An Update on Cell Therapy News from AABB | JANUARY 2019
IN THIS ISSUE
Upcoming AABB eCasts in CT:
Registration for AABB eCasts is available for 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.
Cellular Therapies Certificate Program Provides CME Opportunity for CT Professionals
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 fill out a program evaluation form will receive a certificate of completion. The program also provides an opportunity to earn continuing education credits (CMEs).
Christina M. Celluzzi, PhD, MS
Kathy Loper, MHS, MT(ASCP)
Jessica Yozwiak, MS
AABB Center for Cellular Therapies
4550 Montgomery Avenue, Suite 700, North Tower, Bethesda, MD 20814 +1.301.907.6977
Deadline to Submit Education Proposals for 2019 AABB Annual Meeting Extended to Jan. 24
There is still time to help build an exciting educational session program for AABB’s premier event, the AABB 2019 Annual Meeting, to be held Oct. 19-22 in San Antonio. The deadline to submit a proposal has been extended to Jan. 24. AABB’s Annual Meeting Education Committee is looking forward to reviewing and selecting a wide range of education topics. Late or incomplete submissions will not be accepted. Do not delay. Make it possible. Submit a proposal today.
Exciting Changes for CT Subsections in the New Year
Membership in subsections provides a unique opportunity to make connections and new friends. The AABB Center for Cellular Therapies, in response to requests to optimize the CT subsection member experience, has re-aligned several of its topic-driven subsections to be more convenient and to enhance professional interactions. The re-alignment combines several current topics to reduce the number of subsection meetings — accommodating busy work schedules — so members do not have to miss discussions that they need and enjoy. There will be two new combined subsections. The Quality, Regulatory and Management subsection will combine the current Quality Operations; Regulatory Affairs; and CT Management subsections. The current Novel Therapies and CT Product Development; Product Manufacturing and Testing; and Product Collections and Clinical Practices subsections will become the CT Current and Emerging Topics subsection. The Cord Blood; Asia Pacific Group; and Spanish Language subsections will remain separate.
Current CT Section members will be automatically enrolled into the new subsection that includes their current subsections. New CT Section members will be able to enroll directly into the new subsections via the AABB member area. The CT Section will provide more details in the coming weeks. Changes are expected to take effect in February.
CT Subsection Asks Respondents to Complete its Survey on Environmental Monitoring for 361 Products
Environmental monitoring is essential to gather information about and assess the effectiveness of the environment in which products are manufactured and handled. To gauge current practices in environmental monitoring for 361 products, members of the AABB Quality Operations subsection have developed a brief survey, Environmental Monitoring for 361 Products. The subsection requests that one individual per facility complete the survey by Jan. 31 to provide an overview of these products across facilities.
AABB eCast Explores Therapeutic Potential of Perinatal Stem Cell Tissues and Cell Products
On Feb. 14, AABB and the Perinatal Stem Cell Society will proudly air Perinatal and Cord Tissue Products, an eCast designed to increase awareness of the therapeutic potential of perinatal stem cell tissue and products. Presented by Kyle Cetrulo, Co-Founder & CEO, Auxocell Laboratories, Inc., and Founder of the International Perinatal Stem Cell Society, Inc., this joint program will cover topics critical to understanding perinatal products. Participants should expect to learn about methods and ethical issues surrounding the sources of perinatal tissues and cells, various ways they are being manufactured, how they are being used in clinics and clinical trials and be able to describe a new sourcing and banking model. More information on this eCast, including pricing and how to earn continuing education credits, is available on the AABB registration site.
Full Agenda Promised at Perinatal Stem Cell Society Congress
The 5th Annual Perinatal Stem Cell Society Congress, to be held Feb. 28-March 1 in Salt Lake City, will begin with a networking event on Feb. 27, followed by two full days of lectures on a wide array of perinatal tissue and cell-based topics. The agenda includes topics such as the use of cord tissue to treat autism and the application of amnion for burns and other amnion-derived products by leading companies. Other sessions will cover regulatory issues that every 361 company should know about and understand, and cord tissue products and how to process the cord; as well as several exosome-related talks. Visit online registration.
