The ASTCT Clinical Education Conference, in Orlando, Florida, from October 13-15, will include educational tracks on the foundations of bone marrow transplantation (BMT), adult care, and pediatric care. There will also be exhibitors and product demonstrations.
The event is open to APPs, nurses, trainees, and fellows, and offers 16.5 hours of ACCME and ANCC continuing education. These hours can also be applied to FACT requirements for continuing education.
Join ASTCT (ASTCT members save 50 USD on registration)
SITC created a series of webinars on immune effector cell (IEC)-related adverse events to further educate clinical providers on how to respond to these events. The recordings are now available on demand and include:
- SITC Clinical Practice Guideline Webinar – Immune Effector Cell-related Adverse Events (available on demand)
- SITC Clinical Practice Guideline Webinar – Practical Management Pearls for Immune Effector Cell-related Adverse Events (available on demand)
- SITC Clinical Practice Guideline Webinar – Case Studies in Immune Effector Cell-related Adverse Events: October 13, 2021, 5:30 PM – 6:30 PM ET (open for registration)
In late 2020, SITC announced the publication of The Society for Immunotherapy of Cancer (SITC) clinical practice guideline on immune effector cell-related adverse events in the Journal for ImmunoTherapy of Cancer (JITC). FACT was pleased to be a part of this effort, represented by Dr. Elizabeth Shpall, current member of FACT’s Immune Effector Cell Task Force and FACT’s first Board president when it was founded 25 years ago. The guideline addresses risk assessment, identification, and management for clinically significant side effects.
The International Society for Cellular Therapy (ISCT) announced the availability of the online Educational Program on Advanced Therapy Manufacturing, offered in partnership with the Andalusian Network for the Design & Translation of Advanced Therapies (And&tAT). The program is offered to ISCT members free of charge.
The program provides six self-serve online courses on the fundamentals of regulations on Advanced Therapy Medicinal Products (ATMPs), specifically for cell therapy, gene therapy, and tissue engineering. Course topics include:
- Cell and Gene Therapy Manufacturing Methods.
- Quality Assurance.
- Product Development Pathways.
- GMP Compliance.
- Investigational Medicinal Product Dossier (IMPD) Writing.
The Worldwide Network for Blood and Marrow Transplantation (WBMT) and the American Society for Transplantation and Cellular Therapy (ASTCT) invite you to join the webinar: “Allogeneic Stem Cell Transplantation for Non-malignant Disorders: a Global Perspective”, which will take place on November 24, 2021, from 13:00 to 14:30 CET.
This webinar will summarize the current knowledge and best practices for allogeneic stem cell transplantation (HCT) in patients with non-malignant disorders (NMD). Find the full program here and register via this link.
The United States Food and Drug Administration (FDA) is hosting its annual conference, Regulatory Education for Industry (REdI), virtually next week from July 19-23. Register for this free conference to learn directly from senior leadership at FDA. Continuing education credits for several professional organizations are available, and this conference can also be used toward GxP training now required by the eighth edition FACT-JACIE Hematopoietic Cellular Therapy Standards.
For the first time, this conference will have tracks for three medical products: drugs, devices, and biologics. The biologics track will focus on different aspects of product development of advanced therapies regulated by the Center for Biologics Evaluation and Research (CBER). Topics include regulation of tissue products under 21 CFR part 1271; development and regulation of cellular, gene, and plasma-derived therapies, and expedited programs for advanced therapies.
Register for the FACT-JACIE and WBMT Webinar: Quality and Accreditation for Cellular Therapy: A Global Perspective
ASTCT Fundamentals of HCT Training Course Takes Place This Weekend – Registration is Still Open! Course Can be Applied Toward FACT Requirements for Continuing Education
FACT encourages you to take advantage of the ASTCT Fundamentals of HCT Training Course. Hosted by one of our parent organizations, this course can be applied toward FACT requirements for continuing education.
