for stem cell-based interventions performed outside of formal clinical trials, such as the unapproved and unproven “treatments” offered by clinicians at direct-to-consumer clinics. The standard is meant to help ensure that patients are informed about the potential benefits and risks of stem cell-based medical interventions and was developed with input from clinicians, ethicists, researchers and regulators from around the world.
Discover What Is Getting Funded with NIH Matchmaker
Knowing what projects are getting funded can help one compete for grants. NIH Matchmaker lives within the larger NIH RePorter site. The Matchmaker service reviews text about your science and posts the most similar other projects. These abstracts can yield insight into the kinds of aims reviewers find attractive and which study section and institute most commonly fund your kind of science. View the
Cellular Immunotherapy Data Resource Launched as Part of Cancer Moonshot
The (U.S.) National Cancer Institute awarded the Center for International Blood & Marrow Transplant Research (CIBMTR) a grant to operate the
Cellular Immunotherapy Data Resource (CIDR) as a part of the Cancer Moonshot to accelerate cancer research, under the Immuno-Oncology Translational Network (IOTN). The Cancer Moonshot helps scientists in different organizations nationwide to join and quickly develop new immune therapies to prevent or cure cancer.
CIBMTR operates the Cellular Therapy Registry, which collects data on cellular immunotherapies for cancer including baseline characteristics of patients, pre- and post-infusion data, infusion details, disease response, and outcomes. The data are analyzed and may be used to plan pre-clinical studies and clinical trials.
Parallel to the CIBMTR’s data infrastructure for hematopoietic cell transplantation, used mostly to treat blood cancers, the CIDR gathers data on cellular therapies for all cancers, including solid tumors. New cellular therapies, such as CAR-T cells, bring chances to help people with cancer. The CIDR collects data about the long-term safety and efficacy of these therapies. The CIDR will give unprecedented access to this data to a diverse group of clinicians, researchers, manufacturers, payers, regulators and the public.
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
The Latest on CT Subsection Activities
The AABB Center for Cellular Therapies encourages members to
enroll in subsections to enrich their professional experience. An assortment of materials presented on the monthly calls can be found on the
CCT projects’ website.
CT-CET: The CT-CET subsection welcomed several speakers, including Rouzbeh R. Taghizadeh, PhD who presented “Perinatal Mesenchymal/Stromal Cell (MSC) Banking Technologies from Umbilical Cord Tissue” and Sandhya Panch, MD, MPH presenting “Importance of Logistics in Cell Processing.”
QRM: The QRM subsection discussed regulatory challenges, current guidances and issues related to managing a cell therapy facility. A recent session focused on a U.S. Centers for Medicare and Medicaid Services (CMS)
decision memo on CAR T reimbursement and coverage issues.
Asia Pacific Group (APG): The APG continued its multi-national lineup of guest speakers, welcoming Joseph Gold, PhD, who presented “GMP Production of Pluripotent Stem Cell-Derived Therapeutics: The Good, The Bad & The Ugly.” J. Wade Atkins, DTM,CC, NIH, presents, “Not All HCT/Ps Are Created Equal: Regulation of Cell and Gene Therapy Products,” during the October session. Residents of the Asia Pacific region who are interested in being a part of AABB may find information on AABB
subsection enrollment online.
Spanish Language Subsection (SLS): The SLS subsection is conducted entirely in Spanish. Presentations can be found on the
4550 Montgomery Avenue, Suite 700, North Tower, Bethesda, MD 20814