Nominations for AABB Memorial Awards Due By Jan. 25
AABB is accepting nominations for the 2019 and 2020 AABB Memorial Awards through Friday, Jan. 25. The awards honor those who have made significant contributions to the fields of transfusion medicine and cellular therapies by recognizing achievements in administration, immunohematology, quality and innovative research, as well as overall outstanding service to these fields. Individuals can nominate candidates by completing and submitting the online nomination form. AABB will present the awards during the 2019 AABB Annual Meeting in San Antonio or during the 2020 AABB Annual Meeting in Baltimore.
BMT Tandem Meetings to be Held Under New Name in 2019
The Transplantation & Cellular Therapy Meetings of ASBMT and CIBMTR (TCT Meetings) are the combined annual meetings of the American Society for Blood and Marrow Transplantation (ASBMT) and the Center for International Blood & Marrow Transplant Research (CIBMTR). The 2019 TCT will be held in Houston on Feb. 20-24. Investigators, clinicians, laboratory technicians, clinical research professionals, nurses, pharmacists, administrators, and allied health professional attendees may benefit from a full scientific program that addresses the latest issues in hematopoietic cell transplantation and cellular therapy. Information and registration can be found on the TCT meeting website.
AABB Thanks All Who Contributed to Making Second World Cord Blood Day a Success
The value of cord blood was celebrated throughout 2018, culminating in a free, live virtual conference marking the second annual World Cord Blood Day (WCBD) on Nov. 15. WCBD, an initiative of Save the Cord Foundation, attracted international attention and drew more than 2,000 participants in 63 countries of whom an estimated 33% of attendees were members of the public and 66% were health professionals.
More than 100 organizations participated in a variety of events to celebrate the day, including presentations on topics ranging from the importance of CB logistics and processes to extending potential cord blood therapies to regenerative therapies for the brain including autism, cerebral palsy and stroke. AABB was an inspiring partner in this event and produced an eCast, Cord Blood - Where Are We 30 Years On? as part of the celebration. This complimentary recording is still available online. CellSource encourages readers to mark their 2019 calendars for WCBD on Nov. 15.
NBF Announces 2018 NBF Grant Recipients
Individuals interested in donating to support future early-career researchers can find a link on the NBF web page.
January Marks Debut of New Web-Based AABB Accreditation System
AABB introduced a new web-based accreditation system to streamline the accreditation process and eliminate a significant amount of paperwork. The new system, APEX, debuted on Jan. 1 for use by all AABB-accredited facilities, assessors and AABB's accreditation staff.
Previously, institutions seeking to renew AABB accreditation were required to complete paperwork every two years, and institutional information could only be updated at the time of accreditation renewal. Using APEX, institutions will be able to access and update their information at any time.
APEX includes several new features to expedite the accreditation process. Facilities may upload any documents not already on file to the system using the document repository feature. In addition, the system is programmed to automatically send alerts to institutions when a deadline is approaching, assessment documentation is missing, or tasks are overdue. APEX's self-assessment feature provides institutions with the ability to complete an optional interim self-assessment to prepare for upcoming assessments or conduct internal audits for quality assurance.
Following the launch of the new system, AABB assessments must now be submitted through the electronic process. Assessors will complete assessments through the assessor portal, which will send information back to the AABB office. Assessors can use the new system on any platform, including smart phones, tablets, laptop computers or personal computers. Assessors will also receive messages from AABB through the system, eliminating the need for emails and phone calls.
Individuals with questions about APEX may contact AABB's accreditation staff at email@example.com.
AABB Updates Circular of Information for the Use of Cellular Therapy Products
An updated version of the Circular of Information for the Use of Cellular Therapy Products was released in Oct. 2018. This version supersedes the July 2016 version. The Circular is intended to be an extension of the cellular therapy product label. It has been jointly prepared by the AABB Circular of Information Cellular Therapies Task Force. The Task Force includes a collaborative group of multiple nongovernmental organizations that represent the cellular therapies field. The Food and Drug Administration and the Health Resources and Service Administration also participated in the development and review process.The Circular and an “overview of changes” document are available on the AABB website.