The Fundamentals of HCT Training Course is a two-day conference that will be taking place virtually on Saturday, April 24 – Sunday, April 25. This course provides a broad overview and introduction of hematopoietic cell transplantation (HCT), also referred to as blood and marrow transplantation (BMT), as well as cellular immunotherapy (CI). Throughout the lectures, participants will be introduced to numerous aspects of the HCT-CI processes, which are designed to develop or enhance skills required in the management of patients undergoing these procedures. This course incorporates case-based learning to emphasize application of concepts taught through didactic lecture with a strong focus on the pharmacotherapeutic management. Additional details, guidance, and review of clinical materials can also be found in the supplemental electronic handbook. The target audience for this course includes new practitioners, residents, fellows, pharmacists, and nurses or those training in this discipline.
Registration to the virtual conference includes access to the newly revised Fundamentals of HCT eBook. The Fundamentals of HCT eBook provides up-to-date clinical information and covers the entire transplant process from pre-transplant consultation to post-transplant care. This is a great resource!
Registration will close at 4PM CT on Friday, April 23.
The second edition of the FACT-SBTMO Accreditation Workshop for transplant centers in Brazil occurred during an online event on October 27, 2020. The pre-conference event took place prior to the SBTMO 2020 Congress and was simulcast in both Portuguese and English. The virtual platform enabled program personnel throughout Brazil to participate in the workshop. Interactive sessions provided an overview of FACT Cellular Therapy Standards, emphasized the importance of a quality management program including document control and validation, and addressed areas that are challenging for new centers. Members from Hospital Israelita Albert Einstein, the first FACT-accredited program in Brazil, shared their experience in organizing and preparing for a successful inspection and accreditation process. Nearly 40 transplant centers in Brazil have expressed their interest and commitment to improving quality and safety through the FACT-SBTMO accreditation program.
FACT-SBTMO workshop presenters enjoy interacting with workshop participants. Pictured from top to bottom are Andrea Kondo, Carlos Bachier, Carlos Ramos, Phyllis Warkentin, and Daniel Kota.
The Effect of the COVID-19 Pandemic on Cord Blood Banking
Monday, June 22, 2020, at 9:00 am ET, 13:00 GMT
Presenters will discuss how cord blood banks have been managing through the COVID-19 pandemic:
Heidi Elmoazzen, PhD
Canadian Blood Services’ Cord Blood Bank & Stem Cell Manufacturing
Dr. Elmoazzen will discuss the impact of the COVID-19 Pandemic on stem cell transplantation in Canada including Canadian Blood Services’ Cord Blood Bank Stem Cell Registry and Public Cord Blood Bank.
Roger Horton, PhD
Anthony Nolan Cord Blood Bank, United Kingdom
Dr. Horton will summarize the demand for UK cords between Jan-May 2019 and 2020, and compare both years to give an idea on the impact of the pandemic on operations. He will provide detail on collections, processing, storage, distribution, product protection, and staffing to demonstrate how Anthony Nolan has adapted or mitigated each issue. Where possible Dr. Horton will compare Anthony Nolan practices with other European partners.
Arvin Faundo, MD
Cordlife Group Limited, Singapore
Dr. Faundo will discuss how the coronavirus pandemic is affecting the operations of the Cordlife Group Limited bank and identify the pandemic-related problems that are specific to private or family cord blood banks.
Donna Regan MT(ASCP), SBB
Donna will present statistics before and through the pandemic (CB orders, shipments, transplants) and the promotion of services that supported this activity. She will also highlight the unique steps taken by the registry to support unrelated transplant, not least of which is leveraging the cord blood story to cryopreserve all unrelated products prior to patient conditioning.
Lydia Foeken, LN
WMDA, Executive Director
CAR T cell therapy is considered one of the most promising new treatments for patients battling relapsed and refractory leukemia, lymphoma and other forms of cancer. The assessment and grading of CRS and ICANS have varied considerably across clinical trials, academic studies, and commercial products, which has made it difficult to compare the safety and measure toxicity across all of these settings. This also has hindered the ability of researchers to develop the best strategies to manage these toxicities. Join Drs. Stephan Grupp and Sattva Neelapu on October 2, 2019, at 2:30 pm CT, for an ASTCT webinar discussing the new definitions and grading for CRS and neurotoxicity that more accurately categorize the severity of these toxicities.
The World Marrow Donor Association (WMDA) and Foundation for the Accreditation of Cellular Therapy (FACT) are teaming up to host the second annual pre-conference WMDA-NetCord & FACT Cord Blood Day. The workshop incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp, and FACT Inspector Training.
We encourage banks to send multiple personnel to attend the various tracks and enlist a member to become a FACT inspector. Registration fees are waived for FACT inspectors and trainees. Apply to become a FACT inspector!
Join leading cord blood experts from around the world for a day of education and hands-on breakout sessions. Register by August 31st and save $135!
Members of the Sociedade Brasileira de Transplante de Medula Óssea (SBTMO) are invited to attend the FACT-SBTMO Cell Therapy Accreditation Workshop on Wednesday, July 31, 2019 during the XXIII Congresso da SBTMO in Brasília.
The blood and marrow transplantation field has been a leader in voluntarily improving quality through FACT accreditation. This workshop will address important topics in the cellular therapy field including the requirements of the FACT-SBTMO joint cell therapy accreditation program in Brazil. FACT and SBTMO representatives will be in attendance to:
• Provide an overview of the FACT International Standards for Hematopoietic Cellular Therapy Product Collection, Processing, and Administration and accreditation process
• Explain how to integrate quality management into clinical, collection, and cell processing programs
• Examine how to prepare for a successful inspection
• Summarize how controlling documentation can improve your program
• Share the experience of an accredited Brazilian transplant center
• Review commonly cited Standards
• Outline the inspector orientation process
• Answer questions
Date: July 31, 2019
Time: 8:00 to 13:15
Location: Hotel Royal Tulip Brasília Alvorada
SHTN Trecho 1 Blocos C Conj. 1 – Asa Norte
Brasília -DF 70800-200
WMDA-NetCord & FACT Cord Blood Day – September 12, 2019 at the Cord Blood Connect International Congress
The World Marrow Donor Association (WMDA) and FACT are teaming up to host the pre-conference WMDA-Netcord & FACT Cord Blood Day, a workshop that incorporates sessions on trends in cord blood banking and harmonization of banking procedures, a Quality Boot Camp, and FACT Inspector Training. FACT accreditation serves as an important mechanism to maintain across-the-board uniform processes that are effective and assist with ensuring efficient bank operations.
Topics will include:
- Global perspectives of the regulation of cord blood banking,
- WMDA serious adverse events and reactions,
- Analysis of CD34+ and CD45+ cells in thawed cord blood samples,
- Analysis of cellular viability in thawed cord blood,
- Significant changes to the NetCord-FACT Seventh Edition Cord Blood Standards, and
- Essential Quality Management Principles
The afternoon offers two tracks:
- WMDA-FACT Quality Boot Camp: Sessions will examine cord blood unit selection strategies and core quality management concepts including risk assessment, validation, and auditing. Come prepared with your quality-related questions to ask the quality experts facilitating the session.
- FACT Inspector Training: This track provides training to new FACT cord blood inspectors on performing an inspection from start to finish. Sessions are accompanied by exercises and group discussions to practically apply lecture concepts to real-world experiences. Attendees training to be an inspector may attend the entire Cord Blood Day FREE in addition to free access to all other on-demand and in-person FACT educational events. Inspector trainees are required to attend the FACT Inspector Training track.
This is an excellent opportunity to network with the cord blood community and learn from experts in cord blood banking. We encourage banks to send multiple personnel to be able to attend both the Quality Boot Camp and nominate a member of your team to train to become a FACT inspector! Register before August 31st to receive the special advanced rate!