FDA INTERACT Meeting Program Designed to Help Accelerate Development and Approval of Innovative Medical Products
Development of innovative investigational products can introduce unique challenges due to unknown safety profiles, complex manufacturing technologies and issues, incorporation of innovative devices, and the use of cutting-edge testing methodologies.
Several months ago, the Food and Drug Administration’s Center for Biologics Evaluation and Research (CBER) introduced a new meeting program, the Initial Targeted Engagement for Regulatory Advice on CBER products (INTERACT) program. The INTERACT program allows potential sponsors to engage with Agency staff and obtain advice on specific topics or issues critical to early product development.
Through an INTERACT meeting, sponsors can obtain initial, nonbinding advice from FDA regarding chemistry, manufacturing and controls; pharmacology/toxicology; and clinical aspects of the development program. This informal meeting can assist sponsors conducting early product characterization and preclinical proof-of-concept studies; initiate discussion for new delivery devices; inform sponsors about overall early-phase clinical trial design elements; and identify critical issues or deficiencies for sponsors to address in the development of innovative products. Prior to requesting an INTERACT meeting, a sponsor needs to have selected a specific investigational product or a product-derivation strategy to evaluate in a clinical study. Information on INTERACT can be found on the FDA website.
Human Skeletal Stem Cell Identified
Stem cell regulation and the hierarchical organization of human skeletal progenitors remain largely unexplored. Chan et al reported the isolation of a self-renewing and multipotent human skeletal stem cell (hSSC) that generates progenitors of bone, cartilage and stroma, but not fat. This short video abstract produced by CellPress describes human skeletal cells and “how to figure it out” where they came from.
T Cell-Transfer Therapy Illustrated
Immunotherapy uses the body’s immune system to fight cancer. This short video animation produced by the National Institutes of Health explains one type of immunotherapy, called T cell-transfer therapy, that is used to treat cancer.
New Research Could Fine-Tune the Gene Scissors CRISPR
The “gene scissors” CRISPR is a tool used for gene editing to correct gene errors; however, it may have side effects on the human genome. Researchers have learned how the molecular machinery behind CRISPR works and expect to be able to fine-tune CRISPR and remove the undesired effects. Stella, Mesa et al have described how one of the CRISPR technologies, the so-called Cas12a, works down to the molecular level making it possible to tweak the gene-editing process to achieve only the desired effects. They used cryo-electron microscopy to explore the cleavage reaction catalyzed by the CRISPR-Cas endonuclease Cas12a. This video produced by CellPress shows CRISPR-Cas in action- showing the conformation of Cas12a and its molecular movements upon encounter with target DNA.
Best Handwashing Techniques Explained
Keeping hands clean is one of the most important steps to avoid getting sick and spreading contaminants to others, especially during the flu season. The Centers for Disease Control and Prevention developed guidance for effective handwashing and use of hand sanitizer based on data from a number of studies. Visit the CDC webpage and read about the science behind the different handwashing recommendations used globally.
Cord Blood Connect Provides Recordings From International Congress
Cord Blood Connect has made complimentary on-line recordings of presentations at the 2018 Cord Blood Connect International Congress available to attendees and others who were unable to attend the congress. The presentations, which are the property of the Cord Blood Association, are posted for personal use of the website visitor.
AABB is honored to be a partner in Cord Blood Connect.
US FDA-Approved Cellular and Gene Therapy Products Listed
CBER regulates cellular therapy products, human gene therapy products and certain devices related to cell and gene therapy. The Center has authority to oversee these products and devices through both the Public Health Service Act and the Federal Food Drug and Cosmetic Act. Cellular therapy products include cellular immunotherapies, cancer vaccines and other types of both autologous and allogeneic cells for certain therapeutic indications, such as hematopoetic stem cells and adult and embryonic stem cells. Human gene therapy is the administration of genetic material to modify or manipulate the expression of a gene product or to alter the biological properties of living cells for therapeutic use. A list of cellular and gene therapy products approved by CBER can be found on the FDA website.
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 readers to explore information about the CT subsections and how they can get involved.
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