The fourth annual FACT-ASBMT Quality Boot Camp, held in conjunction with the TCT | Transplantation and Cellular Therapy Meetings of ASBMT and CIBMTR, will be held on February 20, 2019. Join the FACT Quality Management Committee and the ASBMT Administrative Directors SIG Quality group, and learn from your quality colleagues. This year’s boot camp includes sessions on:
- Developing a Dashboard: Program Status at a Glance
- Performing a Risk Assessment in the Clinical Setting
- Embracing Standardization to Create a Cohesive and Efficient System of Documentation
- Vendor Qualification
- Preparing for Immune Effector Cellular Therapy Accreditation
- BMT After – Hours Call
A short self-assessment will be distributed in preparation for the boot camp to assess your needs and identify ongoing challenges.
WMDA-NetCord & FACT Events at the Inaugural Cord Blood Connect International Congress Were a Success
The WMDA and FACT hosted a Cord Blood Day at the 2018 Cord Blood Connect International Congress in Miami, Florida on September 14. Over 50 members of the cord blood community from fourteen different countries attended. The day included topics such as global perspectives of cord blood transplants, ethical dilemmas in cord blood banking, common FACT-NetCord accreditation citations, and an overview of the WMDA cord blood bank survey. Breakout sessions in the afternoon included a FACT inspector training track and a WMDA-NetCord & FACT cord blood quality boot camp track.
The WMDA and FACT were honored to have Dr. Eliane Gluckman in attendance at the WMDA-NetCord & FACT Cord Blood Day. She performed the first successful human umbilical cord blood transplant and, with colleague Hal Broxmeyer, PhD, successfully showed that unrelated cord blood could be used as a source of hematopoietic stem cells. Dr. Gluckman received the first Cord Blood Association (CBA) Lifetime Achievement Award, celebrating the 30th anniversary of that event.
In addition to the WMDA-NetCord & FACT Cord Blood Day, FACT welcomed visitors to its exhibit booth and hosted the first Regenerative Medicine InterCHANGE, during which several societies working to advance regenerative medicine discussed their initiatives and current challenges in the regenerative medicine field.
All events were successful and FACT looks forward to the next Cord Blood Connect International Congress September 13-15, 2019, in Miami Beach!
By Heather Conway, FACT Quality Manager
To assess compliance with FACT standard B9, the FACT-CIBMTR Data Audit Committee reviews each program’s most recent CIBMTR data audit results including implementation, adequacy, and effectiveness of the corrective action plan (CAP). The committee’s goal is to provide education and assistance to cellular therapy programs throughout the accreditation cycle to achieve quality improvement in data management. At the time of accreditation renewal, the FACT Accreditation Committee assesses the completeness and accuracy of a program’s data management based on the clinical inspector’s report and the report of the FACT-CIBMTR Data Audit Committee.
Since its inception, the committee has provided extensive guidance and assistance to programs regarding data management, audit, and quality improvement principles. Using this experience, the committee created a Data Management resources area to assist programs. Programs are encouraged to review this information, which contains CIBMTR resources, FACT educational resources, guidelines for data management submissions, templates, and examples.
The FACT-CIBMTR collaborative data audit process was formed to reduce duplicative efforts, enhance quality improvement efforts, and provide support to accredited transplant programs. The program intensifies support and improvement of data management and reporting processes, and these new resources support these efforts. In addition to the website, view previous newsletter articles about the program:
The American Society for Apheresis (ASFA), in collaboration with the American Society for Clinical Pathology (ASCP), now offers a new credential in apheresis medicine.
The Qualification in Apheresis (QIA) is offered through ASCP and follows the Hemapheresis Practitioner (HP) and Apheresis Technician (AT) certifications. QIA certification expands credentialing for apheresis medicine professionals. There are specific eligibility routes that must be satisfied, including an eligibility route for international professionals.
The 50-question exam covers six areas: Basic Science; Clinical Applications; Donor/Patient Care; Instrumentation; Operational Considerations; and Standards, Guidelines, and Regulations. The qualification is valid for three years, and requalification requires participation in continuing education.
For more information on eligibility routes and available resources, visit the Qualification in Apheresis (QIA) page on the ASFA website.